Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults

总结 在阅读老年人治疗的安全性和有效性的证据中存在一个关键的差距， 慢性腰痛（CLBP）针灸已被发现是有效的治疗cLBP在年轻 成年人了然而，试验很少包括老年人，他们有更多的合并症， 与典型的试验参与者不同。我们设计了一个实用的随机试验来解决这个问题 间隙经过一年的规划，以完善战略，以确定和招募病人，最终确定针灸协议， 为了确保数据基础设施和质量，我们将在828名≥65岁的成年人中进行一项三组试验 用cLBP来评估针灸与常规护理的对比。我们将比较一个标准的12周课程， 针灸加针灸强化疗程（12周标准疗程加12周 维持疗程）至cLBP的常规医疗护理。这项大型试验的主要结果将回来- 26周时的相关功能。这些和其他生物心理社会措施将在12日，26日， 52-随机化后10周。我们预测，老年人cLBP的背部相关功能将是最重要的， 在增强针灸组的参与者中有所改善，其次是标准针灸组， 在那些只接受常规护理的人中，改善最少。医疗保险也对价值数据感兴趣 为老年人提供针灸服务，为覆盖决策和有效实施提供信息。因此， 除了从成效试验所得的知识外，我们会进行成本效益分析， 两种形式的针灸相比，通常的护理以及全面的定性评价， 理解、描述和解释采用、实施和可持续性的障碍和促进因素 针灸治疗老年人。我们的大样本将从4个不同的健康计划中招募， 代表医疗保险注册者的种族和种族构成，以及最常见的方式， 针灸被纳入基于保险的慢性疼痛护理。如果成功，这一务实的RCT将 为针灸改善功能状态和减轻疼痛的价值提供明确的指导 强度和疼痛干扰的老年人与cLBP。这些证据将提供重要的信息 对于Medicare关于承保范围的决定，以及对于个别医生和患者决定课程， 的治疗。

SUMMARY A critical gap exists in the evidence reading the safety and effectiveness of treatments for older adults with chronic low back pain (cLBP). Acupuncture has been found to be effective in treating cLBP in younger adults. Yet trials have rarely included older adults, who have more comorbidities and may respond differently than typical trial participants. We have designed a pragmatic randomized trial to address this gap. After a planning year to refine strategies to identify and recruit patients, finalize acupuncture protocols, and ensure data infrastructure and quality, we will conduct a three-arm trial of 828 adults ≥65 years of age with cLBP to evaluate acupuncture versus usual care. We will compare a standard 12-week course of acupuncture with an enhanced course of acupuncture (12-week standard course, plus 12-week maintenance course) to usual medical care for cLBP. The primary outcomes of this large trial will be back- related function at 26 weeks. These and other biopsychosocial measures will be collected at 12, 26, and 52-weeks post randomization. We predict that back-related function in older adults with cLBP will be most improved among participants in the enhanced acupuncture arm, followed by the standard acupuncture arm, and least improved among those receiving only usual care. Medicare is also interested in data on the value of acupuncture for older adults to inform coverage decisions and efficient implementation. As such, to supplement knowledge gained from the effectiveness trial, we will conduct a cost-effectiveness analysis of both forms of acupuncture compared to usual care as well as comprehensive qualitative evaluations to understand, describe and explain barriers and facilitators to adoption, implementation, and sustainability of acupuncture treatment for older adults. Our large sample will be recruited from 4 diverse health plans to represent the ethnic and racial composition of Medicare enrollees as well as the most common ways acupuncture is incorporated in insurance-based care for chronic pain. If successful, this pragmatic RCT will offer clear guidance about the value of acupuncture for improving functional status and reducing pain intensity and pain interference for older adults with cLBP. This evidence will provide essential information for Medicare regarding coverage decisions and for individual physicians and patients deciding on a course of treatment.