110
Participants
Start Date
March 8, 2022
Primary Completion Date
December 31, 2024
Study Completion Date
December 31, 2024
Acupuncture
Participants will receive acupuncture, three times per week for eight weeks. The selected acupoints include bilateral BL33, BL35, SP6, and ST36. All acupoints areas have been sterilized before acupuncture. For BL33, a needle (Ф0.40×100mm) will be inserted with an angle of 60° in an inferomedial direction at a depth of 90-100mm. For BL35, the same needle will be inserted with a direction to the ischial rectal fossa at a depth of 60-70 mm deep. For SP6 and ST36, needles (Ф0.30×50mm) will be directly inserted at a depth of 25-30 mm deep. After the needles are inserted, a portable electro-acupuncture machine will be connected to the handles of needles located in BL33 and BL35 to provide the electrical stimulation for 30 minutes with a disperse-dense wave (4/20Hz). All current intensities will be as high as can be tolerated.
Sham acupuncture
The sham acupoints will be located at 20 mm outward to BL33, BL35, SP6, and ST36, and the needless will be inserted with a depth of 2 mm. The BL33 and BL35 will not receive any electrical stimulation, though the handles of needles will be connected to the same machine as the acupuncture group, and the parameter setting and course are also the same.
RECRUITING
Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
OTHER