Lateral Wedge Insole With Subtalar Strapping for Knee Osteoarthritis

Study Overview
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Brief Summary
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This is a clinical study to evaluate the efficacy of a lateral wedge insole with subtalar strapping in knee osteoarthritis treatment.

Detailed Description
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The objective of this study is to evaluate the efficacy of a lateral wedge insole with subtalar strapping in knee osteoarthritis treatment. Fifty-eight patients with knee osteoarthritis were randomized to use either a lateral wedge or a neutral insole. VAS, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Lequesne questionnaires were applied at baseline, and weeks two, eight, and 24.

Official Title
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Lateral Wedge Insole With Subtalar Strapping for Knee Osteoarthritis: a Randomized Clinical Trial

Conditions
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Osteoarthritis

Intervention / Treatment
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* Other: Neutral insole with subtalar strapping (sham)
* Other: Lateral wedge insole with subtalar strapping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet the American College of Rheumatology criteria for knee Osteoarthritis Varus malalignment of the knee Absence of previous fracture on the index knee Absence of previous surgery on the index knee Absence of Rheumatoid Arthritis No Intra-articular injection on the index knee in the past 6 months Receiving usual care for Osteoarthritis for at least 6 months Be able to understand and agree with the informed consent Exclusion Criteria: Undergo surgery during the study Undergo Intra-articular injection during the study Develop articular infection of the index joint during the study
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wedge<br>Lateral wedge insole with subtalar strapping Use of lateral wedge insoles with subtalar strapping for 5 to 10 hours daily | Other: Lateral wedge insole with subtalar strapping<br>* Lateral wedge insole with subtalar strapping<br>* Other names: Wedge;|
| Sham Comparator: Neutral<br>Neutral insole with subtalar strapping (sham) Use of neutral insoles with subtalar strapping for 5 to 10 hours daily | Other: Neutral insole with subtalar strapping (sham)<br>* Neutral insole with subtalar strapping (sham)<br>* Other names: Neutral;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms | Evaluation of patient's symptoms using WOMAC (western ontario and mcmaster universities osteoarthritis index), VAS (visual analogic scale of pain) and Lequesne questionaires | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ankle pain | Number of patients that reported ankle pain related to the use of the insole as a measure of tolerability | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, osteoarthritis, knee, foot orthoses, orthotic insoles