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Change Temperature of Skin Surface at the Acupuncture Site, the Neck and the Face When Using Tonifying Acupuncture Manipulations or Dispersing Acupuncture Manipulations at Dazhui in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT05578014
Recruitment Status : Recruiting
First Posted : October 13, 2022
Last Update Posted : January 10, 2023
Sponsor:
Information provided by (Responsible Party):
Bui Pham Minh Man, University of Medicine and Pharmacy at Ho Chi Minh City

Study Description
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Brief Summary:
Acupuncture is a treatment method since ancient times and it has been recognized as an international treatment method by the World Health Organization. Although the structure and physiological effects of acupoints have been extensively studied, they have not been fully elucidated. A lot of studies on physiological effects of acupoints on the 12 main merdians have been published, but acupoints outside the meridians or acupoints on the eight extraordinary vessels have not been noticed. In particular, the Dazhui is one of the acupoints on the Du Merdian that is often used clinically. In the other side, several researches have shown that using different acupuncture manipulations can achieve different therapeutic effects. In our study, we want to determinate and compare the change temperature of skin surface at the acupuncture site, the neck and the face when using tonifying acupuncture manipulations or dispersing acupuncture manipulations at Dazhui in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Procedure: Acupuncture Not Applicable

Detailed Description:
Participants and Methods: A pilot study is conducted by comparing the change in skin surface temperature before and after using sham or tonifying or dispersing acupuncture manipulations at EX-B2 T3 in right side and Dazhui in heatlhy volunteers. A total of 57 participants will be randomly divided into 3 groups (group STD, group TDS and group DST). Each group has 19 participants and undergo 3 trial phases, corresponding to 3 times of acupuncture in 14 days, each time is 7 days apart. For group STD, the first trial phase: participants received acupuncture at EX-B2 T3 point in right side as sham acupuncture; the second trial phase: participants received acupuncture with tonifying manipulations at Dazhui point and tonifying manipulations was replaced by dispersing ones in the third trial phase. For group TDS, the first trial phase: participants received acupuncture with tonifying manipulations at Dazhui point; the second trial phase: participants received acupuncture with dispersing manipulations at Dazhui point and participants received acupuncture at EX-B2 T3 point in right side as sham acupuncture in the third trial phase. Similarly, for group DST, the first trial phase: participants received acupuncture with dispersing manipulations at Dazhui point; the second trial phase: participants received acupuncture at EX-B2 T3 point in right side as sham acupuncture and sham acupuncture was replaced byacupuncture with tonifying manipulations at Dazhui in the third trial phase. The primary outcome was the change temperature of skin surface at the acupuncture site, the neck and the face when using tonifying or dispersing acupuncture manipulations at Dazhui point. This trial will be performed as a pilot study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: A pilot study
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Survey on Change Temperature of Skin Surface at the Acupuncture Site, the Neck and the Face When Using Tonifying Acupuncture Manipulations or Dispersing Acupuncture Manipulations at Dazhui in Healthy Volunteers: a Pilot Study
Actual Study Start Date : October 1, 2022
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group STD

19 participant received sham acupuncture at EX-B2 T3 point in right side or acupuncture with tonyfying or dispersing manipulations at Dazhui point, corresponding to 3 times of acupuncture in 14 days, each time is 7 days aparts. In each time, temperature of skin surface at the acupuncture site, the neck and the face will be recorded.

Procedure/Surgery: Acupuncture with disposable acupuncture needles (the size of 0.30 x 25 mm) at EX-B2 T3 point in right side as sham acupoint in the first trial phase. We used the same type of acupuncture needles as aboved to acupuncture at Dazhui with tonifying manipulations in the second trial phase and with dispersing manipulatiuons in the third trial phase.

 Procedure: Acupuncture
To conduct this intervention, we used disposable acupuncture needles with the size of 0.30 x 25 mm to acupuncture the sham acupoint (EX-B2 T3 point) or Dazhui point.
Experimental: Group TDS

19 participant received acupuncture with tonyfying or dispersing manipulations at Dazhui or sham acupuncture at EX-B2 T3 point in right side, corresponding to 3 times of acupuncture in 14 days, each time is 7 days aparts. In each time, temperature of skin surface at the acupuncture site, the neck and the face will be recorded.

Procedure/Surgery: Acupuncture with disposable acupuncture needles (the size of 0.30 x 25 mm) at Dazhui with tonifying manipulations in the first trial phase and with dispersing manipulatiuons in the second trial phase. We used the same type of acupuncture needles as aboved to acupuncture at EX-B2 T3 point in right side as sham acupoint in the third trial phase.

 Procedure: Acupuncture
To conduct this intervention, we used disposable acupuncture needles with the size of 0.30 x 25 mm to acupuncture the sham acupoint (EX-B2 T3 point) or Dazhui point.
Experimental: Group DST

19 participant received acupuncture with tonyfying or dispersing manipulations at Dazhui or sham acupuncture at EX-B2 T3 point in right side, corresponding to 3 times of acupuncture in 14 days, each time is 7 days aparts. In each time, temperature of skin surface at the acupuncture site, the neck and the face will be recorded.

Procedure/Surgery: Acupuncture with disposable acupuncture needles (the size of 0.30 x 25 mm) at Dazhui with tonifying manipulations in the first trial phase and with dispersing manipulatiuons in the second trial phase. We used the same type of acupuncture needles as aboved to acupuncture at EX-B2 T3 point in right side as sham acupoint in the third trial phase.

 Procedure: Acupuncture
To conduct this intervention, we used disposable acupuncture needles with the size of 0.30 x 25 mm to acupuncture the sham acupoint (EX-B2 T3 point) or Dazhui point.


Outcome Measures
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Primary Outcome Measures :
  1. Change temperature of skin surface at at the acupuncture site, the neck and the face when using tonifying acupuncture manipulations at Dazhui [ Time Frame: During procedure ]
  2. Change temperature of skin surface at at the acupuncture site, the neck and the face when using dispersing acupuncture manipulations at Dazhui [ Time Frame: During procedure ]

Eligibility Criteria
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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 volunteers, regardless of gender or profession
  • Age between enough 18 and 30 years old.
  • BMI: 18.5 - 23 kg/m2
  • Mental alertness, good contact, cooperation with researchers.
  • DASS 21 score within normal limits.
  • Have no disease which change the body temperature, like hyperthyroidism, hypothyroidism.

  • Vital sign within normal limits:

    • Heart rates from from 60 to 100 beats/minute.
    • Systolic blood pressure between 90 and 139 mmHg.
    • Diastolic blood pressure between 60 and 89 mmHg.
    • Body temperature: 36.59 ± 0.43 0C.
    • SpO2 from 95 to 99%.
  • Volunteers who agree to participate and sign the Informed Consent Form, following a detailed explanation of clinical trials.
  • Not currently participating in other intervention studies.
  • Have no acupuncture experience yet.

Exclusion Criteria:

  • Having an inflammatory injury in the site of the skin to be investigated.
  • Using heat therapy, for example massage, cupping therapy, acupuncture in the site of the skin to be investigated within 24h.
  • Applying chemical or pharmaceutical products to the site of the skin to be survey before conducting the study.
  • Other diseases that could affect or interfere with outcomes, including common cold or flu.
  • Curently having neck-pain or having skin diseases, for example: tinea versicolor, eczema in the site of the skin to be investigated.
  • Taking stimulant (alcohol, beer, coffee, tobacco) within 24h.
  • Staying up at night or having insomnia before the day of the study.
  • Playing sport within 2h.
  • Pregnant woman or breastfeeding woman or woman in period.
  • Currently using certain drugs which dilate blood vessels and drop in blood pressure.
  • Anxiety, depression, stress before conducting the study with DASS 21 score < 15.
Contacts and Locations
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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): NCT05578014


Contacts
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Contact: Minh-Man Pham Bui, Medical Doctor +84916080803 bpmman@ump.edu.vn
Contact: Phuong-Quynh Ngoc Le, Medical Doctor +84904945885 quynh510laura@gmail.com

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    +84916080803    bpmman@ump.edu.vn   
Principal Investigator: Phuong-Quynh Ngoc Le, Medical Doctor         
Sponsors and Collaborators
Bui Pham Minh Man
More Information
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Additional Information:

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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: NCT05578014    
Other Study ID Numbers: 678/HDDD-DHYD
First Posted: October 13, 2022    Key Record Dates
Last Update Posted: January 10, 2023
Last Verified: January 2023
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:
Acupuncture Manipulations
Tonifying Acupuncture Manipulations
Dispersing Acupuncture Manipulations