Comparison of Pulsed and Thermal Radiofrequency for the Treatment of Trigeminal Neuralgia: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to compare the effectiveness of Pulsed Radiofrequency (PRF) with Pulsed and Thermal Radiofrequency (PRF + TRF) in treating Trigeminal Neuralgia (TN) in adults. The main questions it aims to answer are: * Does PRF or PRF + TRF provide better pain relief for patients with trigeminal neuralgia? * What is the safety profile and complication rate of PRF versus PRF + TRF? Researchers will compare the effects of PRF and PRF + TRF to see if thermal lesioning in addition to pulsed RF provides superior long-term pain relief and reduces the need for analgesic medication. Participants will: * Undergo either PRF or PRF + TRF treatment targeting the trigeminal nerve. * Be assessed for pain relief, functional status, and adverse events over a 3-month follow-up period.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Zagazig University, Faculty of Medicine
RECRUITING
Zagazig
Contact Information
Primary
Ahmed A Bessar, MD, PhD
Ahmedawadbessar@gmail.com
+201000089595
Time Frame
Start Date: 2024-11-10
Estimated Completion Date: 2025-04-10
Participants
Target number of participants: 60
Treatments
Experimental: Pulsed Radiofrequency (PRF)
Participants in this group will receive pulsed radiofrequency (PRF) treatment targeted to the trigeminal nerve. The procedure will involve a standard PRF protocol.
Active_comparator: Pulsed and Thermal Radiofrequency (PRF + TRF)
Participants in this group will receive a combination of pulsed radiofrequency (PRF) and thermal radiofrequency (TRF). The TRF procedure will involve creating a thermal lesion at a target temperature in addition to the standard PRF treatment protocol.
Related Therapeutic Areas
Sponsors
Leads: Zagazig University

This content was sourced from clinicaltrials.gov