研究疾病:
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偏头痛
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研究疾病代码:
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Target disease:
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magrin
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段:
Study phase:
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其它
Others
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研究目的:
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应用砭石疗法为干预措施,通过客观、科学的临床评价手段,观察砭石治疗在五个访视时间点对肝阳上亢型偏头痛的临床疗效,评价穴位按摩效应的持续性并挖掘其基本规律,对改善肝阳上亢偏头痛患者症状及生活质量的改善作用具有重要的实践意义,并进一步推广了中医适宜技术的发展。
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Objectives of Study:
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Objective and scientific clinical evaluation method was used to observe the clinical efficacy of Bian stone therapy on migraine with hyperactivity of liver Yang at five visiting time points, evaluate the persistence of acupoint massage effect and explore its basic rules. It has important practical significance to improve the symptoms and quality of life of migraine patients with hyperactivity of liver Yang, and further promote the development of acupuncture therapy The development of appropriate technology of traditional Chinese medicine has been expanded.
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药物成份或治疗方案详述:
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试验组:梳形砭板(北京耿乃光物性检测技术研究中心生产)。患者取仰卧位,充分暴露头颈部、小腿配合治疗。腧穴定位参照《腧穴名称与定位》,取穴:印堂、神庭、百会、四神聪、头维、太阳、凤池、行间、复溜等。 操作手法如下:①刮法:用砭板侧棱垂直方向移动,刮擦体表;②点揉法:用砭板的边尖,在体表施以压力并摆动按揉。 操作流程如下:①点揉法,先从印堂向上至神庭3~5次,再至两侧头维再向两侧太阳穴。由内向外,不可逆行,速度宜慢。每穴约2分钟;②点揉百会、2分钟;③从百会刮试到四神聪点揉风池穴2分钟;④刮试太阳-风池连线2分钟;⑤刮头部五经:(梳形砭板的齿边分别刮人头部中间的督脉,两旁的膀胱经、胆经,左右相加,共五条经脉,所以称之为“五经”),采用梳头式刮法,沿督脉、膀胱经和胆经由前向后顺序进行梳头样的操作,力量由轻渐重,约2-3分钟;⑥点揉行间(手法采用泻法)、复溜(手法采用补法。力量由轻渐重,以患者感觉轻度酸痛即可. 每穴约2分钟。 砭石疗法组均为一周三次,每次为20min,12次为1个疗程,共治疗1个疗程,为期一个月。
对照组:西药治疗,发作时以镇痛、镇静为目的,解热镇痛药、麦角胺咖啡因、安定等,发作间歇时则以预防发作为目的,西比灵是常用药物。西比灵通用名:盐酸氟桂利嗪胶囊,生产厂家:西安杨森制药有限公司,批准文号:国药准字H10930003,药品规格:5mg*20粒,每日10~20mg。 常规护理:偏头痛患者注意室内通风,戒烟酒。注意避风寒,保暖,不要暴晒淋雨,防止诱发致病。保持稳定心情,避免情绪起伏过大。睡眠规律,避免熬夜。少吃可能引发头痛的食物,如乳酪、巧克力、味精、腌制食品等。患者纳入研究后当天予以发放健康教育处方并进行讲解,确保患者掌握其内容,患者入组治疗周期内每周电话或门诊随访,指导患者对于健康教育处方的落实。
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Description for medicine or protocol of treatment in detail:
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Intervention group: the comb type needle plate with the specification of 120mm x 60mm x 10mm (produced by Beijing Geng Naiguang physical property testing technology research center) was used. Patients with supine position, fully exposed head and neck, leg with treatment. Acupuncture points: Yintang, Shenting, Baihui, Sishencong, Touwei, Sun, Fengchi, Xingjian, Fuliu, etc.
Control group: Western medicine is used for analgesia and sedation in the attack, antipyretic analgesics, ergotamine, caffeine, diazepam, etc., and for prevention in the intermission. Sibelium is a commonly used drug.
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纳入标准:
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1.符合偏头痛的西医诊断标准以及肝阳上亢偏头痛中医诊断标准;
2.年龄在18~65岁之间;
3.神志清楚,能配合中医适宜技术;
4.签署知情同意书者;
5.无严重心、肝、肾疾病,无其他重要脏器器质性病变,能配合检查及治疗患者。
6.能够完成基线期头痛日记。
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Inclusion criteria
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1. Meet the western medicine diagnostic criteria for migraine and TCM diagnostic criteria for migraine with hyperactivity of liver Yang;
2. Aged 18 to 65 years;
3. Clear mind, able to cooperate with the appropriate technology of traditional Chinese medicine;
4. Signed informed consent;
5. No severe gravity, liver and kidney diseases, no other important organ organic lesions, able to cooperate with the examination and treatment of patients;
6. Be able to complete the baseline headache diary.
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排除标准:
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1. 患有相对严重心、肝、肾、血液系统疾病,癌症、精神系统疾病患者;
2. 怀孕、哺乳或在研究中可能怀孕不能采取有效措施的妇女;
3. 操作部位有伤口、感染等操作禁忌症者;
4. 出血倾向性疾病者;
5. 正在参加其他临床试验者;
6. 其他器质性疾病,如蛛网膜下腔出血、脑梗塞、脑出血、高血压等疾病引起的头痛者;
7. 体内留有任何金属物品者。
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Exclusion criteria:
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1. Patients with relatively serious heart, liver, kidney and blood system diseases, cancer and mental system diseases;
2. Pregnant, lactating or pregnant women who may not be able to take effective measures in the study;
3. Operation contraindications such as wound and infection at operation site;
4. Bleeding tendency diseases;
5. Patients participating in other clinical trials;
6. Other organic diseases, such as Headache caused by subarachnoid hemorrhage, cerebral infarction, cerebral hemorrhage, hypertension and other diseases;
7. Any metal objects left in the body.
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研究实施时间:
Study execute time:
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从From
2018-09-01
至To
2019-08-31
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征募观察对象时间:
Recruiting time:
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从From
2018-09-01
至To
1990-01-01
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