Acupuncture for Pain in the Emergency Department

NCT02540512 | Withdrawn Early Phase 1 DMC

• 1 other identifier: 15063
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Musculoskeletal Pain; Pain

Outcome Measures

Primary Outcomes (1)

• Pain Intensity Measure (VAS score 0-10)

  Measurement of patient's pain level over 48 hours (VAS score 0-10)

  48 hours

Secondary Outcomes (3)

• Recurrence of Pain (VAS score 0-10)

  48 hours

• Medication Usage

  48 hours

• Past Trauma History

  48 hours

Study Arms (3)

Standard Drug Group

PLACEBO COMPARATOR

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; Procedure: Placebo Acupuncture; Drug: hydrocodone / acetaminophen 5mg/325mg

Standard Drug Plus Acupuncture Group

EXPERIMENTAL

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; Device: Acupuncture; Drug: hydrocodone / acetaminophen 5mg/325mg

Acupuncture Group

EXPERIMENTAL

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; Device: Acupuncture; Drug: Placebo Pill

Interventions

Auricular Acupuncture PROCEDURE

Aiguille Semi-Permanent (ASP) acupuncture needles will be used following the Battlefield Acupuncture Protocol

Also known as: Battlefield Acupuncture

Acupuncture Group; Standard Drug Plus Acupuncture Group

Acupuncture DEVICE

ASP Needles: Small, semi-permanent acupuncture needles that will be used for acupuncture in the ear or taped over the ear for placebo.

Also known as: Aiguille Semi-Permanent (ASP) acupuncture needles

Acupuncture Group; Standard Drug Group; Standard Drug Plus Acupuncture Group

Placebo Acupuncture PROCEDURE

The ASP needles will be double taped onto the ear for this procedure.

Standard Drug Group

hydrocodone / acetaminophen 5mg/325mg DRUG

Narcotic/NSAID medication used as the "standard medical treatment"

Also known as: Norco (generic)

Standard Drug Group; Standard Drug Plus Acupuncture Group

Placebo Pill DRUG

Pills will be filled with methylcellulose and administered as a placebo for this intervention.

Also known as: methylcellulose (sugar pill)

Acupuncture Group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Loma Linda University: lead

Related Publications (38)

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MeSH Terms

Conditions

Musculoskeletal Pain; Pain

Interventions

Acupuncture, Ear; Acupuncture Therapy; Hydrocodone; Acetaminophen; oxycodone-acetaminophen; Drugs, Generic; Methylcellulose; Sugars

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Auriculotherapy; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pharmaceutical Preparations; Cellulose; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Traci Marin, PhD

  Assistant Professor-Research Scientist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - Research Scientist

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: September 4, 2015
• Study Start: July 27, 2017
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: July 28, 2017

Record last verified: 2017-07