NCT01278355

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 17, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

December 3, 2013

Status Verified

December 1, 2012

Enrollment Period

1 year

First QC Date

January 14, 2011

Last Update Submit

December 2, 2013

Conditions

Musculoskeletal Pain

Keywords

painacupuncture

Outcome Measures

Primary Outcomes (1)

  • Pain

    March 2013

Study Arms (1)

Pain Patients

Device: Ear acupuncture

Interventions

Ear acupunctureDEVICE

Ear acupuncture

Pain Patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Military beneficiaries undergoing aeromedical evacuation from Ramstein Air Base to Andrews Air Force Base who are experiencing pain.

You may qualify if:

  • Age 18 or over
  • NRS Pain rating \> 0
  • Military beneficiaries undergoing aeromedical evacuation from RAB to AAFB

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ramstein Air Base

Ramstein, Germany

Location

MeSH Terms

Conditions

Musculoskeletal PainPain

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acupuncture TherapyComplementary TherapiesTherapeuticsAuriculotherapy

Study Officials

  • Richard Niemtzow, MD, PhD, MPH

    United States Air Force

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2011

First Posted

January 17, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

December 3, 2013

Record last verified: 2012-12

Locations

DE(1)