Multisite RCT Investigating the Efficacy of Massage in Osteoarthritis

描述(申请人提供)：骨关节炎(OA)是一种缓慢进展的关节退行性疾病，困扰着大约2700万美国人。OA已经是最常被报道的老年人慢性病，预计到2030年将影响超过6700万美国人。传统的治疗骨性关节炎的方法并不完全有效，有时还会产生严重的副作用，使许多人面临手术或慢性的、通常使人虚弱的疼痛、肌肉无力、缺乏耐力和功能丧失。髋关节或膝盖的骨性关节炎尤其严重，因为它限制了行走。在2004年膝关节骨性关节炎(OA)推拿疗法的试点RCT(CDC SIP-14-00)中，我们展示了瑞典推拿疗法的可行性、安全性和明显疗效，在停止治疗8周后仍能增加功能和减轻疼痛。确定瑞典按摩治疗膝骨性关节炎的最佳剂量和频率的第二阶段剂量发现研究(NIH/NCCAM R01AT004623)即将完成。建议的下一步调查是：一项盲法、双部位随机对照试验，以验证最佳手动按摩剂量的疗效，评估维持剂量的效用，并收集数据支持后续的成本效益分析。这项研究将利用我们的第二阶段研究确定的实用的最佳按摩剂量。这项拟议的研究使用了几种新的方法：1)由正式的剂量发现试验确定的非药物干预，2)纳入经证实的可行性和临床反应的手动按摩干预，3)在按摩治疗中使用主动和被动对照，以及4)调查干预在一年期间的持久性，以及维持剂量的效用。我们的目标是：1)验证为期8周的瑞典按摩，以最佳剂量，与主动(轻触)对照和被动(日常护理)对照，对219名患有膝骨性关节炎的成人患者进行缓解疼痛和增强功能的有效性。2)评估8周瑞典按摩的疗效持续时间，以及3)评估维持剂量的按摩或轻触摸身体工作的效用。4)收集成本和利用率数据，以便进行正式的成本效益分析。这项由经验丰富的合作者团队进行的研究是一系列调查中不可或缺的一步，有可能改变临床实践。证明按摩是一种有价值和可行的治疗选择，并为将其确立为可报销的治疗选择奠定了基础，这构成了对骨性关节炎标准临床管理的一项非常重要的创新。

DESCRIPTION (provided by applicant): Osteoarthritis (OA) is a slowly progressive degenerative disease of the joints that afflicts approximately 27 million Americans. Already the most frequently reported chronic condition in the elderly, OA is projected to affect more than 67 million Americans by 2030. Conventional therapies for OA are incompletely effective and at times impose serious side effects, leaving many facing surgery or chronic, often debilitating, pain, muscle weakness, lack of stamina, and loss of function. OA of the hip or knee is particularly disabling because it limits ambulation. In a 2004 pilot RCT of massage therapy for osteoarthritis (OA) of the knee (CDC SIP-14-00), we demonstrated the feasibility, safety, and apparent efficacy of Swedish massage, with benefits of increased function and decreased pain persisting eight weeks following treatment cessation. A Phase 2 dose-finding study (NIH/NCCAM R01AT004623) to determine the optimal dose and frequency of Swedish massage for the treatment of OA of the knee is near completion. Proposed is the next step in this line of inquiry: a blinded, dual-site RCT to verify the efficacy of the optimal dose of manualized massage, assess the utility of maintenance dosing, and gather data to support subsequent cost-effectiveness analysis. This study will utilize a practical 'optimal' dose of massage determined by our Phase 2 study. The proposed study utilizes several novel approaches: 1) a nonpharmacological intervention defined by a formal dose-finding trial, 2) incorporation of a manualized massage intervention with demonstrated feasibility and clinical response, 3) the use of both active and passive controls for massage therapy, and 4) the investigation of the durability of the intervention over a one-year period, as well as the utility of maintenance dosing. We aim to: 1) Verify the efficacy of an 8-week course of Swedish massage, at an optimized dose, for reducing pain and increasing function compared to an active (light touch) control and passive (usual care) control in 219 adults with OA of the knee 2) Assess the duration of therapeutic effect of 8 weeks of Swedish massage, and 3) Assess the utility of maintenance doses of massage or light-touch bodywork. 4) Collect cost and utilization data to subtend a formal, cost-effectiveness analysis. This study by an experienced team of collaborators is an integral step in a line of inquiry with the potential to change clinical practice. Demonstrating massage to be a valuable and viable treatment option, and laying the foundation to establish it as a reimbursable one, constitutes a highly significant innovation for the standard clinical management of OA.