A Prospective, Randomized, Controlled, Blinded-endpoint Study to Evaluate the Efficacy and Safety of Stellate Ganglion Block for CM Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- the change from baseline in mean monthly migraine days
研究概览
简要总结
To assess the 6-months effects and safety of stellate ganglion block(SGB) for Chronic Migraine (CM) patients who failure to undergo preventive therapy and are seeking a more suitable non-pharmacological therapy.
详细描述
The investigators aim to investigate whether the stellate ganglion block(SGB) is better than traditional medication treatment and provides medical evidence for the clinical application and promotion of SGB to provide a minimally invasive, safe, and effective treatment for patients with chronic migraine(CM) who failed to receive standardized drug 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
Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 65 years;
- •Diagnosed with CM according to the International Classification of Headache Disorders, 3rd (ICHD-3) criteria [Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38:1-211].
- •not received prior prophylactic migraine treatment or, due to lack of efficacy or tolerability, had failed or had not been suitable for up to three previous prophylactic treatments from the following: Metoprolol/propranolol, amitriptyline, and flunarizine.
排除标准
- •BMI <15 kg/m2 or >35 kg/m2；
- •Previous SGB treatment；
- •History of other neurological disorders；
- •History of severe cardiopulmonary, hepatic or renal dysfunction；
- •History of allergies to any of the study drugs；
- •Patients with chronic use of opioids；
- •Preoperative coagulation abnormalities (activated partial thromboplastin time greater than 1.5 time normal value)；
- •Infection or mass near the puncture site；
- •Neck anatomic structural changes (caused by radiotherapy or surgery);
- •Pregnant or breast feeding;
- •Psychological disorders;
- •Refusal to sign informed consent.
研究组 & 干预措施
Stellate Ganglion Block plus standardized drug treatment group
Besides orally topiramate plus ibuprofen as standardized drug treatment, patients will also receive SGBs plus standardized drug therapy; SGB will be performed once a week for 4 consecutive times in an individual series. The interval of each separate SGB procedure is 1 week. Every time patients with bilateral headache will be administered SGB alternately on each side at an interval of 40 min, and patients with unilateral headache will be administered SGB on the ipsilateral side;
干预措施: Stellate Ganglion Block (SGB) (Procedure)
Stellate Ganglion Block plus standardized drug treatment group
Besides orally topiramate plus ibuprofen as standardized drug treatment, patients will also receive SGBs plus standardized drug therapy; SGB will be performed once a week for 4 consecutive times in an individual series. The interval of each separate SGB procedure is 1 week. Every time patients with bilateral headache will be administered SGB alternately on each side at an interval of 40 min, and patients with unilateral headache will be administered SGB on the ipsilateral side;
干预措施: standardized drug treatment (Drug)
standardized drug treatment group
The patients will only receive Topiramate plus ibuprofen as standardized drug treatment according to the guidelines for the treatment of CM.
干预措施: standardized drug treatment (Drug)
结局指标
主要结局
the change from baseline in mean monthly migraine days
时间窗: 6-month period
The primary outcome is the change from baseline in mean monthly (defined as 4 weeks) migraine days across 6-months follow-up period, which will be assessed by a blinded independent central review (BICR). Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. A migraine day is defined as a calendar day with symptoms of a migraine attack lasting at least 30 min.
次要结局
- Proportion of patients achieved≥50% reduction in monthly migraine days(1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery)
- The Pittsburgh Sleep Quality Index (PSQI)(at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery)
- The six item headache impact test (HIT-6)(at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery)
- adverse events(at 0 day , 1 week, 2 week, 3 week, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery)
- Total effective rate(1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery)
- The mean Numeric Rating Scale(NRS) score during headache attack(at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery)
- the Migraine Disability Assessment score(MIDAS)(at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery)
- Patients satisfaction (PS)(1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery)
研究者
Fang Luo
Director of Department of Day surgery and Pain Management
Beijing Tiantan Hospital