Clinical trial NCT06684275: Comparison of Pulsed and Thermal Radiofrequency for Trigeminal Neuralgia
Official title: Comparison of Pulsed and Thermal Radiofrequency for the Treatment of Trigeminal Neuralgia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Trigeminal Neuralgia
Keywords: Trigeminal Neuralgia
Pulsed Radiofrequency
Thermal Radiofrequency
Neuropathic Pain
Facial Pain
Radiofrequency Ablation
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2024-11-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of the two groups (PRF or PRF + TRF)
Primary purpose: TREATMENT

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Pain Relief - Numeric Rating Scale (NRS)
timeFrame: Baseline, 1 week, 4 weeks, and 12 weeks post-procedure
measure: Pain Relief - Visual Analog Scale (VAS)
timeFrame: Baseline, 1 week, 4 weeks, and 12 weeks post-procedure
Secondary outcomes:
measure: Medication Consumption
timeFrame: 12 weeks post-procedure
measure: Procedure-Related Adverse Events
timeFrame: Immediately post-procedure, 1 week, 4 weeks, and 12 weeks post-procedure
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University, Faculty of Medicine
state: Sharkia
Study officials:
affiliation: Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.
name: Ahmed A Bessar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: