Multisite RCT Investigating the Efficacy of Massage in Osteoarthritis

描述（由申请人提供）：骨关节炎（OA）是一种缓慢进展的关节退行性疾病，约有2700万美国人患有此病。OA已经是老年人中最常见的慢性疾病，预计到2030年将影响6700多万美国人。OA的传统治疗方法并不完全有效，有时会产生严重的副作用，导致许多人面临手术或慢性，经常使人衰弱，疼痛，肌肉无力，缺乏耐力和功能丧失。髋部或膝关节的骨关节炎尤其致残，因为它限制了行动。在2004年的一项针对膝关节骨关节炎（OA）的按摩治疗的试验性随机对照试验（CDC SIP-14-00）中，我们证明了瑞典式按摩的可行性、安全性和明显的疗效，在治疗停止后的8周内，其功能增强和疼痛减轻的益处持续存在。一项旨在确定瑞典式按摩治疗膝关节OA的最佳剂量和频率的2期剂量研究（NIH/NCCAM R01AT004623）即将完成。研究的下一步是：采用双盲双中心随机对照试验来验证最佳手动按摩剂量的疗效，评估维持剂量的效用，并收集数据以支持随后的成本-效果分析。这项研究将利用我们在第二阶段研究中确定的实用的“最佳”按摩剂量。拟议的研究采用了几种新方法：1)通过正式的剂量发现试验确定的非药物干预，2)结合具有可行性和临床反应的手动按摩干预，3)使用主动和被动对照进行按摩治疗，4)调查干预的持久性，为期一年，以及维持剂量的效用。我们的目标是：1)验证与主动（轻触）对照和被动（常规护理）对照相比，8周瑞典式按摩的最佳剂量对减轻疼痛和增强功能的疗效，219名患有膝关节OA的成年人；2)评估8周瑞典式按摩的治疗效果持续时间；3)评估按摩或轻触身体维持剂量的效用。收集成本和使用数据，进行正式的成本效益分析。由经验丰富的合作团队进行的这项研究是有可能改变临床实践的一系列调查中不可或缺的一步。证明按摩是一种有价值和可行的治疗选择，并为其成为一种可报销的治疗选择奠定基础，是OA临床规范管理的重大创新。

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.