PainPhase 1NCT01017211
Does Auricular Acupuncture Improve Tolerance to Electromyography (EMG) Testing?
A Phase 1 study testing auricular acupuncture in people with Pain, run by Kessler Foundation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- auricular acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jun 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Kessler Institute for Rehabilitation
West Orange, New Jersey, 07052
About this study
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.
- Conditions
- Pain
- Being tested
- auricular acupuncture
- Keywords
- Pain, Electromyography, Acupuncture, Randomized controlled trial, Rehabilitation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
auricular acupunctureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| auricular acupuncture protocol | Experimental | Not described Receives: Other: auricular acupuncture |
| sham auricular acupuncture | Sham comparator | Not described Receives: Other: auricular acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS)
Measured: pre- and post- intervention
Secondary outcomes (1)
Global Impression of Change
Measured: pre- and post- intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2009 (estimated)
- Study startSep 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Jeff Cole, M.D., Study director, Kessler Institute for Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017211
- Sponsor's protocol ID
- R-654-09
- Status last verified
- May 2011
- First submitted
- 18 Nov 2009
- Last updated
- 17 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Auricular Acupuncture Improve Tolerance to Electromyography (EMG) Testing?
- ClinicalTrials.gov ID
- NCT01017211
- Acronym / sponsor ID
- R-654-09
- Conditions
- Pain
- Keywords
- Pain, Electromyography, Acupuncture, Randomized controlled trial, Rehabilitation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 20 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| auricular acupuncture protocol | Experimental | Other: auricular acupuncture |
| sham auricular acupuncture | Sham comparator | Other: auricular acupuncture |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Gender: male or female
- Of any racial or ethnic group
- Adult between the ages 18 to 65 years
- Healthy
- Normal sensation and strength
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| auricular acupunctureExperimental group to receive ear needles in the Battlefield Acupuncture points. Sham group to receive ear needles at points thought to be ineffective but standardized. | Other | auricular acupuncture protocol, sham auricular acupuncture |
Primary outcome
Numeric Rating Scale (NRS)
Time frame: pre- and post- intervention
1 secondary outcome
Global Impression of Change
Time frame: pre- and post- intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff Cole, M.D. study director
Kessler Institute for Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing auricular acupuncture in people with Pain, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (NRS) (time frame: pre- and post- intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2011.