Laterally Wedged Insoles for Patients With Knee Osteoarthritis

NCT ID: NCT01763515

Last Updated: 2013-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-10-31

Brief Summary

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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

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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.

Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Laterally wedged insoles

Intervention Type PROCEDURE

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.

Interventions

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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 Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Isfahan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Farnaz Dehgan Hosseinabadi

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Farnaz Dehghan, MD

Role: PRINCIPAL_INVESTIGATOR

Isfahan University of Medical Sciences

Locations

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Department of Rehabilitation, Alzahra Hospital

Isfahan, Isfahan, Iran

Site Status

Countries

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Iran

References

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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.

Reference Type BACKGROUND
PMID: 19939281 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17892539 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14697682 (View on PubMed)

Other Identifiers

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13913008

Identifier Type: -

Identifier Source: org_study_id

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