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膝骨关节炎中医康复临床方案优化及中医康复结局评价系统的建立与研究
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注册号:

Registration number:

ChiCTR2000033351 

最近更新日期:

Date of Last Refreshed on:

2020-05-29 

注册时间:

Date of Registration:

2020-05-29 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

膝骨关节炎中医康复临床方案优化及中医康复结局评价系统的建立与研究 

Public title:

The establishment and research on the optimization of clinical rehabilitation plan and the evaluation system of rehabilitation outcome of traditional Chinese medicine for knee osteoarthritis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

膝骨关节炎中医康复临床方案优化及中医康复结局评价系统的建立与研究 

Scientific title:

The establishment and research on the optimization of clinical rehabilitation plan and the evaluation system of rehabilitation outcome of traditional Chinese medicine for 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:

ChiMCTR2000003352 

申请注册联系人:

仲卫红 

研究负责人:

杨珊莉 

Applicant:

Zhong Weihong 

Study leader:

Yang Shanli 

申请注册联系人电话:

Applicant telephone:

+86 18950308699 

研究负责人电话:

Study leader's telephone:

+86 18965903772 

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:

zwh7118@126.com 

研究负责人电子邮件:

Study leader's E-mail:

49688400@qq.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:

福建省福州市鼓楼区湖东支路13号 

研究负责人通讯地址:

福建省福州市鼓楼区湖东支路13号 

Applicant address:

13 Hudong Branch Road, Gulou District, Fuzhou, Fujian 

Study leader's address:

13 Hudong Branch Road, Gulou District, Fuzhou, Fujian 

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:

福建中医药大学附属康复医院 

Applicant's institution:

Rehabilitation Hospital affiliated to Fujian University of Traditional Chinese Medicine 

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:

2020KF-005-01 

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:

福建中医药大学附属康复医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Rehabilitation Hospital affiliated to Fujian University of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-04-02 

伦理委员会联系人:

修春英 

Contact Name of the ethic committee:

Xiu Chunying 

伦理委员会联系地址:

福建省福州市鼓楼区湖东支路13号 

Contact Address of the ethic committee:

13 Hudong Branch Road, Gulou District, Fuzhou, Fujian 

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:

中国中医科学院望京医院 

Primary sponsor:

Wangjing Hospital, Chinese Academy of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

北京市朝阳区花家地街 

Primary sponsor's address:

Huajiadi Street, Chaoyang District, Beijing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

福建

市(区县):

福州

Country:

China

Province:

Fujian

City:

Fuzhou

单位(医院):

福建中医药大学附属康复医院

具体地址:

鼓楼区湖东支路13号

Institution
hospital:

Rehabilitation Hospital affiliated to Fujian University of Traditional Chinese Medicine

Address:

13 Hudong Branch Road, Gulou District

经费或物资来源:

国家中医药管理局 

Source(s) of funding:

State Administration of traditional Chinese medicine of China 

研究疾病:

膝骨性关节炎 

Target disease:

Osteoarthritis of knee 

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:

其它 

Study phase:

N/A 

研究目的:

1. 建立膝骨关节炎循证能力建设优化协同工作机制; 2. 优化膝骨关节炎中医康复方案,开展随机对照试验验证康复方案的临床疗效,形成具有高级别循证证据的中医康复临床推荐方案; 3. 从中西医临床实践指南、系统评价/meta分析、大样本RCT三方面进行严格评价、信息提取、建成膝骨关节炎中医康复的临床决策数据库。 

Objectives of Study:

1. To establish evidence-based capacity building and optimize the cooperative work mechanism of knee osteoarthritis; 2. Optimize the rehabilitation program of traditional Chinese medicine for knee osteoarthritis, carry out a randomized controlled trial to verify the clinical efficacy of the rehabilitation program, and form a high-level evidence-based rehabilitation program of traditional Chinese medicine; 3. The clinical decision-making database of traditional Chinese and Western medicine rehabilitation was established by strict evaluation and information extraction from three aspects: clinical practice guide of traditional Chinese and Western medicine, systematic evaluation / meta-analysis and large sample RCT. 

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 符合膝骨关节炎诊断标准; ②符合Kellgren - Lawrance(K-L)的放射学诊断分级Ⅱ级或Ⅲ级。(K-L 的分级标准:0级,完全正常;Ⅰ级,关节间隙可疑狭窄,可能有骨赘;Ⅱ级,明显的骨赘,关节间隙正常或可疑变窄;Ⅲ级,中度骨赘,关节间隙明确狭窄,软骨下骨部分硬化;Ⅳ级,巨大骨赘,关节间隙明显狭窄,软骨下骨严重硬化,明确畸形) ③ 年龄50~80 岁; ④ 自愿参与且签署知情同意书。 

Inclusion criteria

1. It is in accordance with the diagnostic standard of knee osteoarthritis; 2. According to Kellgren - Lawrance (K-L), the radiology diagnosis was classified as grade II or grade III. (grading standard of K-L: grade 0, completely normal; grade I, joint space is suspected to be narrow, and there may be osteophyte; grade II, obvious osteophyte, joint space is normal or suspected to be narrow; grade III, moderate osteophyte, joint space is clear and narrow, subchondral bone is partially sclerotic; grade IV, giant osteophyte, joint space is obviously narrow, subchondral bone is severely sclerotic, and deformity is clear); 3. Aged 50-80 years; 4. Volunteer and sign informed consent. 

排除标准:

① 并发病影响到膝关节者,如牛皮癣、梅毒性神经病、夏科氏关节病、褐黄病、代谢性骨病、急性创伤等;合并心血管、脑血管、肝、肾、造血系统、内分泌系统等严重原发性疾病及精神病患者;继发性或创伤性膝骨关节炎患者; ② 正在参加影响本研究结果评价的其它临床试验者; ③ 近3个月内曾行关节内类固醇注射或关节置换手术;近6个月内曾行关节内透明质酸注射;在一年内准备进行全膝关节置换术者; ④ 无法独立步行,需要依赖辅助器具如手杖方能行走; ⑤ 其他原因不能配合评估、治疗及检测者。 

Exclusion criteria:

1. Patients with knee joint disease, such as psoriasis, syphilitic neuropathy, Charcot's disease, brown yellow disease, metabolic osteopathy, acute trauma, etc., with cardiovascular, cerebrovascular, liver, kidney, hematopoietic system, endocrine system and other serious primary diseases and psychosis, secondary or traumatic knee osteoarthritis; 2. Participants in other clinical trials affecting the evaluation of the results of this study; 3. In the past 3 months, the patients had received intraarticular steroid injection or arthroplasty; in the past 6 months, the patients had received intraarticular hyaluronic acid injection; in one year, they were ready for total knee arthroplasty; 4. Unable to walk independently, need to rely on auxiliary equipment such as walking stick to walk; 5. Those who are unable to cooperate with assessment, treatment and testing for other reasons. 

研究实施时间:

Study execute time:

From2019-05-01To 2021-05-31 

干预措施:

Interventions:

组别:

试验组

样本量:

100

Group:

experimental group

Sample size:

干预措施:

中医综合康复方案

干预措施代码:

Intervention:

Comprehensive rehabilitation program of traditional Chinese Medicine

Intervention code:

组别:

对照组

样本量:

100

Group:

control group

Sample size:

干预措施:

物理治疗方案

干预措施代码:

Intervention:

physicotherapeutics

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

福建 

市(区县):

福州 

Country:

China 

Province:

Fujian 

City:

Fuzhou 

单位(医院):

福建中医药大学附属康复医院 

单位级别:

三级甲等 

Institution
hospital:

Rehabilitation Hospital affiliated to Fujian University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

福建 

市(区县):

福州 

Country:

China 

Province:

Fujian 

City:

Fuzhou 

单位(医院):

泉州正骨医院 

单位级别:

三级乙等 

Institution
hospital:

Quanzhou Orthopaedic-Traumatological Hospital  

Level of the institution:

Tertiary B 

国家:

中国 

省(直辖市):

上海 

市(区县):

徐汇区 

Country:

China 

Province:

Shanghai 

City:

Xuhui District 

单位(医院):

上海中医药大学附属龙华医院 

单位级别:

三级甲等 

Institution
hospital:

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

甘肃 

市(区县):

兰州 

Country:

China 

Province:

Gansu 

City:

Lanzhou 

单位(医院):

甘肃省中医院 

单位级别:

三级甲等 

Institution
hospital:

Gansu Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

WOMAC评分

指标类型:

主要指标 

Outcome:

WOMAC

Type:

Primary indicator 

测量时间点:

干预前后

测量方法:

采用国际公认的西安大略和麦克马斯特大学骨关节炎指数(Western Ontario and McMaster Universities Osteoarthritis Index, WOMAC)量表积分评分。WOMAC为国际公认的骨关节炎评价量表,主要包括疼痛(20分)、僵硬(8分)和日常功能活动(68分)3个方面,积分为0~96分,总积分越高,说明膝关节功能障碍越严重。研究采用 V3.1普通话版五方格评分法。

Measure time point of outcome:

Measure method:

指标中文名:

疼痛视觉模拟评分

指标类型:

主要指标 

Outcome:

visual analogue scale, VAS

Type:

Primary indicator 

测量时间点:

干预前后

测量方法:

使用一条100mm长的线段,左侧标记为0分代表无任何疼痛,右侧标记为10分代表无法忍受的疼痛,分值越高表示疼痛程度越严重;患者主观判断自身膝关节疼痛程度以划定疼痛分值。

Measure time point of outcome:

Measure method:

指标中文名:

膝功能结果调查-日常生活能力量表

指标类型:

主要指标 

Outcome:

Knee Outcome Survey Activities of Daily Living Scale, KOS-ADLS

Type:

Primary indicator 

测量时间点:

干预前后

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

计时起立-行走测试

指标类型:

次要指标 

Outcome:

ime up and go test, TUG

Type:

Secondary indicator 

测量时间点:

干预前后

测量方法:

患者坐在有扶手的椅子上,被要求站起身,尽量快且安全地到达三米处的地点,而后返回重新坐下,整个过程被计时,单位为秒。10秒以内的时间表示活动正常,11~20秒是体弱的老年人和残疾人的正常范围,超过20秒的时间表示需要帮助,表示需要进一步检查和干预。

Measure time point of outcome:

Measure method:

The patient sits on an armchair, is asked to stand up, reaches the place three meters as quickly and safely as possible, and then returns to sit again. The whole process is timed in seconds. Time within 10 seconds indicates normal activity, 11-20 seconds is the normal range for the frail elderly

指标中文名:

6分钟行走测试

指标类型:

次要指标 

Outcome:

6-minute walk test

Type:

Secondary indicator 

测量时间点:

干预前后

测量方法:

患者被要求在6分钟的时间范围内尽量前行,如果需要,也可以停下休息。以60秒为间隔给予标准化的口头鼓励:“你做的很好,继续保持这样。”如果需要,患者可以使用正常的步行辅助工具。测试在无障碍的水平路面进行,测量患者行走的距离,单位为米。

Measure time point of outcome:

Measure method:

指标中文名:

楼梯测试

指标类型:

次要指标 

Outcome:

Stair test

Type:

Secondary indicator 

测量时间点:

干预前后

测量方法:

患者被要求用其日常的方式上行并下行9级楼梯,每级20cm,步伐舒适安全,整个过程被计时,单位为秒。

Measure time point of outcome:

Measure method:

指标中文名:

膝关节被动活动度

指标类型:

次要指标 

Outcome:

Passive mobility of knee joint

Type:

Secondary indicator 

测量时间点:

干预前后

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

膝关节主动活动度

指标类型:

次要指标 

Outcome:

Active mobility of knee joint

Type:

Secondary indicator 

测量时间点:

干预前后

测量方法:

Measure time point of outcome:

Before and after intervention

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

尿液

组织:

Sample Name:

urine

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 50 years
最大 Max age 80 years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

由林妙然博士将入组的200例中央随机分为试验组、对照组,每组100例,试验组:基础治疗+膝骨关节炎中医康复方案;对照组:基础治疗+物理治疗方案。 ① 建立SPSS数据文件:设一个变量(NO),输入受试对象的编号1~200; ② 设定随机种子:54321; ③ 产生随机数; ④ 对随机数编秩; ⑤ 对随机数秩次排列:按照随机数秩次从小到大进行升序排列,规定秩次1~100归入第一组,101~200归入第二组。 INPUT PROGRAM. LOOP x=1 TO 220. COMPUTE block=RND ((x-1)/4+0.5). END CASE. END LOOP. END FILE. END INPUT PROGRAM. EXECUTE. SET SEED=11000. COMPUTE random=UNIFORM(220). RANK VARIABLES=random

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

Dr. Lin Miaoren randomly divided the 200 cases into two groups: the experimental group and the control group. Each group has 100 cases. The experimental group: basic treatment + traditional Chinese medicine rehabilitation program of knee osteoarthritis; the control group: basic treatment + physical treatment program.

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):

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):

2022年1月1日后在临床试验公共管理平台,网址www.medresman.org.cn 上公开原始数据

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

After January 1, 2022, on the public management platform for clinical trials, website www.medresman.org.cn.

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:

1 源文件记录与保存的责任者规定:源文件记录的责任者是实验员,源文件保存的责任者是各临床研究机构专业科室、科研管理部门、档案室。 2 源文件记录的规定: 2.1 试验中的任何观察、检查结果均应及时、准确完整、规范、真实地记录于源文件; 2.2 源文件和源数据的修改必须有充分的证据,如需修改必须注明原因、更改者签名及日期,否则以首次判断(记录)为准。 3 源文件保存的规定: 3.1 源文件应有专门的保存地方,在研的源文件保存于专业科室的临床研究室,已完成的源文件应及时集中归档; 3.2 源文件的安全性:事先规定源文件和源数据的访问权限; 3.3 源文件的保存期限:根据GCP原则及医疗文件保存的规定,本研究源文件的保存期限为5年。 4 源文件查阅的规定: 4.1 源文件查阅应遵循医院医疗文件查阅的规定; 4.2 监查员进行现场监查(SDV)时,临床研究机构应提供方便,并在规定的场所查阅; 4.3 需要源文件的副本,应隐藏受试者的隐私信息。

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

1. The person in charge of the recording and preservation of source documents stipulates that the person in charge of the recording of source documents is the experimenter, and the person in charge of the preservation of source documents is the professional department, scientific research management department and archive room of each clinical research institution. 2. Regulations on source document records: 2.1 any observation and inspection results in the test shall be recorded in the source document timely, accurately, completely, normatively and truthfully; 2.2 there must be sufficient evidence for the modification of source documents and source data. If the modification is required, the reason, signature of the person who made the modification and the date must be indicated. Otherwise, the first judgment (record) shall prevail. 3. Regulations on the preservation of source documents: 3.1 the source documents shall be kept in a special place. The source documents under research shall be kept in the clinical research room of the professional department, and the completed source documents shall be filed in a centralized manner in a timely manner; 3.2 security of source files: specify the access rights of source files and source data in advance; 3.3 retention period of source documents: according to GCP principles and regulations on medical documents retention, the retention period of source documents in this study is 5 years. 4. Regulations on source documents: 4.1 the reference of source documents should follow the regulations of hospital medical documents; 4.2 when the surveyors carry out on-site surveillance (SDV), the clinical research institution shall provide convenience and consult in the specified place; 4.3 a copy of the source file is required, and the privacy information of the subject should be hidden.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-05-29
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