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
|Condition or disease||Intervention/treatment||Phase|
|Pain||Other: Acupuncture||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
One session of acupuncture prior to receiving pain medications after arriving to the emergency department with pain as a symptom.
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.
- 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.
- 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.
- 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.
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
|United States, Minnesota|
|Abbott Northwestern Hospital|
|Minneapolis, Minnesota, United States, 55407|