Emergency Department Acupuncture for Acute Musculoskeletal Pain Management

Duke University

Status: Completed

Conditions: Musculoskeletal Pain

Treatments: Procedure: Peripheral Acupuncture; Procedure: Auricular (Battlefield) Acupuncture

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04290741

Pro00104140

Details and patient eligibility

About

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.

Enrollment: 599 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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599 participants in 3 patient groups

Auricular (Battlefield) Acupuncture

Experimental group

Description:

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.

Treatment:

Procedure: Auricular (Battlefield) Acupuncture

Peripheral Acupuncture

Experimental group

Description:

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

Treatment:

Procedure: Peripheral Acupuncture

Control

No Intervention group

Description:

Standard of care without acupuncture