IN RESPOND
Research type
Research Study
Full title
The effect of lateral wedge INsoles on pain in individuals with medial knee osteoarthritis who biomechanically RESPOND: The IN_RESPOND study
IRAS ID
169340
Contact name
David Felson
Contact email
Sponsor organisation
The University of Manchester
Duration of Study in the UK
2 years, 1 months, 31 days
Research summary
Knee osteoarthritis (OA) is the most common cause of knee pain and few effective treatments for it exist. For the most common type of knee osteoarthritis, the type affecting the inner (medial) side of the knee, special wedge insoles that fit inside the shoe have been recommended because they reduce the load (a force that is put on a weight bearing joint during activity) across the medial side of the knee. However, trials of these wedges have shown that, on average, they don’t reduce knee pain. The studies of loading have found that the wedge’s effect on medial load is extremely inconsistent and that in many persons, the wedge can increase or worsen load. Further, osteoarthritis in the knee cap may get worse if medial load is reduced.
Bone marrow lesions (or BMLs) are bruises to the bone and are common in knees with OA. These lesions occur in areas where there is increased stress on bone due to knee misalignment. BMLs are strongly associated with the progression of osteoarthritis and pain. Targeting BMLs for treatment means attempting to correct the misalignment therefore reducing stress on the bone. An approach to reduce knee loading with insoles should therefore, also reduce the volume of these medial bone bruises.
The IN RESPOND study proposes to re-evaluate the effect of wedge insoles on medial knee osteoarthritis. We will carry out a randomised trial of wedge insoles vs. a placebo, a neutral shoe insole, evaluating pain and also examining whether the reduction in medial load leads to a reduction in bone bruising that can be seen and measured on an MRI scan.
REC name
North West - Preston Research Ethics Committee
REC reference
15/NW/0158
Date of REC Opinion
6 Mar 2015
REC opinion
Favourable Opinion