Department of Rheumatology, Sint Maartenskliniek, Nijmegen, The Netherlands.
Osteoarthritis Cartilage. 2013 Jul;21(7):901-10. doi: 10.1016/j.joca.2013.03.016. Epub 2013 Apr 11.
To examine the efficacy of a multidisciplinary non-pharmacological intervention in patients with hand osteoarthritis (OA).
Parallel group randomized controlled trial was performed in three participating rheumatology outpatient clinics in the Netherlands. Block randomization was performed using a computer generated permuted block scheme (blocks of four). An independent person randomly assigned 151 participants with clinical hand OA to four sessions of multidisciplinary non-pharmacological treatment, or 30 min education followed by 3 months waiting time. Participants and therapists were not blinded to the assigned intervention. The research assistant who assessed all outcomes was blinded to the assigned intervention. Subscale limitations in activities of the Australian Canadian Osteoarthritis Hand Index (AUSCAN) and OARSI responder criteria (primary outcomes) and secondary outcome measures, were assessed at baseline and 12 weeks. Linear or logistic regression analyses were used, where appropriate, with the outcome as dependent and the intervention group as independent variable. The analyses were adjusted for baseline values.
At 3 months no significant and no relevant differences were observed between the experimental (n = 76) and control group (n = 75) in any of the primary or secondary outcome measures. In both groups about one-third of patients were classified as responder.
There is insufficient evidence to confirm a clinically relevant treatment effect on the short term, between patients who followed a multidisciplinary treatment program and those who received only written information. Since hand OA causes a range of impairments and limitations in activities, programs with more guidance to formulate and implement individually tailored treatment plans could be probably more effective. Furthermore, more research is needed on the efficacy of single treatment elements. (Dutch Trial Register trial number NTR1191).
研究多学科非药物干预对手部骨关节炎(OA)患者的疗效。
在荷兰的 3 家参与风湿病门诊进行了平行组随机对照试验。采用计算机生成的随机区组方案(区组大小为 4)进行块随机化。一名独立人员将 151 名手部临床 OA 患者随机分为 4 组接受多学科非药物治疗,或接受 30 分钟的教育后等待 3 个月。参与者和治疗师对分配的干预措施不知情。评估所有结局的研究助理对分配的干预措施不知情。在基线和 12 周时评估澳大利亚加拿大骨关节炎手部指数(AUSCAN)的亚量表限制和 OARSI 应答标准(主要结局)和次要结局测量。适当的情况下使用线性或逻辑回归分析,将结局作为因变量,干预组作为自变量。分析调整了基线值。
在 3 个月时,实验组(n=76)和对照组(n=75)在任何主要或次要结局测量中均未观察到显著和无相关差异。两组中约有三分之一的患者被归类为应答者。
没有足够的证据证实短期多学科治疗方案与仅接受书面信息的患者之间存在临床相关的治疗效果。由于手部 OA 会导致一系列活动受限和活动能力受损,因此可能更有效的方案是提供更多指导,以制定和实施个体化的治疗计划。此外,还需要更多关于单一治疗要素疗效的研究。(荷兰试验注册处试验编号:NTR1191)。