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

This study is currently recruiting participants.

Verified by University of Melbourne, December 2006

Sponsors and Collaborators:	University of Melbourne National Health and Medical Research Council, Australia
Information provided by:	University of Melbourne
ClinicalTrials.gov Identifier:	NCT00415259

Purpose

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.

Condition	Intervention
Osteoarthritis	Device: Laterally wedged shoe insoles

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Further study details as provided by University of Melbourne:

Estimated Enrollment:	200
Study Start Date:	May 2005
Estimated Study Completion Date:	December 2008

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00415259

Locations

Australia, Victoria
Centre for Health Exercise & Sports Medicine, School of Physiotherapy, The University of Melbourne	Recruiting
Melbourne, Victoria, Australia, 3010
Contact: Kim L Bennell, PhD +61 3 8344 44135 k.bennell@unimelb.edu.au
Principal Investigator: Kim Bennell, PhD
Sub-Investigator: Rana Hinman, BPhysio(Hons), PhD
Sub-Investigator: Craig Payne, PhD
Sub-Investigator: Flavia Ciccuttini, PhD
Sub-Investigator: Anthony Harris, PhD

Sponsors and Collaborators

University of Melbourne

National Health and Medical Research Council, Australia

Investigators

Principal Investigator:

Kim Bennell, PhD

University of Melbourne

More Information

Study ID Numbers:	350297
Study First Received:	December 21, 2006
Last Updated:	December 21, 2006
ClinicalTrials.gov Identifier:	NCT00415259
Health Authority:	Australia: National Health and Medical Research Council; Australia: Department of Human Services Radiation Safety Commitee; Australia: Human Research Ethics Committee

Study placed in the following topic categories:

Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases

Arthritis
Disease Progression
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 16, 2009