NCT06684275

Comparison of Pulsed and Thermal Radiofrequency for Trigeminal Neuralgia

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Zagazig University · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a randomized controlled trial designed to evaluate the efficacy and safety of Pulsed Radiofrequency (PRF) versus Pulsed and Thermal Radiofrequency (PRF + TRF) for treating Trigeminal Neuralgia (TN). Trigeminal neuralgia is a debilitating chronic pain condition that affects the trigeminal nerve, causing intense facial pain. The study will enroll participants with TN, randomized into two groups: * Group 1 (PRF): Patients will receive pulsed radiofrequency treatment with parameters set to standard levels for pain relief. * Group 2 (PRF + TRF): Patients will receive pulsed radiofrequency combined with thermal lesioning (60-70°C) to target the trigeminal nerve. Both procedures will be performed under aseptic conditions with appropriate monitoring and anesthesia. The primary outcome will be pain reduction measured using the Numeric Rating Scale (NRS) and Visual Analog Scale (VAS) over a 12-week period. Secondary outcomes include changes in medication consumption assessed by the Medication Quantification Scale III (MQS III) and the recording of procedure-related adverse events. Participants will undergo follow-up assessments at Week 1, Week 4, and Week 12 post-treatment.

Conditions

• Trigeminal Neuralgia

Interventions

Type	Name	Description
PROCEDURE	Pulsed Radiofrequency (PRF)	Participants will receive pulsed radiofrequency (PRF) treatment targeting the trigeminal nerve to manage pain associated with trigeminal neuralgia. This non-ablative technique uses electrical pulses to modulate nerve function, aiming to provide pain relief without creating a thermal lesion.
PROCEDURE	Pulsed and Thermal Radiofrequency (PRF + TRF)	Participants will receive a combination of pulsed radiofrequency (PRF) and thermal radiofrequency (TRF) treatments targeting the trigeminal nerve. This approach combines the non-ablative effects of PRF with the thermal lesioning of TRF to provide long-term pain relief for trigeminal neuralgia.

Timeline

• Start date: 2024-11-10
• Primary completion: 2025-03-10
• Completion: 2025-04-10
• First posted: 2024-11-12
• Last updated: 2024-12-31

Locations

1 site across 1 country: Egypt