The Efficacy and Safety of Sphenopalatine Ganglion Pulsed Radiofrequency Treatment for Chronic Cluster Headache
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- The mean attack frequency in the last 4 weeks (week 8-12) after procedure
研究概览
简要总结
Cluster headache (CH) is a devastating disorder characterized by ipsilateral headache and associated trigeminal autonomic symptoms, with a yearly prevalence of 0.1%. There is a huge clinically unmet demand for an effective therapeutic method for CH. Previous evidences indicate that pulse radiofrequency (PRF) targeting the sphenopalatine ganglion (SPG) is a safe, minimally invasive, effective treatment for CH. This randomized, controlled trial aimed to establish the safety and efficacy of SPG PRF for patients with chronic CH.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic cluster headache;
- •At least four attacks per week;
- •Minimum age of 18 years;
- •Non-response to verapamil and lithium treatment in the past, intolerance, or contraindication to verapamil and lithium, along with non-response, intolerance, or contraindica-tion to topiramate, or gabapentin.
排除标准
- •Pregnancy or breastfeeding;
- •Presence of cardiac pacemaker or other neuromodulatory devices;
- •Pyschiatric and cognitive disorders;
- •Serious drug habituation or overuse of acute-headache medication;
- •History of stroke or intracranial aneurysm, or at risk for serious or acute cardiovascular events;
- •Infection at the puncture site;
- •Previous history of invasive treatments such as sphenopalatine ganglion radiofrequency thermocoagulation and chemical destruction.
结局指标
主要结局
The mean attack frequency in the last 4 weeks (week 8-12) after procedure
时间窗: In the last 4 weeks (week 8-12) after procedure
The overall mean change from baseline in mean weekly attack frequency
次要结局
- Mean attack frequency(From baseline to each 4-week interval through 1 year after procedure)
- 50% reduction of mean attack frequency(From baseline to each 4-week interval through 1 year after procedure)
- 30% reduction of mean attack frequency(From baseline to each 4-week interval through 1 year after procedure)
- Patient Global Impression of Improvement(At month 1, month 2, month 3, month 6, and month 12 after procedure)
- Patient satisfaction scores(At month 1, month 2, month 3, month 6, and month 12 after procedure)
- Mean attack intensity(From baseline to each 4-week interval through 1 year after procedure)
- The incidence of perioperative adverse events(Across 1 year after procedure)
研究者
Fang Luo
Director of Department of Pain Management
Beijing Tiantan Hospital