Clinical trial NCT05578014: 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: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Acupuncture Manipulations
Tonifying Acupuncture Manipulations
Dispersing Acupuncture Manipulations
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: A pilot study
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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.

Primary outcomes:
measure: Change temperature of skin surface at at the acupuncture site, the neck and the face when using tonifying acupuncture manipulations at Dazhui
timeFrame: During procedure
measure: Change temperature of skin surface at at the acupuncture site, the neck and the face when using dispersing acupuncture manipulations at Dazhui
timeFrame: During procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Faculty of Traditional medicine - University of Medicine and Pharmacy of Ho Chi Minh City
Study officials:
References: