Emergency Department Acupuncture for Acute Musculoskeletal Pain Management
Completed · Not applicable
Conditions studied: Musculoskeletal Pain
In brief
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.
Key facts
- Study ID
- NCT04290741
- Run by
- Duke University
- People needed
- 599
- Starts
- 2020-02-10
- Expected to finish
- 2023-06-15
- Last updated by the study team
- 2026-05-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Duke University Hospital Emergency Department — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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