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2700万美国人患有这种疾病。OA已经是老年人中最常报告的慢性疾病，预计到2030年将影响超过6700万美国人。OA的常规疗法不完全有效，有时会产生严重的副作用，使许多人面临手术或慢性，通常使人衰弱，疼痛，肌肉无力，缺乏耐力和功能丧失。髋关节或膝关节的OA特别致残，因为它限制了截肢。 在2004年的一项膝关节骨关节炎（OA）按摩治疗的试点RCT（CDC SIP-14-00）中，我们证明了瑞典按摩的可行性、安全性和明显疗效，其益处是在治疗停止后持续8周增加功能和减少疼痛。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II期剂量探索研究（NIH/NCCAM R 01 AT 004623）即将完成。这一系列调查的下一步是：一项双盲、双中心随机对照试验，以验证最佳剂量的手动按摩的疗效，评估维持剂量的效用，并收集数据以支持后续的成本效益分析。 这项研究将利用我们的2期研究确定的实际“最佳”按摩剂量。拟定研究采用了几种新方法：1）通过正式剂量探索试验定义的非药物干预，2）纳入经证明可行性和临床反应的手动按摩干预，3）使用按摩治疗的主动和被动对照，以及4）研究一年内干预的持久性以及维持给药的效用。我们的目标是：1）在219名膝关节骨性关节炎成人患者中，与主动（轻触）控制和被动（常规护理）控制相比，验证8周瑞典式按摩疗程（优化剂量）在减轻疼痛和增加功能方面的疗效; 2）评估8周瑞典式按摩的治疗效果持续时间; 3）评估维持剂量按摩或轻触式身体锻炼的效用。4)收集成本和利用率数据，以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，并奠定基础，建立它作为一个可报销的，构成了一个非常重要的创新标准的临床管理的OA。

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.