The Efficacy and Safety of the Application of Pulsed Radiofrequency, Combined With Low-temperature Continuous Radiofrequency, to the Gasserian Ganglion for the Treatment of Primary Trigeminal Neuralgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- The percentage of participants with a modified Barrow Neurological Institute Pain Intensity Score of I-III
研究概览
简要总结
Trigeminal neuralgia is a very painful condition, and radiofrequency therapy is reserved for patients who are resistant or intolerant to pharmacological therapy. Continuous radiofrequency and pulsed radiofrequency both have advantages and disadvantages. Recently, studies have found that pulsed radiofrequency combined with low-temperature (<65 °C) continuous radiofrequency increases the efficacy of the treatment, without leading to a significant increase in complications caused by nerve lesions. However, these reports have some limitations. The investigators plan to conduct a randomized, controlled study to compare the efficacy of applying high-voltage pulsed radiofrequency, with and without low-temperature continuous radiofrequency, to the gasserian ganglion for the treatment of trigeminal neuralgia. The primary outcome will be the effectiveness of the treatment after 12 months which is the percentage of participants with a modified Barrow Neurological Institute Pain Intensity Score between I-III.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with trigeminal neuralgia according to the International Classification of Headache Disorders, 3rd Edition criteria.
- •Aged 18-75 years (inclusive), no sex limitation.
- •Suffering from severe trigeminal neuralgia that cannot be alleviated effectively using conservative medical therapy such as carbamazepine, oxcarbazepine.
- •Numeric rating scale score≥7 before the procedure.
- •Agreed to sign the informed consent form.
排除标准
- •Secondary trigeminal neuralgia such as trigeminal neuralgia attributed to a space-occupying lesion or multiple sclerosis.
- •Infection at the puncture site.
- •A history of psychiatric disease.
- •Disorder indicated in the results of routine blood tests, hepatic function, renal function, coagulation function, electrocardiogram, or chest X-ray.
- •Serious systemic diseases such as uncontrolled hypertension or diabetes, and cardiac dysfunction (II-III of the New York Heart Association classification).
- •A history of abuse of narcotics.
- •A history of receiving continuous radiofrequency to the gasserian ganglion or peripheral branches; glycerol rhizolysis; balloon compression; gamma knife; or any other neuroablative treatments.
- •A history of receiving microvascular decompression.
结局指标
主要结局
The percentage of participants with a modified Barrow Neurological Institute Pain Intensity Score of I-III
时间窗: Twelve months after the procedure
The modified Barrow Neurological Institute Pain Intensity Score (I: No pain, off medications; II: Occasional pain, off medications; IIIa: No pain, continued use of medications; IIIb: Pain persists, but adequately controlled with medications; IV: Pain not adequately controlled with medications; V: No relief) will be used to evaluate the efficacy of the treatment. Twelve months after the procedure, participants with Barrow Neurological Institute scores of I-III will be defined as having received effective treatment. The primary outcome will be the effectiveness of the treatment after 12 months.
次要结局
- The modified Barrow Neurological Institute Pain Intensity Score(On day 1; at 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure)
- Number of participants with adverse reactions(Within two weeks of the procedure)
- Patient satisfaction scores on the 5-point Likert scale(After 1, 6 and 12 months following the procedure)
- Numbness(On day 1; at 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure)
- Numeric rating scale(On day 1; at 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure)
- The World Health Organization Quality of Life (WHOQOL)-BREF(After 1, 6 and 12 months following the procedure)
- Number of participants with anesthesia dolorosa(Within 12 months of the procedure)
- Dose of carbamazepine or oxcarbazepine(On day 1; at 1 and 2 weeks; and after 1, 2, 3, 6, and 12 months following the procedure)
- Number of participants with masticator weakness(Within 12 months of the procedure)
- Number of participants with keratitis(Within 12 months of the procedure)
- Number of participants with corneal anesthesia(Within 12 months of the procedure)
研究者
Fang Luo
Director of Department of Pain Management
Beijing Tiantan Hospital