Laterally Wedged Insoles for Patients With Knee Osteoarthritis

Phase 2

• Conditions: Osteoarthritis, Knee
• Interventions: Procedure: Laterally wedged insoles

• Registration Number: NCT01763515
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-12-28
• Status Verified: 2013-01
• Study First Submitted QC: 2013-01-08
• Last Update Submitted: 2013-01-08
• Study First Posted: 2013-01-09
• Last Update Posted: 2013-01-09
• Primary Completion: 2013-08
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laterally wedged insoles	Laterally wedged insoles	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in knee pain severity after 2 months.	Up to 2 months	The pain score (100 mm Visual Analogue Score ) is evaluated at baseline and then after 2 months of therapy.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in knee's functional degree after 2 months.	Up to 2 months.	Knee's functional degree (Edinburg Index) is evaluated at baseline and then 2 months after therapy.

Trial Locations

Locations (1)

Department of Rehabilitation, Alzahra Hospital; 🇮🇷 Isfahan, Iran, Islamic Republic of