不同灸量治疗膝骨关节炎的随机对照试验

注册号:

Registration number:

AMCTR-IPR-18000226 

注册号获得时间:

Date of releasing the registration number:

2018/11/20 10:27:55 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

不同灸量治疗膝骨关节炎的随机对照试验 

Public title:

Moxibustion of different treatment doses for knee osteoarthritis:a randomized controlled trial 

研究课题的正式科学名称:

不同灸量治疗膝骨关节炎的临床疗效观察 

Scientific title:

Moxibustion of different treatment doses for knee osteoarthritis:a randomized controlled trial 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

陈瑜 

研究负责人:

贾春生 

Applicant:

Yu Chen 

Study leader:

Chunsheng Jia 

申请注册联系人电话:

Applicant telephone:

15633872346 

研究负责人电话:

Study leader's telephone:

13373013018 

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:

1356652382@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

jia7158@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:

河北省石家庄市桥西区新石南路326号 

研究负责人通讯地址:

河北省石家庄市桥西区新石南路326号 

Applicant address:

326 Xinshinanlu,Qiaoxi District, Shijiazhuang, Hebei, P.R.China HeBei University of Chinese Medicine 

Study leader's address:

326 Xinshinanlu,Qiaoxi District, Shijiazhuang, Hebei, P.R.China HeBei University of Chinese Medicine 

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:

050090 

申请人所在单位:

河北中医学院 

Applicant's institution:

Hebei University of 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:

[2018]007 

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:

河北中医学院伦理委员会 

Name of the ethic committee:

HeBei University of Chinese Medicine Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-11-01 

研究实施负责(组长)单位:

河北中医学院 

Primary sponsor:

Hebei University of Chinese Medicine 

研究实施负责(组长)单位地址:

河北省石家庄市桥西区新石南路326号 

Primary sponsor's address:

326 Xinshinanlu,Qiaoxi District, Shijiazhuang, Hebei, P.R.China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

自筹经费 

Source(s) of funding:

Self-financing 

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 

研究所处阶段:

预实验 

Study phase:

Polit 

研究目的:

比较不同灸量治疗膝骨关节炎的安全性和疗效。 

Objectives of Study:

To compare the safety and efficacy of different moxibustion doses in a pilot randomized controlled trial of knee osteoarthritis. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

1.符合膝骨关节炎的诊断标准; 2.年龄45-75岁之间,男女不限; 3.单/双侧膝关节疼痛,病程超过6个月; 4.6个月以内的放射检查显示KL分级Ⅰ、Ⅱ、Ⅲ级; 5.4≤NRS≤7; 6.签署知情同意书。 

Inclusion criteria

1.Meeting the knee osteoarthritis criteria; 2.Aged 45–75 years; 3.Unilateral or bilateral knees pain ,duration of more than 6 months; 4.Radiological assessment of knee osteoarthritis rated as grade 1,2 and 3 on the Kellgren-Lawrence Grading Scale in previous 6 months; 5.An overall score is from 4 to 7 on the Number Rating Scale(NRS); 6.Signing informed consent; 

排除标准:

1.有膝关节手术史或正在等待膝关节手术(膝关节置换或膝关节镜手术); 2.其他疾病引起的膝部疼痛(如关节游离体、关节腔严重积液、感染、恶性肿瘤、自身免疫疾病、外伤、骨折、痛风等); 3.评价关节1年之内有关节镜检查史、近4个月有关节腔注射史; 4.近3月内接受艾灸治疗; 5.严重的急性或慢性器质性或精神神经类疾病; 6.凝血功能障碍(如血友病); 7.具有心脏起搏器; 8.妊娠期或意向妊娠及哺乳期妇女; 9.正在参加其他临床研究; 10.拒绝签知情同意书. 

Exclusion criteria:

1.Surgery history in the target knee joint or waiting for knee surgery(?total?knee?arthroplasty or arthroscopy); 2.Knee pain caused by other diseases(joint free body, severe effusion in the joint cavity,infection,malignant tumor,autoimmune disease,trauma,fracture,gout,and so on ); 3.Arthroscopy history in the target knee joint in previous 1 year and intra-articular injection history in the target knee joint in previous 4 months; 4.History of moxibustion treatment in previous 3 months; 5.Any serious organic or mental diseases; 6.Coagulation disorder 7.With Cardiac pacemaker; 8.Pregnant and intentional pregnancy or lactation women; 9.Participating in other clinical trials; 10.Refusal to sign informed consent. 

研究实施时间:

Study execute time:

From2018-11-17To 2019-12-16 

干预措施:

Interventions:

组别:

艾灸Ⅰ组

样本量:

37

Group:

group 1

Sample size:

干预措施:

高灸量

干预措施代码:

Intervention:

high moxibustion dose

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

数字评定量表

指标类型:

主要指标 

Outcome:

NRS

Type:

Primary indicator 

指标中文名:

西安大略和麦克马斯特大学骨关节炎指数功能亚表

指标类型:

主要指标 

Outcome:

WOMAC

Type:

Primary indicator 

指标中文名:

健康调查简表

指标类型:

次要指标 

Outcome:

SF-12

Type:

Secondary indicator 

指标中文名:

数字评定量表

指标类型:

次要指标 

Outcome:

NRS

Type:

Secondary indicator 

指标中文名:

WOMAC疼痛亚表

指标类型:

次要指标 

Outcome:

Pain sub-table in WOMAC

Type:

Secondary indicator 

指标中文名:

WOMAC功能亚表

指标类型:

次要指标 

Outcome:

Functional sub-table in WOMAC

Type:

Secondary indicator 

指标中文名:

WOMAC僵硬亚表

指标类型:

次要指标 

Outcome:

Stiff sub-table in WOMAC

Type:

Secondary indicator 

指标中文名:

整体疗效评价

指标类型:

次要指标 

Outcome:

Overall Treatment Efficacy

Type:

Secondary indicator 

指标中文名:

体表温度

指标类型:

次要指标 

Outcome:

Body surface temperature

Type:

Secondary indicator 

指标中文名:

血压

指标类型:

次要指标 

Outcome:

Blood pressure

Type:

Secondary indicator 

指标中文名:

心电图

指标类型:

次要指标 

Outcome:

Electrocardiogram

Type:

Secondary indicator 

指标中文名:

血常规

指标类型:

次要指标 

Outcome:

Blood routine examination

Type:

Secondary indicator 

指标中文名:

尿常规

指标类型:

次要指标 

Outcome:

urine routine examination

Type:

Secondary indicator 

指标中文名:

肝功能检查

指标类型:

次要指标 

Outcome:

Liver function test

Type:

Secondary indicator 

指标中文名:

肾功能检查

指标类型:

次要指标 

Outcome:

Renal function test

Type:

Secondary indicator 

指标中文名:

艾灸不良反应

指标类型:

副作用指标 

Outcome:

Adverse events about moxibustion

Type:

Adverse events 

指标中文名:

可信度评价

指标类型:

副作用指标 

Outcome:

Credibility evaluation

Type:

Adverse events 

指标中文名:

盲法评价

指标类型:

副作用指标 

Outcome:

Blind evalution

Type:

Adverse events 

指标中文名:

肿瘤坏死因子-α

指标类型:

次要指标 

Outcome:

Tumor Necrosis Factor-α

Type:

Secondary indicator 

指标中文名:

白细胞介素10

指标类型:

次要指标 

Outcome:

Interleukin-10

Type:

Secondary indicator 

指标中文名:

超氧化物歧化酶

指标类型:

次要指标 

Outcome:

Superoxide Dismutase

Type:

Secondary indicator 

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

Pending

年龄范围:

Participant age:

最小 Min age 45 years
最大 Max age 75 years

随机方法(请说明由何人用什么方法产生随机序列):

应用SPSS软件生成随机数字进行随机分组

性别:

男女均可

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

Randomly group patients using SPSS version 21.0 statistical software(SPSS,Chicago,IL)

Gender:

Both

盲法:

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

原始数据将在研究中心封存

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

The initial data will be stored in the research center.

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

原始数据将密封保存,制作电子数据,保存在2台不同电脑。

The repository and management of the data(Please specify what repository will be used for management of the metadata):

Initial data will be sealed to preserve. The electronic data shoulded be stored in 2 different computers.

创建人:

Creater Name:

 2018-11-13
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