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Assessing the Feasibility of Integrating Ear Acupuncture Into the Aeromedical Evacuation System From RAB to AAFB

This study is currently recruiting participants.
Verified December 2012 by Samueli Institute for Information Biology
Sponsor:
Information provided by (Responsible Party):
Samueli Institute for Information Biology
ClinicalTrials.gov Identifier:
NCT01278355
First received: January 14, 2011
Last updated: December 14, 2012
Last verified: December 2012
History of Changes
  Purpose

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).


Condition Intervention
Musculoskeletal Pain
 Device: Ear acupuncture

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samueli Institute for Information Biology:

Primary Outcome Measures:
  • Pain [ Time Frame: March 2013 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pain Patients Device: Ear acupuncture
Ear acupuncture

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01278355

Contacts
Contact: Charlotta Leader, RN charlotta.leader@ramstein.af.mil

Locations
Germany
Ramstein Air Base Recruiting
Ramstein, Germany
Contact: Nancy Steele, PhD, RNC, NP     (314) 590-6982     Nancy.Steele2@AMEDD.ARMY.MIL    
Sub-Investigator: Nancy Steele, PhD, RNC, NP            
Sponsors and Collaborators
Samueli Institute for Information Biology
Investigators
Principal Investigator: Richard Niemtzow, MD, PhD, MPH United States Air Force
  More Information

No publications provided

Responsible Party: Samueli Institute for Information Biology
ClinicalTrials.gov Identifier: NCT01278355     History of Changes
Other Study ID Numbers: C.2010.041dt
Study First Received: January 14, 2011
Last Updated: December 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Samueli Institute for Information Biology:
pain
acupuncture

ClinicalTrials.gov processed this record on June 17, 2013