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Diagnostic value of modified shoulder abduction test in cervical spondylotic radiculopathy
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注册号:

Registration number:

ChiCTR2000033299 

最近更新日期:

Date of Last Refreshed on:

2020-05-27 

注册时间:

Date of Registration:

2020-05-27 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

吴浩医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 改良肩关节外展试验在神经根型颈椎病中的诊断价值 

Public title:

Diagnostic value of modified shoulder abduction test in cervical spondylotic radiculopathy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

改良肩关节外展试验在神经根型颈椎病中的诊断价值 

Scientific title:

Diagnostic value of modified shoulder abduction test in cervical spondylotic radiculopathy 

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:

吴浩 

研究负责人:

孔清泉 

Applicant:

Hao Wu 

Study leader:

Qingquan Kong 

申请注册联系人电话:

Applicant telephone:

+86 18842637152 

研究负责人电话:

Study leader's telephone:

+86 18980601954 

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:

wuhaoly1992@163.com 

研究负责人电子邮件:

Study leader's E-mail:

kqqspine@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:

四川省成都市武侯区国学巷37号 

研究负责人通讯地址:

四川省成都市武侯区国学巷37号 

Applicant address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China 

Study leader's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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:

四川大学华西医院 

Applicant's institution:

West China Hospital of Sichuan University 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

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:

四川大学华西医院 

Primary sponsor:

West China Hospital of Sichuan University 

研究实施负责(组长)单位地址:

四川省成都市武侯区国学巷37号 

Primary sponsor's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川大学华西医院

具体地址:

武侯区国学巷37号

Institution
hospital:

West China Hospital of Sichuan University

Address:

37 Guoxue Lane, Wuhou District

经费或物资来源:

国家老年疾病临床医学研究中心(四川大学华西医院)项目(Z2018B07) 

Source(s) of funding:

Supported by National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University (Z2018B07) 

研究疾病:

神经根型颈椎病 

Target disease:

Cervical Radiculopathy 

研究疾病代码:

 

Target disease code:

 

研究类型:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

本研究在肩关节外展试验基础之上设计了一种加强试验,基于颈椎MRI联合双斜位X线,肩关节外展改良试验鉴别神经根型颈椎病的准确性和特异性进行探讨。 

Objectives of Study:

In this study, based on the shoulder abduction test, an enhanced test is designed. Based on the cervical MRI combined with double oblique X-ray, the accuracy and specificity of the shoulder abduction improvement test to distinguish nerve root type cervical spondylosis are discussed. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

1. 表现为肩部及/或上肢麻木、疼痛病人; 2. 同时行改良肩关节外展试验与颈椎MRI+颈椎双斜位X线检查的病人; 3. 病程>2周,年龄>18岁。 

Inclusion criteria

1. Patients with numbness and pain of shoulder and / or upper extremity; 2. Patients who underwent modified shoulder abduction test and cervical MRI + cervical double oblique X-ray examination at the same time; 3. Course of disease > 2 weeks, aged > 18 years. 

排除标准:

合并手术史、外伤史、肿瘤、风湿、类风湿、先天畸形等。 

Exclusion criteria:

Combining history of surgery, trauma, tumor, rheumatism, rheumatoid, congenital malformation, etc.. 

研究实施时间:

Study execute time:

From2020-05-26To 2021-05-26 

诊断措施:

Diagnostic measures:

金标准或参考标准(即可准确诊断某疾病的单项方法或多项联合方法,在本研究中用于诊断是否有该病的临床参考标准):

颈椎MRI联合颈椎双斜位X线

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

Cervical MRI combined with cervical oblique X-ray

指标试验(即本研究的待评估诊断试验,无论为方法、生物标志物或设备,均请列出名称):

改良肩关节外展试验

Index test:

Modified shoulder abduction test

目标人群(可以是某种疾病患者或正常人群,详细描述其疾病特征,注意应纳入符合分布特点的全序列病例,具有良好的代表性)

诊断为神经根型颈椎病的肩颈痛病人

例数:

Sample size:

50

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

Patients with neck and shoulder pain diagnosed as cervical radiculopathy

容易混淆的疾病人群(即与目标疾病不易区分的一种或多种不同疾病,应避免采用正常人群对照的病例-对照设计):

其他肩颈痛病人

例数:

Sample size:

50

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

Other patients with neck and shoulder pain

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

四川大学华西医院 

单位级别:

三级甲等 

Institution
hospital:

West China Hospital, Sichuan University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

西藏自治区人民政府驻成都办事处医院 

单位级别:

三级甲等 

Institution
hospital:

Hospital of Chengdu Office of People's Government of Tibetan Autonomous Region  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

四川省骨科医院 

单位级别:

三级甲等 

Institution
hospital:

Sichuan Provincial Orthopedics Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

视觉模拟评分

指标类型:

主要指标 

Outcome:

visual analog scale

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

临床症状

指标类型:

主要指标 

Outcome:

clinical manifestation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

颈椎核磁共振

指标类型:

主要指标 

Outcome:

cervical MRI

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

颈椎双斜位X线

指标类型:

主要指标 

Outcome:

cervical oblique 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:

SEN, SPE, ACC, AUC of ROC

指标类型:

主要指标 

Outcome:

SEN, SPE, ACC, AUC of ROC

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:

组织:

Sample Name:

N/A

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 90 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):

不适用

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

N/A

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

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):

论文公开

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

Publication in papers

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:

病例记录表

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

Case Record Form

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-05-27
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