Comparing two types of radiofrequency treatments for trigeminal neuralgia pain
The Efficacy and Safety of Fluoroscopic-Guided Bipolar Versus Monopolar Pulsed Radiofrequency for Refractory Trigeminal Neuralgia: An Exploratory Study
This study is testing which type of radiofrequency treatment, bipolar or monopolar, works better for relieving pain in people with trigeminal neuralgia who haven't found relief from other medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Sex | All |
| Sponsor | Alexandria University Academic / other |
| Locations | 2 sites (Alexandria and 1 other locations) |
| Trial ID | NCT06779578 on ClinicalTrials.gov |
What this trial studies
This prospective exploratory study aims to compare the effectiveness of bipolar versus monopolar pulsed radiofrequency ablation in patients suffering from medically refractory trigeminal neuralgia. Participants will be randomly assigned to one of the two treatment groups, and their pain levels will be assessed at multiple intervals post-treatment using a nominal rating scale. The study will also evaluate patient satisfaction and monitor any complications that arise during or after the procedure. Data on sociodemographic factors and clinical history will be collected to better understand the patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with classical trigeminal neuralgia who have not responded adequately to medical treatments.
Not a fit: Patients with trigeminal neuralgia caused by structural issues or those with atypical facial pain disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with refractory trigeminal neuralgia, potentially leading to significant pain relief.
How similar studies have performed: Other studies have shown promising results with radiofrequency ablation techniques for trigeminal neuralgia, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Alexandria and 1 other locations
- Alexandria University Faculty of Medicine — Alexandria, Egypt (Recruiting)
- Cairo University Kasr Alainy Faculty of Medicine — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Eman Hamdy, PhD
- Email: eman.ameen@alexmed.edu.eg
- Phone: +201061402092
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.