Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-26 @ 11:07 PM
Study NCT ID:
NCT00415259
Status:
COMPLETED
Last Update Posted:
2013-01-17
First Post:
2006-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Shoes Insoles on Symptoms and Disease Progression in Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-15', 'studyFirstSubmitDate': '2006-12-21', 'studyFirstSubmitQcDate': '2006-12-21', 'lastUpdatePostDateStruct': {'date': '2013-01-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee pain via a visual analogue scale', 'timeFrame': 'Measured at baseline and 12 months'}, {'measure': 'Disease progression via MRI measurements of knee cartilage volume', 'timeFrame': 'Measured at baseline and 12 months'}], 'secondaryOutcomes': [{'measure': 'Western Ontario and McMaster Universities (WOMAC) Oestoarthritis Index', 'timeFrame': 'Measured at baseline and 12 months'}, {'measure': 'Patient perceived response to treatment', 'timeFrame': 'Measured at baseline and 12 months.'}, {'measure': 'Health-related quality-of-life (via SF-36, AQoL questionnaires)', 'timeFrame': 'Measured at baseline and 12 months'}, {'measure': 'Recorded use of health care', 'timeFrame': 'Measured at baseline and 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '21593096', 'type': 'DERIVED', 'citation': 'Bennell KL, Bowles KA, Payne C, Cicuttini F, Williamson E, Forbes A, Hanna F, Davies-Tuck M, Harris A, Hinman RS. Lateral wedge insoles for medial knee osteoarthritis: 12 month randomised controlled trial. BMJ. 2011 May 18;342:d2912. doi: 10.1136/bmj.d2912.'}, {'pmid': '17892539', 'type': 'DERIVED', 'citation': 'Bennell K, Bowles KA, Payne C, Cicuttini F, Osborne R, Harris A, Hinman R. Effects of laterally wedged insoles on symptoms and disease progression in medial knee osteoarthritis: a protocol for a randomised, double-blind, placebo controlled trial. BMC Musculoskelet Disord. 2007 Sep 24;8:96. doi: 10.1186/1471-2474-8-96.'}]}, 'descriptionModule': {'briefSummary': 'It is hypothesised that laterally wedged insoles will result in reduced knee pain and cartilage volume loss after 12 months of wear, compared to control insoles. People with symptomatic knee osteoarthritis will be recruited from the community and randomised to wear either laterally wedged insoles or control insoles for 12 months. Patients will be assessed at baseline and at 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligibility will be confirmed by radiographic and clinical examination\n* People with medial tibiofemoral joint OA fulfilling American College of Rheumatology classification criteria and reporting average knee pain on walking \\>3 on an 11-point scale\n* varus knee malalignment on standing anteroposterior lower limb x-ray.\n\nExclusion Criteria:\n\n* advanced radiographic knee OA (Kellgren and Lawrence stage 4\n* knee surgery or intra-articular corticosteroid injection within 6 months\n* current or past (within 4 weeks) oral corticosteroid use\n* systemic arthritic conditions\n* history of tibiofemoral/patellofemoral joint replacement or tibial osteotomy\n* any other muscular, joint or neurological condition affecting lower limb function\n* ankle/foot pathology or pain that precludes the use of insoles\n* use of foot orthotics within past 6 months and\n* use of footwear that does not accomodate an insole.'}, 'identificationModule': {'nctId': 'NCT00415259', 'briefTitle': 'Effects of Shoes Insoles on Symptoms and Disease Progression in Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'University of Melbourne'}, 'officialTitle': 'Effects of Shoes Insoles on Symptoms and Disease Progression in Knee Osteoarthritis', 'orgStudyIdInfo': {'id': '350297'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laterally wedged shoe insoles', 'description': 'Full-length 5 degree lateral wedged insoles worn inside the shoes daily for 12 months', 'interventionNames': ['Device: Laterally wedged shoe insoles']}, {'type': 'OTHER', 'label': 'Flat control insoles', 'interventionNames': ['Device: Control insole group']}], 'interventions': [{'name': 'Laterally wedged shoe insoles', 'type': 'DEVICE', 'description': 'Full-length 5 degree lateral wedged insoles worn inside the shoes daily for 12 months', 'armGroupLabels': ['Laterally wedged shoe insoles']}, {'name': 'Control insole group', 'type': 'DEVICE', 'description': 'Flat control insoles worn inside the shoes daily for 12 months', 'armGroupLabels': ['Flat control insoles']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Centre for Health Exercise & Sports Medicine, School of Physiotherapy, The University of Melbourne', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Kim Bennell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Melbourne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Melbourne', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Health and Medical Research Council, Australia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Kim Bennell', 'investigatorFullName': 'Kim Bennell', 'investigatorAffiliation': 'University of Melbourne'}}}}