Effect of Electroacupuncture for Trigeminal Neuralgia: Study Protocol for a Multicenter Randomized Controlled Trial

Area of Science:

• Neurology
• Pain Management
• Integrative Medicine

Background:

• Trigeminal neuralgia (TN) is a debilitating neuropathic pain condition.
• Existing treatments can have significant side effects, necessitating alternative strategies.
• Electroacupuncture (EA) shows promise for chronic pain but needs evaluation for TN.

Purpose of the Study:

• To assess the short-term effectiveness and safety of an electroacupuncture (EA) regimen for trigeminal neuralgia (TN).
• To explore EA's potential as a pharmacotherapy-sparing strategy in TN management.
• To examine changes in neuro-immune biomarkers (IL-6, 5-HT) associated with pain and mood in TN patients.

Main Methods:

• A multicenter, randomized, double-simulation, placebo-controlled trial involving 126 TN patients.
• Comparison of EA plus placebo versus sham EA plus carbamazepine (CBZ) over 2 weeks, with a 6-week follow-up.
• Primary outcome: ≥50% reduction in Visual Analog Scale (VAS) pain score at week 2. Secondary outcomes include pain diaries, quality of life, and psychological assessments.

Main Results:

• Primary outcome data (≥50% VAS reduction at week 2) are pending analysis.
• Secondary outcome data on pain, mood, and quality of life are pending analysis.
• Biomarker and safety data (IL-6, 5-HT, hepatic/renal function) at baseline and week 2 are pending analysis.

Conclusions:

• Study results on the efficacy and safety of EA for TN are not yet available.
• Further analysis is required to determine if EA can serve as a pharmacotherapy-sparing option for TN.
• The study will provide insights into neuro-immune mechanisms underlying TN pain and affective symptoms.