Effectiveness of Shoe Stiffening Inserts for First Metatarsophalangeal Joint Osteoarthritis: A Proof-of-Concept Study.

OBJECTIVE: The objective of this study was to determine the feasibility of shoe stiffening inserts to reduce pain in first metatarsophalangeal joint osteoarthritis. DESIGN: Thirty-one participants with first metatarsophalangeal joint osteoarthritis were prescribed shoe stiffening inserts and were evaluated at baseline and at 1 and 3 mos. The primary outcome measure was foot pain, assessed using the foot pain domain of the Foot Health Status Questionnaire (possible score ranges from 0 to 100). Secondary outcome measures included foot-related disability (foot function domain of the Foot Health Status Questionnaire), self-reported treatment effectiveness, use of rescue medication and other co-interventions, and adverse events. RESULTS: At 1 and 3 mos, statistically significant improvements in foot pain and foot-related disability were observed (mean difference at 3 mos: foot pain = 18.8, 95% confidence interval, 13.3-24.3; foot function = 11.8, 95% confidence interval, 4.3-17.3). Treatment was reported to be effective by 78% of participants. Few participants (4%) reported using pain-relieving medication. Minor adverse events were reported by 30% of participants. CONCLUSIONS: Full-length shoe stiffening inserts may be an effective intervention in first metatarsophalangeal joint osteoarthritis. However, further controlled studies are required.