Department of Pediatrics, Yale University School of Medicine, 2 Church Street South, New Haven, CT 06519, USA.
Trials. 2012 Oct 4;13:185. doi: 10.1186/1745-6215-13-185.
Clinical trial design of manual therapies may be especially challenging as techniques are often individualized and practitioner-dependent. This paper describes our methods in creating a standardized Swedish massage protocol tailored to subjects with osteoarthritis of the knee while respectful of the individualized nature of massage therapy, as well as implementation of this protocol in two randomized clinical trials.
The manualization process involved a collaborative process between methodologic and clinical experts, with the explicit goals of creating a reproducible semi-structured protocol for massage therapy, while allowing some latitude for therapists' clinical judgment and maintaining consistency with a prior pilot study.
The manualized protocol addressed identical specified body regions with distinct 30- and 60-min protocols, using standard Swedish strokes. Each protocol specifies the time allocated to each body region. The manualized 30- and 60-min protocols were implemented in a dual-site 24-week randomized dose-finding trial in patients with osteoarthritis of the knee, and is currently being implemented in a three-site 52-week efficacy trial of manualized Swedish massage therapy. In the dose-finding study, therapists adhered to the protocols and significant treatment effects were demonstrated.
The massage protocol was manualized, using standard techniques, and made flexible for individual practitioner and subject needs. The protocol has been applied in two randomized clinical trials. This manualized Swedish massage protocol has real-world utility and can be readily utilized both in the research and clinical settings.
Clinicaltrials.gov NCT00970008 (18 August 2009).
手法治疗的临床试验设计可能特别具有挑战性，因为技术通常是个体化的，依赖于治疗师。本文介绍了我们在为膝骨关节炎患者制定标准化瑞典式按摩方案时的方法，该方案尊重按摩治疗的个体化性质，并在两项随机临床试验中实施了该方案。
手工制作过程涉及方法学和临床专家之间的合作过程，明确目标是为按摩疗法创建一个可重复的半结构化方案，同时允许治疗师有一定的临床判断余地，并与之前的试点研究保持一致。
规范化方案用标准的瑞典式手法处理了相同的指定身体区域，同时有 30 分钟和 60 分钟的特定方案，每个方案都指定了每个身体区域的时间分配。规范化的 30 分钟和 60 分钟方案在膝关节骨关节炎的双地点 24 周随机剂量发现试验中得到实施，目前正在三地点 52 周规范化瑞典式按摩疗效试验中实施。在剂量发现研究中，治疗师遵循了方案，显示出显著的治疗效果。
该按摩方案是规范化的，使用标准技术，并根据个体治疗师和患者的需求进行了灵活处理。该方案已应用于两项随机临床试验。这种规范化的瑞典式按摩方案具有实际应用价值，既可以在研究中也可以在临床中得到广泛应用。
Clinicaltrials.gov NCT00970008（2009 年 8 月 18 日）。
