Auricular Acupuncture for Acute Pain
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional

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

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.
    

Intervention name(s): Acupuncture
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic