Laterally Wedged Insoles for Patients With Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01763515
• Other study ID #: 13913008
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• First received: December 28, 2012
• Last updated: January 8, 2013
• Start date: October 2012
• Est. completion date: October 2013

Study information

• Verified date: January 2013
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: October 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Department of Rehabilitation, Alzahra Hospital	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (3)

Bennell K, Bowles KA, Payne C, Cicuttini F, Osborne R, Harris A, Hinman R. Effects of laterally wedged insoles on symptoms and disease progression in medial knee osteoarthritis: a protocol for a randomised, double-blind, placebo controlled trial. BMC Musculoskelet Disord. 2007 Sep 24;8:96. — View Citation

Hinman RS, Bowles KA, Bennell KL. Laterally wedged insoles in knee osteoarthritis: do biomechanical effects decline after one month of wear? BMC Musculoskelet Disord. 2009 Nov 25;10:146. doi: 10.1186/1471-2474-10-146. — View Citation

Pham T, Maillefert JF, Hudry C, Kieffert P, Bourgeois P, Lechevalier D, Dougados M. Laterally elevated wedged insoles in the treatment of medial knee osteoarthritis. A two-year prospective randomized controlled study. Osteoarthritis Cartilage. 2004 Jan;12(1):46-55. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	No