Recurrence of Trigeminal Neuralgia in Patient's Undergoing Radiofrequency Ablation

Sponsor

Shifa Clinical Research Center (Other)

Overall Status

Completed

CT.gov ID

NCT05101577

Collaborator

(none)

Enrollment

61.6

Actual Duration (Months)

Study Details

Study Description

Brief Summary

This study aims to find recurrence rate of the trigeminal neuralgia after patients undergo stereotactic rhizotomy by radiofrequency ablation at 80 degrees Celsius for 90 seconds under fluoroscopic guidance, a protocol that was modified from the originally described parameters for rhizotomy by John Tew, Chad J. Morgan and Andresw Grande et al. The presumption being that the higher temperature of the probe tip would lead to a more long-lasting lesion and lesser recurrence, but at the cost of more frequent sensory and motor deficits.

Condition or Disease	Intervention/Treatment	Phase
Trigeminal Neuralgia, Idiopathic

Study Design

Study Type:

Observational

Actual Enrollment :

56 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Recurrence Rate of Trigeminal Neuralgia in Patients Treated With Percutaneous Stereotactic Continuous Radiofrequency Rhizotomy at 80 Degrees Celsius for 90 Seconds- a Single Center Study.

Actual Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

Aug 31, 2021

Actual Study Completion Date :

Oct 20, 2021

Outcome Measures

Primary Outcome Measures

Recurrence rate of trigeminal neuralgia after stereotactic rhizotomy [Recurrence within 12 months of the intervention]
Recurrence of pain in the same distribution of the trigeminal nerve branch or branches for which the stereotactic rhizotomy was originally performed
Proportion of patients with neurological deficits after stereotactic rhizotomy [5 years]
locally deviced protocol for stereotactic rhizotomy of the involved trigeminal gangion dictates the use of higher temperature of 80 degree Celsius for 90 seconds, which translates into better pain relief and longer pain free intervals at the cost of higher percentage of sensory and motor deficits

Eligibility Criteria

Criteria

Ages Eligible for Study:

27 Years to 91 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

1. Patients fulfilling ICHD criteria:

Recurrent paroxysms of unilateral facial pain in the distribution(s) of one or more divisions of the trigeminal nerve, with no radiation beyond, and fulfilling criteria B and C

A. Pain has all of the following characteristics:

lasting from a fraction of a second to 2 minutes
severe intensity
electric shock-like, shooting, stabbing or sharp in quality B. Precipitated by innocuous stimuli within the affected trigeminal distribution C. Not better accounted for by another ICHD-3 diagnosis.
Age: Adults of both sexes 3. MRI brain ruled out organic or structural pathologies

Exclusion Criteria:

1. Patient with concomitant co-morbid conditions like brain tumours, vascular pathologies or coagulopathies.

Patients who had previously undergone trigeminal ganglion neurolysis with either alcohol or phenol.
Patients who were lost to follow-up before the completion of 6-month period or had not visited back after the procedure 4. Patients on oral anticoagulants 5. Patients declared high risk or ASA 3 and above for general anaesthesia.