84
Participants
Start Date
March 16, 2022
Primary Completion Date
December 24, 2024
Study Completion Date
January 23, 2025
electroacupuncture
"The prespecified acupoints applied here will include bilateral Sanyinjiao(SP6), Shenshu(BL23), Ciliao(BL32), Zhongliao(BL33), Zhibian(BL54) .~Acupuncture treatment is carried out by acupuncturists who have been well trained. Acupuncture will be performed with disposable and sterile needles in the specification of 0.25 ×40 mm(diameter: 0.25mm; Suzhou Medical Products Factory Co., Ltd, China). Electroacupuncture procedures will be performed with electronic instruments (Hans-100A, Nanjing Jisheng Medical TechnologyCo., Ltd, China). Two paired of acupoints (i.e., two Shenshu(BL23) and two Ciliao(BL32), respectively) are connected to the EA apparatus. Alternating-frequency mode is selected and frequency is 2/100 Hz. EA intensity is determined in accordance with patients' endurance. EA will last for 30 min for each treatment. Patients will receive a total number of 12 EA sessions, with the frequency of 3 sessions per week for 4 weeks."
Amitriptyline
Participants in the medication group will be merely treated with oral administration of amitriptyline capsule. The dosage of amitriptyline is 25mg bid, for 4 weeks. Any changes in the medications of individual participants will be recorded on diary cards.
sham electroacupuncture
"In the trunk region, the points are 5 cm away from respective acupoints. In the lower limb region, the point is 3 cm away from Sanyinjiao(SP6). All points will only receive shallow insertion.~Acupuncture will be performed with disposable and sterile needles in the specification of 0.25 ×40 mm(diameter: 0.25mm; Suzhou Medical Products Factory Co., Ltd, China).The needles are shallowly inserted to the subcutaneous area, and acupoints are connected to the EA apparatus without electricity. The frequency, intensity and duration of treatment will be the same as the electric needle group."
RECRUITING
The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou
The Third Affiliated hospital of Zhejiang Chinese Medical University
OTHER