NCT01017211CompletedPhase 1
Does Auricular Acupuncture Improve Tolerance to Electromyography (EMG) Testing?
Kessler Foundation2 sites in 1 country21 target enrollmentStarted: September 1, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 21
- Locations
- 2
- Primary Endpoint
- Numeric Rating Scale (NRS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Gender: male or female
- •Of any racial or ethnic group
- •Adult between the ages 18 to 65 years
- •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
Outcomes
Primary Outcomes
Numeric Rating Scale (NRS)
Time Frame: pre- and post- intervention
Secondary Outcomes
- Global Impression of Change(pre- and post- intervention)
Investigators
Study Sites (2)
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