Acupuncture in the Emergency Department for Pain Management (ACUITY)

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

Our goal is to use the R01 mechanism to conduct a two-arm multisite, feasibility RCT (Acupuncture vs Usual Care) to refine procedures for conducting a future fully powered multi-site RCT. The effort will be led by the BraveNet Coordinating Center at Einstein and include 3 BraveNet PBRN sites University Hospitals/ Case Western Reserve University (UH/Case), Vanderbilt University Medical Center (VUMC), and University of California-San Diego (UCSD). During Year 1 (Aim 1), we will develop the manualized acupuncture intervention with consensus from experts in the delivery of acupuncture for acute pain. At the end of Year 1 (prior to the start of the RCT), a study investigator meeting will be held to ensure consistent training of all study coordinators and acupuncturists to the study data collection, human subjects, intervention delivery, and reporting requirements. In Year 2-3 (Aim 2), we will enroll 165 participants (55 per site) into the randomized trial (1:1 assignment to Acupuncture or Usual Care) over a ~9-month enrollment period for each site. Sites will participate in the study sequentially, thus general findings from the implementation evaluation may be used to improve implementation at subsequent sites. Treatment outcomes include pain intensity, state anxiety and pain medication utilization within the ED (via EHR data extraction). In Aim 2a, 75 structured qualitative interviews of ED providers, staff, study acupuncturists (~10 per site) and acupuncture patients (~15 per site) and direct observation at each site will be used to identify barriers and facilitators of successful implementation. The Implementation Evaluation includes two broad categories of data: implementation outcomes (collected in Aim 2 as the feasibility study is conducted at each site) and explanatory factors (Aim 2a).

Study Overview

• Status: Completed
• Conditions: Acute Pain; Pain Management; Acupuncture; Emergency Department
• Intervention / Treatment: Procedure: Acupuncture for pain management; Other: Usual care for pain management

Detailed Description

The goal is to use the R01 mechanism to conduct a two-arm multisite, feasibility RCT (Acupuncture vs Usual Care) to refine procedures for conducting a future fully powered multi-site RCT. The effort will include the BraveNet Coordinating Center at Einstein and include 3 BraveNet PBRN sites University Hospitals/ Case Western Reserve University (UH/Case), Vanderbilt University Medical Center (VUMC), and University of California-San Diego (UCSD). During Year 1 (Aim 1), the investigators will develop the manualized acupuncture intervention with consensus from experts in the delivery of acupuncture for acute pain. Prior to the start of the RCT at all sites, study investigator meetings will be held to ensure consistent training of all study coordinators and acupuncturists to the study data collection, human subjects, intervention delivery, and reporting requirements. In Year 2-3 (Aim 2), the investigators will enroll 165 participants (55 per site) into the randomized trial (1:1 assignment to Acupuncture or Usual Care) over a ~9-month enrollment period for each site. Sites will participate in the study sequentially, thus general findings from the implementation evaluation may be used to improve implementation at subsequent sites. Study outcomes include responsive manualization of acupuncture intervention, recruitment, retention, patient adoption, patient acceptability, and provider acceptability. Measures will be collected including pain intensity, state anxiety and pain medication utilization within the ED (via EHR data extraction). In Aim 2a, 75 structured qualitative interviews of ED providers, staff, study acupuncturists (~10 per site) and acupuncture patients (~15 per site) and direct observation at each site will be used to identify barriers and facilitators of successful implementation. The Implementation Evaluation includes two broad categories of data: implementation outcomes (collected in Aim 2 as the feasibility study is conducted at each site) and explanatory factors (Aim 2a).

• Study Type: Interventional
• Enrollment (Actual): 290
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • University of California San Diego
  • New York
    • The Bronx, New York, United States, 10461
      • Einstein School of Medicine
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals/Case Western Reserve University- Cleveland Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vandebilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients ≥18 years of age
• Ability to communicate in English.
• Level 3, 4, 5 on triage rate scale
• Presentation with acute non-emergent (musculoskeletal, back, pelvic, non-cardiac chest, abdominal, flank or head) pain ≥4 on a 0-10-point NRS due to non-penetrating injury.

Exclusion Criteria:

• Fever exceeding 100° F
• Presenting with a chief complaint of a psychological / psychiatric concern
• Presenting with chief complaint of Migraine
• Patient arriving via ambulance or skipping triage
• Current Pregnancy
• Self-reported opioid medication taken orally within 4 hours
• Presenting with chief complaint of Joint Dislocation
• Presenting with chief complaint of Bone Fracture
• Confirmed or suspected COVID-19

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture; This arm will receive acupuncture for pain management, and any pain medications will be delayed until after receipt of acupuncture.	Procedure: Acupuncture for pain management; A manualized acupuncture protocol will be performed by a licensed acupuncturist in the patient's emergency department room.; Other: Usual care for pain management; Patient will receive usual care for pain management.
Active Comparator: Usual Care; This arm will receive usual care for pain management.	Other: Usual care for pain management; Patient will receive usual care for pain management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful Recruitment of Participants Into the Study.	The recruitment rate (# enrolled / # approached) were assessed for the overall study. Separate recruitment rates were calculated by site.	At Enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Retained in the Study at Post Treatment	Retained patients will be defined as those providing patient reported outcomes scores (e.g., pain, anxiety) at post-treatment. Separate retention rates (# retained / # enrolled) will be assessed overall and by site.	At post treatment (45-60 minutes)
Percentage of Patients Retained at 1-week Follow up	Retained patients will be defined as those providing patient reported outcomes scores at 1 week. Separate retention rates (# retained / # enrolled) will be assessed overall and by site.	One-week after the participant was discharged from the ED
Patient Satisfaction Question 1 at Post-treatment	Question 1: "How satisfied are you with how your pain was managed during your ED visit" on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied).	At post-treatment (45-60 minutes after baseline)
Patient Satisfaction Question 2 at Post-treatment	"Overall how satisfied are you with your treatment during your ED visit?" on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied).	At post-treatment (45-60 minutes after baseline)
Patient Satisfaction Question 1 at 1-Week	"How satisfied are you with how your pain was managed during your ED visit" on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied).	One week after participant was discharged from the ED
Patient Satisfaction Question 2 at 1 Week	"Overall how satisfied are you with your treatment during your ED visit?" on the 5-point Likert scale (1-Very Satisfied; 2-Satisfied; 3-Neither Satisfied nor Dissatisfied; 4-Dissatisfied; 5-Strongly Dissatisfied).	One week after participant was discharged from the ED
Provider Satisfaction Question1	"Do you view acupuncture in general as an appropriate intervention for the ED setting?" on a 5 point scale (0: Very inappropriate; 1: Inappropriate; 2: Neutral; 4: Appropriate; 4: Very appropriate). Higher scores are better.	After enrollment at the provider's site completed (~6 months after first enrollee).
Provider Satisfaction Question 2	"Do you view acupuncture in general as helpful in managing patient pain in the ED?" on a 5 point scale (0: Not at all helpful; 1: Somewhat Unhelpful; 2: Neutral; 3: Somewhat Helpful; 4: Very Helpful). Higher scores are better.	After enrollment at the provider's site completed (~6 months after first enrollee).
Provider Satisfaction Question 3	"How satisfied are you with the way that the acupuncture intervention was implemented in your setting" on the 5-point Likert scale (4-Very Satisfied; 3-Satisfied; 2-Neither Satisfied nor Dissatisfied; 1-Dissatisfied; 0-Very Dissatisfied). Higher scores are better	After enrollment at the provider's site completed (~6 months after first enrollee).
Provider Satisfaction Que4	"Did the ACUITY project impose a burden on ED staff in your setting?" on the 4-point Likert scale (0-Not at all a burden; 1-Somewhat of a burden; 2-Moderate burden 3-Extreme burden). Lower scores are better	After enrollment at the provider's site completed (~6 months after first enrollee).

Collaborators and Investigators

• Sponsor: Case Western Reserve University
• Collaborators: University of California, San Diego; Albert Einstein College of Medicine; Vanderbilt University Medical Center; University of Massachusetts, Worcester
• Investigators: Principal Investigator: M. Diane McKee, MD, University of Massachusetts, Worcester; Principal Investigator: Jeffery A Dusek, PhD, University California-Irvine

Publications and helpful links

General Publications

• Dusek JA, Kallenberg GA, Hughes RM, Storrow AB, Coyne CJ, Vago DR, Nielsen A, Karasz A, Kim RS, Surdam J, Segall T, McKee MD. Acupuncture in the emergency department for pain management: A BraveNet multi-center feasibility study. Medicine (Baltimore). 2022 Mar 4;101(9):e28961. doi: 10.1097/MD.0000000000028961.
• Nielsen A, Olson J, Quesada M, Zhu C, Raskin E, Vang B, Painovich J, Scott M, Xiong VJ, Dusek JA. Acupuncture intervention for acute pain in the Emergency Department trial: a consensus process. Acupunct Med. 2022 Aug;40(4):339-346. doi: 10.1177/09645284221076507. Epub 2022 Mar 1.
• Dyer NL, Surdam J, Dusek JA. A Systematic Review of Practiced-Based Research of Complementary and Integrative Health Therapies as Provided for Pain Management in Clinical Settings: Recommendations for the Future and a Call to Action. Pain Med. 2022 Jan 3;23(1):189-210. doi: 10.1093/pm/pnab151.
• Dusek JA, Kallenberg GA, Storrow AB, Hughes RM, Coyne CJ, Vago DR, Nielsen A, Karasz A, Kim RS, Surdam J, Segall T, Faryar KA, Dyer NL, Barton BA, McKee MD. Acupuncture in the emergency department (ACUITY): Results from a BraveNet multi-center feasibility randomized controlled trial. Integr Med Res. 2024 Dec;13(4):101095. doi: 10.1016/j.imr.2024.101095. Epub 2024 Oct 21.
• Nielsen A, Dyer NL, Lechuga C, McKee MD, Dusek JA. Fidelity to the acupuncture intervention protocol in the ACUpuncture In The EmergencY department for pain management (ACUITY) trial: Expanding the gold standard of STRICTA and CONSORT guidelines. Integr Med Res. 2024 Jun;13(2):101048. doi: 10.1016/j.imr.2024.101048. Epub 2024 May 10.

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2021
• Primary Completion (Actual): September 24, 2022
• Study Completion (Actual): August 31, 2025

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Disease Attributes; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergencies; Acute Pain; Agnosia; Health Services Administration; Therapeutics; Complementary Therapies; Patient Care Management; Disease Management; Acupuncture Therapy; Pain Management
• Other Study ID Numbers: R01AT010598-01A1 (U.S. NIH Grant/Contract); R01AT010598 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No