Status:
COMPLETED
Effects of Shoes Insoles on Symptoms and Disease Progression in Knee Osteoarthritis
Lead Sponsor:
University of Melbourne
Collaborating Sponsors:
National Health and Medical Research Council, Australia
Conditions:
Osteoarthritis
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
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 osteoarth...
Eligibility Criteria
Inclusion
- Eligibility will be confirmed by radiographic and clinical examination
- 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
- varus knee malalignment on standing anteroposterior lower limb x-ray.
Exclusion
- advanced radiographic knee OA (Kellgren and Lawrence stage 4
- knee surgery or intra-articular corticosteroid injection within 6 months
- current or past (within 4 weeks) oral corticosteroid use
- systemic arthritic conditions
- history of tibiofemoral/patellofemoral joint replacement or tibial osteotomy
- any other muscular, joint or neurological condition affecting lower limb function
- ankle/foot pathology or pain that precludes the use of insoles
- use of foot orthotics within past 6 months and
- use of footwear that does not accomodate an insole.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00415259
Start Date
May 1 2005
End Date
December 1 2008
Last Update
January 17 2013
Active Locations (1)
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1
Centre for Health Exercise & Sports Medicine, School of Physiotherapy, The University of Melbourne
Melbourne, Victoria, Australia, 3010