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

项目摘要 下背痛在美国是一个很大的医疗负担， 每年有100万人次急诊（艾德）就诊。在近三分之二的这些访问中，阿片类药物是 这使得腰痛成为阿片类药物处方的最常见原因。 尽管有这种积极的药物治疗方法，但艾德因背痛就诊后的患者结局仍然存在 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持续性功能障碍。 患者报告继续使用阿片类药物。此外，腰痛仍然是一个主要的驱动力，不必要的 诊断成像近三分之一的艾德访视腰痛导致平片，尽管 多个专业协会指南建议不要进行常规成像。 ED启动的物理治疗（ED-PT）是一种有前途的新资源，以改善患者的护理腰痛。 越来越多的ED现在有专门的物理治疗师，可以咨询评估和治疗 患者通过教育，预期指导，早期动员和锻炼相结合。我们 初步数据表明，与常规治疗相比，接受ED-PT的患者报告更快的功能恢复， 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 由于患者接受ED-PT的医生判断而导致的治疗选择偏倚，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治疗急性腰痛的疗效，我们建议（目的1）开发一种 ED-PT的修订模型，其中物理治疗师“嵌入”主要艾德治疗团队 在整个治疗过程的早期评估所有急性腰痛患者：西北 嵌入式急诊科物理治疗（NEED-PT）协议。然后，我们将（目标2）进行 NEED-PT与常规治疗的医生随机试验（即，无物理治疗）的急性艾德患者中 下背痛，比较患者报告的功能的主要结局和 阿片类药物使用的主要终点为3个月。最后，我们将（目标3）比较诊断成像 接受NEED-PT与常规治疗的艾德背痛访视的利用率。我们假设病人 接受NEED-PT的患者将在功能方面得到更大的改善，阿片类药物的使用率更低，并且艾德 NEED-PT访视将使用较少的诊断成像。从这项研究中产生的结果有 有可能有意义地减轻目前对阿片类药物治疗腰痛的依赖。因此，我们认为， 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）。

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).