A prospective cohort study of heat-sensitive moxibustion in reducing the outcome of joint replacement in patients with knee osteoarthritis

注册号:

Registration number:

ITMCTR2000003325

最近更新日期:

Date of Last Refreshed on:

2020-05-19

注册时间:

Date of Registration:

2020-05-19

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

热敏灸减少膝骨性关节炎患者关节置换结局的前瞻性队列研究

Public title:

A prospective cohort study of heat-sensitive moxibustion in reducing the outcome of joint replacement in patients with knee osteoarthritis

注册题目简写:

English Acronym:

研究课题的正式科学名称:

热敏灸减少膝骨性关节炎患者关节置换结局:一项等待对照、两组平行设计、多中心、前瞻性队列研究

Scientific title:

Heat-sensitive moxibustion in reducing the outcome of joint replacement in patients with knee osteoarthritis: a waiting control, two-group parallel design, multicenter, prospective cohort study

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:

ChiCTR2000033073 ; ChiMCTR2000003325

申请注册联系人:

张波

研究负责人:

张波

Applicant:

Zhang Bo

Study leader:

Zhang Bo

申请注册联系人电话:

Applicant telephone:

+86 13767049323

研究负责人电话:

Study leader's telephone:

+86 13767049323

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:

364343248@qq.c0m

研究负责人电子邮件:

Study leader's E-mail:

364343248@qq.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:

江西省南昌市东湖区八一大道445号

研究负责人通讯地址:

江西省南昌市东湖区八一大道445号

Applicant address:

445 Bayi Avenue, Donghu District, Nanchang, Jiangxi, China

Study leader's address:

445 Bayi Avenue, Donghu District, Nanchang, Jiangxi, China

申请注册联系人邮政编码:

Applicant postcode:

330006

研究负责人邮政编码:

Study leader's postcode:

330006

申请人所在单位:

江西中医药大学附属医院

Applicant's institution:

Tthe Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

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:

JZFYKYL20200427011

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

江西中医药大学附属医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of the Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2020/4/28 0:00:00

伦理委员会联系人:

邹勇

Contact Name of the ethic committee:

Zou Yong

伦理委员会联系地址:

江西省南昌市东湖区八一大道445号

Contact Address of the ethic committee:

445 Bayi Avenue, Donghu District, Nanchang, Jiangxi, 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:

江西中医药大学附属医院

Primary sponsor:

The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

江西省南昌市东湖区八一大道445号

Primary sponsor's address:

445 Bayi Avenue, Donghu District, Nanchang, Jiangxi, 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):

江西

市(区县):

南昌

Country:

China

Province:

Jiangxi

City:

Nanchang

单位(医院):

江西中医药大学附属医院

具体地址:

东湖区八一大道445号

Institution
hospital:

The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

Address:

445 Bayi Avenue, Donghu District

经费或物资来源:

国家中医临床基地

Source(s) of funding:

National Traditional Chinese Medicine Clinical Base

研究疾病:

膝关节骨性关节炎

研究疾病代码:

Target disease:

Knee osteoarthritis

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

非随机对照试验

Non randomized control

研究所处阶段:

Study phase:

探索性研究/预试验

Pilot clinical trial

研究目的:

探讨热敏灸干预膝骨膝关节炎对减少关节置换率的临床意义。

Objectives of Study:

To explore the clinical significance of Heat-sensitive moxibustion intervention in knee osteoarthritis to reduce the rate of joint replacement.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

以下各项全部具备者方可纳入本试验: a.符合前述膝骨性关节炎西医诊断标准; b.准备进行膝关节置换术; c.临床症状评分积分属于重度; d.年龄40-70岁,男女不限; e.患者愿意接受本课题规定的方法治疗; f.膝关节区域(阴陵泉-阳陵泉-梁丘-血海穴组成的区域内)出现穴位热敏。

Inclusion criteria

All of the following items can be included in this test: 1. Patients who meet the western medicine diagnosis standard of knee osteoarthritis; 2. Prepare patients for knee replacement; 3. The score of clinical symptom is severe; 4. Aged 40-70 years, male and female unlimited. 5. Patients who are willing to accept the treatment methods specified in this project; 6. There is acupoint heat sensitivity in the knee joint area (in the area composed of yinlingquan Yanglingquan Liangqiu Xuehai points).

排除标准:

具备以下项目之一者不可纳入本试验: a.妊娠或哺乳期妇女; b.合并有心脑血管、肝、肾和造血系统等严重危及生命的原发性疾病以及精神病患者; c.病情危重,难以对本治疗的有效性和安全性作出确切评价者; d.某种原因未按规定接受或完成治疗而无法判断疗效或资料不全者; e.膝关节急性创伤及局部皮肤破溃者。

Exclusion criteria:

Those with one of the following items shall not be included in the test: 1. Pregnant or lactating women; 2. The patients with primary diseases such as cardiovascular, cerebrovascular, liver, kidney, hematopoietic system and other serious life-threatening psychosis; 3. Patients who are in critical condition and are difficult to evaluate the efficacy and safety of the treatment; 4. Patients who fail to receive or complete treatment according to regulations for some reason and cannot judge the curative effect or incomplete data; 5. Patients with acute knee trauma and local skin rupture.

研究实施时间:

Study execute time:

From 2020-03-01

To      2022-03-31

征募观察对象时间:

Recruiting time:

From 2020-06-01

To      2021-04-30

干预措施:

Interventions:

组别:

等待对照组

样本量:

160

Group:

Waiting control group

Sample size:

干预措施:

常规健康教育

干预措施代码:

Intervention:

General health education

Intervention code:

组别:

热敏灸组

样本量:

160

Group:

Heat sensitive Moxibustion Group

Sample size:

干预措施:

热敏灸治疗

干预措施代码:

Intervention:

Heat sensitive Moxibustion

Intervention code:

样本总量 Total sample size : 320

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广州中医药大学第一附属医院

单位级别:

三甲

Institution/hospital:

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

浙江

市(区县):

杭州

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江省中医院

单位级别:

三甲

Institution/hospital:

Zhejiang Provincial Hospital of Traditional Chinese Medicine

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广东省中医院

单位级别:

三甲

Institution/hospital:

Guangdong Provincial Hospital of Traditional Chinese Medicine

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

江西

市(区县):

南昌

Country:

China

Province:

Jiangxi

City:

Nanchang

单位(医院):

江西中医药大学附属医院

单位级别:

三甲

Institution/hospital:

Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

重庆

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆市中医院

单位级别:

三甲

Institution/hospital:

Chongqing Traditional Chinese Medicine Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

广东

市(区县):

佛山

Country:

China

Province:

Guangdong

City:

Foshan

单位(医院):

广东省中西医结合医院

单位级别:

三甲

Institution/hospital:

Guangdong Hospital of Integrated Traditional Chinese and Western Medicine

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

江苏

市(区县):

南京

Country:

China

Province:

Jiangsu

City:

Nanjing

单位(医院):

江苏省中医院

单位级别:

三甲

Institution/hospital:

Jiangsu Provincial Hospital of Traditional Chinese Medicine

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

安徽

市(区县):

合肥

Country:

China

Province:

Anhui

City:

Hefei

单位(医院):

安徽中医药大学第一附属医院

单位级别:

三甲

Institution/hospital:

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

西安大略和麦克马斯特大学骨关节炎评分

指标类型:

主要指标

Outcome:

Western Ontario and McMaster University Osteoarthritis Score, WOMC

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

关节置换发生率

指标类型:

主要指标

Outcome:

Incidence of joint replacement

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:

尚未开始

Not yet recruiting

年龄范围:

最小 40
Min age years
最大 70
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):

未使用

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

Non-randomization.

盲法:

本研究中,采用盲评价者,即研究的评价者为非本试验的操作人员,评价者不清楚分组情况和相关意义,所有评价者均接受本研究的统一培训。除CRF表上所需的内容外,研究的评价者不得询问病例调差表以外的受试者的相关信息。

Blinding:

Blind evaluators are used in this study: the evaluators of the study are not the operators of this trial,the evaluators are not clear about the grouping and related significance. All evaluators receive unified training in this study. Except for what is required on the CRF form, the study evaluator must not ask for information about subjects other than those on the CRF form.

是否共享原始数据:

IPD sharing:

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):

公开数据的时间为试验完成后的6个月内,方式为:联系统计师

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

The time to disclose the data is within 6 months of the completion of the trial by: Contacting the statistician

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:

数据采集: 本研究主要通过病例记录表(Case Record Form,CRF)进行相关数据的采集 数据管理: 各研究单位将完成的研究报告表15个工作日内汇集至研究承担单位,由课题承担单位制定两名数据录入人员,审核研究数据的完整性和准确性后,建立数据库。同一份病历由两人分别填报。两次录入完成后,核对其一致性,校对原始数据并修改错误数据。

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

Data collection: The main way of this study is to collect relevant data through Case Record Form (CRF) Data management: Each research unit will collect the completed research report form to the research undertaking unit within 15 working days. The research undertaking unit will appoint two data entry personnel to check the completeness and accuracy of the research data, and then establish a database. The same medical record shall be filled in by two persons respectively. After the two entries are completed, check the consistency, proofread the original data and correct the wrong data.

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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