1201966_Menz,H_2022.pdf (1.27 MB)
Footwear, foot orthoses and strengthening exercises for the non-surgical management of hallux valgus: protocol for a randomised pilot and feasibility trial
journal contributionposted on 2022-06-21, 05:57 authored by Hylton MenzHylton Menz, Polly LimPolly Lim, Sheree E Hurn, Karen MickleKaren Mickle, Andrew BuldtAndrew Buldt, Matthew CotchettMatthew Cotchett, Edward Roddy, Anita E Wluka, Bircan ErbasBircan Erbas, Shannon MunteanuShannon Munteanu
BACKGROUND: Hallux valgus is a common and disabling condition. This randomised pilot and feasibility trial aims to determine the feasibility of conducting a fully-powered parallel group randomised trial to evaluate the effectiveness of a multifaceted non-surgical intervention for reducing pain associated with hallux valgus. METHODS: Twenty-eight community-dwelling women with painful hallux valgus will be randomised to receive either a multifaceted, non-surgical intervention (footwear, foot orthoses, foot exercises, advice, and self-management) or advice and self-management alone. Outcome measures will be obtained at baseline, 4, 8 and 12 weeks. The primary outcome is feasibility, which will be evaluated according to demand, acceptability, adherence, adverse events, and retention rate. Limited efficacy testing will be conducted on secondary outcome measures including foot pain (the Manchester-Oxford Foot Questionnaire), foot muscle strength (hand-held dynamometry), general health-related quality of life (the Short Form-12), use of cointerventions, and participants' perception of overall treatment effect. Biomechanical testing will be conducted at baseline to evaluate the immediate effects of the footwear/orthotic intervention on pressure beneath the foot and on the medial aspect of the first metatarsophalangeal joint and hallux. DISCUSSION: This study will determine the feasibility of conducting a fully-powered randomised trial of footwear, foot orthoses, foot exercises, advice and self-management for relieving pain associated with hallux valgus and provide insights into potential mechanisms of effectiveness. TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registry ( ACTRN12621000645853 ).
This study is funded by the La Trobe University Research Focus Area in Sport, Exercise and Rehabilitation Grant-ready Scheme. The footwear was provided at a discounted cost by Global Footcare (Coomera, Queensland, Australia) and the foot orthoses were donated by Foot Science International (Christchurch, New Zealand). The funders were not involved in the design of the study, in the writing of the protocol, or in the decision to submit the manuscript for publication.
JournalJournal of Foot and Ankle Research
Rights Statement© The Author(s) 2022. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
Life Sciences & BiomedicineMILDMODERATEOLDER-PEOPLEOrthopedicsOUTCOMESPAINQUESTIONNAIRESCALESScience & TechnologySURGERYVALIDATIONAustraliaFeasibility StudiesFemaleFoot OrthosesHallux ValgusHumansPainPilot ProjectsQuality of LifeRandomized Controlled Trials as TopicTreatment OutcomeClinical Sciences not elsewhere classifiedPublic Health and Health Services not elsewhere classified