Footwear, foot orthoses and strengthening exercises for the non-surgical management of hallux valgus: protocol for a randomised pilot and feasibility trial.

Autor: Menz HB; School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, VIC, 3086, Australia. h.menz@latrobe.edu.au., Lim PQ; School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, VIC, 3086, Australia., Hurn SE; School of Clinical Sciences, Faculty of Health, Queensland University of Technology, Kelvin Grove, QLD, 4059, Australia., Mickle KJ; School of Environment and Life Sciences, College of Engineering, Science and Environment, University of Newcastle, Ourimbah, NSW, 2258, Australia., Buldt AK; School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, VIC, 3086, Australia., Cotchett MP; School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, VIC, 3086, Australia., Roddy E; Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, ST5 5BG, Staffordshire, UK.; Haywood Academic Rheumatology Centre, Midlands Partnership NHS Foundation Trust, Haywood Hospital, Burslem, ST6 7AG, Staffordshire, UK., Wluka AE; Department of Epidemiology and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, VIC, 3004, Australia., Erbas B; School of Psychology and Public Health, College of Science, Health and Engineering, La Trobe University, Melbourne, VIC, 3086, Australia., Munteanu SE; School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, VIC, 3086, Australia.
Jazyk: angličtina
Zdroj: Journal of foot and ankle research [J Foot Ankle Res] 2022 Jun 03; Vol. 15 (1), pp. 45. Date of Electronic Publication: 2022 Jun 03.
DOI: 10.1186/s13047-022-00553-4
Abstrakt: 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 ).
(© 2022. The Author(s).)
Databáze: MEDLINE
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