- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00253994
Auricular Acupuncture for Acute Pain
September 4, 2007 updated by: Samueli Institute for Information Biology
Auricular Acupuncture in the Treatment of Acute Pain Syndromes (AATAPS) Pilot
- Auricular Acupuncture in the Treatment of Acute Pain Syndromes (AATAPS)
- Study Period: August 1, 2003 - December 31, 2004
Study Overview
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
Enrollment
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Andrews AFB, Maryland, United States, 20762
- Malcolm Grow Medical Center, Andrews Air Force Base
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Before leaving the ER; 24 hours post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Medication Use, if any
Time Frame: Baseline; 24 hours post-treatment
|
Baseline; 24 hours post-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Christine Goertz, DC, PhD, Samueli Institute for Information Biology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2003
Study Completion (Actual)
December 1, 2004
Study Registration Dates
First Submitted
November 10, 2005
First Submitted That Met QC Criteria
November 14, 2005
First Posted (Estimate)
November 15, 2005
Study Record Updates
Last Update Posted (Estimate)
September 5, 2007
Last Update Submitted That Met QC Criteria
September 4, 2007
Last Verified
September 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MIL-03-01
- MGMC IRB #: FMG20030009H
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Pain
-
Rajavithi HospitalCompletedTotal Abdominal Hysterectomy ,Pain , Acute Postoperative,Gabapentin , CelecoxibThailand
-
Schulthess KlinikNot yet recruiting
-
Seoul National University HospitalNot yet recruiting
-
Chung-Ang University Gwangmyeong HospitalRecruitingPostoperative Pain, AcuteKorea, Republic of
-
TC Erciyes UniversityCompletedPostoperative Pain, AcuteTurkey
-
Cairo UniversityNot yet recruitingPostoperative Pain, Acute
-
Armed Forces College of Medicine, Cairo, EgyptNot yet recruiting
-
Federal State Budgetary Organization, Federal Center...Completed
-
University of California, San DiegoEnrolling by invitationPostoperative Pain, AcuteUnited States
-
University of California, San DiegoEnrolling by invitation
Clinical Trials on Acupuncture
-
Federal University of São PauloCompleted
-
University of ZurichCharite University, Berlin, Germany; First Teaching Hospital of Tianjin University...CompletedExperimental Dental PainSwitzerland
-
University of SkövdeCompleted
-
National Research Centre of Complementary and Alternative...Norwegian Acupuncture CollegeUnknown
-
Chengdu University of Traditional Chinese MedicineChongqing Medical University; Hunan University of Traditional Chinese MedicineCompletedFunctional Dyspepsia | Postprandial Distress SyndromeChina
-
Chang Gung Memorial HospitalRecruitingIntracranial HemorrhagesTaiwan
-
University of MichiganMassachusetts General Hospital; National Center for Complementary and Integrative...Completed
-
University Medicine GreifswaldRecruitingGagging During Transesophageal EchocardiographyGermany
-
Huazhong University of Science and TechnologyThe University of Hong Kong; Heilongjiang University of Chinese Medicine; Hubei...CompletedPolycystic Ovary SyndromeChina
-
China Medical University HospitalNot yet recruiting