Clinical trial NCT05581329: Change in Skin Surface Temperature at the Neck When Using Acupuncture at Houxi Point in Healthy Volunteers
Official title: Change in Skin Surface Temperature at the Neck When Using Acupuncture at Houxi Point in Healthy Volunteers: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Acupuncture
Skin surface temperature
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2-arm parallel design, randomized, controlled and single blinded trial
Primary purpose: BASIC_SCIENCE

Brief summary: Acupuncture is a method of inserting very thin needles into special points on the body which are called acupoints, to treat diseases. This treatment has been widely applied in health care for over 2500 years. Currently, by synthesizing the results of many clinical studies, the World Health Organization (WHO) has recognized the importance of acupuncture as an effective treatment for various diseases. However, the specific effect of acupoints is still controversial. Until now, several studies have shown that acupoints are associated with certain areas of the human body that are far from the acupoints and can alter the temperature of those area. In our study, we will survey on the change in skin surface temperature at the neck when using acupuncture at Houxi point in healthy volunteers.

Detailed description: Participants and Methods: A randomize controlled trial will be conducted by comparing the change in the skin surface temperature before and after using acupunture at the control acupoint (Yuji - LU10) and the research acupoint (Houxi - SI3) on either the left or right hand in healthy volunteers. A total of 60 participants will be randomly assigned to 2 group (A and B) and the allocation was 1:1. Both groups will undergo two trial phases 07 days apart, corresponding to one acupoint on the same hand in each step. Group A (acupoints on the left hand): participants will be received acupuncture at the control acupoint (Yuji - LU10) in the first trial phase, and the second phase will be conducted after 07 days at the research acupoint (Houxi - SI3). Group B: proceeding similarly to group A, but the points are on the right hand. The primary outcome will be the change in skin surface temperature at the neck when using acupuncture at Houxi point on each hand. This trial will be performed as a 2-arm parallel design, randomize, controlled and single blinded.

Eligibility criteria: Inclusion Criteria:

* Healthy males and females were individual age between enough 18 and 30 years old.
* BMI: 18.5 - 23 kg/m2
* Mental alertness, good contact, cooperation with researchers.
* Having no psychiatric stress problem during acupuncture day (confirmed by answering the DASS21 questionnaire with stress point less than 15 points).
* Vital sign within normal limits:

  * Heart rates from from 60 to 99 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.
  * Breathing rate: 16 ± 3 respirations/minute .
* Having no disease or using drugs that change the body temperature.
* Not currently participating in other intervention studies.
* Volunteers who agree to participate and sign the Informed Consent Form, following a detailed explanation of clinical trials.
* Having no acupuncture knowledge and experience yet.

Exclusion Criteria:

* Playing sport 2 hours before the study.
* Taking stimulant (alcohol, beer, coffee and tobacco) within 24 hours before conducting the study.
* Staying up late at night or having insomnia before the day of the study.
* Women who were in menstruation period, pregnancy, or breastfeeding.
* Having skin injuries, dermatitis-skin infections or wounds in the area to be investigated.
* Curently having neck-pain or other diseases that could affect or interfere with outcomes, including common cold.
* Currently taking sedatives or drugs that cause vasodilation, affect blood pressure and heart rate.
* Applying chemical or pharmaceutical products to the site of the skin to be investigated before conducting the study.
* Using physical therapy, heat therapy, cupping therapy, massage, acupuncture in the site of the skin to be investigated within 24 hours.
* Anxiety, depression, stress before conducting the study with DASS 21 score \< 15.

Primary outcomes:
measure: The change in skin surface temperature at the neck when using acupuncture at Houxi point on each hand.
timeFrame: During procedure
measure: Survey the change in temperature at the neck area respectively when using acupuncture at the left and right research acupoints (Houxi - SI3) compared with the control acupoints group (Yuji - LU10).
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: