Emergency Department Acupuncture for Acute Musculoskeletal Pain Management

• ClinicalTrials.gov Identifier: NCT04290741
• Recruitment Status: Enrolling by invitation
• First Posted: March 2, 2020
• Sponsor: Duke University
• Collaborators: The Duke Endowment; Substance Abuse and Mental Health Services Administration (SAMHSA)
• Information provided by (Responsible Party): Duke University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Musculoskeletal Pain	Procedure: Auricular (Battlefield) Acupuncture; Procedure: Peripheral Acupuncture	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 750 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Emergency Department Acupuncture for Acute Musculoskeletal Pain Management
• Actual Study Start Date: February 10, 2020
• Estimated Primary Completion Date: April 15, 2023
• Estimated Study Completion Date: June 15, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Procedure: Auricular (Battlefield) Acupuncture; Placement of needles based on battlefield acupuncture protocol which includes up to 5 sites on each ear to treat pain.
Experimental: 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	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
No Intervention: Control; Standard of care without acupuncture

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, North Carolina

Duke University Hospital Emergency Department

Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

The Duke Endowment

Substance Abuse and Mental Health Services Administration (SAMHSA)

Investigators

• Principal Investigator: Stephanie Eucker, MD, PhD; Duke University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT04290741
• Other Study ID Numbers: Pro00104140
• First Posted: March 2, 2020
• Last Update Posted: March 9, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duke University:

Acupuncture; Pain; Emergency Department

Additional relevant MeSH terms:

Musculoskeletal Pain; Emergencies; Disease Attributes; Pathologic Processes; Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations