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Thermal radiofrequency ablation of trigeminal nerve for treatment of electric like shooting pain along the distribution of that nerve

Effect of conventional radiofrequency in trigeminal neuralgia: A prospective study - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/03/018165
Enrollment
30
Registered
2019-03-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G500- Trigeminal neuralgia

Interventions

Intervention1: Thermal Radiofrequency of Trigeminal nerve: 22G radiofrequency needle of 10 cm length, with 5 mm of active tip â?? needle will be introduced in foramen ovale under fluoroscopic guidance

Sponsors

ESI Institute of Pain Management
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Classical Trigeminal Neuralgia according to ICHD-3 criteria for more than 6 months. 2. Failed medical management. (Optimum medical management tried at least for 3 months, or side effects of medications are unbearable). 3. Pain in Numeric Rating Scale (NRS) score of more than 7/10 with a poor quality of life. 4. No organic disease on brain MRI and MR angiography and no involvement of any artery and vein.

Exclusion criteria

Exclusion criteria: 1. Patient is unwilling to undergo procedure 2. Bleeding disorders 3. Patients on regular anticoagulants 4. Local infection 5. Sepsis 6. Uncontrolled hypertension (Blood pressure > 170/100 mm of Hg) 7. Uncontrolled diabetes mellitus 8. Unstable cardiovascular status 9. Psychiatric disorder 10. Intracranial benign/ malignant space occupying lesion (SOL) 11. Multiple sclerosis 12. Patients previously underwent surgical treatment (microvascular decompression, gamma knife radiosurgery, balloon decompression, other invasive procedures.) 13. Oro-maxillofacial diseases, tumours, congenital malformations.

Design outcomes

Primary

MeasureTime frame
Pain in Numeric Rating ScoreTimepoint: Before RF and after 7 days, 1 month, 6 months, 12 months, 36 months of intervention

Secondary

MeasureTime frame
Analgesic dose requirementTimepoint: Before RF and after 7 days, 1 month, 6 months, 12 months, 36 months of intervention;Baclofen doseTimepoint: Before RF and after 7 days, 1 month, 6 months, 12 months, 36 months of intervention;BNI Pain ScoreTimepoint: Before RF and after 7 days, 1 month, 6 months, 12 months, 36 months of intervention;Carbamazepine doseTimepoint: Before RF and after 7 days, 1 month, 6 months, 12 months, 36 months of intervention;Gabapentin/ Pregabalin doseTimepoint: Before RF and after 7 days, 1 month, 6 months, 12 months, 36 months of intervention;SF 36 Quality of Life ScoreTimepoint: Before RF and after 7 days, 1 month, 6 months, 12 months, 36 months of intervention

Countries

India

Contacts

Public ContactSubrata Goswami

ESI Institute of Pain Management

drsgoswami@gmail.com09830430430

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026