Remote Tai Chi for Knee Osteoarthritis: an Embedded Pragmatic Trial

项目总结/摘要 症状性骨关节炎（OA）影响美国超过3250万人，是导致关节炎的主要原因。 残疾和日益增加的医疗费用。与膝关节OA疼痛药物治疗相关的毒性 导致推荐治疗的数量随着时间的推移而减少。现在严重缺乏 膝关节OA患者的治疗选择，特别是因为合并症使治疗复杂化 选择在老年人群体中非常普遍。 太极拳是一种多维度的练习，融合了身体，心理和行为成分， 在慢性膝关节OA疼痛状况中表现出临床显著改善。The American College of 流变学临床实践指南强烈推荐太极作为膝关节OA的干预措施。最近 在大流行期间进行的研究表明，远程太极拳是一种有前途的、可扩展的 治疗膝关节OA疼痛的策略。然而，远程太极拳在现实世界中的有效性仍然存在关键差距 用于膝关节OA及其在多个医疗保健系统中的实施。 我们提出了一个嵌入式的，务实的，随机试验，将比较3个月的效果，每周两次 在四个医疗保健机构的20-25个诊所中，远程提供基于网络的太极干预与常规护理 系统（塔夫茨医学中心、波士顿医学中心、加州大学洛杉矶卫生部和 克利夫兰诊所俄亥俄州和克利夫兰诊所佛罗里达）在四个地理区域（东马萨诸塞州， 南加州、东北俄亥俄州、南佛罗里达）。我们将招募600名不同的患者， 膝关节OA的诊断。参与者将在基线和3个月时进行评估，并在6个月时进行额外随访。 还有12个月我们假设，在四个国家实施远程太极拳是可行的。 卫生保健系统和太极，与常规护理相比，将改善身体健康（包括膝盖， 相关疼痛和功能）和心理健康以及医疗保健利用。 我们的创新研究是第一次严格的多地点，嵌入式，务实的远程太极身心试验 计划，在多个卫生保健系统门诊实践和利用基于网络的技术，设计 改善以患者为中心的膝关节OA结局。这些结果将使身心平衡理论得到广泛采用。 方法，并为未来的试验奠定基础， 不同实施策略的有效性。

PROJECT SUMMARY/ABSTRACT Symptomatic Osteoarthritis (OA) affects over 32.5 million individuals in the U.S. and is a leading cause of disability and increasing medical costs. Toxicities associated with drug therapies for knee OA pain have caused the number of recommended treatments to decrease over time. There is now a critical shortage of treatment options for people with knee OA, especially because comorbidities that complicate treatment selection are highly prevalent in this older adult population. Tai Chi, a multi-dimensional practice that integrates physical, psychosocial, and behavioral components, has exhibited clinically significant improvements in chronic knee OA pain conditions. The American College of Rheumatology clinical practice guidelines strongly recommend Tai Chi as an intervention for knee OA. Recent studies conducted during the pandemic suggest that remotely delivered Tai Chi is a promising and scalable strategy for knee OA pain. However, critical gaps remain as to the real-world effectiveness of remote Tai Chi for knee OA and its implementation across multiple Health Care Systems. We propose an embedded, pragmatic, randomized trial that will compare the effects of a 3-month twice weekly remotely delivered web-based Tai Chi intervention versus routine care in 20-25 clinics across four Health Care Systems (Tufts Medical Center, Boston Medical Center, University of California Los Angeles Health, and Cleveland Clinic Ohio and Cleveland Clinic Florida) in four geographic regions (Eastern Massachusetts, Southern California, Northeast Ohio, Southern Florida). We will enroll 600 diverse patients with a clinical diagnosis of knee OA. Participants will be evaluated at baseline and 3 months, with additional follow-up at 6 and 12 months. We hypothesize that implementation of remotely delivered Tai Chi is feasible across four Health Care Systems and that Tai Chi, compared to Routine Care, will improve physical health (including knee- related pain and function) and mental health as well as healthcare utilization. Our innovative study is the first rigorous multi-site, embedded, pragmatic trial of a remote Tai Chi mind-body program, in the multiple Health Care Systems outpatient practice and utilizing web-based technology, designed to improve patient centered outcomes of knee OA. The results will enable widespread adoption of mind-body approaches for knee OA across Health Care Systems and lay the groundwork for future trials comparing the effectiveness of different implementation strategies.