Comparison of Pulsed and Thermal Radiofrequency for Trigeminal Neuralgia

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.
• Процедура 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.

Первичные конечные точки

• Pain Relief - Numeric Rating Scale (NRS) [Срок оценки: Baseline, 1 week, 4 weeks, and 12 weeks post-procedure]
• Pain Relief - Visual Analog Scale (VAS) [Срок оценки: Baseline, 1 week, 4 weeks, and 12 weeks post-procedure]

Вторичные конечные точки (2)

• Medication Consumption [Срок оценки: 12 weeks post-procedure]
• Procedure-Related Adverse Events [Срок оценки: Immediately post-procedure, 1 week, 4 weeks, and 12 weeks post-procedure]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Zagazig University, Faculty of Medicine — Zagazig

Идентификаторы

NCT: NCT06684275 · PRF-TRF-TN

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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