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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    57
  • sponsor
    Bui Pham Minh Man
Updated on 28 October 2022
Accepts healthy volunteers

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.

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.

Details
Condition Healthy Volunteers
Treatment Acupuncture with tonifying or dispersing manipulations
Clinical Study IdentifierNCT05578014
SponsorBui Pham Minh Man
Last Modified on28 October 2022

Eligibility

Yes No Not Sure

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\
Clear my responses

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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