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

Phase 4

Conditions: Health Condition 1: G500- Trigeminal neuralgia

Registration Number: CTRI/2019/03/018165

Lead Sponsor: ESI Institute of Pain Management

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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