Munteanu, SE, Landorf, KB, McClelland, JA, Roddy, E ORCID: https://orcid.org/0000-0002-8954-7082, Cicuttini, FM, Shiell, A, Auhl, M, Allan, JJ, Buldt, AK and Menz, HB ORCID: https://orcid.org/0000-0002-2045-3846 (2021) Shoe-stiffening inserts for first metatarsophalangeal joint osteoarthritis: a randomised trial. Osteoarthritis and Cartilage, 29 (4).

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Abstract

OBJECTIVE: To evaluate the efficacy of carbon-fibre shoe-stiffening inserts in individuals with first metatarsophalangeal joint osteoarthritis. DESIGN: This was a randomised, sham-controlled, participant- and assessor-blinded trial. One hundred participants with first metatarsophalangeal joint osteoarthritis received rehabilitation therapy and were randomised to receive either carbon fibre shoe-stiffening inserts (n = 49) or sham inserts (n = 51). The primary outcome measure was the Foot Health Status Questionnaire (FHSQ) pain domain assessed at 12 weeks. RESULTS: All 100 randomised participants (mean age 57.5 (SD 10.3) years; 55 (55%) women) were included in the analysis of the primary outcome. At the 12 week primary endpoint, there were 13 drop-outs (7 in the sham insert group and 6 in the shoe-stiffening insert group), giving completion rates of 86 and 88%, respectively. Both groups demonstrated improvements in the FHSQ pain domain score at each follow-up period, and there was a significant between-group difference in favour of the shoe-stiffening insert group (adjusted mean difference of 6.66 points, 95% CI 0.65 to 12.67, P = 0.030). There were no between-group differences for the secondary outcomes, although global improvement was more common in the shoe-stiffening insert group compared to the sham insert group (61 vs 34%, RR 1.73, 95% CI 1.05 to 2.88, P = 0.033; number needed to treat 4, 95% CI 2 to 16). CONCLUSION: Carbon-fibre shoe-stiffening inserts were more effective at reducing foot pain than sham inserts at 12 weeks. These results support the use of shoe-stiffening inserts for the management of this condition, although due to the uncertainty around the effect on the primary outcome, some individuals may not experience a clinically worthwhile improvement.

Item Type: Article
Additional Information: The final version of this accepted manuscript and all relevant information related to it can be found online at; https://www.oarsijournal.com/article/S1063-4584(21)00037-6/fulltext
Subjects: R Medicine > R Medicine (General) > R735 Medical education. Medical schools. Research
R Medicine > RA Public aspects of medicine
R Medicine > RC Internal medicine > RC925 Diseases of the musculoskeletal system
Divisions: Faculty of Medicine and Health Sciences > School of Primary, Community and Social Care
Related URLs:
Depositing User: Symplectic
Date Deposited: 29 Apr 2021 15:43
Last Modified: 29 Apr 2021 15:43
URI: https://eprints.keele.ac.uk/id/eprint/9400

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