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NCT01278355 Clinical Trial

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

Musculoskeletal Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01278355
Other study ID # C.2010.041dt
Secondary ID
Status Completed
Phase N/A
First received January 14, 2011
Last updated December 2, 2013
Start date January 2011
Est. completion date January 2012

Study information
Verified date December 2012
Source Samueli Institute for Information Biology
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• Ear acupuncture
Ear acupuncture

Locations
Country Name City State
Germany Ramstein Air Base Ramstein

Sponsors (1)
Lead Sponsor Collaborator
Samueli Institute for Information Biology

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain March 2013 No
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