Clinical trial NCT01763515: Laterally Wedged Insoles for Patients With Knee Osteoarthritis
Official title: The Effects of Laterally Wedged Insoles on Symptoms Reduction of Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Osteoarthritis, Knee
Keywords: Joint Diseases
Arthritis
Osteoarthritis
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-01-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in knee pain severity after 2 months.
timeFrame: Up to 2 months
Secondary outcomes:
measure: Change from baseline in knee's functional degree after 2 months.
timeFrame: Up to 2 months.
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Department of Rehabilitation, Alzahra Hospital
Study officials:
affiliation: Isfahan University of Medical Sciences
name: Farnaz Dehghan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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. doi: 10.1186/1471-2474-8-96.
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. doi: 10.1016/j.joca.2003.08.011.