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: 10861170
• 负责人: Howard S Kim
• 金额: $ 10万
• 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/10861170
• 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).

项目总结 在美国，下腰痛是一种重大的医疗负担，占近4 每年急诊科就诊人次为100万人次。在近三分之二的就诊中，阿片类药物是 给药或开药，使下腰痛成为开阿片类药物的最常见原因。 尽管这种以药物为基础的积极方法，患者因背部疼痛而去急诊室就诊后的结果仍然存在 差：三个月后，近一半的患者报告持续的功能障碍，五分之一的患者报告说 患者报告继续使用阿片类药物。此外，腰背痛仍然是不必要的主要驱动因素 诊断成像。近三分之一的急诊室因腰痛而就诊时会得到平片，尽管 多个专业协会的指南建议不要常规成像。 ED发起的物理治疗(ED-PT)是一种很有前途的新资源，可以改善患者对下腰痛的护理。 越来越多的急诊室现在有专门的理疗师，可以咨询他们来评估和治疗 通过教育、预见性指导以及早期动员和锻炼相结合的方式对患者进行干预。我们的 初步数据显示，与常规护理相比，接受ED-PT治疗的患者报告功能更快 改善，使用更少的阿片类药物，接受更少的诊断成像。然而，这些观测数据是 由于医生酌情决定患者接受ED-PT治疗而在治疗选择上存在偏见，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治疗急性下腰痛的疗效，我们建议(目标1)开发一种 修订的ED-PT模型，其中物理治疗师被“嵌入”在初级ED治疗团队中 在整个疗程的早期评估所有急性下腰痛患者：西北大学 嵌入式急诊科理疗(Need-PT)协议。然后我们将(目标2)进行一次 急性期ED患者的Need-PT与常规治疗(即不进行物理治疗)的随机对照试验 下腰痛，比较患者报告的功能的主要结果和患者报告的次要结果 在三个月的主要终点使用阿片类药物。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背痛就诊中的利用。我们假设病人 接受Need-PT将在功能上有更大的改善，并减少阿片类药物的使用，而且ED 使用Need-PT访问将使用较少的诊断性成像。这项研究产生的发现具有 有可能有意义地减轻目前对阿片类药物治疗下腰痛的依赖。因此，我们相信这一点 建议既及时又响应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(非HS-18-015)。

项目成果

Tramadol, Codeine, and Risk of Adverse Outcomes.

曲马多、可待因和不良后果的风险。

• DOI: 10.1001/jama.2021.14306
• 发表时间: 2021
• 期刊: JAMA
• 作者: Kim,HowardS;McCarthy,DanielleM;Lank,PatrickM
• 通讯作者: Lank,PatrickM