Clinical trial NCT04757948: Acupuncture vs TENS for Gag Reflex
Official title: Acupuncture vs TENS for Gag Reflex
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gagging
Keywords: acupuncture
TENS
acupressure
acupoint
gag
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examines if acupuncture or TENS of P-6 and St-36 acupoints has a measurable effect on gag tolerance.

Detailed description: The gag reflex is a normal protective mechanism, and portion of the population has an exaggerated reflex that can present major problems in dentistry as well as endoscopy. Early studies with acupuncture have been promising, but these studies are limited as has not been a way to objectively measure the response to gag reflex. Recent work by Drs. Karibe and Goddard has determined a novel way of measuring gag reflex in healthy subjects, which makes it possible to study the effects of an intervention on gag reflex.

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

Eligibility criteria: Inclusion Criteria:

* English Speaking

Exclusion Criteria:

* bleeding dyscrasias
* severe needlephobia
* pacemaker or other implanted electrical device

Primary outcomes:
measure: Insertion length
timeFrame: immediately after procedure
measure: Severity of gag reflex
timeFrame: immediately after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Andrew Shubov, MD
role: PRINCIPAL_INVESTIGATOR
References: