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医患合作综合干预方案治疗颈椎病的临床评价研究
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注册号:

Registration number:

ChiCTR-IPR-15006820 

最近更新日期:

Date of Last Refreshed on:

2015-07-27 

注册时间:

Date of Registration:

2015-07-27 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

医患合作综合干预方案治疗颈椎病的临床评价研究 

Public title:

A comparison of neck muscle strength training methods of doctor-patient cooperation for the cervical spondylosis: A randomized controlled study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

医患合作综合干预方案治疗颈椎病的临床评价研究 

Scientific title:

A comparison of neck muscle strength training methods of doctor-patient cooperation for the cervical spondylosis: A randomized controlled pilot study 

研究课题代号(代码):

Study subject ID:

上海市科学技术委员会15401934100 

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:

王辉昊 

研究负责人:

王辉昊 

Applicant:

Huihao Wang 

Study leader:

Huihao Wang 

申请注册联系人电话:

Applicant telephone:

+86 021-20256519 

研究负责人电话:

Study leader's telephone:

+86 021-20256519 

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:

huihaowang@126.com 

研究负责人电子邮件:

Study leader's E-mail:

huihaowang@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:

上海市张衡路528号,骨伤科研究所 

研究负责人通讯地址:

上海市张衡路528号,骨伤科研究所 

Applicant address:

528 Zhangheng Road, Shanghai 

Study leader's address:

528 Zhangheng Road, Shanghai 

申请注册联系人邮政编码:

Applicant postcode:

201203 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

上海中医药大学附属曙光医院 

Applicant's institution:

Shuguang Hospital Affiliated to Shanghai University of TCM 

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:

ChiECRCT-20150040 

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:

中国注册临床试验伦理委员会 

Name of the ethic committee:

Chinese Ethics Committee of Registering Clinical Trials, ChiECRCT 

伦理委员会批准日期:

Date of approved by ethic committee:

2015-07-12 

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:

上海中医药大学附属曙光医院 

Primary sponsor:

Shuguang Hospital Affiliated to Shanghai University of TCM 

研究实施负责(组长)单位地址:

上海市张衡路528号,骨伤科研究所 

Primary sponsor's address:

528 Zhangheng Road, Shanghai 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海中医药大学附属曙光医院

具体地址:

上海市张衡路528号,骨伤科研究所

Institution
hospital:

Shuguang Hospital Affiliated to Shanghai University of TCM

Address:

528 Zhangheng Road, Shanghai

经费或物资来源:

上海市科学技术委员会(No: 15401934100) 

Source(s) of funding:

Shanghai Science and Technology Commission (No: 15401934100) 

研究疾病:

颈椎病 

Target disease:

cervical spondylosis 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

开展非劣效随机对照试验,采用墨尔本诊治方案(The Melbourne Protocol, TMP)的颈椎多功能测试训练系统( Multi-cervical Unit System, MCU)为观察组与“石氏伤科强筋健颈功”为对照组,比较研究颈椎病的复发率和远期疗效; 

Objectives of Study:

The objective of the present randomized controlled study was to compare the effect ofthe multi-cervical spine function testing and training system (MCU) based on the Melbourne protocol (TMP) as the observation group and Shi's Qiang Jin Jian Jing Gong (Strengthen tendon and consolidate spine exercise) as the control group on the recurrence rate and long-term efficacy of the cervical spondylosis. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

①年龄在18-50岁之间,男女不限; ②符合颈椎病诊断标准,VAS≤6分; ③病程<1年; ④自愿加入本实验,并签署“知情同意书”者。 

Inclusion criteria

1. Age between 18-50 years old, male and female; 2. Accordance with the diagnosis of the cervical spondylosis, VAS<=6; 3. The course of disease is less than 1 years; 4. Subjects volunteered to join this experiment, and signed the "informed consent". 

排除标准:

①具有手术指征或手法禁忌症的颈椎病患者; ②颈椎外伤处于急性期或功能障碍无法完成主动锻炼者; ③合并心脑血管、肝、肾、造血、消化系统等严重疾病或精神病患者; ④试验期间同时接受其他有关治疗,可能影响本研究的效应指标观测者; ⑤孕妇或待孕女性患者; ⑥不愿加入本试验者; ⑦研究者认为不宜参加本研究的其它情况者; ⑧正参加其它临床试验的患者。 

Exclusion criteria:

1. The subjects has the operation indication or the contraindications of manipulation; 2. The subjects was cervical trauma in acute stage or dysfunction which can not complete the active exercise; 3. The subjects merged with other severe diseases involved with heart blood vessel, liver, kidney, blood, digestive system; 4. The subjects accept other relevant treatment during this project,which may affect the effect index; 5. The exclusion of pregnantor pregnant women; 6. The subjects were reluctant to join the project; 7. The researchers believe that the subject is not suitable for the study; 8. The subjects participating in other clinical trials. 

研究实施时间:

Study execute time:

From2015-07-01To 2018-06-30 

征募观察对象时间:

Recruiting time:

From2016-01-01To 2017-12-31 

干预措施:

Interventions:

组别:

A

样本量:

55

Group:

A

Sample size:

干预措施:

基于墨尔本方案(TMP)的颈椎多功能测试训练系统(MCU)训练方法

干预措施代码:

Intervention:

the multi-cervical spine function testing and training system (MCU) based on the Melbourne protocol (TMP)

Intervention code:

组别:

B

样本量:

55

Group:

B

Sample size:

干预措施:

石氏伤科强筋健颈功

干预措施代码:

Intervention:

Shi's Qiang Jin Jian Jing Gong (Strengthen tendon and consolidate spine exercise)

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海中医药大学附属曙光医院 

单位级别:

三级甲等 

Institution
hospital:

Shuguang Hospital Affiliated to Shanghai University of TCM  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

颈椎功能障碍指数

指标类型:

主要指标 

Outcome:

The Neck Disability Index

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

颈椎活动度

指标类型:

主要指标 

Outcome:

Range of motion

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量量表

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:

疼痛视觉模拟量表

指标类型:

次要指标 

Outcome:

VAS

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

等长肌力功能

指标类型:

次要指标 

Outcome:

Isometric force of neck muscles

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:

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 50 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):

采用最小化随机分组法,由统计师采用SPSS 17.0产生随机号。

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

Using the minimization of the random grouping method, the random numbers of statistical division was generated by SPSS 17.0.

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

上海中医药大学附属曙光医院

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

Shuguang Hospital Affiliated to Shanghai University of TCM

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:

上海中医药大学附属曙光医院

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

Shuguang Hospital Affiliated to Shanghai University of TCM

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2015-07-27
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