Splinting for thumb carpometacarpal osteoarthritis: protocol for a feasibility randomized controlled trial
Splinting for thumb carpometacarpal osteoarthritis: protocol for a feasibility randomized controlled trial
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 randomized 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. Randomization 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.
Thumb, carpometacarpal, feasibility study, osteoarthritis, randomized controlled trial, splinting, trapeziometacarpal
196-204
Buhler, M.
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Chapple, C.M.
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Stebbings, S.
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Adams, J.
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Gwynne-jones, D.
b4f3a760-fa4c-419d-bb10-a577969d6da4
Baxter, G.D.
96260719-c9c6-4f7c-b51e-8f0a024a56e3
Buhler, M.
8268fa45-3fb1-47ab-94e0-212683abf1a4
Chapple, C.M.
01a9189c-86ff-44f8-af2e-28a78f0eecf4
Stebbings, S.
1d79a80d-6d98-4ad9-bb23-7ec582d235d1
Adams, J.
6e38b8bb-9467-4585-86e4-14062b02bcba
Gwynne-jones, D.
b4f3a760-fa4c-419d-bb10-a577969d6da4
Baxter, G.D.
96260719-c9c6-4f7c-b51e-8f0a024a56e3
Buhler, M., Chapple, C.M., Stebbings, S., Adams, J., Gwynne-jones, D. and Baxter, G.D.
(2020)
Splinting for thumb carpometacarpal osteoarthritis: protocol for a feasibility randomized controlled trial.
Physical Therapy Reviews, 25 (3), .
(doi:10.1080/10833196.2020.1763662).
Abstract
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 randomized 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. Randomization 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.
Text
Splinting for thumb carpometacarpal osteoarthritis protocol for a feasibility randomized controlled trial
- Accepted Manuscript
More information
Accepted/In Press date: 27 April 2020
e-pub ahead of print date: 13 May 2020
Additional Information:
Funding Information:
An industry partner (At Therapy, Auckland, New Zealand) will supply the splints and loan of a pinch grip assessment equipment at no cost, with no influence on study design, data analysis or reporting. Ms Buhler’s work is supported by a University of Otago Doctoral Scholarship and the Centre for Health, Activity and Rehabilitation Research, School of Physiotherapy, University of Otago. The authors thank the Hand Therapy New Zealand-registered hand therapists who participated in the stakeholder focus groups and interview for the development of the standardized usual care and splint intervention: Amy Wang, Kirsty Clunie, Julie Collis, Diana Edwards, Shirley Collocott, Elaine Duguid, Evangeline Leys, Helen Hills, and Jane Sweeney.
Publisher Copyright:
© 2020 Informa UK Limited, trading as Taylor & Francis Group.
Keywords:
Thumb, carpometacarpal, feasibility study, osteoarthritis, randomized controlled trial, splinting, trapeziometacarpal
Identifiers
Local EPrints ID: 441398
URI: http://eprints.soton.ac.uk/id/eprint/441398
ISSN: 1083-3196
PURE UUID: 742865bf-4113-4266-8a25-055ea144a169
Catalogue record
Date deposited: 11 Jun 2020 16:31
Last modified: 17 Mar 2024 05:39
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Contributors
Author:
M. Buhler
Author:
C.M. Chapple
Author:
S. Stebbings
Author:
D. Gwynne-jones
Author:
G.D. Baxter
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