Comparing two types of radiofrequency treatments for trigeminal neuralgia pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.