64
Participants
Start Date
November 1, 2024
Primary Completion Date
June 30, 2026
Study Completion Date
October 31, 2026
Acupuncture
"Acupuncture sessions will use sterile, disposable stainless-steel needles (0.3 mm × 40 mm and 0.3 mm × 75 mm). Each session has two phases:~Supine Position:~* Needles (0.35 mm × 75 mm) are inserted into ST25, ST15, and SP14, reaching the abdominal muscle layer.~* Needles (0.30 mm × 40 mm) are inserted into CV12, CV4, ST36, ST37, and SP6.~* Electroacupuncture (EA) at ST25, SP15, and ST36 uses a continuous 5 Hz wave, 0.1 to 2.0 mA.~Prone Position:~* Needles are inserted into BL32, BL33, and BL35 with precise angles and depths.~* EA at BL32, BL33, and BL35 uses a continuous 5 Hz wave, 2.0 to 6.5 mA. Sessions occur three times a week for the first 4 weeks, then twice a week for weeks 5 to 8, each lasting 40 minutes, totaling 20 sessions."
Sham acupuncture
Sterile, disposable stainless-steel needles (0.30 mm × 25 mm) will be used. After skin sterilization, needles will be inserted into the same points as the acupuncture group but to a shallow depth of 2 to 3 mm and lightly manipulated for blinding. Paired alligator clips will be attached to the same points, but the sham EA apparatus will have no current output, though it mimics the active EA apparatus in appearance and sound. Sham sessions will follow the same schedule as the acupuncture group: three times a week for the first 4 weeks and twice a week for weeks 5 to 8, each lasting 40 minutes, totaling 20 sessions.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
OTHER