Fluoroscopic-Guided Bipolar Versus Monopolar Pulsed Radiofrequency for Refractory Trigeminal Neuralgia
Launched by ALEXANDRIA UNIVERSITY · Jan 13, 2025
Trial Information
Current as of July 23, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at two types of treatments for a condition called trigeminal neuralgia, which causes severe facial pain. The researchers want to compare the effectiveness of two methods of radiofrequency ablation: one using a bipolar approach and the other using a monopolar approach. This study is specifically for patients who have not found relief from their pain through medications and have been experiencing this pain for more than three months.
To be eligible for the trial, participants must have a confirmed diagnosis of classical trigeminal neuralgia and their pain must be severe enough that it has not improved with standard treatments. Patients with certain types of facial pain or those who have had previous surgeries that might affect the treatment are not eligible. If you decide to participate, you will have the opportunity to receive one of the two treatments being studied, and the goal is to find out which method helps reduce pain better for people suffering from this challenging condition.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Patients with a definitive diagnosis of classical TN based on the third version of the International Classification of Headache Disorders (ICHD-3).
- • 2. Either purely paroxysmal classical TN or classical TN with concomitant chronic pain.
- • 3. Patients with idiopathic TN, with symptomatic clinical topography of V2 and/or V3.
- • 4. Patients with brain magnetic resonance imaging (MRI) unremarkable for structural etiology for the trigeminal pain.
- • 5. 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:
- • 1. Painful trigeminal neuropathy based on the third version of the International Classification of Headache Disorders (ICHD-3).
- • 2. Trigeminal neuralgia with V1 symptomatic clinical topography.
- • 3. Trigeminal neuralgia comorbid with other atypical facial pain disorders.
- • 4. Structural TN e.g., due to vascular compression, posterior fossa tumors, central demyelination, ...etc.
- • 5. Patients exposed to previous radiofrequency procedures, as this may impair the nerve response to current PRF.
- • 6. Patients who refused to participate in the study.
About Alexandria University
Alexandria University, a leading academic institution in Egypt, is dedicated to advancing medical research and improving healthcare outcomes through innovative clinical trials. With a strong emphasis on collaboration and interdisciplinary approaches, the university leverages its extensive resources and expertise to conduct rigorous studies that address pressing health challenges. By fostering partnerships with healthcare professionals, industry leaders, and regulatory bodies, Alexandria University aims to contribute to the global body of medical knowledge and enhance the quality of patient care through evidence-based findings.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Alexandria, , Egypt
Cairo, , Egypt
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported