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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01017211
• Other study ID #: R-654-09
• Status: Completed
• Phase: Phase 1
• First received: November 18, 2009
• Last updated: May 16, 2011
• Start date: September 2009
• Est. completion date: June 2010

Study information

• Verified date: May 2011
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Kessler Institute for Rehabilitation	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Rating Scale (NRS)		pre- and post- intervention	No
Secondary	Global Impression of Change		pre- and post- intervention	No