Effect of foot orthoses vs sham insoles on first metatarsophalangeal joint osteoarthritis symptoms: a randomized controlled trial

KL Paterson; RS Hinman; BR Metcalf; F McManus; SE Jones; HB Menz; SE Munteanu; KL Bennell

Journal article

Effect of foot orthoses vs sham insoles on first metatarsophalangeal joint osteoarthritis symptoms: a randomized controlled trial

KL Paterson, RS Hinman, BR Metcalf, F McManus, SE Jones, HB Menz, SE Munteanu, KL Bennell

Osteoarthritis and Cartilage | Published : 2022

DOI: 10.1016/j.joca.2022.01.014

Abstract

Objectives: To compare contoured foot orthoses to sham flat insoles for first MTP joint OA walking pain. Design: This was a participant- and assessor-blinded, sham-controlled, multi-centre randomized clinical trial set in community-based private practices. Eighty-eight adults aged ≥45 years with symptomatic radiographic first MTP joint OA were randomized to receive contoured foot orthoses (n = 47) or sham flat insoles (n = 41), worn at all times when wearing shoes for 12 weeks. Primary outcome was change in first MTP joint walking pain (11-point numerical rating scale (NRS), 0–10) over 12 weeks. Secondary outcomes included additional first MTP joint and foot pain measures, physical function,..

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University of Melbourne Researchers

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Grants

Awarded by University of Melbourne

Funding Acknowledgements

This study is funded by the National Health and Medical Research Council (Program Grant #1124418). KLP is supported by a National Health & Medical Research Council Emerging Leadership Investigator Grant (#1174229). KLB is supported by a National Health & Medical Research Council Leadership Investigator Grant (#1174431). RSH is supported by a National Health & Medical Research Council Senior Research Fellowship (#1154217). HBM is supported by a National Health & Medical Research Council Senior Research Fellowship (#1135995). Foot orthoses and sham insoles were provided by Foot Science International at no cost. The study sponsor (University of Melbourne) and National Health & Medical Research Council, had no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the article for publication.