Healthy Participants Clinical Trial
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
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?
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. ;
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