None listed
Conditions
Brief summary
Knee osteoarthritis (OA) is a painful and costly condition. Wedged shoe insoles are a simple intervention that may reduce pain and slow disease progression in people with knee OA and bow legs. They are thought to work by changing the alignment of the knee, altering muscle activity and ultimately reducing load across the knee joint. This project will compare the effect of a lateral wedged insole and a flat insole to see whether the lateral wedges are a useful treatment for people with knee OA. Participants will be screened over the phone first then will attend the Centre for Health, Exercise and Sports Medicine for further screening to assess their suitability. If they pass the screening, they will undergo baseline testing at the Centre which will take around 2 hours. They will complete questionnaires about their knee pain and function, quality of life, expectation of treatment benefit, physical activity levels and self motivation. Measurements will also be taken of walking, muscle strength, and foot type. Participants will attend the Epworth Hospital for a magnetic resonance imaging scan of the knee which will take about 1 hour. Participants will be randomly allocated into one of two groups (i) wedged shoe insoles (ii) control shoe insoles (with no wedging). Participants will wear the insoles in both shoes full time for 12 months. They will be provided with several pairs for replacement and for different shoes. Participants will be asked to complete a log-book during this time to record their insole wear compliance, any negative effects of the insoles, medication use, visits to health professionals and any additional home support. Some of the questionnaires will be completed at home after wearing the insoles for 6 months. At 12 months, participants will return to the Centre for repeat testing and to the Epworth for another knee scan.
Interventions
A Project Examiner will conduct preliminary screening over the phone. Participants will undergo examination by the Project Examiner and the Project Podiatrist to ensure they fulfil selection criteria. An x-ray will be performed to ensure varus knee joint malalignment. Baseline testing including assessment of knee pain and MRI measurements of knee cartilage volume will be performed on all subjects, following whoich the particpant will be randomised into one of two groups: (i) laterally wedged ins
A Project Examiner will conduct preliminary screening over the phone. Participants will undergo examination by the Project Examiner and the Project Podiatrist to ensure they fulfil selection criteria. An x-ray will be performed to ensure varus knee joint malalignment. Baseline testing including assessment of knee pain and MRI measurements of knee cartilage volume will be performed on all subjects, following whoich the particpant will be randomised into one of two groups: (i) laterally wedged insoles or, (ii) control insoles. The intervention period will be 12 months after which participants will be reassessed.
Sponsors
Prof Kim Bennell
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
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 will be included. Other inclusion criteria will be: (i) varus knee malalignment on standing anteroposterior lower limb x-ray.
Exclusion criteria
(i) advanced radiographic knee OA (Kellgren and Lawrence stage 4; (ii) knee surgery or intra-articular corticosteroid injection within 6 months; (iii) current or past (within 4 weeks) oral corticosteroid use; (iv) systemic arthritic conditions; (v) history of tibiofemoral/patellofemoral joint replacement or tibial osteotomy; (vi) any other muscular, joint or neurological condition affecting lower limb function; (vii) ankle/foot pathology or pain that precludes the use of insoles; (viii) use of foot orthotics within past 6 months and; (ix) use of footwear that does not accomodate an insole.
Outcome results
None listed