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低强度聚焦超声联合透明质酸钠治疗中度膝骨关节炎
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注册号:

Registration number:

ChiCTR-INR-16009413 

最近更新日期:

Date of Last Refreshed on:

2016-10-15 

注册时间:

Date of Registration:

2016-10-14 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

低强度聚焦超声联合透明质酸钠治疗中度膝骨关节炎  

Public title:

Low intensity pulsed ultrasound(LIPUS) combined with sodium hyaluronate(SH) for the treatment of moderate knee Osteoarthritis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

低强度聚焦超声联合透明质酸钠治疗中度膝骨关节炎  

Scientific title:

Low intensity pulsed ultrasound(LIPUS) combined with sodium hyaluronate(SH) for the treatment of moderate knee Osteoarthritis 

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:

吴兴 

研究负责人:

吴兴 

Applicant:

Xing Wu 

Study leader:

Xing Wu 

申请注册联系人电话:

Applicant telephone:

+86 18917683195 

研究负责人电话:

Study leader's telephone:

+86 18917683195 

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:

wuxinggood@163.com 

研究负责人电子邮件:

Study leader's E-mail:

wuxinggood@163.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:

上海市延长中路301号 

研究负责人通讯地址:

上海市延长中路301号 

Applicant address:

301 Middle Yanchang Road, Shanghai , China 

Study leader's address:

301 Middle Yanchang Road, Shanghai , 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:

上海市第十人民医院骨科 

Applicant's institution:

Department of Orthopaedics, Shanghai Tenth People's Hospital 

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:

SHSY-IEC-3.1/16-95/01 

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:

上海市第十人民医院伦理委员会 

Name of the ethic committee:

The ethic committee, Shanghai tenth People’s Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

 

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:

上海市第十人民医院 

Primary sponsor:

Shanghai Tenth People's Hospital 

研究实施负责(组长)单位地址:

上海市延长中路301号 

Primary sponsor's address:

No.301 Middle Yanchang Road, Shanghai , 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市第十人民医院

具体地址:

上海市延长中路301号

Institution
hospital:

Shanghai tenth People’s Hospital

Address:

301 Middle Yanchang Road, Shanghai, China

经费或物资来源:

上海申康医院发展中心《促进市级医院临床技能与临床创新三年行动计划项目》 

Source(s) of funding:

Clinical Research Plan of SHDC 

研究疾病:

膝骨关节炎 

Target disease:

knee Osteoarthritis 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

探索LIPUS联合SH治疗膝关节中度OA的疗效  

Objectives of Study:

TO explore the therapeutic effect of LIPUS combined with SH for moderate knee Osteoarthritis 

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:

中度膝骨关节炎(骨关节诊治指南,2007年版) 

Inclusion criteria

moderate knee Osteoarthritis(Guide for the diagnosis and treatment of osteoarthritis, Edition 2007) 

排除标准:

轻、重度膝骨关节炎,其它感染、风湿性、痛风性、结核性等关节炎,用其他消炎止痛用药物等 

Exclusion criteria:

mild and severe osteoarthritis,others including infection, rheumatism,gout and tuberculosis arthritises other therapeutic methods such as anti-inflammatory and analgesic drugs. 

研究实施时间:

Study execute time:

From2016-12-01To 2019-11-30 

干预措施:

Interventions:

组别:

1

样本量:

100

Group:

1

Sample size:

干预措施:

透明质酸钠

干预措施代码:

Intervention:

sodium hyaluronate

Intervention code:

组别:

2

样本量:

100

Group:

2

Sample size:

干预措施:

低强度聚焦超声

干预措施代码:

Intervention:

Low intensity pulsed ultrasound

Intervention code:

组别:

3

样本量:

100

Group:

3

Sample size:

干预措施:

低频聚焦超声联合透明质酸钠

干预措施代码:

Intervention:

Low intensity pulsed ultrasound combined with sodium hyaluronate

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):

上海市第十人民医院 

单位级别:

三甲医院 

Institution
hospital:

Shanghai tenth People’s Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

JOA评分

指标类型:

主要指标 

Outcome:

JOA Scores

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

改善率

指标类型:

主要指标 

Outcome:

improvement rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

优良率

指标类型:

主要指标 

Outcome:

fine and good rate

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:

膝关节液

组织:

Sample Name:

Knee joint fluid

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:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

计算机产生随机序列-随机数字表法

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

Computer generates the random number sequence(random number table )

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):

公开日期:2020年后,方式:数据库

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

Publication dates: After 2020 years. Pattern: Data base.

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:

Excel 数据库

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

Excel data base

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-10-14
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