Today is 2019-12-13

An epidemiological investigation of cranial muscles related chronic headache in Harbin university students
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注册号:

Registration number:

ChiCTR1900025989 

最近更新日期:

Date of Last Refreshed on:

2019-09-22 

注册时间:

Date of Registration:

2019-09-16 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

哈尔滨大学生颅周肌群相关性慢性头痛流行病学调查 

Public title:

An epidemiological investigation of cranial muscles related chronic headache in Harbin university students 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

哈尔滨大学生颅周肌群相关性慢性头痛流行病学调查 

Scientific title:

Cranial muscles related chronic headache in Harbin university students: an epidemiological investigation 

研究课题代号(代码):

Study subject ID:

2019yjscx053 

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:

 

申请注册联系人:

姜若文 

研究负责人:

王伟华 

Applicant:

Jiang Ruo-Wen 

Study leader:

Wang Wei-Hua 

申请注册联系人电话:

Applicant telephone:

+86 13772120921 

研究负责人电话:

Study leader's telephone:

+86 18646026188 

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:

jiangruowen1995@126.com 

研究负责人电子邮件:

Study leader's E-mail:

wangweihua1968@126.com 

申请单位网址(自愿提供):

Applicant 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:

黑龙江省哈尔滨市香坊区和平路24号黑龙江中医药大学 

研究负责人通讯地址:

黑龙江省哈尔滨市南岗区民益街33号4楼 

Applicant address:

24 Heping Road, Xiang-Fang, Harbin, Heilongjiang, China 

Study leader's address:

33 Minyi Street , Nan'gang, Harbin, Heilongjiang, 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:

黑龙江中医药大学 

Applicant's institution:

Heilongjiang University of Chinese Medicine 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

中医大二院伦[2019]74 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

黑龙江中医药大学附属第二医院伦理委员会 

Name of the ethic committee:

The Ethics Committee of the Second Affiliated Hospital of Heilongjiang University of Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-09-12 

伦理委员会联系人:

王曼玉 

Contact Name of the ethic committee:

Man-Yu Wang 

伦理委员会联系地址:

黑龙江省哈尔滨市南岗区果戈里大街411号 

Contact Address of the ethic committee:

Second Affiliated Hospital of Heilongjiang University of Chinese Medicine, 411 Guogeli Street, Nan'gang, Harbin, Heilongjiang, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0451-53628834 

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:

黑龙江中医药大学附属第二医院 

Primary sponsor:

Second Affiliated Hospital of Heilongjiang University of Chinese Medicine 

研究实施负责(组长)单位地址:

黑龙江省哈尔滨市南岗区果戈里大街411号 

Primary sponsor's address:

411 Guogeli Street, Nan'gang, Harbin, Heilongjiang, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

黑龙江省

市(区县):

哈尔滨市

Country:

China

Province:

Heilongjiang

City:

Harbin

单位(医院):

黑龙江中医药大学附属第二医院

具体地址:

黑龙江省哈尔滨市南岗区果戈里大街411号

Institution
hospital:

Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

Address:

411 Guogeli Street, Nan'gang, Harbin, Heilongjiang, China

经费或物资来源:

2019年黑龙江中医药大学研究生创新科研项目 

Source(s) of funding:

Innovative research project for graduate students of Heilongjiang University of Chinese Medicine in 2019 

研究疾病:

慢性头痛 

Target disease:

Chronic Headache 

研究疾病代码:

 

Target disease code:

 

研究类型:

流行病学研究 

Study type:

Epidemilogical research 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

为了探究颅周肌群相关性慢性头痛(CMCH)的发病情况、发病特点等流行病学特征,结合实际情况,选取哈尔滨市高校学生为主要调查对象,了解CMCH发病率与相关情况(病程、程度、对生活的影响)与颅周肌群异常(紧张、压痛)、生活习惯、心里状态等因素的相关性。 

Objectives of Study:

To explore the epidemiological characteristics of Cranial Muscles related Chronic Headache (CMCH). The students of Harbin University were selected as the participants to research the incidence of CMCH. Relevant conditions (disease, degree, impact on life) and the correlation between abnormalities of the cranial muscles (tension, pressing pain), living habits, and mental state. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

横断面 

Study design:

Cross-sectional 

纳入标准:

本研究纳入人群为各高校(院系)在校本科生,涵盖入学新生至毕业年级各学年。在各高校(院系)通过所有学生学号依次编码后使用计算机软件随机抽样,不区分健康者与患者。 

Inclusion criteria

The enrolled participants are undergraduate students in colleges and universities, covering the freshmen to the graduation year. After each student is coded by students' ID numbers, they are randomly sampled using computer software, and no distinction is made between healthy people and patients. 

排除标准:

排除意识不清或患有严重精神疾病以致不能配合调查者,拒绝接受调查的受试者,且均记为失应答者。记录失应答原因(身体原因、拒绝调查)。 

Exclusion criteria:

Participants who were unconscious or who had serious mental illness and were unable to cooperate with the investigator and refused to be investigated were all recorded as non-participant. Record the cause of the loss of response (physical reasons, refusal to investigate). 

研究实施时间:

Study execute time:

From2019-09-23To 2020-06-30 

干预措施:

Interventions:

组别:

Case series

样本量:

2500

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

黑龙江省 

市(区县):

哈尔滨市 

Country:

China 

Province:

Heilongjiang 

City:

Harbin 

单位(医院):

黑龙江中医药大学 

单位级别:

大学 

Institution
hospital:

Heilongjiang University of Chinese Medicine  

Level of the institution:

University 

国家:

中国 

省(直辖市):

黑龙江省 

市(区县):

哈尔滨市 

Country:

China 

Province:

Heilongjiang 

City:

 

单位(医院):

黑龙江大学 

单位级别:

大学 

Institution
hospital:

Heilongjiang University of China  

Level of the institution:

University 

国家:

中国 

省(直辖市):

黑龙江省 

市(区县):

哈尔滨市 

Country:

China 

Province:

Heilongjiang 

City:

 

单位(医院):

哈尔滨师范大学 

单位级别:

大学 

Institution
hospital:

Harbin Normal University  

Level of the institution:

University 

国家:

中国 

省(直辖市):

黑龙江省 

市(区县):

哈尔滨市 

Country:

China 

Province:

Heilongjiang 

City:

Harbin 

单位(医院):

哈尔滨金融学院 

单位级别:

大学 

Institution
hospital:

Harbin Finance University  

Level of the institution:

University 

国家:

中国 

省(直辖市):

黑龙江省 

市(区县):

哈尔滨 

Country:

China 

Province:

Heilongjiang 

City:

Harbin 

单位(医院):

哈尔滨华德学院 

单位级别:

大学 

Institution
hospital:

Harbin Huade University  

Level of the institution:

University 

测量指标:

Outcomes:

指标中文名:

慢性头痛患病率

指标类型:

主要指标 

Outcome:

Prevalence rate of chronic headache

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

颅周肌群相关性慢性头痛患病率

指标类型:

主要指标 

Outcome:

Prevalence rate of cranial muscle related chronic headache

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

头痛患病率

指标类型:

次要指标 

Outcome:

Prevalence rate of headache

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

颅周肌群相关头痛患病率

指标类型:

次要指标 

Outcome:

Prevalence rate of cranial muscle related chronic headache

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

各类型头痛所占比例

指标类型:

次要指标 

Outcome:

Proportion of each type headache

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

颈椎活动度

指标类型:

附加指标 

Outcome:

Cervical activity

Type:

Additional indicator 

测量时间点:

测量方法:

训练合格的调查者使用关节量角器测量

Measure time point of outcome:

Measure method:

Trained investigators use joint protractor measurements.

指标中文名:

头前倾程度

指标类型:

附加指标 

Outcome:

Degree of head forward position

Type:

Additional indicator 

测量时间点:

测量方法:

自然直立。经枕骨粗隆后缘冠状面与经第七颈椎棘突尖冠状面的水平距离

Measure time point of outcome:

Measure method:

Natural standing straight. And measuring the horizontal distance from the coronal plane of the posterior occipital trochanter and the coronal plane of the seventh cervical spine

指标中文名:

吸烟史

指标类型:

附加指标 

Outcome:

Smoking

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

酗酒史

指标类型:

附加指标 

Outcome:

Drinking

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

既往史

指标类型:

附加指标 

Outcome:

Past history

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

睡眠时长与质量

指标类型:

附加指标 

Outcome:

Sleep time and quality

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

伏案时长

指标类型:

附加指标 

Outcome:

Time of keeping sedentary or with desk

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

家族中是否有人受头痛困扰

指标类型:

附加指标 

Outcome:

Is anyone in the family troubled by headache?

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

户外运动时间与项目

指标类型:

附加指标 

Outcome:

Outdoor sports time and types

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

电子产品使用时间

指标类型:

附加指标 

Outcome:

Time of using electronic product

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

近视或远视

指标类型:

附加指标 

Outcome:

Myopia or hyperopia

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

头痛对生活的影响

指标类型:

附加指标 

Outcome:

The impact of headache on life

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

自觉压力情况

指标类型:

附加指标 

Outcome:

Conscious stress

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

头痛时伴随症状

指标类型:

附加指标 

Outcome:

Symptoms associated with headache

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

年级

指标类型:

附加指标 

Outcome:

Grade

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

专业类别

指标类型:

附加指标 

Outcome:

Professional category

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

头痛持续时间

指标类型:

附加指标 

Outcome:

Headache duration

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

头痛频率

指标类型:

附加指标 

Outcome:

Headache frequency

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

头痛范围

指标类型:

附加指标 

Outcome:

Headache range

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

头痛性质

指标类型:

附加指标 

Outcome:

Headache nature

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

头痛管理情况

指标类型:

附加指标 

Outcome:

Management of headache

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

年龄

指标类型:

附加指标 

Outcome:

Age

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

性别

指标类型:

附加指标 

Outcome:

Gender

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

身高

指标类型:

附加指标 

Outcome:

Height

Type:

Additional indicator 

测量时间点:

测量方法:

脱鞋直立

Measure time point of outcome:

Measure method:

Take off shoes and stand upright

指标中文名:

体重

指标类型:

附加指标 

Outcome:

Body weight

Type:

Additional indicator 

测量时间点:

测量方法:

除去饰品、钥匙、厚重衣物等物品

Measure time point of outcome:

Measure method:

Remove items such as jewelry, keys, heavy clothing, etc.

指标中文名:

颅周肌群压痛

指标类型:

附加指标 

Outcome:

Cranial muscle tenderness

Type:

Additional indicator 

测量时间点:

测量方法:

培训合格的调查者触诊

Measure time point of outcome:

Measure method:

Trained investigators to palpate

指标中文名:

颅周肌群紧张感

指标类型:

附加指标 

Outcome:

Cranial muscle tension

Type:

Additional indicator 

测量时间点:

测量方法:

培训合格的调查者触诊

Measure time point of outcome:

Measure method:

Trained investigators to palpate

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 30 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

N/A

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

N/A

盲法:

受试者首先完成“体格检查”后,再填写“自评问卷”部分。以避免调查员了解到受试者的头痛情况后倾向性进行体格检查。

Blinding:

After the participant first completes the physical examination, the self-assessment questionnaire is filled out. Physical examination was performed to avoid the tendency of the investigator to understand the participant's headache.

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

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):

原始数据在2020年6月30日后通过研究负责人电子邮件联系获取

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

The IPD can be accessed by e-mail of PI after June 30, 2020

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:

加密的EXCEL文件

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

EXCEL files with a entry password

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-09-16
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