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

University of Melbourne1 site in 1 country200 target enrollmentMay 2005

ConditionsOsteoarthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteoarthritis
Sponsor: University of Melbourne
Enrollment: 200
Locations: 1
Primary Endpoint: Knee pain via a visual analogue scale
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 2005

End Date

December 2008

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Melbourne

Responsible Party

Principal Investigator

Kim Bennell

Professor Kim Bennell

University of Melbourne

Eligibility 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.

Outcomes

Primary Outcomes

Knee pain via a visual analogue scale

Time Frame: Measured at baseline and 12 months

Disease progression via MRI measurements of knee cartilage volume

Time Frame: Measured at baseline and 12 months

Secondary Outcomes

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