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Acupuncture in the Emergency Department

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ClinicalTrials.gov Identifier: NCT02888340
Recruitment Status : Completed
First Posted : September 5, 2016
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Allina Health System

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.

Condition or disease Intervention/treatment Phase
Pain Other: Acupuncture Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Acupuncture in the Emergency Department: A Pilot Study
Study Start Date : April 2016
Actual Primary Completion Date : July 6, 2017
Actual Study Completion Date : July 6, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Acupuncture
One session of acupuncture prior to receiving pain medications after arriving to the emergency department with pain as a symptom.
Other: Acupuncture
Acupuncture involves inserting thin, sterile needles into the skin. The needles do not go into the skin very far. Number of acupuncture sessions: one.

No Intervention: Usual Care
Usual care for pain, without intervention, after arriving to the emergency department with pain as a symptom.



Primary Outcome Measures :
  1. Feasibility of delivering acupuncture via a Randomized Controlled Trial in the Emergency Department [ Time Frame: At study completion, one year ]
    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 :
  1. Pain Reduction [ Time Frame: During day 1 of study participation ]
    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.

  2. Opioid use [ Time Frame: At study completion, one year ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02888340


Locations
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United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Sponsors and Collaborators
Allina Health System

Publications:
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Responsible Party: Allina Health System
ClinicalTrials.gov Identifier: NCT02888340     History of Changes
Other Study ID Numbers: S01022016
First Posted: September 5, 2016    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Allina Health System:
Acupuncture
Emergency Department
Pain
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes