Acupuncture Mechanism in Relief of Gag Reflex (AcuGagDiff)

The Mechanism of Acupuncture for Relief of Pharyngeal (Gag) Reflex - an Experimental Crossover Investigation

The gag reflex relief effect of acupuncture of CV24 acupoint will be compared to acupuncture of PC6 and K3 acupoints in healthy volunteers in crossover mode. Second step will be the investigation whether local anesthesia using EMLA creme will block the gag relief effect of CV24 acupuncture in healthy volunteers.

Study Overview

• Status: Recruiting
• Conditions: Gag (Pharyngeal) Reflex
• Intervention / Treatment: Other: Acupuncture

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Taras I Usichenko, Prof. Dr. med., MD, PhD; Phone Number: +49 (0) 3434864028; Email: tarasik@me.com

Study Locations

• Germany
  • Greifswald, Germany, 17475
    • Recruiting
    • University Medicine of Greifswald
    • Contact: Taras I Usichenko, Prof. Dr. med., MD, PhD; Phone Number: +49 (0) 3834864028; Email: tarasik@me.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy volunteers aged between 20-40 years old with an American Society of Anesthesiologists physical status of I to II naïve to acupuncture
2. Participants without previous opioid and psychotropic medication
3. Without use of recreational drugs 3 days prior to study sessions
4. Without systemic disease or local skin lesions at the sites of acupuncture
5. Without drug allergy to local anesthetics, especially EMLA preparation
6. Participants who have given written informed consent

Exclusion Criteria:

1. Local skin infection at the sites of acupuncture
2. Aged < 20 or > 35 years
3. History of drug allergy to local anesthetics
4. Participants who are unable to understand the consent form or to use numeric rating scale NRS-11

Discontinuation Criteria

1. Any adverse effects during study session
2. In case of local or systemic infection
3. In case if subject will withdraw from participation in this study at any time, for any reason, specified or non-specified, and without penalty or loss of benefits

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CV24; Needling of acupoint PC6	Other: Acupuncture; Needling of acupoints CV24, PC6 and K3
Active Comparator: PC6; Needling of acupoint PC6	Other: Acupuncture; Needling of acupoints CV24, PC6 and K3
Active Comparator: K3; Needling of acupoint K3	Other: Acupuncture; Needling of acupoints CV24, PC6 and K3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of saliva injector insertion (cm)	Saliva injector is inserted intraoral slowly until the gagging (pharyngeal reflex) is elicited; the length of insertion of saliva injector will be measured in centimeters	Day 1 ( before and after acupuncture)

Secondary Outcome Measures

Outcome Measure	Time Frame
Severity of gagging, measured using the Numeric Rating Scale NRS-11 (0=no gagging; 10=maximal)	Day 1 ( before and after acupuncture)

Collaborators and Investigators

• Sponsor: University Medicine Greifswald

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: June 8, 2026
• First Submitted That Met QC Criteria: June 23, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Complementary Therapies; Acupuncture Therapy
• Other Study ID Numbers: BB150/25 (Other Identifier: Ethics Commission of the University Medicine of Greifswald)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Corresponding author will share the anonymized, statistically calculated data on request after publication of the results
• IPD Sharing Time Frame: After publication of study results
• IPD Sharing Access Criteria: On request via email contact to the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No