Munteanu, SE and Landorf, KB and McClelland, JA and Roddy, E and Cicuttini, FM and Shiell, A and Auhl, M and Allan, JJ and Buldt, AK and Menz, HB (2017) Shoe-stiffening inserts for first metatarsophalangeal joint osteoarthritis (the SIMPLE trial): study protocol for a randomised controlled trial. Trials, 18 (1). 198 - ?. ISSN 1745-6215

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Abstract

BACKGROUND: This article describes the design of a parallel-group, participant- and assessor-blinded randomised controlled trial comparing the effectiveness of shoe-stiffening inserts versus sham shoe insert(s) for reducing pain associated with first metatarsophalangeal joint (MTPJ) osteoarthritis (OA). METHODS: Ninety participants with first MTPJ OA will be randomised to receive full-length shoe-stiffening insert(s) (Carbon Fibre Spring Plate, Paris Orthotics, Vancouver, BC, Canada) plus rehabilitation therapy or sham shoe insert(s) plus rehabilitation therapy. Outcome measures will be obtained at baseline, 4, 12, 24 and 52 weeks; the primary endpoint for assessing effectiveness being 12 weeks. The primary outcome measure will be the foot pain domain of the Foot Health Status Questionnaire (FHSQ). Secondary outcome measures will include the function domain of the FHSQ, severity of first MTPJ pain (using a 100-mm Visual Analogue Scale), global change in symptoms (using a 15-point Likert scale), health status (using the Short-Form-12® Version 2.0 and EuroQol (EQ-5D-5L™) questionnaires), use of rescue medication and co-interventions, self-reported adverse events and physical activity levels (using the Incidental and Planned Activity Questionnaire). Data will be analysed using the intention-to-treat principle. Economic analysis (cost-effectiveness and cost-utility) will also be performed. In addition, the kinematic effects of the interventions will be examined at 1 week using a three-dimensional motion analysis system and multisegment foot model. DISCUSSION: This study will determine whether shoe-stiffening inserts are a cost-effective intervention for relieving pain associated with first MTPJ OA. The biomechanical analysis will provide useful insights into the mechanism of action of the shoe-stiffening inserts. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, identifier: ACTRN12616000552482 . Registered on 28 April 2016.

Item Type: Article
Additional Information: This is the final published version of the article (version of record). It first appeared online via BioMed Central at http://dx.doi.org/10.1186/s13063-017-1936-1 - please refer to any applicable terms of use of the publisher.
Uncontrolled Keywords: Osteoarthritis, Metatarsophalangeal joint, Hallux rigidus, Foot orthoses
Subjects: R Medicine > RC Internal medicine > RC925 Diseases of the musculoskeletal system
Divisions: Faculty of Medicine and Health Sciences > Primary Care Health Sciences
Related URLs:
Depositing User: Symplectic
Date Deposited: 22 May 2017 09:35
Last Modified: 22 May 2017 10:07
URI: http://eprints.keele.ac.uk/id/eprint/3481

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