研究疾病:
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慢性偏头痛
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研究疾病代码:
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Target disease:
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chronic migraine
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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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非随机对照试验
Non randomized control
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研究所处阶段:
Study phase:
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探索性研究/预试验
Pilot clinical trial
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研究目的:
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辨经选穴针刺防治慢性偏头痛时间-疗效关系显著,即短期改善头痛症状,长期预防复发,但其内在中枢生物学效应机制至今尚未有明晰的解释。针对上述情况,本项目采用多模态脑核磁共振成像技术,以针刺即时效应与持续效应为切入点,从功能与结构角度,阐释辨经选穴针刺防治偏头痛的中枢效应机制。
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Objectives of Study:
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The relationship between time and curative effect of acupuncture on chronic migraine is significant, that is, short-term improvement of headache symptoms and long-term prevention of recurrence, but the mechanism of its internal central biological effect has not been clearly explained. In view of the above situation, this project adopts the multi-modal brain MRI technology, takes the immediate effect and the sustained effect of acupuncture as the starting point, and explains the central effect mechanism of acupuncture on the prevention and treatment of migraine from the perspective of function and structure.
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药物成份或治疗方案详述:
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本研究计划对慢性偏头痛患者进行辨经选穴针刺干预,而健康受试者则不进行针刺或其他任何方式的干预。
选穴:阿是穴、百会、丝竹空、率谷、太阳、风池,以上均取双侧,根据经络辨证而配伍其他穴位(如表)。以上穴位选自偏头痛非药物防治中国专家共识,且为课题组前期应用的腧穴组合,已经临床验证有效。腧穴定位参照《经穴名称与定位》国家标准,标准编号:GB/T12346-2021。
操作:令患者处于仰卧位或坐位,常规消毒穴位后,选用一次性无菌针灸针(华佗牌,规格:0.25×40mm),刺入皮肤。所有穴位针刺操作及深度参考教材《经络腧穴学》(新世纪第五版,中国中医药出版社,主编 沈学勇、刘存志),通过提插捻转手法得气。得气后行平补平泻手法数次并留针20分钟。针刺操作由具备国家中医师资格的同一针灸医师承担,保证进针、行针手法基本一致。
疗程:每周治疗3次,每次留针20分钟,连续治疗8周。
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Description for medicine or protocol of treatment in detail:
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In this study, patients with chronic migraine will be treated with acupoint acupuncture intervention, while healthy subjects will not be treated with acupuncture or any other intervention.
Select points: A Shi point, Baihui, Sizhu Kong, rate valley, Sun, Fengchi, the above are taken on both sides, according to the meridian differentiation and other points (such as table). The above points were selected from the consensus of Chinese experts on non-drug prevention and treatment of migraine, and were the combination of acupoints applied by the research group in the early stage, which has been clinically validated and effective. Reference is made to the national standard "Name and Location of Meridian Points", standard number: GB/T12346-2021.
Operation: Put the patient in a supine or seated position. After routine disinfection of acupuncture points, select a disposable sterile acupuncture needle (Huatuo brand, size: 0.25×40mm) and prick the skin. All acupoint acupuncture operation and depth reference textbook "Study of meridian and Acupoint" (the fifth edition of the new century, China Traditional Chinese Medicine Publishing House, editor-in-chief Shen Xueyong, Liu Cunzhi), through the lifting, thrusting and twisting techniques to obtain Qi. After obtaining qi, perform leveling, replenishing and purging for several times and leave the needle for 20 minutes. The acupuncture operation is undertaken by the same acupuncturist with the national TCM qualification to ensure that the needles are basically the same.
Course of treatment: 3 times a week, each time keeping the needle for 20 minutes, continuous treatment for 8 weeks.
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纳入标准:
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慢性偏头痛患者必须符合以下所有入选标准才有资格入选研究:
1.符合国际头痛学会头痛分类委员会《国际头痛疾病分类》第3版(ICHD-3)中慢性偏头痛诊断标准;
2.18-60岁,接受教育时间≥6年,右利手;
3.每月头痛发作天数≥15天,每月偏头痛发作频率≥2次,持续3个月以上,其中至少8天具有偏头痛特征;
4.大脑结构基本正常,既往无抑郁症病史、脑血管病史、帕金森氏病史或其他锥体外系疾病史,无其它系统重大疾病史;
5.身体其他部位无明显长期慢性疼痛如慢性腰腿痛、颈痛等;
6.近4周以来未接受过非药物治疗如针刺治疗等,且未服用过具有防治偏头痛作用的药物,如β受体阻断剂、钙通道阻滞剂、抗癫痫药、抗抑郁药和5-HT受体阻断剂等;
7.无MRI检测禁忌;
8.受试者本人签署知情同意书,志愿参加本试验。
健康受试者必须符合以下所有入选标准才有资格入选研究:
1.不符合偏头痛诊断标准;
2.年龄18~45岁,接受教育时间≥6年,右利手;
3.大脑结构基本正常,既往无抑郁症病史、脑血管病史、帕金森氏病史或其他锥体外系疾病史,无其它系统重大疾病史;
4.无MRI检测禁忌;
5.受试者本人签署知情同意书,志愿参加本试验。
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Inclusion criteria
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To be eligible for the study, patients with chronic migraine must meet all of the following inclusion criteria:
1. Meet the diagnostic criteria for chronic migraine in the International Classification of Headache Disorders (ICHD-3) of the Headache Classification Committee of the International Headache Society;
2.18-60 years old, education period ≥6 years, right-handed;
3. The number of headache attacks per month is ≥15 days, the frequency of migraine attacks per month is ≥2 times, lasting for more than 3 months, of which at least 8 days have migraine characteristics;
4. Basically normal brain structure, no previous history of depression, cerebrovascular disease, Parkinson's disease or other extrapyramidal diseases, no history of major diseases of other systems;
5. No obvious long-term chronic pain in other parts of the body, such as chronic waist and leg pain, neck pain, etc.;
6. Have not received non-drug treatment such as acupuncture therapy in the past 4 weeks, and have not taken drugs that have the effect of preventing and treating migraine, such as beta blockers, calcium channel blockers, anti-epileptic drugs, antidepressants and 5-HT receptor blockers;
7. No MRI detection contraindications;
8. The subjects signed the informed consent and volunteered to participate in the experiment.
To be eligible for study, healthy subjects must meet all of the following inclusion criteria:
1. Does not meet the diagnostic criteria for migraine;
2. Age 18-45 years old, education period ≥6 years, right-handed;
3. Basically normal brain structure, no previous history of depression, cerebrovascular disease, Parkinson's disease or other extrapyramidal diseases, no history of major diseases of other systems;
4. No MRI detection contraindications;
5. The subjects signed the informed consent and volunteered to participate in the experiment.
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排除标准:
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1.由器质性疾病引起或其他类型及部位的头痛;
2.焦虑自评量表SAS评分≥50分;
3.在MRI扫描中发现严重头颅解剖结构不对称或有明确病变;
4.酒精或其他成瘾性药物滥用者;
5.不能配合完成本研究者。
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Exclusion criteria:
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1. Headache caused by organic diseases or other types and parts;
2. SAS score ≥50 points on anxiety self-rating scale;
3. Severe anatomical asymmetry or clear lesions were found in MRI scan;
4. Abusers of alcohol or other addictive drugs;
5. Unable to cooperate with the researcher.
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研究实施时间:
Study execute time:
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从From
2024-06-01
至To
2026-06-30
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征募观察对象时间:
Recruiting time:
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从From
2024-08-19
至To
2026-05-31
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