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Completed

NCT Number: NCT06200337

The Change in Cutaneous Temperature When Using Acupuncture at TB-3 and BL-65 Acupoints in Healthy Participants

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?

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Medicine, Vietnam National University at Ho Chi Minh City

Ho Chi Minh City, 70000, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fine needle acupuncture

Procedure

All participants underwent three 24-hour apart sessions. In each session, the acupuncturist inserted two sterile needles into the left and right acupoints with a 90-degree angle and 0.5 to 1 cun in depth for TB3, 0.3 to 0.5 cun for BL65, and 0.3 to 0.5 cun for SP3. The acupuncturist rotated the needle at an angle of 180-270 degrees within 1 minute, with a frequency of 60 - 120 times/minute for stimulation.

Primary outcomes

  1. The change in skin surface temperature at the neck

    Time frame: Five time points: baseline; 6 minutes (after needled and fisrt rotation); 12 minutes (after second rotation); 17 minutes (after rejection); and 22 minute

    The change in skin surface temperature (in degree Celsius) at the neck area when using acupuncture at Zhongzhu (TB3) and Shugu (BL65), in comparison with Taibai (SP3).

  2. The change in skin surface temperature at the cutaneous zone of Taiyang and Shaoyang meridians

    Time frame: Five time points: baseline; 6 minutes (after needled and fisrt rotation); 12 minutes (after second rotation); 17 minutes (after rejection); and 22 minute

    The change in skin surface temperature (in degree Celsius) at the cutaneous zone of the Taiyang meridian compared with the Shaoyang meridian when using acupuncture at Zhongzhu (TB3) and Shugu (BL65).

Secondary outcomes

  1. Adverse effects

    Time frame: During and 7-day after procedure

    Investigating the adverse events (in percentage) when using acupuncture at Zhongzhu (TB3), Shugu (BL65), and Taibai (SP3) acupoints

  2. The adaptation to acupoints effects

    Time frame: Five time points: baseline; 6 minutes (after needled and fisrt rotation); 12 minutes (after second rotation); 17 minutes (after rejection); and 22 minute

    Comparision of the change in skin surface temperature (in degree Celsius) at the neck between 3 groups when using acupuncture at Zhongzhu (TB3), Shugu (BL65), Taibai (SP3), respectively

Other outcomes

  1. Blood pressure

    Time frame: Baseline and 5 minutes after needle rejection

    Comparison of the blood pressure in mmHg when acupuncture at Zhongzhu (TB3), Shugu (BL65), Taibai (SP3).

    Comparison of the blood pressure, heart rate, body temperature, and skin surface temperature at the neck before acupuncture at Zhongzhu (TB3), Shugu (BL65), Taibai (SP3).

  2. Pulse rate

    Time frame: Baseline and 5 minutes after needle rejection

    Comparison of the pulse rate in rate per minute when acupuncture at Zhongzhu (TB3), Shugu (BL65), Taibai (SP3).

  3. Body temperature

    Time frame: Baseline and 5 minutes after needle rejection

    Comparison of the body temperature in degree Celsius when acupuncture at Zhongzhu (TB3), Shugu (BL65), Taibai (SP3).

Sponsors and collaborators

Lead sponsor

Loc Cong Dai Tran, MD

Other

Collaborators

  • University of Medicine and Pharmacy at Ho Chi Minh City

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 11, 2024
Registry last updated
Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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