NCT05164302

Brief Summary

Auricular acupuncture is a method for diagnosing and treating physical and psychosomatic dysfunctions by stimulating a specific point in the ear. Some studies prove that the acupoints on the pinna have a corresponding relationship to the areas of the body. Some research also show that acupuncture acupoints on the body can change the temperature of the corresponding area. In our study, we survey the skin surface's temperature change when using auricular acupuncture at jaw point and tooth point in each side of the ear in heatlhy people.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 20, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

November 28, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

November 26, 2021

Last Update Submit

November 25, 2022

Conditions

Keywords

Auricular Acupuncture

Outcome Measures

Primary Outcomes (1)

  • Change temperature of skin surface at the pinna and lower jaw when using auricular acupuncture at tooth point in each side of the ear

    During procedure

Secondary Outcomes (1)

  • Change temperature of skin surface at the pinna and lower jaw when using auricular acupuncture at jaw point in each side of the ear

    During procedure

Study Arms (2)

Group A: LO1 point (Tooth)

EXPERIMENTAL

Participant received auricular acupuncture and sham acupuncture at LO1 point in each side of the ear. In each session, temperature of skin surface at the pinna and lower jaw will be recorded.

Procedure: Auricular acupuncture

Group B: LO3 point (Jaw)

EXPERIMENTAL

Participant received auricular acupuncture and sham acupuncture at LO3 point in each side of the ear. In each session, temperature of skin surface at the pinna and lower jaw will be recorded.

Procedure: Auricular acupuncture

Interventions

Auricular acupuncture is a method for diagnosing and treating physical and psychosomatic dysfunctions by stimulating a specific point in the ear. To conducting this intervention, we use press tack needles to perform auricular acupuncture.

Group A: LO1 point (Tooth)Group B: LO3 point (Jaw)

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteer with normal vital signs
  • Volunteers who agree to participate and sign the Informed Consent Form, following a detailed explanation of clinical trials
  • DASS 21 score within normal limits
  • BMI: 18.5 - 23 kg/m2

You may not qualify if:

  • Inappropriate condition for auricular acupuncture due to skin disease (the skin of the acupuncture point is swollen, hot and red)
  • Pregnant woman or breastfeeding woman or woman in period
  • Other diseases that could affect or interfere with outcomes, including cardiovascular disease, thyroid disorder, facial disease.
  • Taking vasodilators or sunscreen in the examined skin areas
  • Taking stimulant (alcohol, beer, coffee, tobacco) within 24h
  • Massage or cupping therapy or acupuncture in facial area within 24h
  • Playing sport within 2h

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Traditional medicine - University of Medicine and Pharmacy of Ho Chi Minh City

Ho Chi Minh City, Vietnam

Location

Related Publications (4)

  • Hou PW, Hsu HC, Lin YW, Tang NY, Cheng CY, Hsieh CL. The History, Mechanism, and Clinical Application of Auricular Therapy in Traditional Chinese Medicine. Evid Based Complement Alternat Med. 2015;2015:495684. doi: 10.1155/2015/495684. Epub 2015 Dec 28.

    PMID: 26823672BACKGROUND
  • Tsuruoka N, Katayama S, Seki T, Matsunaga T, Iijima R, Haga Y. Focused Ultrasound PC-6 Stimulation Effects on Blood Flow Volume, Skin Temperature, and Coldness of the Finger and Toe. Complement Med Res. 2019;26(6):404-409. doi: 10.1159/000501149. Epub 2019 Jul 5.

    PMID: 31280256BACKGROUND
  • Wang D, Ji B, Yan M, Bai H, Sun X, Dai J, Lu Y, Liu Y, You M, Wu J, Ge Y, Su H, Cheng K, Zhao G. Effect of electroacpuncture of Neiguan (PC 6) and Tianquan (PC 2) on skin temperature, blood perfusion, and adrenoceptor response in rats with acute myocardial ischemia. J Tradit Chin Med. 2017 Dec;37(6):794-803.

    PMID: 32188189BACKGROUND
  • Guan L, Li G, Yang Y, Deng X, Cai P. Infrared thermography and meridian-effect evidence and explanation in Bell's palsy patients treated by moxibustion at the Hegu (LI4) acupoint: Overall regulation or a specific target? Neural Regen Res. 2012 Mar 25;7(9):680-5. doi: 10.3969/j.issn.1673-5374.2012.09.007.

    PMID: 25745463BACKGROUND

MeSH Terms

Interventions

Acupuncture, Ear

Intervention Hierarchy (Ancestors)

Acupuncture TherapyComplementary TherapiesTherapeuticsAuriculotherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 2-arm crossover design, a pilot study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

November 26, 2021

First Posted

December 20, 2021

Study Start

January 1, 2022

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

November 28, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

Demographic characteristic and outcome data will be shared

Shared Documents
STUDY PROTOCOL, ICF, CSR

Locations