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Acupuncture for Pain in the Emergency Department

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02540512
Recruitment Status : Withdrawn (No participants enrolled)
First Posted : September 4, 2015
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
Traci Marin, Loma Linda University

Brief Summary:

The purpose of the study is to test auricular (ear) acupuncture for the acute management of patient pain in the Emergency Department as an alternative and adjunct to standard medical treatment.

Currently, physicians who practice medicine here in the United States only have pharmacological intervention at their disposal as the only available treatment tool they have for the treatment and management of pain, and as a result, painkiller misuse, overdose, and death has become the leading health epidemic in America. American healthcare is in desperate need of alternative and safer ways to prevent prescription painkiller overdoses and to better manage pain. If prescription painkiller dependencies can be avoided at the source, potentially many lives and healthcare dollars can be saved. Acupuncture is an alternative treatment that has been effectively used to treat pain for thousands of years in countries around the world. The National Institutes of Health (NIH) and the United Nations World Health Organization (WHO) have stated that acupuncture is a safe and effective treatment for the management of pain. Supported by many studies illustrating seventy-five to ninety-nine percent effectiveness in treating pain with an instantaneous drop in pain by twenty-five to eighty percent, acupuncture appears to be the safest and most effective option available to manage pain syndromes in the emergency department.

Auricular acupuncture has demonstrated beneficial effects to reduce acute and chronic pain intensity. Specifically, for the thesis of this clinical trial, the investigators hypothesize that auricular acupuncture can be an effective alternative and/or adjunct treatment tool in the civilian emergency department for the acute management of pain.

In order to test the safety and efficacy of using auricular acupuncture in the emergency department, people presenting to the emergency department with pain who are willing to participate in the study will be randomized into three separate groups:

  1. Standard medical group (tape on ear + standard medical drug)
  2. Standard medical group plus auricular acupuncture (acupuncture + standard medical drug)
  3. Auricular acupuncture group (acupuncture + placebo pill)

The design of these groups will allow the investigators to best test the efficacy of auricular acupuncture versus the placebo effect and standard medical care as well as an adjunct to standard medical care. To accomplish the objective of this proposal, the investigators will pursue the following specific aims:

Specific Aim 1: To prove the efficacy of auricular acupuncture over a placebo group in the management of pain syndromes. By having the acupuncture group and sham acupuncture group, the investigators will be able to effectively compare the difference in pain levels with a placebo-group.

Specific Aim 2: To prove that auricular acupuncture is an effective alternative and/or adjunct to standard medical care in the Emergency Department.

By testing the efficacy of acupuncture in conjunction with standard medical treatment, the investigators expect to see a potentiation of analgesic effects, and this will be noted by an increased reduction in pain between the standard medical plus acupuncture group versus the standard group and acupuncture group.

Specific Aim 3: To prove that auricular acupuncture as an effective pain management alternative that decreases short-term prescription painkiller dependency.

Through a series of follow up questionnaires and a medication diary that the investigators will give to the patient prior to discharge, the investigators will track the patient's need and use of additional pain medications post treatment. These surveys will give a good indication as to the effectiveness of auricular acupuncture to reduce a patient's dependency on painkiller drugs in the short-term setting.


Condition or disease Intervention/treatment Phase
Musculoskeletal Pain Pain Procedure: Auricular Acupuncture Device: Acupuncture Procedure: Placebo Acupuncture Drug: hydrocodone / acetaminophen 5mg/325mg Drug: Placebo Pill Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Auricular Acupuncture for the Acute Management of Pain in the Emergency Department
Estimated Study Start Date : July 27, 2017
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Placebo Comparator: Standard Drug Group
Participants randomized into this group will be receiving the standard medical care and "placebo" acupuncture. For the placebo acupuncture procedure, the ASP® needles will be double taped onto the ear in the same anatomical position as the acupuncture groups. The needles will be taped so that the needles will never puncture the skin. The patients will then be given hydrocodone / acetaminophen 5mg/325mg (generic) with a prescription to take home and use as needed.
Device: Acupuncture
ASP Needles: Small, semi-permanent acupuncture needles that will be used for acupuncture in the ear or taped over the ear for placebo.
Other Name: Aiguille Semi-Permanent (ASP) acupuncture needles

Procedure: Placebo Acupuncture
The ASP needles will be double taped onto the ear for this procedure.

Drug: hydrocodone / acetaminophen 5mg/325mg
Narcotic/NSAID medication used as the "standard medical treatment"
Other Name: Norco (generic)

Experimental: Standard Drug Plus Acupuncture Group
The participants in this group will receive auricular acupuncture following the Battlefield Acupuncture Protocol. The patients will then be given hydrocodone / acetaminophen 5mg/325mg (generic) with a prescription to take home and use as needed (in the acupuncture groups, the physician administering the treatment will not know if the patient is receiving the standard drug or the placebo pill). The physician can administer up to 10 needles (5 in each ear) until the patient has a "significant" drop in pain (pain level 0 or 1).
Procedure: Auricular Acupuncture
Aiguille Semi-Permanent (ASP) acupuncture needles will be used following the Battlefield Acupuncture Protocol
Other Name: Battlefield Acupuncture

Device: Acupuncture
ASP Needles: Small, semi-permanent acupuncture needles that will be used for acupuncture in the ear or taped over the ear for placebo.
Other Name: Aiguille Semi-Permanent (ASP) acupuncture needles

Drug: hydrocodone / acetaminophen 5mg/325mg
Narcotic/NSAID medication used as the "standard medical treatment"
Other Name: Norco (generic)

Experimental: Acupuncture Group
The participants in this group will receive auricular acupuncture following the Battlefield Acupuncture Protocol. The physician can administer up to 10 needles (5 in each ear) until the patient has a "significant" drop in pain (pain level 0 or 1). The patient will then be given a placebo pill.
Procedure: Auricular Acupuncture
Aiguille Semi-Permanent (ASP) acupuncture needles will be used following the Battlefield Acupuncture Protocol
Other Name: Battlefield Acupuncture

Device: Acupuncture
ASP Needles: Small, semi-permanent acupuncture needles that will be used for acupuncture in the ear or taped over the ear for placebo.
Other Name: Aiguille Semi-Permanent (ASP) acupuncture needles

Drug: Placebo Pill
Pills will be filled with methylcellulose and administered as a placebo for this intervention.
Other Name: methylcellulose (sugar pill)




Primary Outcome Measures :
  1. Pain Intensity Measure (VAS score 0-10) [ Time Frame: 48 hours ]
    Measurement of patient's pain level over 48 hours (VAS score 0-10)


Secondary Outcome Measures :
  1. Recurrence of Pain (VAS score 0-10) [ Time Frame: 48 hours ]
    Monitoring of patient's pain level over 48 hours (VAS score 0-10)

  2. Medication Usage [ Time Frame: 48 hours ]
    Monitoring of patients medication usage over 48 hours with a medication diary which they will take home and fill out each time they use their medication.

  3. Past Trauma History [ Time Frame: 48 hours ]
    Using Center for Disease Control questionnaires to assess past trauma history



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All hemodynamically stable, adult patients presenting to the Emergency Department (ED) with a chief complaint of pain AND a physician diagnosis of acute, non-critical, musculoskeletal pain.
  • Musculoskeletal pain includes pain to any bones, muscles, cartilage, or nerves associated with such.
  • Patients will be diagnosed by a physician as non-critical meaning they can be treated and sent home without needing to be admitted to the hospital.
  • Blood pressure: 90-180/60-110
  • Cardiac rate with no dysrhythmias 50-149
  • Ventilatory rate 10-35
  • Oxygen saturation >87%
  • Alert and able to follow commands and respond appropriately

Exclusion Criteria:

  • Patients that are altered and/or present with vital signs outside of the inclusion criteria ranges.
  • Those deemed in critical condition by triage nurse and/or ER physician.
  • Patients with a history of narcotic drug abuse/dependency.
  • Patients who have had Battlefield Acupuncture done in the past.
  • Pregnant or nursing women (confirmed by a pregnancy test)
  • Allergic to adhesive tape, gold, or other needle components
  • Allergic to aspirin, NSAIDs, or narcotics
  • Patients at risk for complications from indwelling acupuncture needles, such as patients with bleeding disorders, those who are immunosuppressed, or those with liver disease (Hepatitis C, cirrhosis, etc.)

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): NCT02540512


Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: Traci Marin, PhD Assistant Professor-Research Scientist

Publications:
Bodnar RJ: Endogenous opiates and behavior: 2011. Peptides 2012; 3(12): 416 -20.
Centers for Disease Control. Prescription Painkiller Overdoses in the U.S. (2012). Prescription Painkiller Overdoses in the U.S.,4.
Cho, Son, Han: (MRI Neurophysiological evidence of acupuncture mechanisms. Med Acupuncture. 2002: 14: 16-22.
Ip, V. (1999). The use of acupuncture for pain relief in a Chinese hospital clinic. Acupuncture In Medicine, 17(2), 101-109.
Mohler, Stanley R. "Acupuncture Helps in Treating Medical Problems." Human Factors & Aviation Medicine. Flight Safety Foundation: September-October 2002, Vol. 49 No. 5
Pickett, H. (2011). Battlefield acupuncture. Journal Of Chinese Medicine, (96), 12-17.
Roberts, C. (2008). Easing Pain with Acupuncture. Soldiers, 63(7), 36-37.
Spielman, F.J. "Acupuncture: What's the Point?" American Journal of Anesthesiology Volume 28 (2001): 306-308.
WHO. The World Health Organization Viewpoint on Acupuncture. <www.sd- acupuncture.com/articles.html>. Aug. 13, 2002.

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Responsible Party: Traci Marin, Assistant Professor - Research Scientist, Loma Linda University
ClinicalTrials.gov Identifier: NCT02540512    
Other Study ID Numbers: 15063
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Musculoskeletal Pain
Emergencies
Disease Attributes
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Acetaminophen, hydrocodone drug combination
Hydrocodone
Oxycodone
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents