Health Condition 1: G500- Trigeminal neuralgia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: a) Patients of classical and idiopathic trigeminal neuralgia on continuous stable maintenance carbamazepine therapy for 4 weeks. b) 18-80 years of age
Exclusion criteria
Exclusion criteria: a) History of intervention for TN treatment within one year (Radiofrequency ablation/ neurolytic injections/ balloon compression) b) Patients taking drugs other than carbamazepine for TN c) Patients on any prior supplemental antioxidant therapy in the previous 3 months d) Patients of trigeminal neuropathy due to space occupying lesions e) Pregnant or lactating patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numerical Rating Scale (NRS) pain scoreTimepoint: Numerical Rating Scale (NRS) pain score at 2 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serial NRS pain scores at 2 weeks, 1 month, 3 months, & 4 months & change from the baseline The number of patient achieving 50% pain relief at 2 weeks, 1 month, 3 months, & 4 monthsNRS pain score Oxidative stress marker level Quality of life by EQ-5D-5L score Changes in carbamazepine dose Rescue analgesic requirementTimepoint: NRS pain scores & change at 2 weeks, 1 month, 3 months, & 4 months Oxidative stress marker levels at 2 months EQ-5D-5L scores at 2 weeks, 1 month, 2months, 3 months, & 4 months Rescue analgesic requirement at 2 weeks, 1 month, 2 months, 3 months, & 4 months Changes in carbamazepine dose at 2 weeks, 1 month, 2 months, 3 months, & 4 months | — |
Countries
India
Contacts
AIIMS, New Delhi