Acupuncture in the Emergency Department for Pain Management: A BraveNet Multi-Center Feasibility Study

疼痛占急诊科就诊患者的78%，急诊科的急性疼痛继续受到当前治疗方法(如阿片类药物)的控制或处理不当。联合委员会(TJC)敦促对医院使用阿片类药物持谨慎态度，从2018年1月1日起，TJC要求其认可的医院/设施提供治疗疼痛的非药物选择，针灸是一种选择。急诊科需要低风险和有效的方法来改善疼痛管理，如针灸。 在我们最近的初步随机对照试验(RCT)中，在0-10数值评分(NRS)中出现疼痛和GT；4的ED患者被随机分为针刺组(n=23)和常规护理组(n=23)。患者报告的疼痛强度变化分数(基线至60分钟)针刺组为-3.0单位，常规护理组为-1.56单位。NRS上-1.3到-2.0单位范围内的减少被认为具有临床意义。 这项试验性随机对照试验的结果是有希望的。然而，要使干预标准化，为未来的多地点务实、明确的随机对照试验做准备，还需要采取进一步的步骤。在这份U01务实试验提案中，我们建议：1)开发针灸干预的“响应性手册”；以及2)进行实施评估，评估(A)随机对照试验中招募参与者和收集数据的可行性；b)针灸干预的实施，包括实施结果、过程、障碍和促进者。 几个系统的综述得出结论，ED中针灸缓解疼痛的证据是有希望的，但下一步需要未来的多部位随机对照试验。因此，我们建议在BraveNet基于实践的研究网络中测试我们改进的研究程序的可行性，该网络是由15家活跃的美国综合医学诊所组成的小组。我们的U01包括爱因斯坦的BraveNet协调中心和BraveNet诊所附属的ED站点：大学医院/凯斯西储大学、范德比尔特大学医学中心和加州大学圣地亚哥分校。总共150名受试者(每个地点50名)将被随机分为针灸组或普通护理组(1：1分配)。此外，参与随机对照试验的患者和每个地点的急诊室提供者将参加结构化访谈，以支持未来、多地点、明确的随机对照试验的实施。 我们的具体目标是：目的1.开发针灸干预措施；以及目的2.进行可行性随机对照试验，以检验数据收集和针灸干预措施实施的可行性。拟议的多站点U01的成功实施将有助于在BraveNet附属诊所的更多急诊室中实施未来的、务实的、多站点的、非劣势的针灸RCT。建议的U01和随后的务实RCT(UG3/UH3)的完成可能提供关键证据，支持将针灸纳入全美的ED。如果成功，这种扩展可以为美国人提供更多的非药物方法来有效地控制疼痛，并理想地减少患者阿片类药物的使用。

Pain accounts for up to 78% of Emergency Department (ED) patient visits and acute pain in the ED continues to be under or improperly managed by current treatments (e.g. opioids). The Joint Commission (TJC) has urged caution regarding use of opioids in hospitals and, effective Jan. 1 2018, TJC required their accredited hospitals/facilities to provide non-pharmacologic options for pain, with acupuncture as one option. Low-risk and effective approaches to improve pain management, such as acupuncture, are needed in the ED. In our recent preliminary, randomized controlled trial (RCT), ED patients presenting with pain >4 on the 0-10 numeric rating scale (NRS) were randomized to either Acupuncture (n=23) or Usual Care (n=23). Patients reported pain intensity change scores (baseline to 60 min) of -3.0 units for Acupuncture and -1.56 units for Usual Care. Decreases in the range of -1.3 to -2.0 units on the NRS are considered clinically significant. Results from this pilot RCT are promising. However, to standardize an intervention in preparation for a future, multi-site pragmatic, definitive RCT, further steps are needed. In this U01 pragmatic trial proposal, we propose to: 1) develop a ‘responsive manualization’ of an acupuncture intervention; and 2) conduct an implementation evaluation, evaluating (a) feasibility of participant recruitment and data collection in an RCT; b) the implementation of the acupuncture intervention, including implementation outcomes, processes, barriers and facilitators. Several systematic reviews have concluded that the evidence for pain relief from acupuncture in the ED is promising, but next steps require future, multi-site RCTs. Accordingly, we propose to test the feasibility of our refined study procedures in the BraveNet Practice Based Research Network, which is a group of 15 active US integrative medicine clinics. Our U01 includes the BraveNet Coordinating Center at Einstein and BraveNet clinic-affiliated ED sites: University Hospitals/Case Western Reserve University; Vanderbilt University Medical Center; and University of California-San Diego. A total of 150 subjects (50 per site) will be randomized to either Acupuncture or Usual Care (1:1 allocation). In addition, RCT participating patients and ED providers at each site will participate in structured interviews to support implementation of a future, multi-site, definitive RCT. Our Specific Aims are: AIM 1. Develop a manualized acupuncture intervention; and AIM 2. Conduct a feasibility RCT to examine the feasibility of data collection and acupuncture intervention implementation. Successful conduct of the proposed multi-site U01 will inform implementation of a future, pragmatic, multi-site, non-inferiority RCT of Acupuncture compared with Usual Care in additional BraveNet clinic-affiliated EDs. Completion of the proposed U01 and the subsequent, pragmatic RCT (UG3/UH3) could provide critical evidence to support inclusion of acupuncture in EDs across the US. If successful, such an expansion could provide Americans with additional non-pharmacologic methods for robust pain management and ideally reduce patients’ opioid use.