Emergency Department Acupuncture for Acute Musculoskeletal Pain Management

The purpose of this project is to determine the feasibility, acceptability and effectiveness of acupuncture in the Emergency Department (ED) for treating acute musculoskeletal pain. The overall goal is to reduce acute and subacute opioid use by improving acute pain, anxiety and disability with non-pharmacologic treatment options at a critical entry point for patients into the healthcare system. This full-scale randomized controlled trial (RCT) has been statistically powered to test the effectiveness of ED-based acupuncture for both one-hour (Stage 1) and one-month (Stage 2) pain reduction outcomes. The feasibility will be assessed based on patient recruitment and retention rates, while the acceptability will be assessed using patient reported outcomes and qualitative semi-structured interviews.

Stage 1 is a 2-phase study design. Phase (1): Enrolled subjects will be randomized to auricular (ear) acupuncture, peripheral acupuncture, or the control group receiving no acupuncture. Subjects assigned to an acupuncture arm will receive information and access to acupuncture in an outpatient clinic for the 4 weeks following ED visit. Subjects may also have a blood draw for biomarker analysis during their ED visit. A planned interim analysis of the first 60 patients (2/3 of the Phase 1 arm completed) will be completed to select the more effective and/or acceptable arm for Phase 2. At interim analysis, it was determined by the DSMB that neither arm was superior, so the recommendation was to continue Stage 1 Phase 2 unchanged with 3 arms. Stage 1 is complete, and we will proceed with Stage 2 powered to the 4-week pain score outcome. Stage 2 will proceed with the same procedures as stage 1, only powered to a different outcome.

Study Overview

• Status: Completed
• Conditions: Musculoskeletal Pain
• Intervention / Treatment: Procedure: Auricular (Battlefield) Acupuncture; Procedure: Peripheral Acupuncture

• Study Type: Interventional
• Enrollment (Actual): 599
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Hospital Emergency Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults age 18 or older
• Clinical diagnosis of acute (≤7 days) musculoskeletal pain as determined by an ED provider
• Able to read and understand the consent form in English

Exclusion Criteria:

• Unable to receive acupuncture due to injury or infection of acupuncture sites
• Unwilling or unable to attend the follow-up outpatient acupuncture clinic
• Severe hearing or speech impairment
• Cognitive impairment, including evidence of drug, medication or alcohol intoxication, that would prevent comprehension of consent procedures or study measures and procedures
• Critical illness
• Deformity
• Medical condition that would contraindicate safe participation as determine by an ED provider

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Auricular (Battlefield) Acupuncture; Auricular acupuncture involves placement of needles based on battlefield acupuncture protocol which involves the placement of needles in up to 5 sites on each ear to treat pain.	Procedure: Auricular (Battlefield) Acupuncture; Placement of needles based on battlefield acupuncture protocol which includes up to 5 sites on each ear to treat pain.
Experimental: Peripheral Acupuncture; Peripheral acupuncture involves placement of needles in up to 30 specific sites in the head, neck, arms from the shoulders to the hands, and legs from the knees to the feet	Procedure: Peripheral Acupuncture; Placement of needles in up to 30 specific sites in the head, neck, arms from the shoulders to the hands, and legs from the knees to the feet
No Intervention: Control; Standard of care without acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Score	11-point Numeric Rating Scale (NRS) for current pain	ED pre-acupuncture (baseline); ED post-acupuncture (up to 1 hour); 2 and 4 weeks post discharge
Number of ED patients eligible for recruitment as measured by patient log		Post implementation, up to 6 weeks
Number of patients enrolled as measured by patient log		Post implementation, up to 6 weeks
Number of patients retained in study as measured by patient log		Post implementation, up to 6 weeks
Number of patients that found acupuncture satisfactory via satisfactory questionnaire	Likert-scale, agree disagree	Post implementation, up to 6 weeks
Number of outpatient acupuncture sessions attended		4 weeks post discharge
Number of adverse events		Post implementation, up to 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in function	PROMIS-29	ED pre-acupuncture (baseline); ED post-acupuncture (up to 1 hour); 2 and 4 weeks post discharge
Change in cognitive function	Neuro-QoL	ED pre-acupuncture (baseline); ED post-acupuncture (up to 1 hour); 2 and 4 weeks post discharge
Number of return ED visits		Up to one year post ED visit
Pain medications received		Up to three months post ED visit
Time in minutes for ED based acupuncture session		Post ED acupuncture session, up to 1 hour

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Substance Abuse and Mental Health Services Administration (SAMHSA); The Duke Endowment
• Investigators: Principal Investigator: Stephanie Eucker, MD, PhD, Duke University

Publications and helpful links

General Publications

• Eucker SA, Glass O, Staton CA, Knisely MR, O'Regan A, De Larco C, Mill M, Dixon A, TumSuden O, Walker E, Dalton JC, Limkakeng A, Maxwell AMW, Gordee A, Kuchibhatla M, Chow S. Acupuncture for acute musculoskeletal pain management in the emergency department and continuity clinic: a protocol for an adaptive pragmatic randomised controlled trial. BMJ Open. 2022 Sep 23;12(9):e061661. doi: 10.1136/bmjopen-2022-061661.

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2020
• Primary Completion (Actual): April 19, 2023
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: February 26, 2020
• First Submitted That Met QC Criteria: February 28, 2020
• First Posted (Actual): March 2, 2020

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Acupuncture; Emergency Department
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Musculoskeletal Diseases; Muscular Diseases; Emergencies; Musculoskeletal Pain
• Other Study ID Numbers: Pro00104140

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