Emergency Department Acupuncture for Acute Musculoskeletal Pain Management

NCT ID: NCT04290741

Last Updated: 2023-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 599 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-10
• Study Completion Date: 2023-06-15

Brief Summary

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.

Conditions

Musculoskeletal Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Auricular (Battlefield) Acupuncture

Intervention Type: PROCEDURE

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

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

Group Type: EXPERIMENTAL

Peripheral Acupuncture

Intervention Type: 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

Control

Standard of care without acupuncture

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Auricular (Battlefield) Acupuncture

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

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Duke Endowment

OTHER

Sponsor Role: collaborator

Substance Abuse and Mental Health Services Administration (SAMHSA)

FED

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephanie Eucker, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Hospital Emergency Department

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36153034 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00104140

Identifier Type: -

Identifier Source: org_study_id