Clinical trial NCT02888340: Acupuncture in the Emergency Department
Official title: A Randomized Controlled Trial of Acupuncture in the Emergency Department: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Acupuncture
Emergency Department
Pain
Lead sponsor: Allina Health System
Sponsor class: OTHER
First posted: 2016-09-05
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will study acupuncture in a pilot, randomized controlled trial (RCT) in the emergency department (ED) of a large, tertiary care hospital, Abbott Northwestern Hospital (ANW). The investigators suggest that the proposed intervention - provision of acupuncture in the ED as an alternative to usual ED care - will reduce pain and interrupt the trajectory (and potential cycle) of medication misuse by providing an alternative at a critical point of contact within the healthcare system, potentially disrupting the pathway from ED visit to opioid usage after discharge.

Detailed description: The investigators will study acupuncture in a pilot, randomized controlled trial (RCT) in the emergency department (ED) of a large, tertiary care hospital, Abbott Northwestern Hospital (ANW). The investigators suggest that the proposed intervention - provision of acupuncture in the ED as an alternative to usual ED care - will reduce pain and interrupt the trajectory (and potential cycle) of medication misuse by providing an alternative at a critical point of contact within the healthcare system, potentially disrupting the pathway from ED visit to opioid usage after discharge. In this study, the investigators will assess the feasibility of implementation, practicality, and expansion of an acupuncture RCT in the ED environment. The study will prospectively measure and analyze change in pain intensity after treatment with acupuncture or usual care, use of opioids during ED visit, prescriptions written for opioids at ED discharge, and use of opioids at 30-day follow-up.

Study data will be collected using electronic health record (EHR) data and patient-reported outcomes. Patient-reported outcomes will be collected via an electronic database and solely for research purposes. The acupuncture intervention provided in the ED will be provided at no cost to the patient and will be paid for by the study sponsor. The practice of providing acupuncture in ANW's ED at no charge to the patient has been in place since November 2013. In conducting this pilot study, it will assess the ability to implement and carry out a RCT of acupuncture in the ED. By comparing pain change and opioid utilization among patients who receive acupuncture versus those who receive usual emergency department care, and by conducting follow-up data collection, the investigators will be able to better understand the potential role of a common non-pharmacological pain management strategy for mitigating pain and reducing opioid use in the emergency medicine setting.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age
* Ability to communicate in English
* Non-critical status as determined at triage and / or by a clinic provider
* Presentation to the emergency department with acute musculoskeletal, back, pelvic, non-cardiac chest, abdominal, and headache pain (≥ 4 on the numerical rating scale), due to non-penetrating injury. Acute pain is defined by pain occurring within 72 hours of ED presentation (this can be an acute flare-up of a chronic pain condition).

Exclusion Criteria:

* Current pregnancy
* Need for emergent treatment as determined at triage and / or by a clinic provider (Level 1 or 2 on triage rating scale)
* Bone fracture
* Joint dislocation
* Fever exceeding 100° F
* Opioid medication taken orally within 4 hours (determined per patient report)
* Current use of a pharmaceutical analgesic patch
* Presenting with a chief complaint of a psychological / psychiatric concern
* Presenting with a migraine
* Having a unique treatment plan (UTP) on file with Abbott Northwestern Hospital
* Patient arriving via ambulance due to skipping triage
* Currently participating in this study due to previous ED admission
* Medical provider decision / clinical judgement

Primary outcomes:
measure: Feasibility of delivering acupuncture via a Randomized Controlled Trial in the Emergency Department
timeFrame: At study completion, one year
Secondary outcomes:
measure: Pain Reduction
timeFrame: During day 1 of study participation
measure: Opioid use
timeFrame: At study completion, one year
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
Study officials:
References:
citation: Reinstein AS, Erickson LO, Griffin KH, Rivard RL, Kapsner CE, Finch MD, Dusek JA. Acceptability, Adaptation, and Clinical Outcomes of Acupuncture Provided in the Emergency Department: A Retrospective Pilot Study. Pain Med. 2017 Jan 30;18(1):169-178. doi: 10.1093/pm/pnv114.