Skip to main content
OpenTrials
Completed

NCT Number: NCT04290741

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Musculoskeletal Pain Disease Attributes Emergencies Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Hospital Emergency Department

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auricular (Battlefield) Acupuncture

Procedure

Placement of needles based on battlefield acupuncture protocol which includes up to 5 sites on each ear to treat pain.

Peripheral Acupuncture

Procedure

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

Primary outcomes

  1. Change in Pain Score

    Time frame: ED pre-acupuncture (baseline); ED post-acupuncture (up to 1 hour); 2 and 4 weeks post discharge

    11-point Numeric Rating Scale (NRS) for current pain

  2. Number of ED patients eligible for recruitment as measured by patient log

    Time frame: Post implementation, up to 6 weeks

  3. Number of patients enrolled as measured by patient log

    Time frame: Post implementation, up to 6 weeks

  4. Number of patients retained in study as measured by patient log

    Time frame: Post implementation, up to 6 weeks

  5. Number of patients that found acupuncture satisfactory via satisfactory questionnaire

    Time frame: Post implementation, up to 6 weeks

    Likert-scale, agree disagree

  6. Number of outpatient acupuncture sessions attended

    Time frame: 4 weeks post discharge

  7. Number of adverse events

    Time frame: Post implementation, up to 2 weeks

Secondary outcomes

  1. Change in function

    Time frame: ED pre-acupuncture (baseline); ED post-acupuncture (up to 1 hour); 2 and 4 weeks post discharge

    PROMIS-29

  2. Change in cognitive function

    Time frame: ED pre-acupuncture (baseline); ED post-acupuncture (up to 1 hour); 2 and 4 weeks post discharge

    Neuro-QoL

  3. Number of return ED visits

    Time frame: Up to one year post ED visit

  4. Pain medications received

    Time frame: Up to three months post ED visit

  5. Time in minutes for ED based acupuncture session

    Time frame: Post ED acupuncture session, up to 1 hour

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Substance Abuse and Mental Health Services Administration (SAMHSA)
  • The Duke Endowment

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 2, 2020
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.