Objectives: To investigate the clinical effectiveness, efficacy and cost effectiveness of splints (orthoses) in people with symptomatic basal thumb joint osteoarthritis (BTOA). Methods: A pragmatic, multi-centre parallel group randomised controlled trial at 17 National Health Service (NHS) hospital departments recruited adults with symptomatic BTOA and at least moderate hand pain and dysfunction. We randomised participants (1:1:1) using a computer-based minimisation 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 minutes therapy over 8 weeks and were followed up for 12 weeks from baseline. AUSCAN hand pain at 8 weeks was the primary outcome, using intention to treat (ITT) analysis. We calculated costs of treatment. Results: We randomised 349 participants to SSM (n=116), SSM+S (n= 116) or SSM+PS (n=117) and 292 (84%) provided AUSCAN 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 to 0.4, p=0.255), SSM+PS vs. SSM -0.1 (95% CI -1.0 to 0.8, p = 0.829) and SSM+S vs. SSM+PS -0.4 (95% CI -1.4 to 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.
Adams, JoBarratt, PaulaRombach, InesArden, NigelBarbosa Bouças, SofiaBradley, SarahDoherty, MichaelDutton, Susan J.Gooberman-Hill, RachaelHislop-Lennie, KellyHutt-Greenyer, CorinneJansen, VictoriaLuengo-Fernadez, RamonWilliams, Mark A.Dziedzic, Krysia
Department of Sport, Health Sciences and Social Work
Year of publication: 2020Date of RADAR deposit: 2020-10-21
“This is a pre-copyedited, author-produced version of an article accepted for publication in Rheumatology following peer review. 'The clinical and cost effectiveness of splints for thumb base osteoarthritis: A randomized controlled clinical trial' is available online at: https://doi.org/10.1093/rheumatology/keaa726.”