- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01278355
Assessing the Feasibility of Integrating Ear Acupuncture Into the Aeromedical Evacuation System From RAB to AAFB
December 2, 2013 updated by: Samueli Institute for Information Biology
The Feasibility of Integrating Ear Acupuncture for Pain in Patients Being Transported Via the Aeromedical Evacuation System From Ramstein Air Base to Andrews AFB, Maryland USA: An Observational Study
The purpose of this study is twofold: 1) to test the feasibility of integrating a simple bilateral ear acupuncture procedure (Auricular Stimulation Procedure - ASP) into the standard care delivered in the Aeromedical Evacuation system and 2) to observe and document any changes in pain scores and in-flight related symptoms and factors (e.g.
sinus block/pain, ear block pain, nausea/air sickness) typically monitored during transportation of wounded warriors from Ramstein Air Base (RAB) to Andrews Air Force Base (AAFB).
Study Overview
Study Type
Observational
Enrollment (Anticipated)
40
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
-
-
-
Ramstein, Germany
- Ramstein Air 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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Military beneficiaries undergoing aeromedical evacuation from Ramstein Air Base to Andrews Air Force Base who are experiencing pain.
Description
Inclusion Criteria:
- Age 18 or over
- NRS Pain rating > 0
- Military beneficiaries undergoing aeromedical evacuation from RAB to AAFB
Exclusion Criteria:
- Medically unstable or otherwise unable to participate including those with the inability to consent
- Allergy to metals
- Ear trauma
- Sepsis
- Unhealed wounds on the ears
- Piercing or scar tissue in any of the ear acupuncture point areas
- Pregnancy
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pain Patients
|
Ear acupuncture
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain
Time Frame: March 2013
|
March 2013
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Richard Niemtzow, MD, PhD, MPH, United States Air Force
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
January 1, 2011
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
January 14, 2011
First Submitted That Met QC Criteria
January 14, 2011
First Posted (Estimate)
January 17, 2011
Study Record Updates
Last Update Posted (Estimate)
December 3, 2013
Last Update Submitted That Met QC Criteria
December 2, 2013
Last Verified
December 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C.2010.041dt
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.
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