Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-01-06 @ 12:59 AM
Study NCT ID:
NCT00638768
Status:
COMPLETED
Last Update Posted:
2025-07-10
First Post:
2008-03-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Physiotherapy for Osteoporotic Spinal Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D016103', 'term': 'Spinal Fractures'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D013124', 'term': 'Spinal Injuries'}, {'id': 'D019567', 'term': 'Back Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2010-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-07', 'studyFirstSubmitDate': '2008-03-12', 'studyFirstSubmitQcDate': '2008-03-12', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Back pain as assessed by a numeric rating scale', 'timeFrame': 'Baseline and 10 weeks'}], 'secondaryOutcomes': [{'measure': 'activity restriction, health-related quality of life and physical activity levels as well as overall perceived rating of change in back pain. Objective measures of thoracic kyphosis, standing balance, back and shoulder muscle endurance', 'timeFrame': 'Baseline and 10 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['physical therapy', 'rehabilitation', 'pain', 'osteoporosis', 'vertebral fracture'], 'conditions': ['Osteoporosis', 'Vertebral Fracture']}, 'referencesModule': {'references': [{'pmid': '20163739', 'type': 'DERIVED', 'citation': 'Bennell KL, Matthews B, Greig A, Briggs A, Kelly A, Sherburn M, Larsen J, Wark J. Effects of an exercise and manual therapy program on physical impairments, function and quality-of-life in people with osteoporotic vertebral fracture: a randomised, single-blind controlled pilot trial. BMC Musculoskelet Disord. 2010 Feb 17;11:36. doi: 10.1186/1471-2474-11-36.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this pilot study was to determine the effect of physiotherapy on impairments and health-related quality of life in people with a painful osteoporotic spinal fracture. It is hypothesised that physiotherapy will reduce impairments and improve quality of life in this patient group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* if female, at least five years post-menopause\n* aged \\> 50 years\n* primary osteoporosis defined as DXA T score \\< -2.5 at either the spine or proximal femur with at least one morphometric vertebral crush fracture sustained between 3 months to 2 years previously\n* back pain/discomfort in thoracic or lumbar region felt at least weekly within the last 6 months\n* stable dose of medication for treatment of osteoporosis (eg. hormone replacement therapy, bisphosphonates)\n* community dwelling and able to attend for treatment\n* English speaking\n\nExclusion Criteria:\n\n* secondary causes of bone loss such as osteomalacia, glucocorticoid medication etc.\n* co-morbidities that would interfere with participation in exercise such as severe heart or pulmonary disease, inflammatory joint disease, severe osteoarthritis, psychiatric condition\n* acute vertebral fracture in past 3 months\n* signs and symptoms arising from nerve root compression\n* back pain radiating into the lower limb\n* previous participation in a formal pain management program for back pain\n* physiotherapy for back pain in the past 6 months\n* allergic reaction to adhesive tape or poor skin condition that would prevent use of tape'}, 'identificationModule': {'nctId': 'NCT00638768', 'briefTitle': 'Effectiveness of Physiotherapy for Osteoporotic Spinal Fracture', 'organization': {'class': 'OTHER', 'fullName': 'University of Melbourne'}, 'officialTitle': 'Effectiveness of Physiotherapy for Vertebral Osteoporotic Fracture: a Randomised Controlled Pilot Trial', 'orgStudyIdInfo': {'id': '010085.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Physiotherapy', 'description': 'Including 10 individual visits with a physiotherapist and home exercises', 'interventionNames': ['Other: Physiotherapy']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'Usual care'}], 'interventions': [{'name': 'Physiotherapy', 'type': 'OTHER', 'description': '10 weekly individual sessions with the therapist each lasting approximately 45 minutes. Techniques included postural taping, massage, mobilisation, exercises. The patients also performed home exercises', 'armGroupLabels': ['Physiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'School of Physiotherapy, University of Melbourne', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Kim L Bennell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Melbourne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Melbourne', 'class': 'OTHER'}, 'collaborators': [{'name': 'ANZ Trustees', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}