Walking shoes and laterally wedged orthoses in the clinical management of medial tibiofemoral osteoarthritis: a one-year prospective controlled trial.

The purpose of the study was to examine the clinical efficacy of individually prescribed laterally wedged orthoses and walking shoes in the treatment of medial knee osteoarthritis using a prospective, single-blind, block-randomized controlled design. Sixty-six subjects (29 males, 37 females, mean age 62.4 years, mean BMI 33.0 kg/m(2)) were block-randomized to a lateral wedge (treatment) or neutral (control) orthotic group. Both groups were issued a standardized walking shoe for use with the orthoses. Primary outcome measures included the pain, stiffness, and functional limitations subscales of the Western Ontario and McMaster Universities index. Secondary outcome measures included the 6-minute walk distance and pain change, and stair negotiation time and pain change. A significant interaction (p=0.039) favoring the treatment group was observed for pain change during the 6-minute walk. The treatment group demonstrated significant improvements at both 1 month (p<0.001) and 1 year (p<0.001) compared to baseline. The control group only demonstrated significant improvements at 1 year (p=0.017). No other interactions were observed. Both groups were improved at each follow-up in the WOMAC subscales for pain (p<0.001), stiffness (p<0.001), and physical function (p<0.001). Both groups also improved in 6-minute walk test distance (p<0.001), stair negotiation test time (p=0.004), and stair negotiation test pain change (p<0.001). The results suggest that both neutral and laterally wedged orthoses may be beneficial in the management of medial knee osteoarthritis when used with walking shoes. However, the addition of lateral wedging was associated with early improvements in 6-minute walk test pain change not seen in the control group.