Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-25 @ 11:53 PM
Study NCT ID:
NCT01502059
Status:
COMPLETED
Last Update Posted:
2011-12-30
First Post:
2011-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilates to Treat Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001416', 'term': 'Back Pain'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026241', 'term': 'Exercise Movement Techniques'}], 'ancestors': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-29', 'studyFirstSubmitDate': '2011-12-27', 'studyFirstSubmitQcDate': '2011-12-29', 'lastUpdatePostDateStruct': {'date': '2011-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain', 'timeFrame': 'Baseline, after 45, 90 and 180 days', 'description': 'Measured with the visual analogue scale ranging from 0 to 10'}], 'secondaryOutcomes': [{'measure': 'Change in function', 'timeFrame': 'Baseline, after 45, 90 and 180 days', 'description': 'Measured by the questionnaire Roland Morris'}, {'measure': 'Change in quality of life', 'timeFrame': 'Baseline, after 45, 90 and 180 days', 'description': 'Measured by the SF-36 questionnaire'}, {'measure': 'Change in nonsteroidal antiinflammatory drugs (NSAIDs) consumption', 'timeFrame': 'Baseline, after 45, 90 and 180 days', 'description': 'Measured by counting the number of tablets consumed per month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pilates', 'Exercise', 'Treatment', 'Low back pain', 'Pain', 'Function'], 'conditions': ['Pain', 'Quality of Life']}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial, with blinded assessor to evaluate the effectiveness of Pilates to treat low back pain.\n\nHypothesis - the Pilates group will have best results than the control group (usual medicament treatment).', 'detailedDescription': 'Background:\n\nLow back pain (LBP) is a common problem among adults. Approximately 70-85% of the adult population experiences this painful complaint at some point in their lives, making LBP the second most common reason for a visit to a clinician. Despite the frequency of this diagnosis, conventional treatment does not always provide patients the desired results of reduced pain and return of normal function. For these patients, alternative modalities are available to assist in the control of pain. These options include chiropractic care, physical therapy, massage therapy, and modalities that fall under the auspices of complementary and alternative medicine, such as acupuncture. Unfortunately, Clinical trials evaluating the efficacy of a variety of interventions for chronic non-specific low back pain indicate limited effectiveness for most commonly applied interventions and approaches.\n\nObjectives:\n\nTo evaluate the effectiveness of a mat and studio Pilates program on pain, function, quality of life and NHAI consumption for chronic non-specific low back pain patients.\n\nMethods:\n\nEligible patient include: chronic non-specific low back pain; age between 18 and 65 years; pain ranging from 4 to 8 in a numerical pain scale. Patients with previous surgery, other causes of low back pain, fibromyalgia, regular physical activity (three or more times per week for at least three months); labor lawsuit and body mass index more than 30. Sixty patients were randomized to the Experimental Group (EG) or Control Group (CG). Patients in EG participated in 90 days of mat and studio Pilates program twice a week (50 minutes per class) and the CG remained with their usual medicament treatment and were included in a waiting list for physiotherapy. Assessment for pain (VAS), function (Roland Morris questionnaire), quality of life (SF-36) and NHAI consumption were done at baseline, after 45 days (T45), after 90 days (T90 - end of the program), after 90 days (T180 - follow up) by a blinded assessor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non specific mechanical low back pain\n* visual analogue scale for pain ranging from 4 to 7\n\nExclusion Criteria:\n\n* previous back surgery\n* spinal tumor\n* spinal fracture\n* pregnancy\n* fibromyalgia\n* inflammatory or infectious spinal diseases\n* litigant patients'}, 'identificationModule': {'nctId': 'NCT01502059', 'acronym': 'PTLBP', 'briefTitle': 'Pilates to Treat Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'The Effectiveness of Pilates to Treat Low Back Pain: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CEP UNIFESP 0208/11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pilates Group', 'description': 'This group keep their usual treatment and did a Pilates treatment twice a week (one hour each class) during 90 days.', 'interventionNames': ['Other: Pilates']}, {'type': 'NO_INTERVENTION', 'label': 'Control Groups', 'description': 'This group keep their usual treatment and can do the Pilates training after the end of the study.'}], 'interventions': [{'name': 'Pilates', 'type': 'OTHER', 'description': 'Pilates training - twice a week (one hour per class) during 90 days', 'armGroupLabels': ['Pilates Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04329010', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Universidade Federal de Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Anamaria Jones, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of São Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Anamaria Jones', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}