Emergency Department Acupuncture for Acute Musculoskeletal Pain Management

Study Overview
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Brief Summary
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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.

Official Title
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Emergency Department Acupuncture for Acute Musculoskeletal Pain Management

Conditions
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Musculoskeletal Pain

Intervention / Treatment
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* Procedure: Auricular (Battlefield) Acupuncture
* Procedure: Peripheral Acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Auricular (Battlefield) Acupuncture<br>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<br>* Placement of needles based on battlefield acupuncture protocol which includes up to 5 sites on each ear to treat pain.<br>|
| Experimental: Peripheral Acupuncture<br>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<br>* 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<br>|
| No Intervention: Control<br>Standard of care without acupuncture | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in function | PROMIS-29 | ED pre-acupuncture (baseline); ED post-acupuncture (up to 1 hour); 2 and 4 weeks post discharge | 
| Change in cognitive function | Neuro-QoL | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Pain, Emergency Department