Acupuncture vs TENS for Gag Reflex

NCT04757948 | Completed FDA Device

• 1 other identifier: IRB#18-000473
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gagging

Keywords

acupuncture; TENS; acupressure; acupoint; gag

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

Acupuncture

EXPERIMENTAL

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.

Procedure: Acupuncture

TENS

EXPERIMENTAL

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.

Device: TENS

Sham-TENS

PLACEBO COMPARATOR

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.

Device: Sham-TENS

Interventions

Acupuncture PROCEDURE

Acupuncture of acupoints P-6 and St-36

Acupuncture

TENS DEVICE

TENS of acupoints P-6 and St-36

TENS

Sham-TENS DEVICE

Sham-TENS of acupoints P-6 and St-36

Sham-TENS

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English Speaking

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Gagging

Interventions

Acupuncture Therapy; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Andrew Shubov, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Masking of the participant: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 17, 2021
• Study Start: June 13, 2018
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2020
• Last Updated: February 17, 2021

Record last verified: 2021-02

Locations

US (1)