Effects of Shoes Insoles on Symptoms and Disease Progression in Knee Osteoarthritis

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

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2008-12-31

Brief Summary

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It is hypothesised that laterally wedged insoles will result in reduced knee pain and cartilage volume loss after 12 months of wear, compared to control insoles. People with symptomatic knee osteoarthritis will be recruited from the community and randomised to wear either laterally wedged insoles or control insoles for 12 months. Patients will be assessed at baseline and at 12 months.

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Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Laterally wedged shoe insoles

Full-length 5 degree lateral wedged insoles worn inside the shoes daily for 12 months

Group Type EXPERIMENTAL

Laterally wedged shoe insoles

Intervention Type DEVICE

Full-length 5 degree lateral wedged insoles worn inside the shoes daily for 12 months

Flat control insoles

Group Type OTHER

Control insole group

Intervention Type DEVICE

Flat control insoles worn inside the shoes daily for 12 months

Interventions

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Laterally wedged shoe insoles

Full-length 5 degree lateral wedged insoles worn inside the shoes daily for 12 months

Intervention Type DEVICE

Control insole group

Flat control insoles worn inside the shoes daily for 12 months

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Eligibility will be confirmed by radiographic and clinical examination
* People with medial tibiofemoral joint OA fulfilling American College of Rheumatology classification criteria and reporting average knee pain on walking \>3 on an 11-point scale
* varus knee malalignment on standing anteroposterior lower limb x-ray.

Exclusion Criteria

* advanced radiographic knee OA (Kellgren and Lawrence stage 4
* knee surgery or intra-articular corticosteroid injection within 6 months
* current or past (within 4 weeks) oral corticosteroid use
* systemic arthritic conditions
* history of tibiofemoral/patellofemoral joint replacement or tibial osteotomy
* any other muscular, joint or neurological condition affecting lower limb function
* ankle/foot pathology or pain that precludes the use of insoles
* use of foot orthotics within past 6 months and
* use of footwear that does not accomodate an insole.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No