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Study on the mechanism and standard of ear acupuncture in treating primary headache and insomnia

注册号：

Registration number：

ITMCTR2200005600

最近更新日期：

Date of Last Refreshed on：

2022-02-04

注册时间：

Date of Registration：

2022-02-04

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

耳针治疗原发性头痛与失眠的机制及规范标准研究

Public title：

Study on the mechanism and standard of ear acupuncture in treating primary headache and insomnia

注册题目简写：

English Acronym：

研究课题的正式科学名称：

耳针治疗原发性头痛与失眠的机制及规范标准研究

Scientific title：

Study on the mechanism and standard of ear acupuncture in treating primary headache and insomnia

研究课题的正式科学名称简写：

Scientific title acronym：

研究课题代号(代码)：

Study subject ID：

ZH19002

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

ChiCTR2200056347 ; ChiMCTR2200005600

申请注册联系人：

孟凡超

研究负责人：

刘若卓

Applicant：

Fanchao Meng

Study leader：

Ruozhuo Liu

申请注册联系人电话：

Applicant telephone：

18946472336

研究负责人电话：

Study leader's telephone：

13611210036

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

mgfanchao@163.com

研究负责人电子邮件：

Study leader's E-mail：

liurz301@163.com

申请单位网址(自愿提供)：

Study leader's website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website
(voluntary supply)：

申请注册联系人通讯地址：

中华人民共和国北京市海淀区复兴路28号

研究负责人通讯地址：

中华人民共和国北京市海淀区复兴路28号

Applicant address：

28 Fuxing Road, Haidian District, Beijing, China

Study leader's address：

28 Fuxing Road, Haidian District, Beijing, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

中国人民解放军总医院第一医学中心

Applicant's institution：

The First Medical Center of the PLA General Hospital

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

伦审S2021-349-02号

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

中国人民解放军总医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of PLA General Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2021/11/1 0:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

中国人民解放军总医院第一医学中心神经内科医学部

Primary sponsor：

The First Medical Center of the PLA General Hospital

研究实施负责（组长）单位地址：

中华人民共和国北京市海淀区复兴路28号

Primary sponsor's address：

28 Fuxing Road, Haidian District, Beijing, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中华人民共和国

省(直辖市)：

北京市

市(区县)：

海淀区

Country：

China

Province：

Beijing

City：

Haidian District

单位(医院)：

中国人民解放军总医院第一医学中心

具体地址：

中华人民共和国北京市海淀区复兴路28号

Institution
hospital：

The First Medical Center of the PLA General Hospital

Address：

28 Fuxing Road, Haidian District, Beijing, China

经费或物资来源：

中国人民解放军总医院

Source(s) of funding：

PLA General Hospital

研究疾病：

原发性头痛与失眠

研究疾病代码：

Target disease：

Primary headache and insomnia

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

单臂

Single arm

研究所处阶段：

Study phase：

探索性研究/预试验

Pilot clinical trial

研究目的：

制定原发性头痛和失眠治疗的标准化耳针标准，并制作标准化耳针。

Objectives of Study：

Develop standardized ear acupuncture for the treatment of primary headache and insomnia, and make standardized ear acupuncture.

药物成份或治疗方案详述：

耳针刺激耳甲区

Description for medicine or protocol of treatment in detail：

We use the ear acupuncture to stimulate the auricular region.

纳入标准：

偏头痛纳入标准： （1）同意参加本临床试验并签署知情同意书的患者 （2）年龄18-65周岁，且首发年龄≤50周岁，符合国际头痛学会分类第三版（ICHD-3）中关于偏头痛的诊断标准 （3）符合（2）条件头痛病史≥1年且头痛发作频率符合3个月内大于2次 （4）进入导入期前3个月，偏头痛发作次数≥2次 （5）受试者能准确识别偏头痛并理解研究说明，能独立完成头痛日记的记录 紧张型头痛纳入标准： （1）同意参加本临床试验并签署知情同意书的患者 （2）年龄18-65周岁，且首发年龄≤50周岁，符合国际头痛学会分类第三版（ICHD-3）中关于紧张型头痛的诊断标准 （3）符合（2）中条件后，头痛病史≥1年且头痛发作频率符合4周内发作大于2次以上 （4）进入导入期前3个月，紧张型头痛发作次数≥2次； （5）受试者能准确识别紧张型头痛并理解研究说明，独立完成头痛日记记录 失眠纳入标准： （1）同意参加本临床试验并签署知情同意书的患者 （2）年龄18-65周岁，且首发年龄≤50周岁，符合国际睡眠障碍分类第三版（ICSD-3）中关于失眠症的诊断标准 （3）进入导入期前3个月，失眠症发作次数≥3次； （4）受试者能准确识别失眠并理解研究者的说明，能独立完成睡眠日记的记录

Inclusion criteria

Inclusion criteria for migraine: (1) Patients who agree to participate in the clinical trial and sign informed consent (2) Patients aged 18-65 with onset age ≤50 met the diagnostic criteria of migraine in the International Headache Society Classification iii (ICHD-3) (2) The history of headache ≥1 year and the frequency of headache ≥ 2 times within 3 months (4) Three months before entering the initiation period, the frequency of migraine attacks ≥2 times (5) Subjects can accurately identify migraine and understand the study instructions, and can independently complete the headache diary Inclusion criteria for tension-type headache: (1) Patients who agree to participate in the clinical trial and sign informed consent (2) 18-65 years of age, with the first episode ≤50 years of age, meeting the diagnostic criteria of tension headache according to the International Headache Society Classification Iii (ICHD-3) (3) After meeting the conditions in (2), headache history ≥1 year and headache attack frequency ≥ 2 times within 4 weeks (4) The frequency of tension-type headache ≥2 times in 3 months before the initiation period; (5) Subjects can accurately identify tension-type headache, understand the study instructions, and independently complete the headache diary Insomnia inclusion criteria: (1) Patients who agree to participate in the clinical trial and sign informed consent (2) 18-65 years of age, with the first episode ≤50 years of age, meeting the diagnostic criteria for insomnia in the International Classification of Sleep Disorders (ICSD-3) (3) Three months before entering the initiation period, the number of insomnia attacks ≥3 times; (4) Subjects can accurately identify insomnia and understand the researcher's instructions, and can independently complete the sleep diary records

排除标准：

如果您是偏头痛患者，请您一定仔细阅读下面文字，以确认您没有下列情况存在： （1）头痛是偏头痛以外的类型； （2）合并有其他类型头痛，包括继发性头痛的患者； （3）血小板减少症、青光眼、周围血管疾病或雷诺综合征的患者； （4）在参与本试验期间和参与前3个月内参与其他临床试验者，包括参与药物疗法和替代疗法（如针灸、推拿、经皮电刺激等）； （5）因整形美容、校正、治疗或外伤等原因进行蝶腭骨神经节区面部手术者； （6）合并肝肾功能损害者：ALT、AST超过正常值上限的1.5倍，Cr超过正常值上限，TBIL超过正常值上限的2倍； （7）合并其他严重的心脑血管疾病、造血系统疾病的患者；恶性肿瘤患者； （8）近期接受过重大手术或外伤等的不宜参加本研究的患者； （9）合并精神分裂症患者、重度抑郁症患者（HAMD量表>24分）、酒精依赖者、药物滥用史者； （10）合并耳部严重疾患的患者； （11）妊娠期、哺乳期妇女及试验期间或服药停止后3个月内计划生育者； （12）过敏体质或既往对多种药物过敏者，或对研究用药中的成分有过敏者； （13）试验前2月内因其他疾病应用过耳针治疗患者； （14）服用止痛药＞10天/月者； （15）试验前1个月内服用过预防性治疗药物者； （16）其他研究者认为不宜参与本研究的患者。 如果您是紧张型头痛患者，请您一定仔细阅读下面文字，以确认您没有下列情况存在： （1）头痛是紧张型头痛以外的类型； （2）合并有其他类型头痛，包括继发性头痛的患者； （3）血小板减少症、青光眼、周围血管疾病或雷诺综合征的患者； （4）在参与本试验期间和参与前3个月内参与其他临床试验者，包括参与药物疗法和替代疗法（如针灸、推拿、经皮电刺激等）； （5）因整形美容、校正、治疗或外伤等原因进行蝶腭骨神经节区面部手术者； （6）合并肝肾功能损害者：ALT、AST超过正常值上限的1.5倍，Cr超过正常值上限，TBIL超过正常值上限的2倍； （7）合并其他严重的心脑血管疾病、造血系统疾病的患者；恶性肿瘤患者； （8）近期接受过重大手术或外伤等的不宜参加本研究的患者； （9）合并精神分裂症患者、重度抑郁症患者（HAMD量表>24分）、酒精依赖者、药物滥用史者； （10）合并耳部严重疾患的患者； （11）妊娠期、哺乳期妇女及试验期间或服药停止后3个月内计划生育者； （12）过敏体质或既往对多种药物过敏者，或对研究用药中的成分有过敏者； （13）试验前2月内因其他疾病应用过耳针治疗患者； （14）服用止痛药＞10天/月者； （15）试验前1个月内服用过预防性治疗药物者； （16）其他研究者认为不宜参与本研究的患者。 如果您是失眠患者，请您一定仔细阅读下面文字，以确认您没有下列情况存在： （1）失眠是急性失眠及慢性失眠以外的类型； （2）合并有其他类型失眠，包括继发性失眠的患者； （3）合并其他的睡眠障碍疾病，如不宁腿综合征、发作性睡病等； （4）在参与本试验期间和参与前3个月内参与其他临床试验者，包括参与药物疗法和替代疗法（如针灸、推拿、经皮电刺激等）； （5）因整形美容、校正、治疗或外伤等原因进行蝶腭骨神经节区面部手术者； （6）合并肝肾功能损害者：ALT、AST超过正常值上限的1.5倍，Cr超过正常值上限，TBIL超过正常值上限的2倍； （7）合并其他严重的心脑血管疾病、造血系统疾病的患者；恶性肿瘤患者； （8）近期接受过重大手术或外伤等的不宜参加本研究的患者； （9）合并精神分裂症患者、重度抑郁症患者（HAMD量表>24分）、重度焦虑症患者、酒精依赖者、药物滥用史者； （10）合并耳部严重疾患的患者； （11）妊娠期、哺乳期妇女及试验期间或服药停止后3个月内计划生育者； （12）过敏体质或既往对多种药物过敏者，或对研究用药中的成分有过敏者； （13）试验前2月内因其他疾病应用过耳针治疗患者； （14）入组前1个月服用睡眠类药物； （15）智力发育异常及痴呆（瑞文推理测验<70）； （16）服用抗精神类的药物； （17）其他研究者认为不宜参与本研究的患者。

Exclusion criteria：

If you suffer from migraines, please read the following carefully to make sure that you do not have any of the following conditions: (1) Headache is a type other than migraine; (2) patients with other types of headache, including secondary headache; (3) patients with thrombocytopenia, glaucoma, peripheral vascular disease or Raynaud's syndrome; (4) Participants in other clinical trials, including pharmacotherapy and alternative therapy (such as acupuncture, massage, percutaneous electrical stimulation, etc.) during the study period and within 3 months prior to the study; (5) patients who underwent facial surgery in the sphenopalatine ganglion region due to plastic surgery, correction, treatment or trauma; (6) Patients with liver and kidney function impairment: ALT and AST were 1.5 times higher than the upper limit of normal value, Cr was more than the upper limit of normal value, and TBIL was more than 2 times higher than the upper limit of normal value; (7) patients complicated with other serious cardiovascular and cerebrovascular diseases and hematopoietic diseases;Patients with malignant tumors; (8) Patients who have recently undergone major surgery or trauma are not eligible to participate in this study; (9) patients with schizophrenia, major depression (HAMD >24 points), alcohol dependence, and history of drug abuse; (10) patients with severe ear diseases; (11) women who are pregnant or breast-feeding, and those who plan to have children during the trial or within 3 months after stopping the medication; (12) Persons with allergic constitution or previous allergy to multiple drugs, or allergic to the ingredients in the drug under study; (13) Patients who had been treated with ear acupuncture for other diseases within 2 months prior to the trial; (14) Taking painkillers for more than 10 days/month; (15) those who had taken prophylactic drugs within 1 month before the trial; (16) Patients considered unsuitable for the study by other researchers. If you are a tension-type headache sufferer, please read the following text carefully to make sure that you do not have the following conditions: (1) Headache is a type other than tension headache; (2) patients with other types of headache, including secondary headache; (3) patients with thrombocytopenia, glaucoma, peripheral vascular disease or Raynaud's syndrome; (4) Participants in other clinical trials, including pharmacotherapy and alternative therapy (such as acupuncture, massage, percutaneous electrical stimulation, etc.) during the study period and within 3 months prior to the study; (5) patients who underwent facial surgery in the sphenopalatine ganglion region due to plastic surgery, correction, treatment or trauma; (6) Patients with liver and kidney function impairment: ALT and AST were 1.5 times higher than the upper limit of normal value, Cr was more than the upper limit of normal value, and TBIL was more than 2 times higher than the upper limit of normal value; (7) patients complicated with other serious cardiovascular and cerebrovascular diseases and hematopoietic diseases;Patients with malignant tumors; (8) Patients who have recently undergone major surgery or trauma are not eligible to participate in this study; (9) patients with schizophrenia, major depression (HAMD >24 points), alcohol dependence, and history of drug abuse; (10) patients with severe ear diseases; (11) women who are pregnant or breast-feeding, and those who plan to have children during the trial or within 3 months after stopping the medication; (12) Persons with allergic constitution or previous allergy to multiple drugs, or allergic to the ingredients in the drug under study; (13) Patients who had been treated with ear acupuncture for other diseases within 2 months prior to the trial; (14) Taking painkillers for more than 10 days/month; (15) those who had taken prophylactic drugs within 1 month before the trial; (16) Patients considered unsuitable for the study by other researchers. If you suffer from insomnia, please be sure to read the following text carefully to ensure that you do not have the following conditions: (1) Insomnia is other than acute insomnia and chronic insomnia; (2) patients with other types of insomnia, including secondary insomnia; (3) with other sleep disorders, such as restless legs syndrome, narcolepsy, etc.; (4) Participants in other clinical trials, including pharmacotherapy and alternative therapy (such as acupuncture, massage, percutaneous electrical stimulation, etc.) during the study period and within 3 months prior to the study; (5) patients who underwent facial surgery in the sphenopalatine ganglion region due to plastic surgery, correction, treatment or trauma; (6) Patients with liver and kidney function impairment: ALT and AST were 1.5 times higher than the upper limit of normal value, Cr was more than the upper limit of normal value, and TBIL was more than 2 times higher than the upper limit of normal value; (7) patients complicated with other serious cardiovascular and cerebrovascular diseases and hematopoietic diseases;Patients with malignant tumors; (8) Patients who have recently undergone major surgery or trauma are not eligible to participate in this study; (9) Patients with schizophrenia, major depression (HAMD >24 points), severe anxiety, alcohol dependence, and history of drug abuse; (10) patients with severe ear diseases; (11) women who are pregnant or breast-feeding, and those who plan to have children during the trial or within 3 months after stopping the medication; (12) Persons with allergic constitution or previous allergy to multiple drugs, or allergic to the ingredients in the drug under study; (13) Patients who had been treated with ear acupuncture for other diseases within 2 months prior to the trial; (14) Taking sleep drugs one month before enrollment; (15) Abnormal mental development and dementia (Raven's Reasoning test <70); (16) taking antipsychotic drugs; (17) Patients considered unsuitable for the study by other researchers.

研究实施时间：

Study execute time：

从From 2022-02-01

至To      2023-02-01

征募观察对象时间：

Recruiting time：

从From 2022-02-07

至To      2023-02-01

干预措施：

Interventions：

组别：

3

样本量：

200

Group：

three

Sample size：

干预措施：

耳针

干预措施代码：

Intervention：

ear acupuncture

Intervention code：

样本总量 Total sample size ： 200

研究实施地点：

Countries of recruitment
and research settings：

国家：

中华人民共和国

省(直辖市)：

北京市

市(区县)：

海淀区

Country：

China

Province：

Beijing

City：

Haidian District

单位(医院)：

中国人民解放军总医院

单位级别：

三级甲等

Institution/hospital：

PLA General Hospital

Level of the institution：

Third rate

测量指标：

Outcomes：

指标中文名：

头痛日记

指标类型：

次要指标

Outcome：

headache diary

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

量表

指标类型：

次要指标

Outcome：

scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

多维热扫描成像

指标类型：

次要指标

Outcome：

Multi-dimensional thermal imaging

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

脑电图

指标类型：

次要指标

Outcome：

electroencephalogram

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

失眠日记

指标类型：

次要指标

Outcome：

insomnia diary

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

颅脑功能核磁共振检查

指标类型：

主要指标

Outcome：

Brain functional magnetic resonance examination

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

blood

Tissue：

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 18 岁
Min age years
最大 65 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

自身前后对照，无随机抽样

Randomization Procedure (please state who generates the random number sequence and by what method)：

Self before and after control, no random sampling

盲法：

单盲

Blinding：

Single-blind study

是否共享原始数据：

IPD sharing：

是

Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

试验完成后6个月内公开在百度云网盘http://panbaidu.com/share/manage.

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Earpins treatment of primary headaches and insomnia mechanism of random, single blind contrast before and after, make their own, single center within 6 months after completion of clinical trials to te

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

ResMan

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

ResMan

数据管理委员会：

Data Managemen Committee：

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
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