Auricular Acupuncture for Acute Pain

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. Identifier: NCT00253994
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : September 5, 2007
United States Department of Defense
Information provided by:
Samueli Institute for Information Biology

Brief Summary:
  • Auricular Acupuncture in the Treatment of Acute Pain Syndromes (AATAPS)
  • Study Period: August 1, 2003 - December 31, 2004

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

Detailed Description:
Although inroads in the study of acupuncture for acute pain conditions have been made, there are still critical gaps in the literature in both basic/mechanistic and clinical areas. Very little is know about what impact conservative, easily transportable and administered treatments, such as acupuncture, might have in preserving military battlefield readiness. The proposed research proposal is an incremental step with the ultimate goal to increase the knowledge base and expand clinical applications of acupuncture for acute pain conditions that are relevant to military personnel and operations.The purpose of this proposal is to conduct a scientifically rigorous investigation of auricular acupuncture for the treatment of acute pain in the emergency room setting at a military hospital using a two phase clinical trial design. This pragmatic investigation will provide a unique opportunity to develop clinically relevant questions that can be further evaluated in the context of basic science and more robust clinical trial designs. The specific aims of this study are to 1) Determine the feasibility of conducting a clinical trial of auricular acupuncture in the treatment of military personnel with acute pain who present to the emergency room at Andrews Air Force Base, using a pilot two phase clinical trial approach and 2) Gather data on the effect size of auricular acupuncture in treating acute pain conditions. Persons presenting to the emergency room at Malcolm Grow with acute pain syndromes that do not require medical attention beyond pain management strategies will be invited to participate in the study and asked for informed consent. The study will involve a preliminary pilot test period during which 20 persons are entered into a consecutive case series study to test the feasibility of collecting data and implementing the treatment procedures in the busy emergency room setting. Treatment will involve auricular acupuncture using SEDATELEC Aiguille Semi-Permanent (ASP) needles bilaterally at two acupuncture points - Cingulate Gyrus and Thalamic Nuclei. Baseline demographic and pain indicator information will be collected prior to treatment. Follow-up data on pain levels and medication use will occur prior to leaving the ER and 24 hours following treatment. The primary endpoint is change in pain levels at 24 hours, as measured by the verbal Numerical Rating Scale (NRS). 24 hour follow-up will occur via the telephone. Following successful completion of the preliminary study, a two arm, randomized clinical pilot trial of 100 participants (N = 50 per arm) will be conducted using the same protocol as the case series study. Patients will be randomized to either usual emergency medical care or acupuncture + medical co-management. Follow-up data will be collected on the schedule outlined above by assessors blinded to treatment assignment.

Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Auricular Acupuncture in the Treatment of Acute Pain Syndromes (AATAPS) Pilot
Study Start Date : August 2003
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Primary Outcome Measures :
  1. The primary endpoint was current level of pain, as measured by the verbal Numerical Rating Scale (NRS [ Time Frame: Before leaving the ER; 24 hours post-treatment ]

Secondary Outcome Measures :
  1. Change in Medication Use, if any [ Time Frame: Baseline; 24 hours post-treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of acute pain syndrome
  • Written Informed Consent
  • Over the age of 18

Exclusion Criteria:

  • Unwilling or unable to participate in study treatment and follow-up
  • Require medical intervention other than pain management
  • Pregnant or nursing
  • Unable to give informed consent for any reason
  • Extreme pain
  • Allergic reaction to adhesive tape, gold or other components of the acupuncture needles
  • Admitted to the hospital for care

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 identifier (NCT number): NCT00253994

United States, Maryland
Malcolm Grow Medical Center, Andrews Air Force Base
Andrews AFB, Maryland, United States, 20762
Sponsors and Collaborators
Samueli Institute for Information Biology
United States Department of Defense
Principal Investigator: Christine Goertz, DC, PhD Samueli Institute for Information Biology Identifier: NCT00253994     History of Changes
Other Study ID Numbers: MIL-03-01
MGMC IRB #: FMG20030009H
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: September 5, 2007
Last Verified: September 2007

Additional relevant MeSH terms:
Acute Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms