Effects of laterally wedged insoles on symptoms and disease progression in medial knee osteoarthritis: A protocol for a randomised, double-blind, placebo controlled trial

Abstract

Background. Whilst laterally wedged insoles, worn inside the shoes, are advocated as a simple, inexpensive, non-toxic self-administered intervention for knee osteoarthritis (OA), there is currently limited evidence to support their use. The aim of this randomised, double-blind controlled trial is to determine whether laterally wedges insoles lead to greater improvements in knee pain, physical function and health-related quality of life, and slower structural disease progression as well as being more cost-effective, than control flat insoles in people with medial knee OA. Methods/Design. Two hundred participants with painful radiographic medial knee OA and varus malalignment will be recruited..