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膝关节置换患者中枢敏化的流行病学调查与临床干预评价
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注册号:

Registration number:

ChiCTR2000031674 

最近更新日期:

Date of Last Refreshed on:

2020-04-07 

注册时间:

Date of Registration:

2020-04-06 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

膝关节置换患者中枢敏化的流行病学调查与临床干预评价 

Public title:

Epidemiological investigation and clinical intervention evaluation of central sensitization in knee arthroplasty candidates 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

膝关节置换患者中枢敏化的流行病学调查与临床干预评价 

Scientific title:

Epidemiological investigation and clinical intervention evaluation of central sensitization in knee arthroplasty candidates 

研究课题代号(代码):

Study subject ID:

宁波市医学科技计划项目2019Y53 

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:

邵龙 

研究负责人:

凌晶 

Applicant:

Shao Long 

Study leader:

Ling Jing 

申请注册联系人电话:

Applicant telephone:

+86 15922747454 

研究负责人电话:

Study leader's telephone:

+86 18906628636 

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:

hipkneedoc@163.com 

研究负责人电子邮件:

Study leader's E-mail:

lingjing07@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:

浙江省宁波市中山东路1059号宁波市第六医院关节外科 

研究负责人通讯地址:

浙江省宁波市中山东路1059号 宁波市第六医院 关节外科 

Applicant address:

1059 Zhongshan Road East, Ningbo, Zhejiang, China 

Study leader's address:

1059 Zhongshan Road East, Ningbo, Zhejiang, 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:

宁波市第六医院 

Applicant's institution:

Ningbo Sixth 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:

K2020005 

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:

宁波市第六医院伦理委员会 

Name of the ethic committee:

Ethical Committee of Ningbo Sixth Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-04-03 

伦理委员会联系人:

陈剑明 

Contact Name of the ethic committee:

Chen Jian-Ming 

伦理委员会联系地址:

浙江省宁波市中山东路1059号 宁波市第六医院伦理委员会 

Contact Address of the ethic committee:

Ethical Committee of Ningbo Sixth Hospital, 1059 Zhongshan Road East, Ningbo, Zhejiang, China 

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:

宁波市第六医院关节外科 

Primary sponsor:

Department of Joint Surgery, Ningbo Sixth Hospital 

研究实施负责(组长)单位地址:

浙江省宁波市中山东路1059号 宁波市第六医院 

Primary sponsor's address:

1059 Zhongshan Road East, Ningbo, Zhejiang, 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):

浙江省

市(区县):

宁波市

Country:

China

Province:

Zhejiang

City:

Ningbo

单位(医院):

宁波市第六医院

具体地址:

浙江省宁波市中山东路1059号

Institution
hospital:

Ningbo 6th Hospital

Address:

1059 Zhongshandong Road

经费或物资来源:

宁波市医学科技计划项目2019Y53 

Source(s) of funding:

Ningbo Medical Science and Technology Plan Project 2019Y53 

研究疾病:

膝关节置换,中枢敏化 

Target disease:

knee arthroplasty,central sensitization 

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:

上市后药物 

Study phase:

研究目的:

通过流行病学研究了解膝关节重度骨性关节炎置换患者中中枢敏化的发病率。研究中枢敏化对膝关节置换术后功能、疼痛、满意度影响,相关临床干预的有效性与安全性。为发现新的临床治疗方法,改进临床疗效,提升患者满意度奠定基础。 

Objectives of Study:

Epidemiological study was conducted to understand the incidence of central sensitization in patients with knee arthroplasty due to severe osteoarthritis. To study the effects of central sensitization on function, pain and satisfaction after knee replacement, and the effectiveness and safety of related clinical interventions. To lay the foundation for discovering new clinical treatment methods, improving clinical efficacy and patient satisfaction. 

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:

膝关节重度骨性关节炎行膝关节置换手术治疗患者, 年满50周岁以上, 小学以上文化, 自愿参与研究并能够提供书面知情同意书的对象 

Inclusion criteria

1. Patients with severe knee osteoarthritis waiting for replacement surgery,; 2. Aged 50 years or older; 3. Objects of culture above primary school; 4. Participants who voluntarily participate in the study and can provide written informed consent. 

排除标准:

1.合并精神障碍、人格障碍及物质滥用/依赖的人; 2.近一周内存在应激事件,拒绝参与本研究患的受试者; 3.未进行膝关节置换手术的受试者,使用非表面置换关节假体的患者。 

Exclusion criteria:

1. People with mental disorder, personality disorder and substance abuse / dependence; 2. Subjects who refused to participate in the study due to stress events in the past week; 3. Subjects who did not have knee replacement surgery, patients who use non surface replacement joint prosthesis. 

研究实施时间:

Study execute time:

From2020-04-04To 2021-12-31 

征募观察对象时间:

Recruiting time:

From2020-04-04To 2021-12-31 

干预措施:

Interventions:

组别:

A

样本量:

50

Group:

A

Sample size:

干预措施:

中枢敏化患者(治疗中枢敏化药物)

干预措施代码:

Intervention:

Central sensitization patients(Medicine for central sensitization)

Intervention code:

组别:

B

样本量:

50

Group:

B

Sample size:

干预措施:

中枢敏化患者(安慰剂)

干预措施代码:

Intervention:

Central sensitization patients(placebo)

Intervention code:

组别:

C

样本量:

50

Group:

C

Sample size:

干预措施:

正常空白对照

干预措施代码:

Intervention:

Normal patients (No-treatment Control)

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江省 

市(区县):

宁波市 

Country:

China 

Province:

Zhejiang 

City:

Ningbo 

单位(医院):

宁波市第六医院 

单位级别:

三级医院 

Institution
hospital:

Ningbo No.6 Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

膝关节功能评分

指标类型:

主要指标 

Outcome:

Knee Osteoarthritis Outcome Score, KOOS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疼痛评分

指标类型:

主要指标 

Outcome:

Visual Analogue Scale/Score, VAS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中枢敏化问卷

指标类型:

主要指标 

Outcome:

Central Sensitization Inventory, CSI

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

膝关节功能

指标类型:

次要指标 

Outcome:

knee function (HHS, ROM, WOMAC)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

并发症

指标类型:

次要指标 

Outcome:

complication

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:

None

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 50 years
最大 Max age 80 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):

临床研究助理使用电脑产生随机数,信封法

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

The clinical research assistant use the computer to generate the random number. sealed envelopes

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

是Yes

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):

网络平台

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

Internet database

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:

电子采集和管理系统

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

Electronic Data Capture

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-04-06
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