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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

Tracking Information
First Submitted Date  ICMJE October 10, 2022
First Posted Date  ICMJE October 13, 2022
Last Update Posted Date January 10, 2023
Actual Study Start Date  ICMJE October 1, 2022
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2022)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
A pilot study
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.

    Intervention: Procedure: Acupuncture
  • 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.

    Intervention: Procedure: Acupuncture
  • 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.

    Intervention: Procedure: Acupuncture
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 10, 2022)		 57
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2023
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Minh-Man Pham Bui, Medical Doctor +84916080803 bpmman@ump.edu.vn
Contact: Phuong-Quynh Ngoc Le, Medical Doctor +84904945885 quynh510laura@gmail.com
Listed Location Countries  ICMJE Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05578014
Other Study ID Numbers  ICMJE 678/HDDD-DHYD
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Demographic characteristic and outcome data will be shared
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Current Responsible Party Bui Pham Minh Man, University of Medicine and Pharmacy at Ho Chi Minh City
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Bui Pham Minh Man
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Medicine and Pharmacy at Ho Chi Minh City
Verification Date January 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP