84
Participants
Start Date
May 10, 2023
Primary Completion Date
June 1, 2025
Study Completion Date
December 31, 2025
the acupuncture group
"The primary choice is to puncture GB20 with a quick puncture, which means regulate the mind and open the way. ①Scalp acupuncture: Du 20(Baihui), EX-HN 3(Yintang), EX-HNl(Sishencong); ②Select acupoints from six acupoints for mind-regulating, ear points (both sides): heart, lung, and Shenmen; body points (both sides): LI20(Yingxiang), EXTRA 12(Anmian), ST36(Zusanli) as the main hole. ③Sleeping three needles(both sides): HT7(Shenmen), PC6(Neiguan), SP6(Sanyinjiao); ④Opening four gates: LI4(Hegu) , LR3(Taichong) ⑤Abdominal four needles:ST25(Tianshu), CV12(Zhongwan), CV4(Guanyuan). For body acupuncture, a 0.3 mm×40 mm needle was used to insert directly for 0.5-1.0 cun, and twisting to gain the qi; for auricular points, a 0.25 mm×40 mm needle was used for 2-3 minutes without manipulating the needle. The acupuncture points were retained for 30 min, and the treatment was performed once every other day, three times a week, and the curative effect was evaluated after 4 weeks of treatment."
the placebo acupuncture group
Subjects in the placebo acupuncture group will receive non-insertive acupuncture using the sham needle supported by the Park device. This needle has a retractable shaft and a blunt tip, they could not penetrate the skin. We gently placed the sham needle and Park device on the skin. The sham needle is then no longer manipulated to minimize any physiological effects. The selected acupoints and needle retention time were the same as for the acupuncture group. Since oblique insertion is required for acupuncture points on the head, the fixed acupuncture body of the Park device could not be used. Therefore, blunt needles are used to stimulate the head points to reduce the amount of stimulation produced by acupuncture. At the end of the treatment, the acupuncturist also used a dry cotton swab to press the acupoints so that patients could feel the withdrawal of 'real' needles.
RECRUITING
The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou
The Third Affiliated hospital of Zhejiang Chinese Medical University
OTHER