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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

Shoe-stiffening inserts for first metatarsophalangeal joint osteoarthritis (the SIMPLE trial): study protocol for a randomised controlled trial

Authors: Shannon E. Munteanu, Karl B. Landorf, Jodie A. McClelland, Edward Roddy, Flavia M. Cicuttini, Alan Shiell, Maria Auhl, Jamie J. Allan, Andrew K. Buldt, Hylton B. Menz

Published in: Trials | Issue 1/2017

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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: ACTRN12616000552​482. Registered on 28 April 2016.
Appendix
Available only for authorised users
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Metadata
Title
Shoe-stiffening inserts for first metatarsophalangeal joint osteoarthritis (the SIMPLE trial): study protocol for a randomised controlled trial
Authors
Shannon E. Munteanu
Karl B. Landorf
Jodie A. McClelland
Edward Roddy
Flavia M. Cicuttini
Alan Shiell
Maria Auhl
Jamie J. Allan
Andrew K. Buldt
Hylton B. Menz
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-1936-1

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