Emergency Department Acupuncture for Acute Musculoskeletal Pain Management

Not Applicable

Completed

• Conditions: Musculoskeletal Pain
• Interventions: Procedure: Auricular (Battlefield) Acupuncture; Procedure: Peripheral Acupuncture

• Registration Number: NCT04290741
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-10
• Study First Submitted: 2020-02-26
• Study First Submitted QC: 2020-02-28
• Study First Posted: 2020-03-02
• Status Verified: 2023-03
• Primary Completion: 2023-04-19
• Study Completion: 2023-06-15
• Last Update Submitted: 2023-07-03
• Last Update Posted: 2023-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 599

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Auricular (Battlefield) Acupuncture	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.
Peripheral Acupuncture	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

Primary Outcome Measures

Name	Time	Method
Number of patients enrolled as measured by patient log	Post implementation, up to 6 weeks
Number of patients that found acupuncture satisfactory via satisfactory questionnaire	Post implementation, up to 6 weeks	Likert-scale, agree disagree
Number of adverse events	Post implementation, up to 2 weeks
Number of ED patients eligible for recruitment as measured by patient log	Post implementation, up to 6 weeks
Number of outpatient acupuncture sessions attended	4 weeks post discharge
Change in Pain Score	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
Number of patients retained in study as measured by patient log	Post implementation, up to 6 weeks

Secondary Outcome Measures

Name	Time	Method
Change in function	ED pre-acupuncture (baseline); ED post-acupuncture (up to 1 hour); 2 and 4 weeks post discharge	PROMIS-29
Change in cognitive function	ED pre-acupuncture (baseline); ED post-acupuncture (up to 1 hour); 2 and 4 weeks post discharge	Neuro-QoL
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

Trial Locations

Locations (1)

Duke University Hospital Emergency Department; 🇺🇸 Durham, North Carolina, United States