Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT03554018
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2018-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Ibuprofen With or Without Acetaminophen for Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D007052', 'term': 'Ibuprofen'}, {'id': 'D018479', 'term': 'Early Intervention, Educational'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'befriedm@montefiore.org', 'phone': '718-920-6626', 'title': 'Benjamin Friedman', 'organization': 'Montefiore'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '48 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Ibuprofen and Acetaminophen', 'description': 'Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.\n\nAcetaminophen: Acetaminophen 500-1000mg every 6 hours\n\nIbuprofen 600 mg: Ibuprofen 600mg every 6 hours\n\nEducational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\\_Info/Back\\_Pain/default.asp)', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 5, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ibuprofen and Placebo', 'description': 'Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.\n\nIbuprofen 600 mg: Ibuprofen 600mg every 6 hours\n\nEducational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\\_Info/Back\\_Pain/default.asp)\n\nPlacebo oral capsule: To match acetaminophen, patients will take one or two capsules every 6 hours', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 2, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibuprofen and Acetaminophen', 'description': 'Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.\n\nAcetaminophen: Acetaminophen 500-1000mg every 6 hours\n\nIbuprofen 600 mg: Ibuprofen 600mg every 6 hours\n\nEducational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\\_Info/Back\\_Pain/default.asp)'}, {'id': 'OG001', 'title': 'Ibuprofen and Placebo', 'description': 'Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.\n\nIbuprofen 600 mg: Ibuprofen 600mg every 6 hours\n\nEducational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\\_Info/Back\\_Pain/default.asp)\n\nPlacebo oral capsule: To match acetaminophen, patients will take one or two capsules every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '11.1', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '11.9', 'spread': '9.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and one week after discharge from emergency department', 'description': 'The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one\'s daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a "yes" or "no". The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ score at one week after discharge from the baseline score. The calculated mean and associated confidence interval values have been verified by staff statisticians.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Moderate or Severe Pain, as Measured on an Ordinal Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibuprofen and Acetaminophen', 'description': 'Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.\n\nAcetaminophen: Acetaminophen 500-1000mg every 6 hours\n\nIbuprofen 600 mg: Ibuprofen 600mg every 6 hours\n\nEducational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\\_Info/Back\\_Pain/default.asp)'}, {'id': 'OG001', 'title': 'Ibuprofen and Placebo', 'description': 'Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.\n\nIbuprofen 600 mg: Ibuprofen 600mg every 6 hours\n\nEducational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\\_Info/Back\\_Pain/default.asp)\n\nPlacebo oral capsule: To match acetaminophen, patients will take one or two capsules every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days after discharge from emergency department', 'description': 'Data collected by telephone questionnaire. Participants asked to assess intensity of low back pain over the previous 24 hours, using a four point ordinal scale: severe, moderate, mild, or none.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 24 Hours.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibuprofen and Acetaminophen', 'description': 'Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.\n\nAcetaminophen: Acetaminophen 500-1000mg every 6 hours\n\nIbuprofen 600 mg: Ibuprofen 600mg every 6 hours\n\nEducational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\\_Info/Back\\_Pain/default.asp)'}, {'id': 'OG001', 'title': 'Ibuprofen and Placebo', 'description': 'Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.\n\nIbuprofen 600 mg: Ibuprofen 600mg every 6 hours\n\nEducational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\\_Info/Back\\_Pain/default.asp)\n\nPlacebo oral capsule: To match acetaminophen, patients will take one or two capsules every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days after discharge from emergency department', 'description': 'Telephone questionnaire is used to assess number of patients needing any analgesic or low back pain medication within the previous 24 hours.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was collected and analyzed for 52 participants in the "Ibuprofen and Placebo" group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ibuprofen and Acetaminophen', 'description': 'Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.\n\nAcetaminophen: Acetaminophen 500-1000mg every 6 hours\n\nIbuprofen 600 mg: Ibuprofen 600mg every 6 hours\n\nEducational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\\_Info/Back\\_Pain/default.asp)'}, {'id': 'FG001', 'title': 'Ibuprofen and Placebo', 'description': 'Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.\n\nIbuprofen 600 mg: Ibuprofen 600mg every 6 hours\n\nEducational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\\_Info/Back\\_Pain/default.asp)\n\nPlacebo oral capsule: To match acetaminophen, patients will take one or two capsules every 6 hours'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ibuprofen and Acetaminophen', 'description': 'Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.\n\nAcetaminophen: Acetaminophen 500-1000mg every 6 hours\n\nIbuprofen 600 mg: Ibuprofen 600mg every 6 hours\n\nEducational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\\_Info/Back\\_Pain/default.asp)'}, {'id': 'BG001', 'title': 'Ibuprofen and Placebo', 'description': 'Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.\n\nIbuprofen 600 mg: Ibuprofen 600mg every 6 hours\n\nEducational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\\_Info/Back\\_Pain/default.asp)\n\nPlacebo oral capsule: To match acetaminophen, patients will take one or two capsules every 6 hours'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '41', 'spread': '12', 'groupId': 'BG000'}, {'value': '41', 'spread': '13', 'groupId': 'BG001'}, {'value': '41', 'spread': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Duration of low back pain', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '96'}, {'value': '48', 'groupId': 'BG001', 'lowerLimit': '12', 'upperLimit': '96'}, {'value': '48', 'groupId': 'BG002', 'lowerLimit': '24', 'upperLimit': '96'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'hours', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-19', 'size': 331869, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-07-13T02:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-22', 'studyFirstSubmitDate': '2018-05-31', 'resultsFirstSubmitDate': '2021-07-13', 'studyFirstSubmitQcDate': '2018-06-11', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-25', 'studyFirstPostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire', 'timeFrame': 'Baseline and one week after discharge from emergency department', 'description': 'The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one\'s daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a "yes" or "no". The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ score at one week after discharge from the baseline score. The calculated mean and associated confidence interval values have been verified by staff statisticians.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Moderate or Severe Pain, as Measured on an Ordinal Scale', 'timeFrame': '7 days after discharge from emergency department', 'description': 'Data collected by telephone questionnaire. Participants asked to assess intensity of low back pain over the previous 24 hours, using a four point ordinal scale: severe, moderate, mild, or none.'}, {'measure': 'Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 24 Hours.', 'timeFrame': '7 days after discharge from emergency department', 'description': 'Telephone questionnaire is used to assess number of patients needing any analgesic or low back pain medication within the previous 24 hours.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'This is a randomized clinical trial comparing two interventions for acute low back pain:\n\n1. Ibuprofen + acetaminophen\n2. Ibuprofen + placebo\n\nParticipants will include patients who present to an emergency room for management of low back pain. Medication will be dispensed to participants at the time of emergency room discharge. Data will be collected from participants by telephone for 1 week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPresent to emergency room primary for management of LBP, defined as pain originating between the lower border of the scapulae and the upper gluteal folds. Flank pain, that is pain originating from tissues lateral to the paraspinal muscles, will not be included.\n\n* Musculoskeletal etiology of low back. Patients with non-musculoskeletal etiologies such as urinary tract infection, ovarian cysts, or influenza like illness will be excluded. The primary clinical diagnosis, at the conclusion of the emergency room visit, must be a diagnosis consistent with non-traumatic, non-radicular, musculoskeletal low back pain.\n* Patient is to be discharged home.\n* Age 18-69\n* Non-radicular pain. Patients will be excluded if the pain radiates below the gluteal folds in a radicular pattern.\n* Pain duration \\<2 weeks (336 hours).\n* Prior to the acute attack of LBP, back pain cannot occur more frequently than once per month.\n* Non-traumatic LBP: no substantial and direct trauma to the back within the previous month\n* Functionally impairing back pain: A baseline score of \\> 5 on the Roland-Morris Disability Questionnaire\n\nExclusion Criteria:\n\n* Not available for follow-up\n* Pregnant\n* Chronic pain syndrome defined as use of any analgesic medication on a daily or near-daily basis\n* Allergic to or intolerant of investigational medications'}, 'identificationModule': {'nctId': 'NCT03554018', 'briefTitle': 'Ibuprofen With or Without Acetaminophen for Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'Ibuprofen With or Without Acetaminophen for Acute, Non-radicular Low Back Pain: A Randomized Trial', 'orgStudyIdInfo': {'id': '2018-9182'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acetaminophen', 'description': 'Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.', 'interventionNames': ['Drug: Acetaminophen', 'Drug: Ibuprofen 600 mg', 'Behavioral: Educational intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.', 'interventionNames': ['Drug: Ibuprofen 600 mg', 'Behavioral: Educational intervention', 'Drug: Placebo oral capsule']}], 'interventions': [{'name': 'Acetaminophen', 'type': 'DRUG', 'description': 'Acetaminophen 500-1000mg every 6 hours', 'armGroupLabels': ['Acetaminophen']}, {'name': 'Ibuprofen 600 mg', 'type': 'DRUG', 'description': 'Ibuprofen 600mg every 6 hours', 'armGroupLabels': ['Acetaminophen', 'Placebo']}, {'name': 'Educational intervention', 'type': 'BEHAVIORAL', 'description': 'Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\\_Info/Back\\_Pain/default.asp)', 'armGroupLabels': ['Acetaminophen', 'Placebo']}, {'name': 'Placebo oral capsule', 'type': 'DRUG', 'description': 'To match acetaminophen, patients will take one or two capsules every 6 hours', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Benjamin W Friedman, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}