Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2018-06-13
2020-01-30
Brief Summary
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Detailed Description
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Acupuncture has been demonstrated to be effective for treating gag reflex, but this effect has not been objectively demonstrated using this novel method. As such, this study investigates the effect of acupuncture against placebo on gag reflex. Practically speaking, these findings are unlikely to be of high value since the availability of acupuncturists at dental offices is limited. For this reason, the investigators added a third arm to evaluate the use of a transcutaneous electrical nerve stimulator (TENS) device on the same acupuncture points as a treatment intervention to see if this is non-inferior to acupuncture. TENS is an FDA regulated treatment for the treatment of pain, and has been 510K cleared for other uses including nausea. The placebo arm uses a TENS device that has the wire severed, so that the light will continue to blink but no current will be applied.
60 total subjects will be recruited and randomized into one of these three groups: acupuncture, TENS and Sham-TENS.
Passive EKG readings will be collected using the FirstBeat Bodyguard 2, which is a 2-lead EKG device that the subject will wear during the study. This is to later evaluate vagal tone by analyzing the spectral analysis of heart rate variability.
Once this device is affixed to the front of the patient's chest, the gag reflex will be measured. The subject will then undergo the appropriate treatment (acupuncture, TENS or Sham-TENS for a total of 20 minutes, with a subsequent gag reflex measurement. The subject will then rest for at least 5 minutes at the end of the study to collect final EKG data, then given a gift card for her time.
It is the hypothesis of the investigators that the treatments will increase gag tolerance in the following stepwise manner: Sham-TENS \< TENS \< Acupuncture
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
The subject is randomized to one of three groups: 1: acupuncture, 2: TENS, and 3: sham-TENS. While those assigned to the acupuncture group are aware of their group assignment, groups 2 and 3 receive an identical TENS pad placement. A sham-TENS unit is used with disconnected wires to provide a blinking light without an electrical signal. Participants are advised that that the sensation of electrical tingling is not necessary.
Masking of the examiner:
The acupuncture or TENS/sham/TENS is performed by one examiner. A second examiner will enter the room to perform the gag reflex measurement, both before and after the treatment
Study Groups
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Acupuncture
Sterile needles are inserted into acupuncture points P-6 and St-36 bilaterally and retained for a total of 20 minutes. Halfway through the treatment, the needles are manipulated in order to re-create the acupuncture sensation. The needles are removed after 20 minutes of treatment prior to the second gag measurement.
Acupuncture
Acupuncture of acupoints P-6 and St-36
TENS
Gel pads are affixed to the acupuncture points P-6 and St-36, bilaterally. The amplitude of the TENS device will be gradually increased up to a maximum setting of 8/10, with the subject asked to notify the examiner as soon as any sensation is noticed. Once a gentle buzzing sensation is noticed, the amplitude will be reduced slightly for comfort and then the device will remain for the duration of 20 minutes. The pads are then removed prior to the second gag reflex measurement.
TENS
TENS of acupoints P-6 and St-36
Sham-TENS
For the sham-TENS group, the protocol is identical to the TENS group, however the electrical wires have been severed and re-attached in the control unit. As such, the unit will flash a light but there will be no current delivered. The subject is told that no sensation is required. The amplitude will be turned up to a maximum setting of 8/10 and left there for 20 minutes, then the device turned off and pads removed.
Sham-TENS
Sham-TENS of acupoints P-6 and St-36
Interventions
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Acupuncture
Acupuncture of acupoints P-6 and St-36
TENS
TENS of acupoints P-6 and St-36
Sham-TENS
Sham-TENS of acupoints P-6 and St-36
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* severe needlephobia
* pacemaker or other implanted electrical device
18 Years
89 Years
ALL
Yes
Sponsors
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University of California, Los Angeles
OTHER
Responsible Party
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Andrew Shubov, MD
Assistant Clinical Professor
Principal Investigators
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Andrew Shubov, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
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University of California, Los Angeles
Los Angeles, California, United States
Countries
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Other Identifiers
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IRB#18-000473
Identifier Type: -
Identifier Source: org_study_id
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