Clinical trial NCT06200337: The Change in Cutaneous Temperature When Using Acupuncture at TB-3 and BL-65 Acupoints in Healthy Participants
Official title: The Change in Cutaneous Temperature When Using Acupuncture at Zhongzhu (TB-3) and Shugu (BL-65) Acupoints in Healthy Participants: A Pilot, Randomized, Double-blind, Self-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Participants
Keywords: acupuncture
skin surface temperature
Lead sponsor: School of Medicine - Vietnam National University at Ho Chi Minh city
Sponsor class: OTHER
Collaborators: name: University of Medicine and Pharmacy at Ho Chi Minh City
First posted: 2024-01-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: For more than 2,500 years, traditional medicine, especially acupuncture, has been widely used in health care and recognized by the World Health Organization (WHO) to manage various diseases. Besides, many molecular biological mechanisms of acupuncture in pain management have been elucidated. Acupuncture is a safe, effective, and cost-effective therapy, reducing the overuse of opioid pain relievers. In neck pain treatment, many clinical studies used remote acupoints, which have specific effects on the neck. Among them, the Stream points in the Five Stream acupoints system are the most used acupuncture points in the treatment of neck pain. However, the relationship between these acupoints and the neck has not been proven. The goal of this trial is to compare the change in skin surface temperature at the neck and the cutaneous zone before and after using acupuncture at the control acupoint (SP3) and two research acupoints (TB3 and BL65) in healthy volunteers. The main questions it aims to answer are:

* Whether the Zhongzhu and Shugu acupoints change the skin temperature in the neck area?
* How does the change in temperature correlate with the cutaneous zone distribution of the Shaoyang and Taiyang meridians, respectively?

Detailed description: Participants and Methods: The change in skin surface temperature before and after acupuncture at the control acupoint (SP3) and two research acupoints (TB3 and BL65) in healthy volunteers will be compared in a randomized, double-blinded, self-controlled trial. A total of 30 participants will be assigned to 3 groups (A, B, and C), and the allocation will be 1:1:1. Every group will go through three trial stages spaced out by 24 hours, with each stage corresponding to one acupoint on both sides. Group A: In the first trial stage, acupuncture will apply at BL65, the second trial stage at TB3, and the third trial stage at SP3. Group B: In the first trial stage, acupuncture will apply at SP3, the second stage at BL65, and the third stage at TB3. Group C: In the first trial stage, acupuncture will apply to participants at TB3, the second stage at SP3, and the third stage at BL65. The primary outcome of acupuncture at the TB3, BL65, and SP3 acupoints will be the alteration in skin surface temperature at the neck area and the cutaneous zone. The skin surface temperature was measured by an Infrared Thermal Camera brand FLIR C5 and thermal images were analyzed by FLIR Thermal Studio software.

Eligibility criteria: Inclusion Criteria:

* Healthy participants.
* 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 points less than 15 points).
* Vital signs within normal limits:

  * Heart rate from 60 to 99 beats per minute.
  * Systolic blood pressure between 90 and 139 mmHg.
  * Diastolic blood pressure between 60 and 89 mmHg.
  * Body temperature: 36.59 ± 0.43 degrees Celsius.
  * Breathing rate: 16 ± 3 breaths per minute.
* Having no disease or using drugs which may 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 yet.

Exclusion Criteria:

* Participate in vigorous physical activities 2 hours before the procedure.
* Taking stimulants (alcohol, beer, coffee, and tobacco) within 24 hours before participating the study.
* Staying up late at night or having a sleep disorder before the procedure
* Women who were in menstruation period, pregnancy, or breastfeeding.
* Having skin injuries, dermatitis-skin infections, or wounds in the area to be investigated.
* Applying chemical or pharmaceutical products to the site of the skin to be investigated before participating the study.
* Using physical therapy, heat therapy, cupping therapy, massage, and acupuncture on the site of the skin to be investigated within 24 hours before participating the study.

Primary outcomes:
measure: The change in skin surface temperature at the neck
timeFrame: Five time points: baseline; 6 minutes (after needled and fisrt rotation); 12 minutes (after second rotation); 17 minutes (after rejection); and 22 minute
measure: The change in skin surface temperature at the cutaneous zone of Taiyang and Shaoyang meridians
timeFrame: Five time points: baseline; 6 minutes (after needled and fisrt rotation); 12 minutes (after second rotation); 17 minutes (after rejection); and 22 minute
Secondary outcomes:
measure: Adverse effects
timeFrame: During and 7-day after procedure
measure: The adaptation to acupoints effects
timeFrame: Five time points: baseline; 6 minutes (after needled and fisrt rotation); 12 minutes (after second rotation); 17 minutes (after rejection); and 22 minute
Other outcomes:
measure: Blood pressure
timeFrame: Baseline and 5 minutes after needle rejection
measure: Pulse rate
timeFrame: Baseline and 5 minutes after needle rejection
measure: Body temperature
timeFrame: Baseline and 5 minutes after needle rejection
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: School of Medicine, Vietnam National University at Ho Chi Minh City
Study officials:
affiliation: University of Medicine and Pharmacy at Ho Chi Minh City
name: Bay Thi Nguyen, MD., PhD.
role: STUDY_DIRECTOR
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