Does Auricular Acupuncture Improve Tolerance to Electromyography (EMG) Testing?
1 other identifier
interventional
21
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 pain
Started Sep 2009
Typical duration for phase_1 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 18, 2009
CompletedFirst Posted
Study publicly available on registry
November 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedMay 17, 2011
May 1, 2011
9 months
November 18, 2009
May 16, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Numeric Rating Scale (NRS)
pre- and post- intervention
Secondary Outcomes (1)
Global Impression of Change
pre- and post- intervention
Study Arms (2)
auricular acupuncture protocol
EXPERIMENTALsham auricular acupuncture
SHAM COMPARATORInterventions
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kessler Institute for Rehabilitation
West Orange, New Jersey, 07052, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jeff Cole, M.D.
Kessler Institute for Rehabilitation
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 18, 2009
First Posted
November 20, 2009
Study Start
September 1, 2009
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
May 17, 2011
Record last verified: 2011-05