School of Medicine, Vietnam National University at Ho Chi Minh City
Ho Chi Minh City, 70000, Vietnam
NCT Number: NCT06200337
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?
Looking for future studies?
Notify Me18 year–30 year
All sexes
Interventional
Not applicable
Ho Chi Minh City, 70000, Vietnam
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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).
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).
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
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
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).
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).
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).
Loc Cong Dai Tran, MD
Other
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
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