Clinical trial NCT04290741: Emergency Department Acupuncture for Acute Musculoskeletal Pain Management
Official title: Emergency Department Acupuncture for Acute Musculoskeletal Pain Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Keywords: Acupuncture
Pain
Emergency Department
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: The Duke Endowment
name: Substance Abuse and Mental Health Services Administration (SAMHSA)
First posted: 2020-03-02
Enrollment: 599
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Pain Score
timeFrame: ED pre-acupuncture (baseline); ED post-acupuncture (up to 1 hour); 2 and 4 weeks post discharge
measure: Number of ED patients eligible for recruitment as measured by patient log
timeFrame: Post implementation, up to 6 weeks
measure: Number of patients enrolled as measured by patient log
timeFrame: Post implementation, up to 6 weeks
measure: Number of patients retained in study as measured by patient log
timeFrame: Post implementation, up to 6 weeks
measure: Number of patients that found acupuncture satisfactory via satisfactory questionnaire
timeFrame: Post implementation, up to 6 weeks
measure: Number of outpatient acupuncture sessions attended
timeFrame: 4 weeks post discharge
measure: Number of adverse events
timeFrame: Post implementation, up to 2 weeks
Secondary outcomes:
measure: Change in function
timeFrame: ED pre-acupuncture (baseline); ED post-acupuncture (up to 1 hour); 2 and 4 weeks post discharge
measure: Change in cognitive function
timeFrame: ED pre-acupuncture (baseline); ED post-acupuncture (up to 1 hour); 2 and 4 weeks post discharge
measure: Number of return ED visits
timeFrame: Up to one year post ED visit
measure: Pain medications received
timeFrame: Up to three months post ED visit
measure: Time in minutes for ED based acupuncture session
timeFrame: Post ED acupuncture session, up to 1 hour
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital Emergency Department
state: North Carolina
Study officials:
affiliation: Duke University
name: Stephanie Eucker, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.