NDLI: Foot orthoses for first metatarsophalangeal joint osteoarthritis: study protocol for the FORT randomised controlled trial

Content Provider	Springer Nature : BioMed Central
Author	Paterson, Kade L. Hinman, Rana S. Metcalf, Ben R. Jones, Sarah E. Menz, Hylton B. Munteanu, Shannon E. Kasza, Jessica Bennell, Kim L.
Abstract	Background First metatarsophalangeal (MTP) joint osteoarthritis (OA) is a painful and debilitating condition affecting nearly one in 10 people aged over 50 years. Non-drug, non-surgical treatments are recommended by OA clinical guidelines, yet there have only ever been two randomised controlled trials (RCTs) evaluating such strategies in people with first MTP joint OA. Foot orthoses are a common non-drug, non-surgical strategy used by allied health professionals for people with first MTP joint OA, however, it is unknown whether these devices are effective in improving the symptoms associated with the condition. This clinical trial aimed to determine whether contoured foot orthoses lead to greater reductions in first MTP joint pain on walking compared to sham flat insoles in people with first MTP joint OA. Methods The FORT trial (Foot ORthoses for big Toe joint osteoarthritis) is a two-arm participant- and assessor-blinded, multi-site RCT conducted in Melbourne, Sydney, Brisbane and the Gold Coast, Australia. We are recruiting 88 community-dwelling people with symptomatic radiographic first MTP joint OA. Following baseline assessment, participants are randomized to receive either: i) contoured foot orthoses; or ii) sham flat insoles following baseline assessment. Participants have two visits with a study podiatrist where they are provided with their allocated insoles, to be worn daily for 12 weeks at all times when wearing shoes. The primary outcome is self-reported first MTP joint pain on walking (numerical rating scale), assessed at baseline and 12 weeks. Secondary outcomes include additional measures of first MTP joint and foot pain, physical function, quality of life, participant-perceived global ratings of change (pain and function), and level of physical activity. Discussion This study will provide novel evidence about whether contoured foot orthoses improve pain and other symptoms compared to sham insoles in people with first MTP joint OA. Outcomes will help to inform clinical guidelines and practice about the use of foot orthoses for managing symptoms in this under-researched group of people with OA. Trial registration Prospectively registered with the Australian New Zealand Clinical Trials Registry (reference: ACTRN12619000926134 ) on 3/07/2019.
Related Links	https://bmcmusculoskeletdisord.biomedcentral.com/counter/pdf/10.1186/s12891-020-03809-x.pdf
Ending Page	9
Page Count	9
Starting Page	1
File Format	HTM / HTML
ISSN	14712474
DOI	10.1186/s12891-020-03809-x
Journal	BMC Musculoskeletal Disorders
Issue Number	1
Volume Number	21
Language	English
Publisher	BioMed Central
Publisher Date	2020-12-10
Access Restriction	Open
Subject Keyword	Orthopedics Rehabilitation Rheumatology Sports Medicine Internal Medicine Epidemiology Osteoarthritis OA Foot Metatarsophalangeal Orthoses Insoles Clinical trial RCT Biomechanics Pain
Content Type	Text
Resource Type	Article
Subject	Orthopedics and Sports Medicine Rheumatology
Journal Impact Factor	2.2/2023
5-Year Journal Impact Factor	2.6/2023

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