Effects of Shoes Insoles on Symptoms and Disease Progression in Knee Osteoarthritis

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Shoes Insoles on Symptoms and Disease Progression in Knee Osteoarthritis

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: Laterally wedged shoe insoles
* Device: Control insole group


Participation Criteria
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Eligibility Criteria
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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 varus knee malalignment on standing anteroposterior lower limb x-ray. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laterally wedged shoe insoles<br>Full-length 5 degree lateral wedged insoles worn inside the shoes daily for 12 months | Device: Laterally wedged shoe insoles<br>* Full-length 5 degree lateral wedged insoles worn inside the shoes daily for 12 months<br>|
| Other: Flat control insoles<br> | Device: Control insole group<br>* Flat control insoles worn inside the shoes daily for 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee pain via a visual analogue scale |  | Measured at baseline and 12 months | 
| Disease progression via MRI measurements of knee cartilage volume |  | Measured at baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Universities (WOMAC) Oestoarthritis Index |  | Measured at baseline and 12 months | 
| Patient perceived response to treatment |  | Measured at baseline and 12 months. | 
| Health-related quality-of-life (via SF-36, AQoL questionnaires) |  | Measured at baseline and 12 months | 
| Recorded use of health care |  | Measured at baseline and 12 months |