Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT01374269
Status:
COMPLETED
Last Update Posted:
2014-04-29
First Post:
2011-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Improvement in Pain,Function and HRQoL ( Health Related Quality of Life) in Subacute Low Back Pain: A Controlled Clinical Trial of Exercise vs NSAIDs (Nonsteroidal Antiinflammatory)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}, {'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D000894', 'term': 'Anti-Inflammatory Agents, Non-Steroidal'}, {'id': 'D009288', 'term': 'Naproxen'}, {'id': 'D000068579', 'term': 'Celecoxib'}, {'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D018712', 'term': 'Analgesics, Non-Narcotic'}, {'id': 'D000700', 'term': 'Analgesics'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000893', 'term': 'Anti-Inflammatory Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D018501', 'term': 'Antirheumatic Agents'}, {'id': 'D009280', 'term': 'Naphthaleneacetic Acids'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fabios@une.net.co', 'phone': '5742196475', 'title': 'Dr. Fabio Salinas Duran', 'organization': 'Grupo Rehabilitacion en Salud'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': "The study population was associated with the university's health service. Female subjects predominated. The 6-month follow-up prevents conclusions about the improvement duration. No subgroup classification was performed. No control group was planned."}}, 'adverseEventsModule': {'timeFrame': 'Adverse effects were recorded that occurred during the 6-month study', 'eventGroups': [{'id': 'EG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.', 'otherNumAtRisk': 46, 'otherNumAffected': 0, 'seriousNumAtRisk': 46, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.', 'otherNumAtRisk': 44, 'otherNumAffected': 14, 'seriousNumAtRisk': 44, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Epigastric pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Not serious'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Not serious'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Not serious'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Visual Analogue Scale of Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.3', 'spread': '19.8', 'groupId': 'OG000'}, {'value': '45.2', 'spread': '22.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the beginning', 'description': 'In the Visual Analogue Sacale the best result is 0 and the worst is 100, The primary outcome was pain the mesurement of the Visual Analog Scale (VAS) (0 \\[no pain\\] to 100 \\[maximum pain\\]) at the beginning.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Oswestry Disability Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.9', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '29.4', 'spread': '15.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the beginning', 'description': 'Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Oswestry Disability Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.9', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '26.6', 'spread': '18.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Oswestry Disability Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.6', 'spread': '13.2', 'groupId': 'OG000'}, {'value': '19.4', 'spread': '13.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.'}, {'type': 'SECONDARY', 'title': 'Oswestry Disability Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.8', 'spread': '12.2', 'groupId': 'OG000'}, {'value': '17.2', 'spread': '14.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.'}, {'type': 'SECONDARY', 'title': 'Roland-Morris Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '5.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the beginning', 'description': "Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. Being worst 24.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Roland-Morris Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '4.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': "Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. Being worst 24.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Roland-Morris Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': "Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. Being worst 24.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.'}, {'type': 'SECONDARY', 'title': 'Roland-Morris Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': "Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. Being worst 24.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.'}, {'type': 'SECONDARY', 'title': 'Quality of Life, Change in Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.6', 'spread': '13.5', 'groupId': 'OG000'}, {'value': '54.5', 'spread': '16.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the beginning', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Visual Analogue Scale of Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.8', 'spread': '20.5', 'groupId': 'OG000'}, {'value': '34.9', 'spread': '25.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'In the VAS the best result is 0 and the worst is 100. The primary outcome was pain improvement of ≥25 mm on the Visual Analog Scale (VAS) (0 \\[no pain\\] to 100 \\[maximum pain\\]) at 4 weeks.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Visual Analogue Scale of Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.0', 'spread': '24.4', 'groupId': 'OG000'}, {'value': '20.6', 'spread': '17.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'In the VAS the best result is 0 and the worst is 100. The primary outcome was pain improvement of ≥25 mm on the Visual Analog Scale (VAS) (0 \\[no pain\\] to 100 \\[maximum pain\\]) at 12 weeks.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.'}, {'type': 'PRIMARY', 'title': 'Visual Analogue Scale of Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.8', 'spread': '21.8', 'groupId': 'OG000'}, {'value': '17.5', 'spread': '18.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'The best result is 0 and the worst is 100, Pain relief more than 25 mm on the Visual Analogue Scale, assessed 24 weeks after intervention.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.'}, {'type': 'SECONDARY', 'title': 'Quality of Life, Change in Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.4', 'spread': '18.1', 'groupId': 'OG000'}, {'value': '61.3', 'spread': '21.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life, Change in Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.3', 'spread': '21.0', 'groupId': 'OG000'}, {'value': '67.0', 'spread': '20.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.'}, {'type': 'SECONDARY', 'title': 'Quality of Life, Change in Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '78.0', 'spread': '18.0', 'groupId': 'OG000'}, {'value': '70.7', 'spread': '18.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.'}, {'type': 'SECONDARY', 'title': 'Quality of Life, Bodily Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.5', 'spread': '13.4', 'groupId': 'OG000'}, {'value': '39.2', 'spread': '13.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the beginning', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life, Bodily Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.8', 'spread': '18.7', 'groupId': 'OG000'}, {'value': '54.0', 'spread': '19.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life, Bodily Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.6', 'spread': '21.7', 'groupId': 'OG000'}, {'value': '58.7', 'spread': '16.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.'}, {'type': 'SECONDARY', 'title': 'Quality of Life, Bodily Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.1', 'spread': '22.4', 'groupId': 'OG000'}, {'value': '68', 'spread': '20.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.'}, {'type': 'SECONDARY', 'title': 'Quality of Life, Emotional Performance.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.2', 'spread': '36.6', 'groupId': 'OG000'}, {'value': '63.4', 'spread': '38.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the beginning', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life, Emotional Performance.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '82.5', 'spread': '32.8', 'groupId': 'OG000'}, {'value': '84.7', 'spread': '29.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life, Emotional Performance.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '91.2', 'spread': '24.5', 'groupId': 'OG000'}, {'value': '82.4', 'spread': '33.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.'}, {'type': 'SECONDARY', 'title': 'Quality of Life, Emotional Performance.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.1', 'spread': '21.2', 'groupId': 'OG000'}, {'value': '93.9', 'spread': '20.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.'}, {'type': 'SECONDARY', 'title': 'Quality of Life, Physical Performance.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.5', 'spread': '34.0', 'groupId': 'OG000'}, {'value': '36.0', 'spread': '40.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the beginning', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life, Physical Performance.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '58.1', 'spread': '39.4', 'groupId': 'OG000'}, {'value': '55.1', 'spread': '42.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life, Physical Performance.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '77.3', 'spread': '33', 'groupId': 'OG000'}, {'value': '72.5', 'spread': '40.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.'}, {'type': 'SECONDARY', 'title': 'Quality of Life, Physical Performance.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.3', 'spread': '33.3', 'groupId': 'OG000'}, {'value': '85.2', 'spread': '30.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.'}, {'type': 'SECONDARY', 'title': 'Quality of Life, Physical Function.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '64.6', 'spread': '21.6', 'groupId': 'OG000'}, {'value': '66.5', 'spread': '17.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the beginning', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life, Physical Function.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.8', 'spread': '17.5', 'groupId': 'OG000'}, {'value': '70.3', 'spread': '23.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life, Physical Function.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.6', 'spread': '16', 'groupId': 'OG000'}, {'value': '77.2', 'spread': '82.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.'}, {'type': 'SECONDARY', 'title': 'Quality of Life, Physical Function.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.1', 'spread': '16.9', 'groupId': 'OG000'}, {'value': '82.6', 'spread': '16.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.'}, {'type': 'SECONDARY', 'title': 'Quality of Life, Social Function.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '71.3', 'spread': '23.5', 'groupId': 'OG000'}, {'value': '65.9', 'spread': '24.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the beginning', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life, Social Function.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '80.7', 'spread': '19.9', 'groupId': 'OG000'}, {'value': '74.8', 'spread': '24.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life, Social Function.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.3', 'spread': '17.2', 'groupId': 'OG000'}, {'value': '80.4', 'spread': '18.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.'}, {'type': 'SECONDARY', 'title': 'Quality of Life, Social Function.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.6', 'spread': '17.4', 'groupId': 'OG000'}, {'value': '86', 'spread': '15.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.'}, {'type': 'SECONDARY', 'title': 'Quality of Life, General Health Perceptions.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '64.3', 'spread': '19.1', 'groupId': 'OG000'}, {'value': '64.7', 'spread': '18.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the beginning', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life, General Health Perceptions.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.3', 'spread': '18.5', 'groupId': 'OG000'}, {'value': '67.1', 'spread': '20.01', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life, General Health Perceptions.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.0', 'spread': '19.9', 'groupId': 'OG000'}, {'value': '69.2', 'spread': '16.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.'}, {'type': 'SECONDARY', 'title': 'Quality of Life, General Health Perceptions.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.4', 'spread': '17.6', 'groupId': 'OG000'}, {'value': '69.3', 'spread': '15.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.'}, {'type': 'SECONDARY', 'title': 'Quality of Life, Mental Health.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.4', 'spread': '20.6', 'groupId': 'OG000'}, {'value': '67.0', 'spread': '19.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the beginning', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life, Mental Health.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '71.4', 'spread': '18.9', 'groupId': 'OG000'}, {'value': '74.6', 'spread': '20.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life, Mental Health.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '76.4', 'spread': '16.4', 'groupId': 'OG000'}, {'value': '75.6', 'spread': '16.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.'}, {'type': 'SECONDARY', 'title': 'Quality of Life, Mental Health.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '78.5', 'spread': '16.1', 'groupId': 'OG000'}, {'value': '76.9', 'spread': '16.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.'}, {'type': 'SECONDARY', 'title': 'Quality of Life, Vitality.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '55.5', 'spread': '17.9', 'groupId': 'OG000'}, {'value': '55.3', 'spread': '17.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the beginning', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life, Vitality.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.3', 'spread': '18.5', 'groupId': 'OG000'}, {'value': '64.0', 'spread': '20.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life, Vitality.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.5', 'spread': '17.7', 'groupId': 'OG000'}, {'value': '66.6', 'spread': '15.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.'}, {'type': 'SECONDARY', 'title': 'Quality of Life, Vitality.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.3', 'spread': '17.0', 'groupId': 'OG000'}, {'value': '62.8', 'spread': '14.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.'}, {'type': 'SECONDARY', 'title': 'PHQ-9 Patient Health Questionnaire (PHQ-9) Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '3.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'PHQ-9 Patient Health Questionnaire (PHQ-9) Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '3.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At the beginning', 'description': 'Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'PHQ-9 Patient Health Questionnaire (PHQ-9) Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.'}, {'type': 'SECONDARY', 'title': 'PHQ-9 Patient Health Questionnaire (PHQ-9) Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '3.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.'}, {'type': 'SECONDARY', 'title': 'Relapses of Lumbar Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'The percentage of patients with relapsed of low back pain was measured.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.'}, {'type': 'SECONDARY', 'title': 'Relapses of Lumbar Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}, {'value': '20.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': 'The percentage of patients with relapsed of low back pain was measured.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.'}, {'type': 'SECONDARY', 'title': 'Treatments Associated With Low Back Pain at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'we are showing in this result, the number of patients who had to receive any additional treatment in either group. The measure is the number of participants who received additional treatment throughout the duration of the study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Missing Workdays', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '6.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks before starting', 'description': 'This result shows the average of the number of missed work days.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Missing Workdays', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'This result shows the average of the number of missed work days.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Missing Workdays', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'This result shows the average of the number of missed work days.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.'}, {'type': 'SECONDARY', 'title': 'Missing Workdays', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'This result shows the average of the number of missed work days.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.'}, {'type': 'SECONDARY', 'title': 'Medical Consultations.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'This result shows, the total number of participants received additional medical consultations.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Medical Consultations.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'This result shows, the total number of participants received additional medical consultations.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.'}, {'type': 'SECONDARY', 'title': 'Medical Consultations.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'OG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': 'This result shows, the total number of participants received additional medical consultations.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'FG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'closed research', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Patients (18 and 60 years) with SLBP (subacute low back pain) (lasting 4-12 weeks) with or without radiculopathy who were assigned to the social security system and living in the metropolitan area were included.', 'preAssignmentDetails': 'A specific cause for the pain (infection, tumor, ankylosing spondylitis, inflammatory conditions or cauda equine syndrome), the presence of red flags, scoliosis \\>15 °, depression or mental illness, history of gastrointestinal bleeding, renal failure, intake of anticoagulants or antiplatelet drugs and NSAID allergy were excluded.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered\n\nExercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.'}, {'id': 'BG001', 'title': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue\n\nNSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.5', 'spread': '12.3', 'groupId': 'BG000'}, {'value': '40.3', 'spread': '13.2', 'groupId': 'BG001'}, {'value': '39.4', 'spread': '12.74', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Colombia', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-18', 'studyFirstSubmitDate': '2011-06-14', 'resultsFirstSubmitDate': '2013-09-20', 'studyFirstSubmitQcDate': '2011-06-14', 'lastUpdatePostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-03-18', 'studyFirstPostDateStruct': {'date': '2011-06-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale of Pain', 'timeFrame': 'At the beginning', 'description': 'In the Visual Analogue Sacale the best result is 0 and the worst is 100, The primary outcome was pain the mesurement of the Visual Analog Scale (VAS) (0 \\[no pain\\] to 100 \\[maximum pain\\]) at the beginning.'}, {'measure': 'Visual Analogue Scale of Pain', 'timeFrame': '4 weeks', 'description': 'In the VAS the best result is 0 and the worst is 100. The primary outcome was pain improvement of ≥25 mm on the Visual Analog Scale (VAS) (0 \\[no pain\\] to 100 \\[maximum pain\\]) at 4 weeks.'}, {'measure': 'Visual Analogue Scale of Pain', 'timeFrame': '12 weeks', 'description': 'In the VAS the best result is 0 and the worst is 100. The primary outcome was pain improvement of ≥25 mm on the Visual Analog Scale (VAS) (0 \\[no pain\\] to 100 \\[maximum pain\\]) at 12 weeks.'}, {'measure': 'Visual Analogue Scale of Pain', 'timeFrame': '24 weeks', 'description': 'The best result is 0 and the worst is 100, Pain relief more than 25 mm on the Visual Analogue Scale, assessed 24 weeks after intervention.'}], 'secondaryOutcomes': [{'measure': 'Oswestry Disability Index', 'timeFrame': 'At the beginning', 'description': 'Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.'}, {'measure': 'Oswestry Disability Index', 'timeFrame': '4 weeks', 'description': 'Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.'}, {'measure': 'Oswestry Disability Index', 'timeFrame': '12 weeks', 'description': 'Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.'}, {'measure': 'Oswestry Disability Index', 'timeFrame': '24 weeks', 'description': 'Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.'}, {'measure': 'Roland-Morris Questionnaire', 'timeFrame': 'At the beginning', 'description': "Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. Being worst 24."}, {'measure': 'Roland-Morris Questionnaire', 'timeFrame': '4 weeks', 'description': "Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. Being worst 24."}, {'measure': 'Roland-Morris Questionnaire', 'timeFrame': '12 weeks', 'description': "Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. Being worst 24."}, {'measure': 'Roland-Morris Questionnaire', 'timeFrame': '24 weeks', 'description': "Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. Being worst 24."}, {'measure': 'Quality of Life, Change in Health', 'timeFrame': 'At the beginning', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.'}, {'measure': 'Quality of Life, Change in Health', 'timeFrame': '4 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.'}, {'measure': 'Quality of Life, Change in Health', 'timeFrame': '12 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.'}, {'measure': 'Quality of Life, Change in Health', 'timeFrame': '24 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.'}, {'measure': 'Quality of Life, Bodily Pain', 'timeFrame': 'At the beginning', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.'}, {'measure': 'Quality of Life, Bodily Pain', 'timeFrame': '4 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.'}, {'measure': 'Quality of Life, Bodily Pain', 'timeFrame': '12 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.'}, {'measure': 'Quality of Life, Bodily Pain', 'timeFrame': '24 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.'}, {'measure': 'Quality of Life, Emotional Performance.', 'timeFrame': 'At the beginning', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.'}, {'measure': 'Quality of Life, Emotional Performance.', 'timeFrame': '4 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.'}, {'measure': 'Quality of Life, Emotional Performance.', 'timeFrame': '12 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.'}, {'measure': 'Quality of Life, Emotional Performance.', 'timeFrame': '24 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.'}, {'measure': 'Quality of Life, Physical Performance.', 'timeFrame': 'At the beginning', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance'}, {'measure': 'Quality of Life, Physical Performance.', 'timeFrame': '4 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance'}, {'measure': 'Quality of Life, Physical Performance.', 'timeFrame': '12 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance'}, {'measure': 'Quality of Life, Physical Performance.', 'timeFrame': '24 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance.'}, {'measure': 'Quality of Life, Physical Function.', 'timeFrame': 'At the beginning', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.'}, {'measure': 'Quality of Life, Physical Function.', 'timeFrame': '4 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.'}, {'measure': 'Quality of Life, Physical Function.', 'timeFrame': '12 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.'}, {'measure': 'Quality of Life, Physical Function.', 'timeFrame': '24 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.'}, {'measure': 'Quality of Life, Social Function.', 'timeFrame': 'At the beginning', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.'}, {'measure': 'Quality of Life, Social Function.', 'timeFrame': '4 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.'}, {'measure': 'Quality of Life, Social Function.', 'timeFrame': '12 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.'}, {'measure': 'Quality of Life, Social Function.', 'timeFrame': '24 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.'}, {'measure': 'Quality of Life, General Health Perceptions.', 'timeFrame': 'At the beginning', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.'}, {'measure': 'Quality of Life, General Health Perceptions.', 'timeFrame': '4 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.'}, {'measure': 'Quality of Life, General Health Perceptions.', 'timeFrame': '12 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.'}, {'measure': 'Quality of Life, General Health Perceptions.', 'timeFrame': '24 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.'}, {'measure': 'Quality of Life, Mental Health.', 'timeFrame': 'At the beginning', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.'}, {'measure': 'Quality of Life, Mental Health.', 'timeFrame': '4 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.'}, {'measure': 'Quality of Life, Mental Health.', 'timeFrame': '12 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.'}, {'measure': 'Quality of Life, Mental Health.', 'timeFrame': '24 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.'}, {'measure': 'Quality of Life, Vitality.', 'timeFrame': 'At the beginning', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.'}, {'measure': 'Quality of Life, Vitality.', 'timeFrame': '4 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.'}, {'measure': 'Quality of Life, Vitality.', 'timeFrame': '12 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.'}, {'measure': 'Quality of Life, Vitality.', 'timeFrame': '24 weeks', 'description': 'Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.'}, {'measure': 'PHQ-9 Patient Health Questionnaire (PHQ-9) Depression', 'timeFrame': '4 weeks', 'description': 'Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).'}, {'measure': 'PHQ-9 Patient Health Questionnaire (PHQ-9) Depression', 'timeFrame': 'At the beginning', 'description': 'Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).'}, {'measure': 'PHQ-9 Patient Health Questionnaire (PHQ-9) Depression', 'timeFrame': '12 weeks', 'description': 'Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).'}, {'measure': 'PHQ-9 Patient Health Questionnaire (PHQ-9) Depression', 'timeFrame': '24 weeks', 'description': 'Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).'}, {'measure': 'Relapses of Lumbar Pain', 'timeFrame': '12 weeks', 'description': 'The percentage of patients with relapsed of low back pain was measured.'}, {'measure': 'Relapses of Lumbar Pain', 'timeFrame': '24 weeks', 'description': 'The percentage of patients with relapsed of low back pain was measured.'}, {'measure': 'Treatments Associated With Low Back Pain at 6 Months', 'timeFrame': '6 months', 'description': 'we are showing in this result, the number of patients who had to receive any additional treatment in either group. The measure is the number of participants who received additional treatment throughout the duration of the study.'}, {'measure': 'Missing Workdays', 'timeFrame': '6 weeks before starting', 'description': 'This result shows the average of the number of missed work days.'}, {'measure': 'Missing Workdays', 'timeFrame': '4 weeks', 'description': 'This result shows the average of the number of missed work days.'}, {'measure': 'Missing Workdays', 'timeFrame': '12 weeks', 'description': 'This result shows the average of the number of missed work days.'}, {'measure': 'Missing Workdays', 'timeFrame': '24 weeks', 'description': 'This result shows the average of the number of missed work days.'}, {'measure': 'Medical Consultations.', 'timeFrame': '4 weeks', 'description': 'This result shows, the total number of participants received additional medical consultations.'}, {'measure': 'Medical Consultations.', 'timeFrame': '12 weeks', 'description': 'This result shows, the total number of participants received additional medical consultations.'}, {'measure': 'Medical Consultations.', 'timeFrame': '24 weeks', 'description': 'This result shows, the total number of participants received additional medical consultations.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['NSAIDS (Nonsteroidal anti-inflammatory drugs)', 'Exercise', 'Physiotherapy', 'Subacute Low Back Pain', 'Pain', 'Visual Analogue Scale', 'oswesrty', 'Roland Morris', 'SF-36', 'Quality of life'], 'conditions': ['Back Pain Lower Back']}, 'descriptionModule': {'briefSummary': 'Our clinical trial has the purpose to evaluate the effectiveness in reducing pain and improving function and quality of life during a 6-months follow-up of a therapeutic exercise program compared to pharmacological treatment with NSAIDs in patients with subacute low back pain attending the physiatrist consultation of several ambulatory health centers in Medellín during the years 2009-2010.', 'detailedDescription': 'General Purpose To evaluate the effectiveness in reducing pain and improving function and quality of life during a 6-months follow-up of a therapeutic exercise program compared to pharmacological treatment with NSAIDs in patients with subacute low back pain attending the physiatrist consultation of several ambulatory health centers in Medellín during the years 2009-2010.\n\nSpecific Objectives\n\n1. To evaluate the efficacy of a protocolized exercise program in reducing low back pain.\n2. To evaluate the efficacy of a protocolized exercise program in improving the function.\n3. To compare the effects of both interventions on quality of life and work absenteeism in the two groups of patients.\n4. To compare the safety of both interventions.\n5. To estimate adherence and causes of non-adherence of patients to different treatments proposed.\n6. To compare in both groups the number of relapses, general and specialized medical consultations, screening studies, images and other treatments associated with low back pain.\n\n Null Hypothesis Management of subacute low back pain patients with a protocolized exercise program is not more effective than treatment with NSAIDs to reduce pain at least in 25 mm, measured with a Visual Analog Scale 0-100 mm.\n\n Alternative hypothesis Management of subacute low back pain patients with a protocolized exercise program is not more effective than treatment with NSAIDs to reduce pain at least in 25 mm, measured with a Visual Analog Scale 0-100 mm.\n\n Methodology:\n\n Type of study: randomized controlled clinical trial, single-blinded with independent evaluators.\n\n Reference population: Patients consulting physiatrists in different physical medicine and rehabilitation departments in Medellin, Colombia.\n\n Study population: patients with subacute low back pain -evolution time more than 6 weeks and less than 3 months-, with or without radiculopathy, and that fulfill inclusion criteria. In addition patients must sign an informed consent to participate in research.\n\n Inclusion criteria:\n * Patients aged between 18 and 60 years with subacute low back pain.\n * Evolution time more than 6 weeks and less than 3 months.\n * That were included in the social security system and live in the metropolitan area.\n\n Exclusion criteria:\n * Antecedents of spinal, pelvis or abdominal trauma.\n * Cancer.\n * Diabetes mellitus.\n * Steroid use.\n * Women over 60 years.\n * Cauda equine syndrome.\n * Men with osteoporosis or compression fractures.\n * Suspicion of infection\n * Insidious onset\n * Constitutional symptoms\n * Intravenous drugs abuse\n * HIV\n * Immunosuppression\n * Previous surgery\n * Rheumatic diseases\n * Urinary tract infections\n * Neurological symptoms in lower limbs\n * Mental illness (schizophrenia, bipolar or somatomorphic disorder, major depression)\n * Deformities in the spine (scoliosis greater than 15º)\n * History of peptic acid disease\n * Renal failure\n * Intake of anticoagulants or antiplatelet drugs\n * Allergy to NSAIDs.\n\n Primary outcome Pain relief more than 25 mm on the Visual Analogue Scale, ranging from 0 to 100, assessed 4 weeks after intervention.\n\n Secondary outcomes:\n\n Improvement in function assessed by the Oswestry Disability Index and Roland-Morris questionnaire comparing baseline to first, three and six months follow-up.\n\n Improvement in quality of life assessed by SF-36 (The Short Form Health Survey) questionnaire at baseline and at first, third and sixth months.\n\n Work absenteeism decrease. Decrease in the number of relapses, general and specialized medical consultations, screening studies, images and other treatments associated with low back pain at 6 months.\n\n Safety of both treatments evaluated in the exercise group by tolerance to training and presence or not of side effects, and in the NSAIDs group by the presence or absence of adverse reactions.\n\n Sample:\n\n Sampling type: simple random. Sample size calculation was based on software "Sample size Javeriana University" Type I error: 0.05 Type II Error: 0.2 Assessments number prior to randomization: 1 Assessments number after randomization: 3 Correlation between evaluations: 0.8 Clinically important difference: 0.33 Number of patients per group: 33 Experimental group control group ratio : 1 to 1 10% of loss: 7 Total: 73\n\n Randomization Randomization was done by means of permuted blocks of size 2, 4 and 6, generated by computer (Ralloc program, co Stata 8.2, College Station, TX, USA). Allocation will be confidential and will not be opened until the investigation is completed, this will be monitored by the Committee of Data Security.\n\n Enrollment Patients with subacute low back pain consulting Physical Medicine and Rehabilitation Departments of hospitals in Medellín, Colombia. There will be an initial assessment, and if patient is considered eligible will be invited to participate and asked to sign an informed consent (Appendix 1). Treatment assignment will be given in an opaque envelope.\n\n Masking Medical researchers who evaluate the patients, research assistants who perform the application of different measure instruments and statistical will be blinded to treatment allocation.\n\n Initial assessment Clinical evaluation will be performed by one of the research physiatrists. Evaluation will include: epidemiological and clinical, Visual Analog Scale (VAS), Oswestry scale, Rolland Morris Scale, and SF-36 quality of life scale.\n\n Intervention One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered. The second group will receive NSAID for 10 days, there will be two different options (naproxen or celecoxib) according to indications and contraindications. In case of increase in pain intensity in either of the two groups, acetaminophen in doses of 1.5 to 2.0 g / day will be used as a rescue.\n\n Adherence to different treatments. To ensure adherence to different treatments each patient will receive a phone call weekly to inquire about assistance, difficulties, tolerance, use of medications, and adverse effects. Patients will be given a questionnaire to verify drugs intake, dosage, time and side effects. They should also register any other drug ingestion.\n\n Telephone calls will be made every 15 days to ask about the health status and ensuring assistance to new assessments.\n\n Assessment will be scheduled at 1, 3, and 6 months Clinical evaluation will be performed by one of the researcher physiatrists or a postgraduate student.\n\n Committee of safety and quality of data. This committee will consist of two researchers and one professional information management responsible for the database. This will be done in Access and SPSS 15 (Statistical Product and Service Solutions) before starting information recollection.\n\n Analysis Plan Categorical univariate variables will be analyzed by frequency distributions and quantitative variables by measures of central tendency (mean, standard deviation, median or range). Both groups will be compared after randomization and before intervention for all variables.\n\n Initially, it will be established for each group if the quantitative variables are of normal distribution, by using the Kolmogorov-Smirnov test.\n\n Pain (primary outcome) will be evaluated in each patient at 1, 3 and 6 months and will be compared with initial pain (mean and confidence intervals) by using Student t test or Mann Whitney for each time period. The same procedure would be for the other outcomes measured quantitatively.\n\n An analysis of variance with repeated measures for the variability between groups and intragroup will be made.\n\n Comparison of categorical variables at each assessment will be done using the Chi2 test.\n\n The level of statistical significance to be used in all cases is 0.05. An analysis by intention to treat and per protocol will be made.\n\n Ethics This research and informed consent is according to "Scientific, technical and administrative standards for health research" of the Ministry of Health and the Decree 309 of 2000 of the Ministry of Environment. This is considered a minimal risk research, because therapeutic interventions are widely used to treat patients with these conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged between 18 and 60 years old\n* Subacute low back pain -evolution time more than 4 weeks and less than 3 months.\n* That have social security system\n* Live in the metropolitan area\n\nExclusion Criteria:\n\n* Antecedents of spinal, pelvis or abdominal trauma\n* Cancer\n* Diabetes mellitus\n* Steroids use\n* Men and Women over 60 years\n* Cauda equine syndrome\n* Women and men with osteoporosis or compression fractures\n* Suspicion of infection.\n* Insidious onset, constitutional symptoms\n* Intravenous drugs abuse\n* HIV\n* Immunosuppression or previous surgery\n* Rheumatic diseases\n* Urinary tract infections\n* Neurological symptoms in lower limbs\n* Mental illness (schizophrenia, bipolar or somatomorphic disorder, major depression)\n* Deformities in the spine (scoliosis greater than 15º)\n* History of peptic acid disease\n* Renal failure\n* Intake of anticoagulants or antiplatelet drugs\n* Allergy to NSAIDs.'}, 'identificationModule': {'nctId': 'NCT01374269', 'acronym': 'DLSEA', 'briefTitle': 'Improvement in Pain,Function and HRQoL ( Health Related Quality of Life) in Subacute Low Back Pain: A Controlled Clinical Trial of Exercise vs NSAIDs (Nonsteroidal Antiinflammatory)', 'organization': {'class': 'NETWORK', 'fullName': 'Grupo Rehabilitacion en Salud'}, 'officialTitle': 'Improvement in Pain, Function and Quality of Life With a Protocolized Exercise Program Compared With Non-steroidal Anti-inflammatory Analgesics in Patients With Subacute Low Back Pain in Medellín, Colombia, 2009-2010', 'orgStudyIdInfo': {'id': 'DLSejervsaine'}, 'secondaryIdInfos': [{'id': 'DLSEjercicioyAINES', 'type': 'REGISTRY', 'domain': 'GrupoRS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Excercise', 'description': 'One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered', 'interventionNames': ['Other: Exercise program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NSAID', 'description': 'Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue', 'interventionNames': ['Drug: NSAID (Nonsteroidal anti-inflammatory drugs)']}], 'interventions': [{'name': 'Exercise program', 'type': 'OTHER', 'otherNames': ['Therapeutic exercise', 'Physiotherapy'], 'description': 'Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.', 'armGroupLabels': ['Excercise']}, {'name': 'NSAID (Nonsteroidal anti-inflammatory drugs)', 'type': 'DRUG', 'otherNames': ['Naproxen', 'Celecoxib', 'Acetaminophen'], 'description': 'The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.', 'armGroupLabels': ['NSAID']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Medellín', 'state': 'Antioquia', 'country': 'Colombia', 'facility': 'Clínica de Las Américas', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}, {'city': 'Medellín', 'state': 'Antioquia', 'country': 'Colombia', 'facility': 'Ips Universitaria', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}], 'overallOfficials': [{'name': 'Luz H Lugo, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad de Antioquia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grupo Rehabilitacion en Salud', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Universidad de Antioquia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Fabio Alonso Salinas Duran', 'investigatorAffiliation': 'Grupo Rehabilitacion en Salud'}}}}