Acupuncture in the Emergency Department for Pain Management (ACUITY)

Case Western Reserve University

Status: Completed

Conditions: Emergency Department; Pain Management; Acupuncture; Acute Pain

Treatments: Other: Usual care for pain management; Procedure: Acupuncture for pain management

Study type: Interventional

Funder types: Other

Identifiers

NCT04880733

R01AT010598-01A1

Details and patient eligibility

About

Our goal is to use the R01 mechanism to conduct a two-arm multisite, feasibility RCT (Acupuncture vs Usual Care) to refine procedures for conducting a future fully powered multi-site RCT. The effort will be led by the BraveNet Coordinating Center at Einstein and include 3 BraveNet PBRN sites University Hospitals/ Case Western Reserve University (UH/Case), Vanderbilt University Medical Center (VUMC), and University of California-San Diego (UCSD). During Year 1 (Aim 1), we will develop the manualized acupuncture intervention with consensus from experts in the delivery of acupuncture for acute pain. At the end of Year 1 (prior to the start of the RCT), a study investigator meeting will be held to ensure consistent training of all study coordinators and acupuncturists to the study data collection, human subjects, intervention delivery, and reporting requirements. In Year 2-3 (Aim 2), we will enroll 165 participants (55 per site) into the randomized trial (1:1 assignment to Acupuncture or Usual Care) over a ~9-month enrollment period for each site. Sites will participate in the study sequentially, thus general findings from the implementation evaluation may be used to improve implementation at subsequent sites. Treatment outcomes include pain intensity, state anxiety and pain medication utilization within the ED (via EHR data extraction). In Aim 2a, 75 structured qualitative interviews of ED providers, staff, study acupuncturists (~10 per site) and acupuncture patients (~15 per site) and direct observation at each site will be used to identify barriers and facilitators of successful implementation. The Implementation Evaluation includes two broad categories of data: implementation outcomes (collected in Aim 2 as the feasibility study is conducted at each site) and explanatory factors (Aim 2a).

Full description

The goal is to use the R01 mechanism to conduct a two-arm multisite, feasibility RCT (Acupuncture vs Usual Care) to refine procedures for conducting a future fully powered multi-site RCT. The effort will include the BraveNet Coordinating Center at Einstein and include 3 BraveNet PBRN sites University Hospitals/ Case Western Reserve University (UH/Case), Vanderbilt University Medical Center (VUMC), and University of California-San Diego (UCSD). During Year 1 (Aim 1), the investigators will develop the manualized acupuncture intervention with consensus from experts in the delivery of acupuncture for acute pain. Prior to the start of the RCT at all sites, study investigator meetings will be held to ensure consistent training of all study coordinators and acupuncturists to the study data collection, human subjects, intervention delivery, and reporting requirements. In Year 2-3 (Aim 2), the investigators will enroll 165 participants (55 per site) into the randomized trial (1:1 assignment to Acupuncture or Usual Care) over a ~9-month enrollment period for each site. Sites will participate in the study sequentially, thus general findings from the implementation evaluation may be used to improve implementation at subsequent sites. Study outcomes include responsive manualization of acupuncture intervention, recruitment, retention, patient adoption, patient acceptability, and provider acceptability. Measures will be collected including pain intensity, state anxiety and pain medication utilization within the ED (via EHR data extraction). In Aim 2a, 75 structured qualitative interviews of ED providers, staff, study acupuncturists (~10 per site) and acupuncture patients (~15 per site) and direct observation at each site will be used to identify barriers and facilitators of successful implementation. The Implementation Evaluation includes two broad categories of data: implementation outcomes (collected in Aim 2 as the feasibility study is conducted at each site) and explanatory factors (Aim 2a).

Enrollment: 290 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients ≥18 years of age
• Ability to communicate in English.
• Level 3, 4, 5 on triage rate scale
• Presentation with acute non-emergent (musculoskeletal, back, pelvic, non-cardiac chest, abdominal, flank or head) pain ≥4 on a 0-10-point NRS due to non-penetrating injury.

Exclusion criteria

• Fever exceeding 100° F
• Presenting with a chief complaint of a psychological / psychiatric concern
• Presenting with chief complaint of Migraine
• Patient arriving via ambulance or skipping triage
• Current Pregnancy
• Self-reported opioid medication taken orally within 4 hours
• Presenting with chief complaint of Joint Dislocation
• Presenting with chief complaint of Bone Fracture
• Confirmed or suspected COVID-19

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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290 participants in 2 patient groups

Acupuncture

Experimental group

Description:

This arm will receive acupuncture for pain management, and any pain medications will be delayed until after receipt of acupuncture.

Treatment:

Procedure: Acupuncture for pain management

Other: Usual care for pain management

Usual Care

Active Comparator group

Description:

This arm will receive usual care for pain management.

Treatment:

Other: Usual care for pain management