Clinical Trial: Auricular Acupuncture for Acute Pain
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Auricular Acupuncture in the Treatment of Acute Pain Syndromes (AATAPS) Pilot
Brief Summary:
- Auricular Acupuncture in the Treatment of Acute Pain Syndromes (AATAPS)
- Study Period: August 1, 2003 - December 31, 2004
Detailed Summary: 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) needl
Sponsor: Samueli Institute for Information Biology
Current Primary Outcome: 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 ]
Original Primary Outcome: The primary endpoint was current level of pain, as measured by the verbal Numerical Rating Scale (NRS), before leaving the ER and again at the time of the 24 hour follow-up.
Current Secondary Outcome: Change in Medication Use, if any [ Time Frame: Baseline; 24 hours post-treatment ]
Original Secondary Outcome: Change in Medication Use, if any, from baseline to 24 hours post-treatment.
Information By: Samueli Institute for Information Biology
Dates:
Date Received: November 10, 2005
Date Started: August 2003
Date Completion:
Last Updated: September 4, 2007
Last Verified: September 2007
