A Cluster-Randomized Trial of the Northwestern Embedded Emergency Department Physical Therapy (NEED-PT) Protocol for Acute Low Back Pain

西北嵌入式急诊科物理治疗 (NEED-PT) 方案治疗急性腰痛的整群随机试验

• 批准号: 10121129
• 负责人: Howard S Kim
• 金额: $ 39.58万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-30 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10121129
• 关键词: Cluster; Randomized; Trial; Northwestern; Embedded

PROJECT SUMMARY Low back pain represents a significant health care burden in the United States and accounts for nearly four million emergency department (ED) visits per year. In nearly two thirds of these visits, an opioid medication is administered or prescribed, making low back pain the most common reason for which opioids are prescribed. Despite this aggressive medication-based approach, patient outcomes after an ED visit for back pain remain poor: after three months, nearly half of all patients report persistent functional impairment, and one in five patients report continued opioid use. Additionally, low back pain continues to be a major driver of unnecessary diagnostic imaging. Nearly one in three ED visits for low back pain results in a plain radiograph, despite multiple professional society guidelines advising against routine imaging. ED-initiated physical therapy (ED-PT) is a promising new resource to improve patient care for low back pain. A growing number of EDs now have dedicated physical therapists that can be consulted to evaluate and treat patients through a combination of education, anticipatory guidance, and early mobilization and exercise. Our preliminary data indicate that patients receiving ED-PT, compared to usual care, report more rapid functional improvement, use fewer opioids, and receive less diagnostic imaging. However, these observational data are limited by biases in treatment selection due to physician discretion in which patients receive ED-PT, as well as other measured and unmeasured confounders. To more rigorously evaluate the efficacy of ED-PT for acute low back pain, we propose (Aim 1) to develop a revised model of ED-PT in which the physical therapist is “embedded” within the primary ED treatment team to evaluate all patients with acute low back pain early in the overall treatment course: the Northwestern Embedded Emergency Department Physical Therapy (NEED-PT) protocol. We will then (Aim 2) conduct a physician-randomized trial of NEED-PT versus usual care (i.e., no physical therapy) in ED patients with acute low back pain, comparing a primary outcome of patient-reported functioning and a secondary outcome of opioid use at the primary endpoint of three months. Finally, we will (Aim 3) compare diagnostic imaging utilization among ED back pain visits receiving NEED-PT versus usual care. We hypothesize that patients receiving NEED-PT will experience greater improvement in functioning and lower use of opioids, and that ED visits with NEED-PT will utilize less diagnostic imaging. The findings generated from this research have the potential to meaningfully mitigate the current reliance on opioids for low back pain. As such, we believe this proposal is both timely and responsive to the ARHQ Special Emphasis Notice on Health Services Research to Address the Opioids Crisis (NOT-HS-18-015).

项目概要 腰痛在美国是一个重大的医疗保健负担，占近四成 每年急诊科 (ED) 就诊人数达 10 万人次。在近三分之二的就诊中，使用阿片类药物 管理或处方，使腰痛成为使用阿片类药物的最常见原因。 尽管采用了这种积极的基于药物的方法，但因背痛而去急诊室就诊后的患者结果仍然存在 差：三个月后，近一半的患者报告持续性功能障碍，五分之一的患者报告 患者报告继续使用阿片类药物。此外，腰痛仍然是不必要的主要驱动因素 诊断成像。尽管有近三分之一的人因腰痛而去急诊室就诊，但结果却是拍X光平片 多个专业协会指南建议不要进行常规成像。 急诊科发起的物理治疗 (ED-PT) 是一种很有前景的新资源，可改善腰痛患者的护理。 越来越多的急诊室现在拥有专门的物理治疗师，可以咨询他们来评估和治疗 通过教育、预期指导以及早期活动和锻炼相结合的方式来帮助患者。我们的 初步数据表明，与常规治疗相比，接受 ED-PT 的患者报告功能更快 改善，使用更少的阿片类药物，并接受更少的诊断成像。然而，这些观测数据 由于医生对患者接受 ED-PT 的判断而造成治疗选择偏差的限制，以及 其他可测量和不可测量的混杂因素。 为了更严格地评估 ED-PT 对急性腰痛的疗效，我们建议（目标 1）开发一种 修订后的 ED-PT 模型，其中物理治疗师“嵌入”主要 ED 治疗团队中 在整个治疗过程的早期评估所有急性腰痛患者：西北大学 嵌入式急诊科物理治疗 (NEED-PT) 协议。然后我们将（目标 2）进行 对急性 ED 患者进行 NEED-PT 与常规护理（即无物理治疗）的医师随机试验 腰痛，比较患者报告的功能的主要结果和 主要终点为三个月的阿片类药物使用。最后，我们将（目标 3）比较诊断成像 接受 NEED-PT 与常规护理的 ED 背痛就诊的利用率。我们假设患者 接受 NEED-PT 的患者的功能将得到更大改善，阿片类药物的使用也会减少，并且 ED NEED-PT 就诊将使用较少的诊断成像。这项研究的结果有 有可能有效减轻目前对阿片类药物治疗腰痛的依赖。因此，我们相信这一点 该提案既及时又响应了 ARHQ 关于卫生服务研究的特别强调通知 解决阿片类药物危机 (NOT-HS-18-015)。