Laterally Wedged Insoles for Patients With Knee Osteoarthritis

Study Overview
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Brief Summary
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Knee osteoarthritis is a common problem with the disease prevalence increasing with advancing age. This study will be performed in the purpose of determination the effects of laterally wedged insoles on symptoms reduction of patients with knee osteoarthritis.

Detailed Description
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Knee osteoarthritis is a common problem with the disease prevalence increasing with advancing age. Because of the high incidence of knee osteoarthritis in the elderly and the seriousness of drug effects in this age group and lack of controlled study in our country regarding the possible benefits or lack of benefit of laterally wedged insoles in patients with knee osteoarthritis and also due to strike, and results of mixed in other studies, this study will be performed in the purpose of determination the effects of laterally wedged insoles on symptoms reduction of patients with knee osteoarthritis.

Official Title
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The Effects of Laterally Wedged Insoles on Symptoms Reduction of Patients With Knee Osteoarthritis

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Procedure: Laterally wedged insoles


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic medial femorotibial knee OA, Daily knee pain for at least 1 month in the last 3 months, Radiographic evidence of medial femorotibial knee OA, Normal erythrocyte sedimentation rate. Exclusion Criteria: Secondary knee OA, hip OA, symptomatic foot deformities, articular space loss more or the same as lateral femorotibial side in radiography, Knee joint lavage in past 3 months, Intra-articular corticosteroid injection during the past 3 months, Tibial osteotomy during last 5 years and changes in drug treatment for OA during last week.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laterally wedged insoles<br>Patients will use laterally wedged insoles with 5o tilt toward medial side and made of ethylene vinyl acetate coated with leather. The medial thickness is 4 mm with lateral thickness of 10 mm. | Procedure: Laterally wedged insoles<br>* Patients will use laterally wedged insoles with 5o tilt toward medial side and made of ethylene vinyl acetate coated with leather. The medial thickness is 4 mm with lateral thickness of 10 mm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in knee pain severity after 2 months. | The pain score (100 mm Visual Analogue Score ) is evaluated at baseline and then after 2 months of therapy. | Up to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in knee's functional degree after 2 months. | Knee's functional degree (Edinburg Index) is evaluated at baseline and then 2 months after therapy. | Up to 2 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Joint Diseases, Arthritis, Osteoarthritis