The Effects of Laterally Wedged Insoles on Symptoms Reduction of Patients With Knee Osteoarthritis
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Change from baseline in knee pain severity after 2 months.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Laterally wedged insoles (Procedure)
Outcomes
Primary Outcomes
Change from baseline in knee pain severity after 2 months.
Time Frame: Up to 2 months
The pain score (100 mm Visual Analogue Score ) is evaluated at baseline and then after 2 months of therapy.
Secondary Outcomes
- Change from baseline in knee's functional degree after 2 months.(Up to 2 months.)
Investigators
Farnaz Dehgan Hosseinabadi
Dr.
Isfahan University of Medical Sciences