Comparing two methods for treating facial pain from trigeminal neuralgia
Comparison of Pulsed and Thermal Radiofrequency for the Treatment of Trigeminal Neuralgia: A Randomized Controlled Trial
This study is testing whether a new combination of treatments for facial pain from trigeminal neuralgia works better than a single treatment to help adults feel less pain and improve their daily life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Zagazig University Government |
| Locations | 1 site (Zagazig, Sharqia Province) |
| Trial ID | NCT06684275 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of Pulsed Radiofrequency (PRF) and a combination of Pulsed and Thermal Radiofrequency (PRF + TRF) in treating adults with Trigeminal Neuralgia (TN). Participants will be randomly assigned to receive either PRF or PRF + TRF treatment targeting the trigeminal nerve. The study will assess pain relief, functional status, and any adverse events over a 12-week follow-up period. The primary outcome will focus on pain reduction measured through established pain scales, while secondary outcomes will evaluate medication consumption and safety profiles.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with a diagnosis of classical trigeminal neuralgia experiencing significant facial pain.
Not a fit: Patients with secondary trigeminal neuralgia or those who have previously undergone surgery or radiofrequency treatment for this condition may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide improved pain relief options for patients suffering from trigeminal neuralgia.
How similar studies have performed: While there have been studies on radiofrequency treatments for trigeminal neuralgia, the specific comparison of PRF versus PRF + TRF is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18-60 years. * Diagnosis of classical trigeminal neuralgia, as per the International Classification of Headache Disorders criteria * Patients experiencing unilateral, episodic facial pain for at least six months with a Numeric Rating Scale (NRS) score greater than 6, despite medical treatment. * Able to provide informed consent. * Agree to follow the study procedures and attend follow-up visits. Exclusion Criteria: * Patients with secondary trigeminal neuralgia (e.g., due to tumors, multiple sclerosis). * Previous surgery or radiofrequency treatment for trigeminal neuralgia. * Pregnant or breastfeeding women. * Known allergies to anesthetics or other agents used in the procedure. * Significant psychiatric disorders that may interfere with pain assessment or study participation. * Coagulopathy or use of anticoagulants that contraindicate the procedure.
Where this trial is running
Zagazig, Sharqia Province
- Zagazig University, Faculty of Medicine — Zagazig, Sharqia Province, Egypt (Recruiting)
Study contacts
- Principal investigator: Ahmed A Bessar, MD, PhD — Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.
- Study coordinator: Ahmed A Bessar, MD, PhD
- Email: Ahmedawadbessar@gmail.com
- Phone: +201000089595
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.