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

January 15, 2013 updated by: Kim Bennell, University of Melbourne
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3010
        • Centre for Health Exercise & Sports Medicine, School of Physiotherapy, The University of Melbourne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laterally wedged shoe insoles
Full-length 5 degree lateral wedged insoles worn inside the shoes daily for 12 months
Device: Laterally wedged shoe insoles
Full-length 5 degree lateral wedged insoles worn inside the shoes daily for 12 months
Other: Flat control insoles
Device: Control insole group
Flat control insoles worn inside the shoes daily for 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Knee pain via a visual analogue scale
Time Frame: Measured at baseline and 12 months
Measured at baseline and 12 months
Disease progression via MRI measurements of knee cartilage volume
Time Frame: Measured at baseline and 12 months
Measured at baseline and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Western Ontario and McMaster Universities (WOMAC) Oestoarthritis Index
Time Frame: Measured at baseline and 12 months
Measured at baseline and 12 months
Patient perceived response to treatment
Time Frame: Measured at baseline and 12 months.
Measured at baseline and 12 months.
Health-related quality-of-life (via SF-36, AQoL questionnaires)
Time Frame: Measured at baseline and 12 months
Measured at baseline and 12 months
Recorded use of health care
Time Frame: Measured at baseline and 12 months
Measured at baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Melbourne

Collaborators

National Health and Medical Research Council, Australia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

December 21, 2006

First Submitted That Met QC Criteria

December 21, 2006

First Posted (Estimate)

December 22, 2006

Study Record Updates

Last Update Posted (Estimate)

January 17, 2013

Last Update Submitted That Met QC Criteria

January 15, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 350297

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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