Emergency Department Acupuncture for Acute Musculoskeletal Pain Management

NCT04290741 | Completed DMC

• 1 other identifier: Pro00104140
• Study Type: interventional
• Target: 599
• Locations: 1 country
• Sites: 1

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

Keywords

Acupuncture; Pain; Emergency Department

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (5)

• Change in function

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

• Change in cognitive function

  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

Study Arms (3)

Auricular (Battlefield) Acupuncture

EXPERIMENTAL

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

Peripheral Acupuncture

EXPERIMENTAL

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

Control

NO INTERVENTION

Standard of care without acupuncture

Interventions

Auricular (Battlefield) Acupuncture PROCEDURE

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

Auricular (Battlefield) Acupuncture

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

Peripheral Acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Duke University: lead
• The Duke Endowment: collaborator
• Substance Abuse and Mental Health Services Administration (SAMHSA): collaborator

Study Sites (1)

Duke University Hospital Emergency Department

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• 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.

  PMID: 36153034 DERIVED

MeSH Terms

Conditions

Musculoskeletal Pain; Pain; Emergencies

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Stephanie Eucker, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: March 2, 2020
• Study Start: February 10, 2020
• Primary Completion: April 19, 2023
• Study Completion: June 15, 2023
• Last Updated: July 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)