Does Auricular Acupuncture Improve Tolerance to Electromyography (EMG) Testing?
This study has been completed.
Sponsor:
Kessler Foundation
Information provided by:
Kessler Foundation
ClinicalTrials.gov Identifier:
NCT01017211
First received: November 18, 2009
Last updated: May 16, 2011
Last verified: May 2011
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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
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 May 23, 2013