Idiopathic Trigeminal Neuralgia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGIntervention：Drug: Carbamazepine
ArmA Dosage：Initial dose 200 mg daily, titrated gradually to maximum 600 mg daily, divided into 2-3 times per day for 12 weeks.
DRUGIntervention：Drug: Carbamazepine + Acyclovir
ArmB Dosage：Carbamazepine 200-600 mg/d; Acyclovir 800 mg three times daily for 12 weeks.
DRUGIntervention：Drug: Carbamazepine + Celecoxib
Dosage：Carbamazepine 200-600 mg/d; Celecoxib 200 mg twice daily for 12 weeks.
Sponsors
Beijing Tiantan Hospital
Beijing Sanbo Brain Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with idiopathic trigeminal neuralgia according to standard clinical criteria. 2. No secondary etiology confirmed by cranial imaging. 3. No severe systemic disease or immune system disease. 4. Voluntary participation and signed informed consent.
Exclusion criteria
1. Secondary trigeminal neuralgia of any cause. 2. Active herpes zoster infection recently. 3. Severe hepatic or renal insufficiency or contraindications to study drugs. 4. Unable to complete questionnaire evaluation independently. 5. Pregnancy or lactation state. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Visual Analogue Scale (VAS) Pain Score | Baseline, 1 week, 2 weeks, 1 month, 3 months after treatment | Pain intensity is evaluated by VAS score. Effective pain relief is defined as a reduction of ≥50% from baseline VAS score. |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life (SF-36) Score | 1 week, 2 weeks, 1 month, 3 months |
| Anxiety and Depression Score (HADS) | 1 week, 2 weeks, 1 month, 3 months |
| Average Daily Carbamazepine Consumption | 1 week, 2 weeks, 1 month, 3 months |
| Adverse Event Incidence | Throughout 12-week treatment and follow-up period |
Contacts
CONTACTTianying Li tyli, doctor
Outcome results
None listed