Fluoroscopic-Guided Bipolar Versus Monopolar Pulsed Radiofrequency for Refractory Trigeminal Neuralgia
Recruiting · NCT06779578 · Interventional (participants receive a specific treatment) · Lead sponsor: Alexandria University
View the official record on ClinicalTrials.gov →Interventions studied
Bipolar pulsed radiofrequencyMopolar pulsed radiofrequency
What this trial is about
A prospective exploratory study aiming at comparing pulsed bipolar versus pulsed unipolar radiofrequency ablation in patients with medically refractory trigeminal neuralgia.
Who can take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
2 locations listed.
- Alexandria University Faculty of Medicine - Alexandria, Egypt
- Cairo University Kasr Alainy Faculty of Medicine - Cairo, Egypt