Comparison of Pulsed and Thermal Radiofrequency for the Treatment of Trigeminal Neuralgia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain Relief - Numeric Rating Scale (NRS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Given the specific nature of the interventions, it may not be possible to blind participants or operators; however, to minimize potential bias, outcome assessors will be blinded to the treatment assignments.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Pulsed Radiofrequency (PRF) (Procedure)
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.
干预措施: Pulsed and Thermal Radiofrequency (PRF + TRF) (Procedure)
结局指标
主要结局
Pain Relief - Numeric Rating Scale (NRS)
时间窗: Baseline, 1 week, 4 weeks, and 12 weeks post-procedure
The primary outcome measure will be the level of pain relief, assessed using the Numeric Rating Scale (NRS), a scale from 0 to 10, where 0 represents "no pain" and 10 represents "worst possible pain." Pain levels will be recorded at baseline (pre-procedure), and at 1 week, 4 weeks, and 12 weeks post-procedure.
Pain Relief - Visual Analog Scale (VAS)
时间窗: Baseline, 1 week, 4 weeks, and 12 weeks post-procedure
Additionally, pain relief will be assessed using the Visual Analog Scale (VAS), a continuous scale ranging from 0 to 100 mm, where 0 represents "no pain" and 100 represents "worst possible pain." Pain levels will be recorded at baseline, 1 week, 4 weeks, and 12 weeks post-procedure.
次要结局
- Medication Consumption(12 weeks post-procedure)
- Procedure-Related Adverse Events(Immediately post-procedure, 1 week, 4 weeks, and 12 weeks post-procedure)
研究者
Ahmed Awad Bessar
Assistant Professor of Diagnostic and Interventional Radiology
Zagazig University