Acupuncture vs TENS for Gag Reflex
Condition: Gagging
MeSH terms: Gagging
Study type: Interventional

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
    

Intervention name(s): Acupuncture; TENS; Sham-TENS
Intervention type(s): Procedure; Device; Device
Intervention description(s): Acupuncture of acupoints P-6 and St-36; TENS of acupoints P-6 and St-36; Sham-TENS of acupoints P-6 and St-36
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: acupuncture; TENS; acupressure; acupoint; gag