Recurrence of Trigeminal Neuralgia in Patient's Undergoing Radiofrequency Ablation

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.

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Key information

Conditions

Trigeminal Neuralgia, Idiopathic Cranial Nerve Diseases Disease Attributes Facial Nerve Diseases Facial Neuralgia Mouth Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Stomatognathic Diseases Trigeminal Nerve Diseases Trigeminal Neuralgia

Age range

27 year–91 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Recurrence rate of trigeminal neuralgia after stereotactic rhizotomy

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Shifa Clinical Research Center

Other

Registry information

Official study 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.

Important dates

Study start: 2016
Primary completion: 2021
Study completion: 2021
First posted: Nov 1, 2021
Registry last updated: Nov 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed