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

University of Melbourne

Status

Completed

Conditions

Osteoarthritis

Treatments

Device: Control insole group

Device: Laterally wedged shoe insoles

Study type

Interventional

Funder types

Other

Identifiers

NCT00415259

350297

Details and patient eligibility

About

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.

Enrollment

200 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.