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

被引:15
作者
Adams, Jo [1 ,2 ]
Barratt, Paula [1 ]
Rombach, Ines [3 ]
Arden, Nigel [2 ,4 ]
Boucas, Sofia Barbosa [5 ]
Bradley, Sarah [6 ]
Doherty, Michael [2 ,7 ]
Dutton, Susan J. [3 ]
Gooberman-Hill, Rachael [8 ]
Hislop-Lennie, Kelly [1 ]
Hutt-Greenyer, Corinne [9 ]
Jansen, Victoria [10 ]
Luengo-Fernadez, Ramon [11 ]
Williams, Mark [12 ]
Dziedzic, Krysia [13 ]
机构
[1] Univ Southampton, Hlth Sci, Southampton, Hants, England
[2] Univ Southampton, Ctr Sport Exercise & Osteoarthrit Res Versus Arth, Southampton, Hants, England
[3] Univ Oxford, Nuffield Dept Orthopaed Rheumatol & Musculoskelet, Oxford Clin Trials Unit, Ctr Stat Med, Oxford, England
[4] Univ Oxford, NDORMS, Oxford, England
[5] Brunel Univ London, Dept Life Sci, Uxbridge, Middx, England
[6] Poole Hosp NHS Trust, Hand Therapy Unit, Poole, Dorset, England
[7] Univ Nottingham, Sch Med, Nottingham, England
[8] Univ Bristol, Elizabeth Blackwell Inst Hlth Res, Bristol, Avon, England
[9] Univ Southampton, Patient & Publ Involvement Grp Hlth Sci, Southampton, Hants, England
[10] Royal Derby Hosp, Pulvertaft Hand Ctr, Derby, England
[11] Univ Oxford, Nuffield Dept Populat Hlth, Oxford, England
[12] Oxford Brookes Univ, Dept Sport Hlth Sci & Social Work, Oxford, England
[13] Keele Univ, Primary Care Ctr Excellence Versus Arthrit, Sch Primary Community & Social Care, Keele, Staffs, England
关键词
thumb splint; orthosis; symptomatic basal thumb joint osteoarthritis; clinical trial; HAND OSTEOARTHRITIS; RISK-FACTOR; RELIABILITY; VALIDITY; PREVALENCE; EXERCISES; EFFICACY;
D O I
10.1093/rheumatology/keaa726
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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 90min therapy over 8weeks and were followed up for 12weeks from baseline. Australian/Canadian (AUSCAN) hand pain at 8weeks 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; pound SSM+S 738; pound and SSM+PS 685 pound. 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.
引用
收藏
页码:2862 / 2877
页数:16
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