Adams Jo, Barratt Paula, Arden Nigel K, Barbosa Bouças Sofia, Bradley Sarah, Doherty Michael, Dutton Susan, Dziedzic Krysia, Gooberman-Hill Rachael, Hislop Lennie Kelly, Hutt Greenyer Corinne, Jansen Victoria, Luengo-Fernandez Ramon, Meagher Claire, White Peter, Williams Mark
School of Health Sciences. Faculty of Environment and Life Sciences, University of Southampton, Southampton, UK
School of Health Sciences. Faculty of Environment and Life Sciences, University of Southampton, Southampton, UK.
BMJ Open. 2019 Oct 22;9(10):e028342. doi: 10.1136/bmjopen-2018-028342.
The economic cost of osteoarthritis (OA) is high. At least 4.4 million people have hand OA in the UK. Symptomatic thumb base OA affects 20% of people over 55 years, causing more pain, work and functional disability than OA elsewhere in the hand. Most evidence-based guidelines recommend splinting for hand OA. Splints that support or immobilise the thumb base are routinely used despite there being limited evidence on their effectiveness. The potential effects of placebo interventions in OA are acknowledged, but few studies investigate the clinical efficacy of rehabilitation interventions nor the impact of any placebo effects associated with splints.
Participants aged 30 years and over with symptomatic thumb base OA will be recruited into the trial from secondary care occupational therapy and physiotherapy centres. Following informed consent, participants will complete a baseline questionnaire and then be randomised into one of three treatment arms: a self-management programme, a self-management programme plus a verum thumb splint or a self-management programme plus a placebo thumb splint. The primary outcome is the Australian Canadian Osteoarthritis Hand Index (AUSCAN) hand pain scale. The study endpoint is 8 weeks after baseline. Baseline assessments will be carried out prior to randomisation and outcomes collected at 4, 8 and 12 weeks. Cost-effectiveness analysis will be conducted and individual qualitative interviews conducted with up to 40 participants after 8 weeks to explore perceptions and outcome expectations of verum and placebo splints and exercise.
South Central-Oxford C Research Ethics Committee approved this study (16/SC/0188). The findings will be disseminated to health professional conferences, journals and lay publications for patient organisations. The research will contribute to improving the management of thumb base OA and help clinicians and patients make informed decisions about the value of different interventions.
ISRCTN54744256.
骨关节炎（OA）的经济成本高昂。在英国，至少有440万人患有手部骨关节炎。有症状的拇指基底骨关节炎影响20%的55岁以上人群，比手部其他部位的骨关节炎导致更多疼痛、工作和功能障碍。大多数循证指南推荐对手部骨关节炎进行夹板固定。尽管关于其有效性的证据有限，但支持或固定拇指基底的夹板仍被常规使用。安慰剂干预在骨关节炎中的潜在作用已得到认可，但很少有研究调查康复干预的临床疗效以及与夹板相关的任何安慰剂效应的影响。
年龄在30岁及以上、患有有症状拇指基底骨关节炎的参与者将从二级保健职业治疗和物理治疗中心招募进入试验。在获得知情同意后，参与者将完成一份基线问卷，然后随机分为三个治疗组之一：自我管理计划组、自我管理计划加真拇指夹板组或自我管理计划加安慰剂拇指夹板组。主要结局是澳大利亚-加拿大骨关节炎手部指数（AUSCAN）手部疼痛量表。研究终点是基线后8周。在随机分组前进行基线评估，并在第4、8和12周收集结局数据。将进行成本效益分析，并在8周后对多达40名参与者进行个体定性访谈，以探讨对真夹板和安慰剂夹板以及锻炼的认知和结局期望。
中南牛津C研究伦理委员会批准了本研究（16/SC/0188）。研究结果将在健康专业会议、期刊以及面向患者组织的大众出版物上进行传播。该研究将有助于改善拇指基底骨关节炎的管理，并帮助临床医生和患者就是否采用不同干预措施做出明智决策。
ISRCTN54744256。
