Does Auricular Acupuncture Improve Tolerance to Electromyography (EMG) Testing?

NCT ID: NCT01017211

Last Updated: 2011-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-06-30

Brief Summary

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Needle Electromyography (EMG) is an important test used to assess muscle and nerve function, but the test can be uncomfortable. It is currently not standard practice to provide any pain-relieving intervention for this procedure. The purpose of this research study is to determine whether auricular (ear) acupuncture will make EMG testing less painful.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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auricular acupuncture protocol

Group Type EXPERIMENTAL

auricular acupuncture

Intervention Type OTHER

Experimental group to receive ear needles in the Battlefield Acupuncture points.

Sham group to receive ear needles at points thought to be ineffective but standardized.

sham auricular acupuncture

Group Type SHAM_COMPARATOR

auricular acupuncture

Intervention Type OTHER

Experimental group to receive ear needles in the Battlefield Acupuncture points.

Sham group to receive ear needles at points thought to be ineffective but standardized.

Interventions

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auricular acupuncture

Experimental group to receive ear needles in the Battlefield Acupuncture points.

Sham group to receive ear needles at points thought to be ineffective but standardized.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Gender: male or female
* Of any racial or ethnic group
* Adult between the ages 18 to 65 years
* Healthy
* Normal sensation and strength
* Pain approximately the same on each side of body with no major difference between right and left sides
* Can understand and are able to complete the outcomes questionnaires which will be explained before the study protocol begins

Exclusion Criteria

* Pregnant or actively trying to become pregnant
* Diabetes mellitus or other systemic disease which may affect nerve function
* History of a neurologic disorder or other cause for abnormal sensation or weakness
* Have had recent trauma to an upper arm, hand or ear
* Have scars or burns on an upper arm, hand or ear that causes abnormal or decreased sensation
* Taking pain medications on a regular basis
* Have a bleeding or clotting disorder
* Taking blood thinners, such as aspirin, heparin, enoxaparin (Lovenox), clopidogrel (Plavix) or coumadin (Warfarin)
* Have received chemotherapy or radiation
* Have a permanent pacemaker
* Have a serious psychiatric disorder (such as schizophrenia)
* More sensitive to pain on one side of my body more than the other
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kessler Foundation

OTHER

Sponsor Role lead

Responsible Party

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Kessler Foundation Research Center

Principal Investigators

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Jeff Cole, M.D.

Role: STUDY_DIRECTOR

Kessler Institute for Rehabilitation

Locations

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Kessler Institute for Rehabilitation

West Orange, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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R-654-09

Identifier Type: -

Identifier Source: org_study_id

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