Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 12:03 AM
Study NCT ID:
NCT00253994
Status:
COMPLETED
Last Update Posted:
2007-09-05
First Post:
2005-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Auricular Acupuncture for Acute Pain
Sponsor:
Samueli Institute for Information Biology
Organization:
Study Overview
Official Title:
Auricular Acupuncture in the Treatment of Acute Pain Syndromes (AATAPS) Pilot
Status:
COMPLETED
Status Verified Date:
2007-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
* Auricular Acupuncture in the Treatment of Acute Pain Syndromes (AATAPS)
* Study Period: August 1, 2003 - December 31, 2004
* 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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| MGMC IRB #: FMG20030009H | None | None | View |