Laterally Wedged Insoles for Patients With Knee Osteoarthritis

Isfahan University of Medical Sciences

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Osteoarthritis, Knee

Treatments: Procedure: Laterally wedged insoles

Study type: Interventional

Funder types: Other

Identifiers

NCT01763515

13913008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Laterally wedged insoles

Experimental group

Description:

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.

Treatment:

Procedure: Laterally wedged insoles