The clinical and cost effectiveness of splints for thumb base osteoarthritis: a randomized controlled clinical trial

<p><strong>Objectives</strong> To investigate the clinical effectiveness, efficacy and cost effectiveness of splints (orthoses) in people with symptomatic basal thumb joint OA (BTOA).</p> <p><strong>Methods</strong> A pragmatic, multicentre parallel group r...

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Main Authors: Adams, J, Barratt, P, Rombach, I, Arden, N, Barbosa Bouças, S, Bradley, S, Doherty, M, Dutton, SJ, Gooberman-Hill, R, Hislop-Lennie, K, Hutt-Greenyer, C, Jansen, V, Luengo-Fernadez, R, Williams, M, Dziedzic, K
Format: Journal article
Language:English
Published: Oxford University Press 2020
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author Adams, J
Barratt, P
Rombach, I
Arden, N
Barbosa Bouças, S
Bradley, S
Doherty, M
Dutton, SJ
Gooberman-Hill, R
Hislop-Lennie, K
Hutt-Greenyer, C
Jansen, V
Luengo-Fernadez, R
Williams, M
Dziedzic, K
author_facet Adams, J
Barratt, P
Rombach, I
Arden, N
Barbosa Bouças, S
Bradley, S
Doherty, M
Dutton, SJ
Gooberman-Hill, R
Hislop-Lennie, K
Hutt-Greenyer, C
Jansen, V
Luengo-Fernadez, R
Williams, M
Dziedzic, K
author_sort Adams, J
collection OXFORD
description <p><strong>Objectives</strong> To investigate the clinical effectiveness, efficacy and cost effectiveness of splints (orthoses) in people with symptomatic basal thumb joint OA (BTOA).</p> <p><strong>Methods</strong> 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.</p> <p><strong>Results</strong> 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.</p> <p><strong>Conclusion</strong> 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.</p> <p><strong>Trial registration</strong> ISRCTN 54744256 (http://www.isrctn.com/ISRCTN54744256).</p>
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spelling oxford-uuid:4608a661-49f6-4338-bd54-cd571a331bf62022-03-26T15:11:23ZThe clinical and cost effectiveness of splints for thumb base osteoarthritis: a randomized controlled clinical trialJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:4608a661-49f6-4338-bd54-cd571a331bf6EnglishSymplectic ElementsOxford University Press2020Adams, JBarratt, PRombach, IArden, NBarbosa Bouças, SBradley, SDoherty, MDutton, SJGooberman-Hill, RHislop-Lennie, KHutt-Greenyer, CJansen, VLuengo-Fernadez, RWilliams, MDziedzic, K<p><strong>Objectives</strong> To investigate the clinical effectiveness, efficacy and cost effectiveness of splints (orthoses) in people with symptomatic basal thumb joint OA (BTOA).</p> <p><strong>Methods</strong> 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.</p> <p><strong>Results</strong> 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.</p> <p><strong>Conclusion</strong> 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.</p> <p><strong>Trial registration</strong> ISRCTN 54744256 (http://www.isrctn.com/ISRCTN54744256).</p>
spellingShingle Adams, J
Barratt, P
Rombach, I
Arden, N
Barbosa Bouças, S
Bradley, S
Doherty, M
Dutton, SJ
Gooberman-Hill, R
Hislop-Lennie, K
Hutt-Greenyer, C
Jansen, V
Luengo-Fernadez, R
Williams, M
Dziedzic, K
The clinical and cost effectiveness of splints for thumb base osteoarthritis: a randomized controlled clinical trial
title The clinical and cost effectiveness of splints for thumb base osteoarthritis: a randomized controlled clinical trial
title_full The clinical and cost effectiveness of splints for thumb base osteoarthritis: a randomized controlled clinical trial
title_fullStr The clinical and cost effectiveness of splints for thumb base osteoarthritis: a randomized controlled clinical trial
title_full_unstemmed The clinical and cost effectiveness of splints for thumb base osteoarthritis: a randomized controlled clinical trial
title_short The clinical and cost effectiveness of splints for thumb base osteoarthritis: a randomized controlled clinical trial
title_sort clinical and cost effectiveness of splints for thumb base osteoarthritis a randomized controlled clinical trial
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