Comparison of Pulsed and Thermal Radiofrequency for Trigeminal Neuralgia

Zagazig University

Status: Enrolling

Conditions: Trigeminal Neuralgia

Treatments: Procedure: Pulsed and Thermal Radiofrequency (PRF + TRF); Procedure: Pulsed Radiofrequency (PRF)

Study type: Interventional

Funder types: Other

Identifiers

NCT06684275

PRF-TRF-TN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Pulsed Radiofrequency (PRF)

Experimental group

Description:

Participants in this group will receive pulsed radiofrequency (PRF) treatment targeted to the trigeminal nerve. The procedure will involve a standard PRF protocol.

Treatment:

Procedure: Pulsed Radiofrequency (PRF)

Pulsed and Thermal Radiofrequency (PRF + TRF)

Active Comparator group

Description:

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.

Treatment:

Procedure: Pulsed and Thermal Radiofrequency (PRF + TRF)