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

This study has been completed.
Sponsor:
Information provided by:
Kessler Foundation
ClinicalTrials.gov Identifier:
NCT01017211
First received: November 18, 2009
Last updated: May 16, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Pain
Other: auricular acupuncture
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Does Auricular Acupuncture Improve Tolerance to Electromyography (EMG) Testing?

Resource links provided by NLM:


Further study details as provided by Kessler Foundation:

Primary Outcome Measures:
  • Numeric Rating Scale (NRS) [ Time Frame: pre- and post- intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Global Impression of Change [ Time Frame: pre- and post- intervention ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: September 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: auricular acupuncture protocol 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.

Sham Comparator: sham auricular acupuncture 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.


  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01017211

Locations
United States, New Jersey
Kessler Institute for Rehabilitation
West Orange, New Jersey, United States, 07052
Sponsors and Collaborators
Kessler Foundation
Investigators
Study Director: Jeff Cole, M.D. Kessler Institute for Rehabilitation
  More Information

No publications provided

Responsible Party: Trevor A. Dyson-Hudson, M.D., Kessler Foundation Research Center
ClinicalTrials.gov Identifier: NCT01017211     History of Changes
Other Study ID Numbers: R-654-09
Study First Received: November 18, 2009
Last Updated: May 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Kessler Foundation:
Pain
Electromyography
Acupuncture
Randomized controlled trial
Rehabilitation

ClinicalTrials.gov processed this record on October 01, 2014