Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-28 @ 3:55 PM
Study NCT ID:
NCT01342432
Status:
COMPLETED
Last Update Posted:
2011-04-27
First Post:
2011-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of a Balance Reeducation Protocol on Pain, Function and Postural Control of Low Back Pain Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-26', 'studyFirstSubmitDate': '2011-04-04', 'studyFirstSubmitQcDate': '2011-04-26', 'lastUpdatePostDateStruct': {'date': '2011-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceived pain', 'timeFrame': '5 weeks', 'description': 'Pain was measured by an Analogic Visual Scale'}], 'secondaryOutcomes': [{'measure': 'Function', 'timeFrame': '5 weeks', 'description': 'Function was measured by the Roland-Morris Questionnaire'}, {'measure': 'Postural Control', 'timeFrame': '5 weeks', 'description': 'Postural control was measured by Functional Reach Test and by posturography'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['low back pain', 'balance reeducation', 'pain', 'function'], 'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effects of a balance reeducation protocol and an evidenced based protocol on pain, function and postural control of low back pain patients.', 'detailedDescription': 'Both groups will perform general exercises for back pain (stretch and strength of paraspinal and abdominal muscles, plus exercises to enhance lumbar and pelvic flexibility but the balance or experimental group will perform in addition five minutes of exercises that challenge postural stability in the sitting position. The evolution of the two groups concerning pain level, function and postural control will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* must have low back pain longer than three months and age between 40 and 69 years old\n\nExclusion Criteria:\n\n* balance or neuromuscular disorders, spine surgery, diabetes.'}, 'identificationModule': {'nctId': 'NCT01342432', 'briefTitle': 'Impact of a Balance Reeducation Protocol on Pain, Function and Postural Control of Low Back Pain Patients', 'organization': {'class': 'OTHER', 'fullName': 'Centro Universitari Fieo'}, 'officialTitle': 'Comparison of Balance Reeducation Plus General Exercises Versus General Exercises Only: Impact on Pain, Function and Postural Control of Low Back Pain Patients', 'orgStudyIdInfo': {'id': '2008/069241'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Balance reeducation plus exercise', 'description': 'exercises that challenge postural control are performed in addition to general exercises for stretch and strength of abdominal and paraspinal muscles', 'interventionNames': ['Other: Balance reeducation plus general exercise']}, {'type': 'OTHER', 'label': 'General exercise only', 'description': 'general exercise for stretch and strength of paraspinal and abdominal muscles', 'interventionNames': ['Other: General exercise only']}], 'interventions': [{'name': 'General exercise only', 'type': 'OTHER', 'otherNames': ['control group'], 'description': 'exercises for stretch and strength of paraspinal and abdominal muscles', 'armGroupLabels': ['General exercise only']}, {'name': 'Balance reeducation plus general exercise', 'type': 'OTHER', 'otherNames': ['balance group, intervention group'], 'description': 'patients perform balance reeducation exercises in addition to general exercises for stretch and strength of back and abdominal muscles', 'armGroupLabels': ['Balance reeducation plus exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06020-190', 'city': 'Osasco', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Centro Universitário Fieo', 'geoPoint': {'lat': -23.5325, 'lon': -46.79167}}], 'overallOfficials': [{'name': 'Thais Bojadsen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro Universitario Fieo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Universitari Fieo', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Sao Paulo', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Thais Weber Alencar Bojadsen, PhD', 'oldOrganization': 'Centro Universitário Fieo'}}}}