Abstract
Wedged insoles are believed to be of clinical benefit to individuals with knee osteoarthritis by reducing the knee adduction moment (KAM) during gait. However, previous clinical trials have not specifically controlled for KAM reduction at baseline, thus it is unknown if reduced KAMs actually confer a clinical benefit. Forty-eight participants with medial knee osteoarthritis were randomly assigned to either a control group where no footwear intervention was given, or a wedged insole group where KAM reduction was confirmed at baseline. KAMs, Knee Injury and Osteoarthritis Outcome Score (KOOS) and Physical Activity Scale for the Elderly (PASE) scores were measured at baseline. KOOS and PASE surveys were re-administered at three months follow-up. The wedged insole group did not experience a statistically significant or clinically meaningful change in KOOS pain over three months (p = 0.173). Furthermore, there was no association between change in KAM magnitude and change in KOOS pain over three months within the wedged insole group (R2 = 0.02, p = 0.595). Improvement in KOOS pain for the wedged insole group was associated with worse baseline pain, and a change in PASE score over the three month study (R2 = 0.57, p = 0.007). As an exploratory comparison, there was no significant difference in change in KOOS pain (p = 0.49) between the insole and control group over three months. These results suggest that reduced KAMs do not appear to provide any clinical benefit compared to no intervention over a follow-up period of three months. ClinicalTrials.gov ID Number: NCT02067208 © 2016 Elsevier B.V.