Effectiveness and Safety of High-voltage Pulsed Radiofrequency on Gasserian Ganglion to Treat Patients With Primary Trigeminal Neuralgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 3
- 主要终点
- Effective rate of Primary Trigeminal Neuralgia treatment
研究概览
简要总结
The study is designed to compare the effectiveness and safety of high-voltage Pulsed radiofrequency and nerve block for the treatment of primary Trigeminal Neuralgia patients with ineffective conservative treatment and explore better non-surgical treatment methods for Trigeminal Neuralgia patients.
详细描述
Trigeminal neuralgia (TN) is a paroxysmal, lightning-like, severe pain in the facial area innervated by trigeminal nerve. Patients who have failed to achieve benefits from drug treatment could try to undergo nerve block, a traditional conservative treatment. Pulsed radiofrequency (PRF) is a noninvasive pain intervention technique for the treatment of TN. However, its treatment effectiveness has rarely been reported and remains controversial among scholars. A recent single-center preliminary clinical study showed that high-voltage PRF had significant effectiveness in the treatment of TN. However, whether high-voltage PRF treatment can become an optional treatment for TN patients who have failed to achieve benefits from drug treatment still needs to be confirmed with standardized clinical studies by utilizing conservative nerve block treatment as a control. The study is designed to compare the effectiveness and safety of high-voltage PRF and nerve block for the treatment of primary TN patients with ineffective conservative treatment and explore better non-surgical treatment methods for TN patients.
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
- Double (Participant, Investigator)
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
- •Diagnosis of Primary Trigeminal Neuralgia meets the criteria of the International Classification of Headache Disorders.
- •18-75 years old.
- •Response to drug treatment poorly or unable to tolerate the side effects of drugs.
- •A BNI pain intensity scale score of IV-V.
- •Supposed to undergo neurosurgical intervention according to Trigeminal Neuralgia treatment guidelines.
- •Agree to participate in this trial and have signed the informed consent.
排除标准
- •Abnormal routine blood, liver or kidney functions, abnormal blood biochemistry test, or coagulation disorders.
- •Abnormal electrocardiogram or chest X-ray results.
- •Severe cardiopulmonary dysfunction.
- •Infection at the puncture site.
- •History of mental illness, or history of narcotic drug abuse.
- •Allergy to local anesthetic drugs or steroids.
- •Cannot cooperate with the treatment.
- •History of invasive treatments, such as radiofrequency thermocoagulation, chemical ablation, balloon compression surgery, gamma knife treatment, peripheral denervation or microvascular decompression.
研究组 & 干预措施
PRF Group
This group will undergo 42°C high-voltage pulsed radiofrequency treatment.
干预措施: High-voltage pulsed radiofrequency (Device)
Nerve Block Group
This group will undergo nerve block treatment with steroid and local anesthesia.
干预措施: Nerve block (Drug)
结局指标
主要结局
Effective rate of Primary Trigeminal Neuralgia treatment
时间窗: 1 year after operation
The Barrow Neurological Institute (BNI) pain intensity score will be used to assess pain degree. Pain relief degree will be evaluated as "excellent" (BNI pain score I-II), "good" (BNI pain score III), and "poor" (BNI pain score IV-V). The effective rate=excellent and good pain relief (BNI I - III)/total number of cases \* 100%.
次要结局
- Data regarding patients with a BNI of IV or V who switch to other treatments(1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after operation)
- Adverse events(1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after opeartion)
- The postoperative response rate(1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 2 years after opeartion)
- Patient satisfaction(1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after operation)
- Dosage of adjuvant antiepileptic drugs(1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 1 year and 2 years after operation)
研究者
Fang Luo
vice director of Department of Anesthesiology and Pain Management
Beijing Tiantan Hospital