Acupuncture in the Emergency Department for Pain Management

NCT04880733 | Completed Results DMC

• 1 other identifier: R01AT010598-01A1
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 4

Brief Summary

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).

Conditions

Acupuncture; Pain Management; Emergency Department; Acute Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Percentage of Participants Retained in the Study at Post Treatment

  At post treatment (45-60 minutes)

• Percentage of Patients Retained at 1-week Follow up

  One-week after the participant was discharged from the ED

• Patient Satisfaction Question 1 at Post-treatment

  At post-treatment (45-60 minutes after baseline)

• Patient Satisfaction Question 2 at Post-treatment

  At post-treatment (45-60 minutes after baseline)

• Patient Satisfaction Question 1 at 1-Week

  One week after participant was discharged from the ED

Study Arms (2)

Acupuncture

EXPERIMENTAL

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; Other: Usual care for pain management

Usual Care

ACTIVE COMPARATOR

This arm will receive usual care for pain management.

Other: Usual care for pain management

Interventions

Acupuncture for pain management PROCEDURE

A manualized acupuncture protocol will be performed by a licensed acupuncturist in the patient's emergency department room.

Acupuncture

Usual care for pain management OTHER

Patient will receive usual care for pain management.

Acupuncture; Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Western Reserve University: lead
• Vanderbilt University Medical Center: collaborator
• University of California, San Diego: collaborator
• Albert Einstein College of Medicine: collaborator
• University of Massachusetts, Worcester: collaborator

Study Sites (4)

University of California San Diego

La Jolla, California, 92093, United States

Location

Einstein School of Medicine

The Bronx, New York, 10461, United States

Location

University Hospitals/Case Western Reserve University- Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Vandebilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (5)

• 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.

  PMID: 39640074 DERIVED

• 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.

  PMID: 38841077 DERIVED

• 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.

  PMID: 35244059 DERIVED

• 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.

  PMID: 35229658 DERIVED

• 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.

  PMID: 34009391 DERIVED

MeSH Terms

Conditions

Agnosia; Emergencies; Acute Pain

Interventions

Acupuncture Therapy; Pain Management

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Disease Management; Patient Care Management; Health Services Administration

Limitations and Caveats

It should be noted that recruitment was conducted during the COVID-19 pandemic.

Results Point of Contact

• Title: Jeffery Dusek
• Organization: University California-Irvine

jdusek@hs.uci.edu

617-519-8082

Study Officials

• Jeffery A Dusek, PhD

  University California-Irvine

  PRINCIPAL INVESTIGATOR

• M. Diane McKee, MD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data collector will be masked to study outcomes via electronic data collection
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 11, 2021
• Study Start: May 3, 2021
• Primary Completion: September 24, 2022
• Study Completion: August 31, 2025
• Last Updated: January 5, 2026
• Results First Posted: February 20, 2024

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)