云生态下颈椎健康智能管理体系的构建研究

注册号:

Registration number:

ITMCTR2025001242

最近更新日期:

Date of Last Refreshed on:

2025-06-21

注册时间:

Date of Registration:

2025-06-21

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

云生态下颈椎健康智能管理体系的构建研究

Public title:

Research on the construction of cervical health intelligent management system under cloud ecology

注册题目简写:

English Acronym:

研究课题的正式科学名称:

云生态下颈椎健康智能管理体系的构建研究

Scientific title:

Research on the construction of cervical health intelligent management system under cloud ecology

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:

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:

李靖

研究负责人:

于杰

Applicant:

Li Jing

Study leader:

Yu Jie

申请注册联系人电话:

Applicant telephone:

13155875818

研究负责人电话:

Study leader's telephone:

13366113469

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:

lijing_100@126.com

研究负责人电子邮件:

Study leader's E-mail:

doctoryujie@aliyun.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:

北京市朝阳区望京中环南路6号

研究负责人通讯地址:

北京市朝阳区望京中环南路6号

Applicant address:

No. 6 South Zhonghuan Road Wangjing Chaoyang District Beijing

Study leader's address:

No. 6 South Zhonghuan Road Wangjing Chaoyang District Beijing

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:

中国中医科学院望京医院

Applicant's institution:

Wangjing Hospital China Academy of Chinese Medical Sciences

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:

WJEC-KT-2024-069-P002

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

中国中医科学院望京医院伦理委员会

Name of the ethic committee:

Ethics Committee of Beijing Hospital of Traditional Chinese Medicine China Academy of Chinese Medical Sciences

伦理委员会批准日期:

Date of approved by ethic committee:

2024/10/28 0:00:00

伦理委员会联系人:

王浩

Contact Name of the ethic committee:

Wang Hao

伦理委员会联系地址:

北京市朝阳区望京中环南路6号

Contact Address of the ethic committee:

No. 6 Zhonghuan South Road Wangjing District Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

010-84739681

伦理委员会联系人邮箱:

Contact email of the ethic committee:

wjyyec@126.com

研究实施负责(组长)单位:

中国中医科学院望京医院

Primary sponsor:

Wangjing Hospital China Academy of Chinese Medical Sciences

研究实施负责(组长)单位地址:

北京市朝阳区望京中环南路6号

Primary sponsor's address:

No. 6 South Zhonghuan Road Wangjing Chaoyang District Beijing

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

朝阳区

Country:

China

Province:

Beijing

City:

Chaoyang

单位(医院):

中国中医科学院望京医院

具体地址:

北京市朝阳区望京中环南路6号

Institution
hospital:

Wangjing Hospital China Academy of Chinese Medical Sciences

Address:

No. 6 South Zhonghuan Road Wangjing Chaoyang District Beijing

经费或物资来源:

中国中医科学院

Source(s) of funding:

China Academy of Chinese Medical Sciences

研究疾病:

颈椎病

研究疾病代码:

Target disease:

cervical spondylosis

Target disease code:

研究类型:

Study type:

流行病学研究

Epidemilogical research

研究设计:

Study design:

横断面

Cross-sectional

研究所处阶段:

Study phase:

其它

Others

研究目的:

1.通过流行病学调查方式,呈现我国居民当前的颈椎健康现状,并建立颈椎健康电子档案信息平台,实现颈椎健康信息的数据化呈现、云生态管理和线上互通共享。 2.结合文献调研和专家讨论,依托颈椎健康流行病学调查和电子档案信息平台,开展真实世界研究,为信息化时代背景下的我国居民开具针对性颈椎健康生活处方。 3.基于前期流行病学调查数据,开展实验室研究,研制颈椎运动生理信息智能监测便携式可穿戴设备,实现颈椎健康情况的自我监测与量化,推动颈椎健康电子信息互通共享的云生态圈构建。

Objectives of Study:

1. Through epidemiological investigation methods present the current cervical health status of Chinese residents and establish an electronic archive information platform for cervical health achieving the data presentation cloud ecosystem management and online interconnection and sharing of cervical health information. 2. Based on literature research and expert discussions relying on cervical health epidemiological investigations and electronic archive information platforms conduct real-world research to issue targeted cervical health lifestyle prescriptions for Chinese residents in the context of the information age. 3. Based on the previous epidemiological investigation data conduct laboratory research develop an intelligent portable wearable device for monitoring cervical movement physiological information enabling self-monitoring and quantification of cervical health conditions and promoting the construction of a cloud ecosystem for the interconnection and sharing of cervical health electronic information.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

在调查当地居住时间超过3个月(含3个月);年龄≥18岁,性别不限;自愿参加本研究,并签署知情同意书

Inclusion criteria

The participants should have resided in the area for more than 3 months (inclusive of 3 months); be at least 18 years old with no gender restrictions; voluntarily participate in this study and sign the informed consent form.

排除标准:

数据不完整的调查对象;患有颈部外伤骨折脱位病史;患有严重的颈椎病畸形、肿瘤、结核以及强直性脊柱炎;长期卧床生活不能自理者;患有精神障碍疾病

Exclusion criteria:

Subjects with incomplete data; having a history of neck trauma fracture and dislocation; suffering from severe cervical spondylosis deformity tumor tuberculosis and ankylosing spondylitis; those who have been bedridden for a long time and are unable to take care of themselves; having mental disorders

研究实施时间:

Study execute time:

From 2023-11-01

To      2025-12-31

征募观察对象时间:

Recruiting time:

From 2024-10-28

To      2025-12-31

干预措施:

Interventions:

组别:

试验组

样本量:

7000

Group:

experimental group

Sample size:

干预措施:

干预措施代码:

Intervention:

no

Intervention code:

样本总量 Total sample size : 7000

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

长春

市(区县):

Country:

China

Province:

Changchun

City:

单位(医院):

长春中医药大学附属医院

单位级别:

三甲医院

Institution/hospital:

Changchun University of Chinese Medicine Affiliated Hospital

Level of the institution:

Grade III Class A Hospital

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院望京医院

单位级别:

三甲医院

Institution/hospital:

Wangjing Hospital China Academy of Chinese Medical Sciences

Level of the institution:

Grade III Class A Hospital

国家:

中国

省(直辖市):

陕西

市(区县):

Country:

China

Province:

Shanxi

City:

单位(医院):

陕西中医药大学附属医院

单位级别:

三甲医院

Institution/hospital:

Affiliated Hospital of Shaanxi University of Chinese Medicine

Level of the institution:

Grade III Class A Hospital

国家:

中国

省(直辖市):

苏州

市(区县):

Country:

China

Province:

Suzhou

City:

单位(医院):

苏州市中医医院

单位级别:

三甲医院

Institution/hospital:

Suzhou Traditional Chinese Medicine Hospital

Level of the institution:

Grade III Class A Hospital

国家:

中国

省(直辖市):

湖南

市(区县):

Country:

China

Province:

Hunan

City:

单位(医院):

湖南中医药大学第一附属医院

单位级别:

三甲医院

Institution/hospital:

The First Affiliated Hospital of Hunan University of Chinese Medicine

Level of the institution:

Grade III Class A Hospital

测量指标:

Outcomes:

指标中文名:

SF-36

指标类型:

次要指标

Outcome:

SF-36

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

颈椎功能障碍指数

指标类型:

次要指标

Outcome:

neck disability index

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X线

指标类型:

主要指标

Outcome:

Cervical spine X-ray

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

颈痛视觉模拟评分

指标类型:

次要指标

Outcome:

Neck pain visual analogue scale

Type:

Secondary 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:

组织:

Sample Name:

No

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:

正在进行

Recruiting

年龄范围:

最小 18
Min age years
最大 99
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):

无分组

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

No grouping

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

No

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):

论文发表

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

论文发表

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:

原始数据通过线上病历记录表电子采集,采集后通过电子数据管理系统保存管理。

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

The original data are electronically collected through online medical record forms and then saved and managed through the electronic data management system.

数据管理委员会:

Data Managemen Committee:

暂未确定

Not yet

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
(name of the journal, volume, issue, pages, time; or website):

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