Journal article
The clinical and cost effectiveness of splints for thumb base osteoarthritis: a randomized controlled clinical trial
- Abstract:
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Objectives To investigate the clinical effectiveness, efficacy and cost effectiveness of splints (orthoses) in people with symptomatic basal thumb joint OA (BTOA).
Methods A pragmatic, multicentre parallel group randomized controlled trial at 17 National Health Service (NHS) hospital departments recruited adults with symptomatic BTOA and at least moderate hand pain and dysfunction. We randomized participants (1:1:1) using a computer-based minimization system to one of three treatment groups: a therapist supported self-management programme (SSM), a therapist supported self-management programme plus a verum thumb splint (SSM+S), or a therapist supported self-management programme plus a placebo thumb splint (SSM+PS). Participants were blinded to group allocation, received 90 min therapy over 8 weeks and were followed up for 12 weeks from baseline. Australian/Canadian (AUSCAN) hand pain at 8 weeks was the primary outcome, using intention to treat analysis. We calculated costs of treatment.
Results We randomized 349 participants to SSM (n = 116), SSM+S (n = 116) or SSM+PS (n = 117) and 292 (84%) provided AUSCAN Osteoarthritis Hand Index hand pain scores at the primary end point (8 weeks). All groups improved, with no mean treatment difference between groups: SSM+S vs SSM −0.5 (95% CI: −1.4, 0.4), P = 0.255; SSM+PS vs SSM −0.1 (95% CI: −1.0, 0.8), P = 0.829; and SSM+S vs SSM+PS −0.4 (95% CI: −1.4, 0.5), P = 0.378. The average 12-week costs were: SSM £586; SSM+S £738; and SSM+PS £685.
Conclusion There was no additional benefit of adding a thumb splint to a high-quality evidence-based, supported self-management programme for thumb OA delivered by therapists.
Trial registration ISRCTN 54744256 (http://www.isrctn.com/ISRCTN54744256).
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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- Files:
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(Supplementary materials, 1.4MB, Terms of use)
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(Preview, Accepted manuscript, 972.7KB, Terms of use)
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- Publisher copy:
- 10.1093/rheumatology/keaa726
Authors
- Publisher:
- Oxford University Press
- Journal:
- Rheumatology More from this journal
- Volume:
- 60
- Issue:
- 6
- Pages:
- 2862–2877
- Publication date:
- 2020-11-30
- Acceptance date:
- 2020-10-19
- DOI:
- EISSN:
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1462-0332
- ISSN:
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1462-0324
- Language:
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English
- Keywords:
- Pubs id:
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1140342
- Local pid:
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pubs:1140342
- Deposit date:
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2020-11-03
Terms of use
- Copyright holder:
- Adams et al.
- Copyright date:
- 2020
- Rights statement:
- © The Authors 2020. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved.
- Notes:
- This is the accepted manuscript version of the article. The final version is available online from Oxford University Press at https://doi.org/10.1093/rheumatology/keaa726
- Licence:
- Other
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