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Recurrence of Trigeminal Neuralgia in Patient's Undergoing Radiofrequency Ablation

S

Shifa Clinical Research Center

Status

Completed

Conditions

Trigeminal Neuralgia, Idiopathic

Study type

Observational

Funder types

Other

Identifiers

NCT05101577
ShifaCRC

Details and patient eligibility

About

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.

Enrollment

56 patients

Sex

All

Ages

27 to 91 years old

Volunteers

Accepts Healthy Volunteers

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:

  1. lasting from a fraction of a second to 2 minutes

  2. severe intensity

  3. 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.

  4. 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.

    2. Patients who had previously undergone trigeminal ganglion neurolysis with either alcohol or phenol.

    3. 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.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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