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Acupuncture in the Emergency Department

Primary Purpose

Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
Allina Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Acupuncture, Emergency Department, Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Abbott Northwestern Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Acupuncture

Usual Care

Arm Description

One session of acupuncture prior to receiving pain medications after arriving to the emergency department with pain as a symptom.

Usual care for pain, without intervention, after arriving to the emergency department with pain as a symptom.

Outcomes

Primary Outcome Measures

Feasibility of delivering acupuncture via a Randomized Controlled Trial in the Emergency Department
Assess feasibility of triaging and treating patients presenting to the emergency department with protocol defining criteria and then having that patient participate in a randomized controlled trial comparing acupuncture to usual care. This will be assessed by the number of patients approached compared to the number of patients consented and by the number of patients able to receive acupuncture while in the Emergency Department.

Secondary Outcome Measures

Pain Reduction
Measure pre- and post-treatment pain scores on an 11-point numerical rating scale for persons randomized to acupuncture or usual care in the emergency department. The goal of this outcome will be to obtain effect size to be used in the sample size calculation in a follow-up efficacy study.
Opioid use
Collect information on opioid use in the emergency department, opioid prescriptions at discharge, and opioid medication usage at 30 days post-discharge in both the acupuncture and usual care arms.

Full Information

First Posted
March 25, 2016
Last Updated
May 3, 2018
Sponsor
Allina Health System
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1. Study Identification

Unique Protocol Identification Number
NCT02888340
Brief Title
Acupuncture in the Emergency Department
Official Title
A Randomized Controlled Trial of Acupuncture in the Emergency Department: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
July 6, 2017 (Actual)
Study Completion Date
July 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allina Health System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Acupuncture, Emergency Department, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
One session of acupuncture prior to receiving pain medications after arriving to the emergency department with pain as a symptom.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual care for pain, without intervention, after arriving to the emergency department with pain as a symptom.
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture involves inserting thin, sterile needles into the skin. The needles do not go into the skin very far. Number of acupuncture sessions: one.
Primary Outcome Measure Information:
Title
Feasibility of delivering acupuncture via a Randomized Controlled Trial in the Emergency Department
Description
Assess feasibility of triaging and treating patients presenting to the emergency department with protocol defining criteria and then having that patient participate in a randomized controlled trial comparing acupuncture to usual care. This will be assessed by the number of patients approached compared to the number of patients consented and by the number of patients able to receive acupuncture while in the Emergency Department.
Time Frame
At study completion, one year
Secondary Outcome Measure Information:
Title
Pain Reduction
Description
Measure pre- and post-treatment pain scores on an 11-point numerical rating scale for persons randomized to acupuncture or usual care in the emergency department. The goal of this outcome will be to obtain effect size to be used in the sample size calculation in a follow-up efficacy study.
Time Frame
During day 1 of study participation
Title
Opioid use
Description
Collect information on opioid use in the emergency department, opioid prescriptions at discharge, and opioid medication usage at 30 days post-discharge in both the acupuncture and usual care arms.
Time Frame
At study completion, one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26917627
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.
Results Reference
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Acupuncture in the Emergency Department

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