Splinting for thumb carpometacarpal osteoarthritis: protocol for a feasibility randomized controlled trial
Buhler, Miranda; Chapple, Cathy; Stebbings, Simon; Adams, Jo; Gwynne-Jones, David; Baxter, G. David
Background: Evidence for the use of splints to reduce pain and improve function and quality of life in thumb carpometacarpal osteoarthritis (CMC OA) is sparse and poor despite recommendations by international guidelines. Objective: To outline the protocol for a study designed to determine the feasibility of conducting a fully powered pragmatic randomised controlled trial (RCT) comparing soft splint vs no splint for thumb CMC OA. Methods: The proposed pragmatic, assessor-blinded, and partial participant blinded parallel-group feasibility RCT will recruit 30 adults with thumb CMC OA and randomise to: splint intervention or usual care control. Randomisation will be stratified by hand dominance. Primary feasibility outcomes are recruitment rate over a 4-month period, retention rate at 6 months, intervention acceptability, and rate of adverse events. Study costs, intervention fidelity, and clinical outcomes will also be evaluated. Measurements will be collected at baseline, 4 weeks, and 6 months post-initiation of treatment. This trial has been registered with the Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12618001639213. Major Findings: N/A Conclusions: If shown to be effective, soft off-the shelf splints would be a good first-line non-pharmacological, non-surgical option for thumb CMC OA as prescribed by health professionals or accessed directly by patients. This feasibility study will inform a future, fully powered RCT as evaluated by success of the recruitment strategy; assessment time and acceptability; implementation and evaluation of 'usual care'; and intervention procedures and adherence.
Publisher: Taylor & Francis Group
Rights Statement: This is a PDF file of an un-revised, unedited pre-print version of a manuscript accepted for publication. The Version of Record of this manuscript has been published and is available in Physical Therapy Reviews 13 May 2020 http://www.tandfonline.com/10.1080/10833196.2020.1763662 Journal copyright statement: "In consideration of the publication of the Article, you hereby grant with full title guarantee all rights of copyright and related rights in the above specified Article as the Version of Scholarly Record which is intended for publication in all forms and all media (whether known at this time or developed at any time in the future) throughout the world, in all languages, for the full term of copyright, to take effect if and when the Article is accepted for publication in the Journal." The Author retains the right "to post and maintain at any time the Author's Original Manuscript (AOM; your manuscript in its original and unrefereed form; a 'preprint')".
Keywords: Thumb; Carpometacarpal; Trapeziometacarpal; Osteoarthritis; Splinting; Randomized controlled trial; Feasibility study
Research Type: Journal Article
Physical Therapy Reviews is an online journal and has no pagination.
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