Fluoroscopic-Guided Bipolar Versus Monopolar Pulsed Radiofrequency for Refractory Trigeminal Neuralgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorAlexandria University
About this trial
A prospective exploratory study aiming at comparing pulsed bipolar versus pulsed unipolar radiofrequency ablation in patients with medically refractory trigeminal neuralgia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with a definitive diagnosis of classical TN based on the third version of the International Classification of Headache Disorders (ICHD-3).
Either purely paroxysmal classical TN or classical TN with concomitant chronic pain.
Patients with idiopathic TN, with symptomatic clinical topography of V2 and/or V3.
Patients with brain magnetic resonance imaging (MRI) unremarkable for structural etiology for the trigeminal pain.
Disqualifiers
Painful trigeminal neuropathy based on the third version of the International Classification of Headache Disorders (ICHD-3).
Trigeminal neuralgia with V1 symptomatic clinical topography.
Trigeminal neuralgia comorbid with other atypical facial pain disorders.
Structural TN e.g., due to vascular compression, posterior fossa tumors, central demyelination, …etc.
Trial design
Design model
Parallel
Treatments tested in this trial
Bipolar pulsed radiofrequency
Procedure/SurgeryBipolar pulsed radiofrequency ablation: the active comparator
Mopolar pulsed radiofrequency
Procedure/SurgeryMonopolar pulsed radiofrequency ablation: the placebo
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Monopolar pulsed radiofrequncyPlacebo comparator 1 intervention
Group B: Bipolar pulsed radiofrequencyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Numerical pain scale (NRS)
50% Pain reduction in the numerical rating scale (NRS)
Time frame
Two weeks, 1 month, 3 months, and 6 monthsSecondary outcomes
1
Adverse events monitoring (Frequency, severity, seriousness, and causality)
Frequency, type, and severity of adverse events. Classification of AEs as mild, moderate, or severe. Assessment of causality between the treatment and the AE
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov