Department of Family Medicine and Community Health, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Department of Veterans Affairs, Central Iowa, Des Moines, IA, USA.
Acupunct Med. 2022 Aug;40(4):339-346. doi: 10.1177/09645284221076507. Epub 2022 Mar 1.
This document describes the consensus process and intervention for a National Institutes of Health (NIH)-funded multi-site feasibility study utilizing acupuncture for te pan in he Emergenc Department (ACUITY). The acupuncture intervention is designed to be flexible and responsive to the most common Emergency Department (ED) scenarios, including trauma, acute pain of the low back, abdomen and/or musculoskeletal system, renal colic and headache.
Opioids remain a primary treatment for acute ED pain with attendant risk of adverse effects, addiction liability, diversion and death. Effective/safer options for acute pain are needed. Although acupuncture therapy has shown promise for acute pain in the ED alone or in conjunction with usual care, pragmatic trials are needed to obtain definitive and generalizable evidence.
An Acupuncture Advisory Panel was convened that included nine acupuncture experts with 5-44 years of experience in practice and 2-16 years of experience in the acute pain care setting. A modified Delphi process was used with provision of a literature review, surveys of our panel members, three online discussions and email discussion as needed. The STandards for Reporting Interventions in Controlled Trials (STRICTA) checklist was used as a guide.
A responsive acupuncture intervention was agreed on for ACUITY. Session forms were fashioned in REDCap (Research Electronic Data Capture program to capture essential treatment data, assess fidelity and inform our design for a future pragmatic multi-site randomized controlled trial (RCT) of acupuncture in the ED, and for use by other future researchers.
Development of a responsive manualization intervention provides the appropriate framework for conducting a future, pragmatic, multi-site, definitive RCT of acupuncture in the ED.
NCT04880733 (ClinicalTrials.gov).
本文件描述了美国国立卫生研究院（NIH）资助的多地点可行性研究的共识过程和干预措施，该研究利用针刺治疗急诊科的疼痛（ACUITY）。针刺干预措施旨在灵活应对最常见的急诊科（ED）情况，包括创伤、腰背和/或肌肉骨骼系统的急性疼痛、肾绞痛和头痛。
阿片类药物仍然是治疗急性 ED 疼痛的主要方法，但存在不良反应、成瘾性、滥用和死亡的风险。需要有更有效的/更安全的急性疼痛治疗选择。尽管针刺疗法已显示出在急诊科单独或与常规护理联合治疗急性疼痛方面的前景，但需要进行实用试验以获得明确和可推广的证据。
召集了一个针刺咨询小组，其中包括九位有 5-44 年实践经验和 2-16 年急性疼痛护理经验的针刺专家。采用改良 Delphi 法，提供文献综述、对我们小组的调查、三次在线讨论和必要时的电子邮件讨论。使用 STRICTA（针刺临床试验报告标准）检查表作为指南。
为 ACUITY 确定了一种响应式的针刺干预措施。制定了 REDCap（Research Electronic Data Capture program，用于捕获基本治疗数据、评估一致性并为我们在未来的 ED 中进行针刺的实用多地点随机对照试验（RCT）设计提供信息，以及供其他未来研究人员使用。
开发一种响应式的规范化干预措施为在 ED 中进行未来实用、多地点、明确的 RCT 提供了适当的框架。
NCT04880733（ClinicalTrials.gov）。
