CT-guided vs Fluoroscopy-guided Trigeminal Ganglion Radiofrequency Thermocoagulation for Idiopathic 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
- 2
- 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 and safety of CT-guided versus fluoroscopy-guided trigeminal ganglion radiofrequency thermocoagulation (TG-RFT) in treating idiopathic trigeminal neuralgia (TN) in adults aged 18 and older.
The main questions it aims to answer are:
- Does CT-guided TG-RFT provide better pain relief compared to fluoroscopy-guided TG-RFT?
- What are the differences in medication consumption between the two methods?
- What are the procedure-related adverse events for both methods?
Investigators will compare CT-guided TG-RFT to fluoroscopy-guided TG-RFT to see if one method is superior in treating idiopathic TN.
Participants will:
- Undergo either CT-guided or fluoroscopy-guided TG-RFT procedure
- Be monitored post-procedure and followed up at 1, 3, and 6 months for pain relief, medication consumption, and adverse events.
详细描述
This randomized controlled trial aims to compare the efficacy and safety of CT-guided versus fluoroscopy-guided trigeminal ganglion radiofrequency thermocoagulation (TG-RFT) in patients with idiopathic trigeminal neuralgia (TN). Idiopathic TN is characterized by severe, recurrent facial pain, and radiofrequency thermocoagulation is a common interventional treatment option.
Participants eligible for this study will be adults over 18 years old, diagnosed with idiopathic TN based on the International Headache Society criteria, experiencing pain for at least six months with a numeric rating scale (NRS) score greater than 6 despite medical treatment.
Exclusion criteria include vascular compression of the trigeminal nerve by MRI, secondary causes such as multiple sclerosis, trigeminal autonomic cephalalgias, dental or temporomandibular joint pathologies, previous interventional procedures or surgery for TN, coagulopathy, use of antiaggregants and anticoagulants, cardiac pacemaker, renal-hepatic insufficiency, psychiatric illness, malignancy, or infection at the injection site or systemic infection.
Participants will be randomly assigned to either the CT-guided or fluoroscopy-guided RFT group using a computer-generated randomization list. Both procedures will be performed under aseptic conditions with appropriate monitoring and anesthesia. The CT-guided RFT will use real-time CT imaging for needle placement and monitoring, while the fluoroscopy-guided RFT will use fluoroscopic imaging.
The primary outcome measure is pain relief, assessed at 1-, 3-, and 6-months post-procedure using the Numeric Rating Scale (NRS) and Visual Analog Scale (VAS). Secondary outcomes include changes in medication consumption assessed by the Medication Quantification Scale III (MQS III) and the recording of procedure-related adverse events.
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
- •Age >18 years
- •Idiopathic trigeminal neuralgia (TN) based on the International Headache Society criteria
- •Pain for at least six months and a 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
- •Vascular compression of the trigeminal nerve by MRI and MRI angiography and the presence of secondary causes such as multiple sclerosis
- •Trigeminal autonomic cephalalgias accompanied by autonomic symptoms
- •Dental or temporomandibular joint pathologies
- •Previous interventional procedures or surgery for TN
- •Coagulopathy or use of antiaggregants and anticoagulants
- •Cardiac pacemaker
- •Renal-hepatic insufficiency
- •Diagnosis of psychiatric illness
- •Malignancy
- •Injection site or systemic infection
- •Current participation in another clinical trial that could interfere with the outcomes of this study.
结局指标
主要结局
Pain Relief - Numeric Rating Scale (NRS)
时间窗: Baseline, immediately post-procedure, 1 month, 3 months, and 6 months post-procedure.
The primary outcome measure will be the level of pain relief, as assessed by the Numeric Rating Scale (NRS), a 0-10 scale where 0 represents "no pain" and 10 represents "worst possible pain.". Pain levels will be recorded at baseline (pre-procedure), immediately post-procedure, and at 1-, 3-, and 6-months post-procedure.
Pain Relief - Visual Analog Scale (VAS)
时间窗: Baseline, immediately post-procedure, 1 month, 3 months, and 6 months post-procedure.
Additionally, pain relief will be assessed by 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 the same time points: baseline, immediately post-procedure, and at 1-, 3-, and 6-months post-procedure.
次要结局
- Medication Consumption(6 months post-procedure)
- Procedure-related Adverse Events(Immediately post-procedure, 1 month, 3 months, and 6 months post-procedure)
研究者
Ahmed Awad Bessar
Assistant Professor of Diagnostic and Interventional Radiology
Zagazig University