Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-02-12 @ 4:19 AM
Study NCT ID:
NCT02062918
Status:
COMPLETED
Last Update Posted:
2014-02-14
First Post:
2014-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Abdominal Belt Use to Treat Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], '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': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-13', 'studyFirstSubmitDate': '2014-02-12', 'studyFirstSubmitQcDate': '2014-02-13', 'lastUpdatePostDateStruct': {'date': '2014-02-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain using VAS', 'timeFrame': 'Baseline, after 1,3, and 6 months'}], 'secondaryOutcomes': [{'measure': 'Change in functional capacity (Roland-Morris questionnaire)', 'timeFrame': 'Baseline, after 1,3 and 6 months'}, {'measure': 'Change in hours of abdominal belt use', 'timeFrame': 'Baseline, after 1,3 and 6 months'}, {'measure': 'Change in patient satisfaction with treatment using VAS', 'timeFrame': 'Baseline, after 1,3 and 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Abdominal belt', 'Chronic low back pain', 'Pain', 'Functional capacity'], 'conditions': ['Chronic Low Back Pain']}, 'descriptionModule': {'briefSummary': 'Objectives: To assess the effectiveness of an abdominal belt in the treatment of chronic mechanical-postural low back pain.\n\nMethods: A randomized controlled trial was carried out, involving 60 consecutively selected patients with chronic low back pain randomly allocated to an intervention group (use of abdominal belt) and control group (non-use of abdominal belt). Patients were evaluated at the baseline of the study (T0) as well as 1 (T1), 3 (T3) and 6 months (T6) after the inclusion. The patients were assessed for: pain (VAS); functional capacity (Roland Morris), patient satisfaction (Likert scale); and number of anti-inflammatory pills ingested. Intention-to-treat analysis was also used.\n\nHypothesis - abdominal belt will improve pain in chronic low back pain patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients from both genders,\n* between 18 and 65 years of age,\n* who sought medical care for a complaint of lumbar pain,\n* diagnosed with Chronic low back pain, with VAS for pain between 4 and 8 cm (0-10),\n* who agreed to participate in the study and signed terms of informed consent.\n\nExclusion Criteria:\n\n* diagnosis or under diagnostic investigation of low back pain from secondary causes (spondyloarthopathy, infection, neoplasm, complete sciatica),\n* fibromyalgia,\n* previous spinal surgery,\n* litigation (patients on leave from work or in work leave processes due to low back pain);\n* having changed physical activity in previous three months;\n* body mass index (BMI) higher than 30;\n* acupuncture treatment or physiotherapy in the previous three months'}, 'identificationModule': {'nctId': 'NCT02062918', 'briefTitle': 'Abdominal Belt Use to Treat Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Effectiveness of Abdominal Belt for the Chronic Low Back Pain Treatment', 'orgStudyIdInfo': {'id': 'CEP?UNIFESP-1726/10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Patients in the control group did not use an abdominal belt.'}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Patients were instructed in how to use the abdominal belt for activities of physical effort that exacerbated lumbar pain as well as during moments of pain, and not to use it during rest. They should record the number of hours of belt use per day on spreadsheets distributed for this purpose.', 'interventionNames': ['Device: Abdominal belt']}], 'interventions': [{'name': 'Abdominal belt', 'type': 'DEVICE', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04023-090', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Universidade Federal de Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Rheumatology Division', 'investigatorFullName': 'Jamil Natour', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}