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Skin Surface's Temperature Change When Auricular Acupuncture at Jaw Point and Tooth Point

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ClinicalTrials.gov Identifier: NCT05164302
Recruitment Status : Recruiting
First Posted : December 20, 2021
Last Update Posted : January 6, 2022
Sponsor:
Information provided by (Responsible Party):
Bui Pham Minh Man, University of Medicine and Pharmacy at Ho Chi Minh City

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.

Condition or disease Intervention/treatment Phase
Healthy Procedure: Auricular acupuncture Not Applicable

Detailed Description:
Participants and Methods: A crossover study is conducted by comparing the in skin surface's temperature change before and after applying auricular acupuncture at Jaw point (LO1) and Tooth point (LO3) in each side of the ear in heatlhy volunteer. A total of 70 participants were randomly assigned to 2 group (A and B) and the allocation was 1:1. In group A: participants received auricular acupuncture at tooth point (LO1) three times: Left ear, Right ear and Sham accupunture. Similarly, LO1 point was replaced by LO3 point (Jaw point) for participants in group B. The primary outcome was change temperature of skin surface at the pinna and lower jaw when using auricular acupuncture at points: LO1 and LO3 in each side of the ear. This trial will be performed as 2-arm crossover design, randomized, controlled.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 2-arm crossover design, a pilot study
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Survey on Skin Surface's Temperature Change When Auricular Acupuncture at Jaw Point (LO1) and Tooth Point (LO3) on Heatlhy Volunteer: a Pilot Study
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Group A: LO1 point (Tooth)
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
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.

Experimental: Group B: LO3 point (Jaw)
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
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.




Primary Outcome Measures :
  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 [ Time Frame: During procedure ]

Secondary Outcome Measures :
  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 [ Time Frame: During procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05164302


Contacts
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Contact: Minh-Man Pham Bui, Medical Doctor +84916080803 bpmman@ump.edu.vn

Locations
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Vietnam
Faculty of Traditional medicine - University of Medicine and Pharmacy of Ho Chi Minh City Recruiting
Ho Chi Minh City, Vietnam
Contact: Minh-Man Pham Bui, Medical Doctor         
Sponsors and Collaborators
University of Medicine and Pharmacy at Ho Chi Minh City
Publications:
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Responsible Party: Bui Pham Minh Man, Medical Doctor, University of Medicine and Pharmacy at Ho Chi Minh City
ClinicalTrials.gov Identifier: NCT05164302    
Other Study ID Numbers: IRB-VN01002
First Posted: December 20, 2021    Key Record Dates
Last Update Posted: January 6, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Demographic characteristic and outcome data will be shared
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bui Pham Minh Man, University of Medicine and Pharmacy at Ho Chi Minh City:
Auricular Acupuncture