Acupuncture vs TENS for Gag Reflex

Gagging Clinical Trial

Official title:

Acupuncture vs TENS for Gag Reflex

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04757948
• Other study ID #: IRB#18-000473
• Status: Completed
• Phase: N/A
• Start date: June 13, 2018
• Est. completion date: January 30, 2020

Study information

• Verified date: February 2021
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• English Speaking

Exclusion Criteria:

• bleeding dyscrasias

• severe needlephobia

• pacemaker or other implanted electrical device

Related Conditions & MeSH terms

• Gagging

Intervention

Procedure:
• Acupuncture
Acupuncture of acupoints P-6 and St-36

Device:
• TENS
TENS of acupoints P-6 and St-36
• Sham-TENS
Sham-TENS of acupoints P-6 and St-36

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insertion length	A standard saliva ejector with a stopper made of heavy-body addition silicone impression putties is inserted into the participants' mouth at the maxillary central incisor, and gradually guided down the participant's throat along the palate. The participants are asked to inform the examiner when their maximum tolerance has been reached by pushing a button that beeps. The examiner then stopped inserting the saliva ejector, remove it, and measure the insertion distance of the saliva ejector from the maxillary central incisor using digital calipers. This distance is recorded as an index of the gag reflex.	immediately after procedure
Primary	Severity of gag reflex	Subjects are also be asked to report the severity of their gagging on a scale of 1-10, with 1 representing the minimum and 10 representing the maximum	immediately after procedure