Assessing the Feasibility of Integrating Ear Acupuncture... | NCT01278355

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

NCT01278355

Sponsor

Samueli Institute for Information Biology

Status

Completed

Last Update Posted

Dec 3, 2013Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Musculoskeletal Pain

Interventions

Ear acupuncture

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2012Actual

First Submitted Date

Jan 14, 2011

First Submission Date that Met QC Criteria

Jan 14, 2011

First Posted Date

Jan 17, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2013

Last Update Posted Date

Dec 3, 2013Estimated

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pain Patients			Device: Ear acupuncture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ear acupuncture	Device	Ear acupuncture	Pain Patients

Measure	Description	Time Frame
Pain		March 2013

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard Niemtzow, MD, PhD, MPH	United States Air Force	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ramstein Air Base		Ramstein			Germany

Condition Browse Module

MeSH Terms

ID	Term
D059352	Musculoskeletal Pain
D010146	Pain

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020831	Acupuncture, Ear

Ancestor Terms

ID	Term
D015670	Acupuncture Therapy
D000529	Complementary Therapies
D013812	Therapeutics
D055097	Auriculotherapy

Browse Leaves

Not provided

Browse Branches

Not provided