This is a multicenter, prospective, randomized, controlled trial. A total of 165 patients with idiopathic trigeminal neuralgia will be enrolled and randomly divided into three groups at a 1:1:1 ratio. The aim is to compare the efficacy and safety of conventional carbamazepine monotherapy, carbamazepine combined with oral antiviral therapy, and carbamazepine combined with anti-inflammatory therapy in pain relief, quality of life improvement and adverse event profiles.
Idiopathic trigeminal neuralgia is a severe neuropathic pain disorder. Carbamazepine is the first-line conventional treatment, but some patients have insufficient pain relief or intolerable side effects. Viral latent infection and neuroinflammation are considered potential pathogenesis of trigeminal neuralgia. This study intends to explore whether adding oral antiviral agent (acyclovir) or non-steroidal anti-inflammatory drug (celecoxib) can further improve pain control, reduce carbamazepine consumption, improve mood status and quality of life, and ensure clinical safety. All participants will receive 12-week standardized treatment and follow-up at 1 week, 2 weeks, 1 month, 3 months and 6 months after enrollment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
165
ArmA Dosage:Initial dose 200 mg daily, titrated gradually to maximum 600 mg daily, divided into 2-3 times per day for 12 weeks.
ArmB Dosage:Carbamazepine 200-600 mg/d; Acyclovir 800 mg three times daily for 12 weeks.
Dosage:Carbamazepine 200-600 mg/d; Celecoxib 200 mg twice daily for 12 weeks.
Changes in Visual Analogue Scale (VAS) Pain Score
Pain intensity is evaluated by VAS score. Effective pain relief is defined as a reduction of ≥50% from baseline VAS score.
Time frame: Baseline, 1 week, 2 weeks, 1 month, 3 months after treatment
Quality of Life (SF-36) Score
Time frame: 1 week, 2 weeks, 1 month, 3 months
Anxiety and Depression Score (HADS)
Time frame: 1 week, 2 weeks, 1 month, 3 months
Average Daily Carbamazepine Consumption
Time frame: 1 week, 2 weeks, 1 month, 3 months
Adverse Event Incidence
Time frame: Throughout 12-week treatment and follow-up period
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