RecruitingNot ApplicableNCT06779578
Fluoroscopic-Guided Bipolar Versus Monopolar Pulsed Radiofrequency for Refractory Trigeminal Neuralgia
The Efficacy and Safety of Fluoroscopic-Guided Bipolar Versus Monopolar Pulsed Radiofrequency for Refractory Trigeminal Neuralgia: An Exploratory Study
Sponsor
Alexandria University
Enrollment
20 participants
Start Date
Jan 1, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
A prospective exploratory study aiming at comparing pulsed bipolar versus pulsed unipolar radiofrequency ablation in patients with medically refractory trigeminal neuralgia.
Eligibility
Inclusion Criteria5
- 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.
- Patients with medically refractory TN defined as pain persisting beyond three months at a level of ≥5/10 after monotherapy or polytherapy in appropriate medical doses.
Exclusion Criteria6
- 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.
- Patients exposed to previous radiofrequency procedures, as this may impair the nerve response to current PRF.
- Patients who refused to participate in the study.
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Interventions
PROCEDUREBipolar pulsed radiofrequency
Bipolar pulsed radiofrequency ablation: the active comparator
PROCEDUREMopolar pulsed radiofrequency
Monopolar pulsed radiofrequency ablation: the placebo
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06779578
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