148
Participants
Start Date
May 20, 2025
Primary Completion Date
December 31, 2028
Study Completion Date
December 31, 2028
Carbarmazepine
If patients were on carbamazepine (CBZ) prior to enrollment, the CBZ dose remained unchanged after enrollment; if patients were on oxcarbazepine (OXC) prior to enrollment, they received half of their pre-enrollment OXC dose as CBZ after enrollment. Orally administered for four consecutive weeks.
Sham Electroacupuncture
In this group, superficial needling (0.5-1 mm depth) was performed at non-meridian points located 1 cm lateral to: (1) primary local acupoints ST2 (Sibai), ST7 (Xiaguan), and ST4 (Dicang) on the affected side; (2) branch-specific supplementary points GB1 (Tongziliao) for ophthalmic branch involvement, SI18 (Quanliao) for maxillary branch involvement, and ST6 (Jiache) for mandibular branch involvement; and (3) bilateral distal points LI4 (Hegu) and TE5 (Waiguan). Local acupoint pairs (ST7 adjacent + GB1 adjacent or ST7 adjacent +SI18 adjacent or ST7 adjacent + ST6 adjacent) and distal pairs (LI4 adjacent +TE5 adjacent) were connected to a modified electroacupuncture device with severed output wires (preventing current flow while maintaining indicator function), followed by 60-minute needle retention after parameter adjustment. Acupuncture was administered 3 times per week (with 1-2-day intervals between sessions) for 4 consecutive weeks, totaling 12 sessions.
Carbarmazepine Placebo
CBZ placebo is a tablet with identical packaging and appearance to CBZ but lacks therapeutic effects. If patients were receiving CBZ prior to enrollment, they were transitioned to a CBZ placebo at an equivalent daily dose post-enrollment. For patients previously treated with oxcarbazepine, the post-enrollment regimen consisted of a CBZ placebo administered at half the pre-enrollment oxcarbazepine dose. Orally administered for four consecutive weeks.
Electroacupuncture
The primary acupoints selected were the affected side's Sibai (ST2), Xiaguan (ST7), and Dicang (ST4). Based on the affected nerve branch, additional acupoints were chosen: for the ophthalmic branch, Tongziliao (GB1); for the maxillary branch, Quanliao (SI18); and for the mandibular branch, Jiache (ST6). Distal acupoints included bilateral Hegu (LI4) and Waiguan (SJ5). Electroacupuncture was applied based on the affected nerve branch. For the ophthalmic branch, the local acupoints selected were Xiaguan + Tongziliao; for the maxillary branch, Xiaguan + Quanliao; and for the mandibular branch, Xiaguan + Jiache. The distal acupoints selected were Hegu + Waiguan. A sparse-dense wave, 2/100Hz, was used, with a treatment duration of 60 minutes. The intensity of the electrical current was adjusted according to the patient's tolerance. Acupuncture was administered 3 times per week (with 1-2-day intervals between sessions) for 4 consecutive weeks, totaling 12 sessions.
Pingyang County Traditional Chinese Medicine Hospital
UNKNOWN
Jiaxing Traditional Chinese Medicine Hospital
UNKNOWN
Yuanyuan Wu
OTHER