Efficacy and Safety of Stellate Ganglion Block With Lidocaine Combined Platelet-rich Plasma to Treat Chronic Migraine: a Protocol of a Multi-center, Prospective, Propensity Score-matched, Cohort Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- the change from baseline in mean headache days across the 1-month follow-up period.
研究概览
简要总结
This is a multicenter, prospective, observational, propensity score matching, cohort, and assessor-blinded study designed to compare the effectiveness and safety of lidocaine combined Platelet-rich plasma (PRP) acting on SGB versus lidocaine alone acting on SGB in patients with CM.
详细描述
Chronic migraine (CM) is a disabling disease that causes serious physical and emotional consequences. Previous studies had suggested the efficacy of stellate ganglion block (SGB) with lidocaine in the treatment of CM. However, the side effects related to repeated procedures limit its applications. Platelet-rich plasma (PRP) as an intervention treatment for chronic pain, has shown promising results to alleviate headache within the distribution range of the greater occipital nerve after trauma. So far, there has not been any report on PRP combined with lidocaine acting on SGB for CM. the investigators will conduct this multicenter, prospective, observational, propensity score matching, cohort, and assessor-blinded study to evaluate the efficacy and safety of lidocaine combined PRP acting on SGB versus lidocaine alone acting on SGB in patients with CM
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age between 18 to 75 years;
- •BMI between 15 and 35 kg/m2 ;
- •Diagnosed with CM in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD-3) criteria (Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211);
- •Visual Analogue Scale (VAS; range, 0-10; 0 = no pain and 10 = worst possible pain; higher scores indicate more severe pain) score≥4;
- •Scheduled for lidocaine acting on SGB treatment for CM；
- •Signed informed consent.
排除标准
- •Previously received SGB treatment;
- •Combined with other types of headaches;
- •Platelet count <105*109/L, use of anticoagulants or antiplatelet agent, coagulation disorders or bleeding disorders;
- •Infection or mass near the puncture site;
- •A history of other neurological disorders;
- •A history of severe cardiopulmonary, hepatic or renal dysfunction;
- •A history of psychological disorders;
- •A history of narcotic drug abuse;
- •Changes in neck anatomic structure caused by radiotherapy or surgery;
- •A history of allergies to any research drugs;
- •Pregnancy or lactation period.
研究组 & 干预措施
PRP+Lidocaine group
Patients will be placed in the supine position, with slightly excessive neck extension to receive stellate ganglion block (SGB). And 2.5 ml of PRP combined with 2.5 ml of 1.0% lidocaine will be injected slowly into the ipsilateral stellate ganglion under the guide of ultrasound visualization technology
干预措施: No interventions (Other)
Lidocaine group
Patients will be placed in the supine position, with slightly excessive neck extension to receive stellate ganglion block (SGB). And 5 ml of 1.0% lidocaine will be injected slowly into the ipsilateral stellate ganglion under the guide of ultrasound visualization technology
干预措施: Not have interventions (Other)
结局指标
主要结局
the change from baseline in mean headache days across the 1-month follow-up period.
时间窗: 1-month period
the change from baseline in mean headache days across the 1-month follow-up period.
次要结局
- 50% responder rate(at weeks 4, 8, 12.)
- Analgesic consumption(at baseline and weeks 4, 8, 12.)
- Mean VAS score during headache attack(at baseline and weeks 4, 8, 12.)
- Patient satisfaction (PS) scores(at weeks 4, 8, 12.)
- Headache impact test version 6 (HIT-6)(at baseline and weeks 4, 8,12.)
- Migraine disability assessment (MIDAS) scores(at baseline and weeks 4, 8, 12.)
- Hospital anxiety and depression scale (HADS) scores(at baseline and weeks 4, 8, 12.)
- Pittsburgh sleep quality index (PSQI) scores(at baseline and weeks 4, 8, 12)
- Adverse events(at day 0, 1, weeks 1, 4, 8, 12)
研究者
Fang Luo
Director of Department of pain management
Beijing Tiantan Hospital