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

摘要 老年糖尿病患者治疗的安全性和有效性在证据方面存在严重差距。 慢性腰痛(CLBP)。针灸被发现对治疗年轻人的慢性下腰痛有效 成年人。然而，试验很少包括老年人，他们有更多的合并症，可能会有反应 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 差距。经过一年的规划，完善了识别和招募患者的策略，敲定了针灸方案， 并确保数据基础架构和质量，我们将对828名65岁的成年人进行三臂试验 使用cLBP评估针灸与常规护理的效果。我们将比较为期12周的标准课程 针灸加强化针灸疗程(12周标准疗程，外加12周 维持课程)对慢性下腰痛患者进行常规医疗护理。这一大型试验的主要结果将会回来- 26周时相关功能恢复。这些措施和其他生物-心理-社会措施将在12、26和 随机化后52周。我们预测患有慢性腰背痛的老年人的背部相关功能将是 在增强针刺组的参与者中有所改善，然后是标准针刺组， 而在那些只接受常规护理的人中，改善最小。联邦医疗保险也对有关价值的数据感兴趣 为老年人针灸提供信息，以便做出覆盖决定和有效实施。因此， 补充从有效性试验中获得的知识，我们将进行成本效益分析 这两种形式的针灸与常规护理以及全面的定性评估相比较 了解、描述和解释采用、实施和可持续的障碍和促进者 针对老年人的针灸治疗。我们的大样本将从4个不同的健康计划中招募，以 代表医疗保险参保人的种族和种族构成以及最常见的方式 针灸被纳入到基于保险的慢性疼痛护理中。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 对患有慢性下腰痛的老年人的强度和疼痛干预。这一证据将提供必要的信息 关于联邦医疗保险的承保决定以及个别医生和患者决定一个疗程 关于治疗的问题。

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.