Acupuncture intervention for acute pain in the Emergency Department trial: a consensus process.

purposeThis document describes the consensus process and intervention for a National Institutes of Health (NIH)-funded multi-site feasibility study utilizing acupuncture for

backgroundOpioids 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.

methodsAn 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.

resultsA 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.

conclusionDevelopment of a responsive manualization intervention provides the appropriate framework for conducting a future, pragmatic, multi-site, definitive RCT of acupuncture in the ED. TRIAL REGISTRATION NUMBER: NCT04880733 (ClinicalTrials.gov).