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Effect of Electroacupuncture for Trigeminal Neuralgia: Study Protocol for a Multicenter Randomized Controlled Trial
Nisang Chen1, Moran Xu1, Junyi Wang1
1The Third Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou, Zhejiang, People's Republic of China.
Introduction:
Trigeminal neuralgia (TN) is a severe neuropathic pain disorder characterized by unpredictable pain paroxysms, significantly impairing patients' quality of life through associated anxiety and depression. Electroacupuncture (EA) has demonstrated clinical value in managing chronic neuropathic pain. However, its specific efficacy as a pharmacotherapy-sparing strategy for TN remains to be systematically evaluated. This study aims to evaluate the short-term effectiveness and safety of an EA regimen for TN, and to examine changes in exploratory neuro-immune biomarkers, including IL-6 and 5-HT, related to pain and affective symptoms.
Methods And Analysis:
This is a multicenter, randomized, double-simulation, placebo-controlled trial designed to compare the efficacy of EA plus placebo with sham EA plus carbamazepine (CBZ) for TN. A total of 126 adults with TN, maintained on a stable, low-to-moderate CBZ dose (200-400 mg/day) to control for baseline medication-masking effects, will be randomly allocated to the EA plus placebo group or the sham EA plus CBZ group at a 1:1 ratio. Participants in the EA plus placebo group will receive EA plus placebo for 2 weeks, while those in the sham EA plus CBZ group will receive sham EA plus active CBZ on the same schedule, followed by a 6-week follow-up. The primary outcome will be the proportion of participants achieving a ≥50% reduction in visual analog scale (VAS) score at week 2. Secondary outcomes will include daily pain diary metrics (attack frequency, intensity, rescue medication use), Patient Global Impression of Change, Brief Pain Inventory-Facial, Short-Form McGill Pain Questionnaire, and psychological assessments (Self-Rating Anxiety and Depression Scales). Furthermore, plasma biomarkers (interleukin-6 and serotonin) and safety profiles (hepatic and renal functions) will be evaluated at baseline and week 2. All analyses will be conducted in accordance with the intention-to-treat principle.
Trial Registration:
ClinicalTrials.gov Identifier: NCT06977932 (March 2, 2026).
