浮针治疗膝骨关节炎随机对照研究

注册号:

Registration number:

AMCTR-IOR-20000340 

注册号获得时间:

Date of releasing the registration number:

2020/6/15 10:53:31 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

浮针治疗膝骨关节炎随机对照研究 

Public title:

A randomized controlled study on the treatment of knee osteoarthritis with Fu’s subcutaneous needling 

研究课题的正式科学名称:

以浮针技术为示例中医技能型干预措施规范与疗效评价的共性技术及方法研究 

Scientific title:

A study on the common techniques and methods of TCM technical intervention measures specification and efficacy evaluation with floating needle technique as an example 

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:

李洪皎 

研究负责人:

李洪皎 

Applicant:

Hongjiao Li 

Study leader:

Hongjiao Li 

申请注册联系人电话:

Applicant telephone:

15011003216 

研究负责人电话:

Study leader's telephone:

15011003216 

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:

lhjiao2013@163.com 

研究负责人电子邮件:

Study leader's E-mail:

lhjiao2013@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:

北京市东直门内南小街16号 

研究负责人通讯地址:

北京市东直门内南小街16号 

Applicant address:

No. 16, Nanxiao Road,Dongzhimen, Dongcheng District, Beijing 

Study leader's address:

No. 16, Nanxiao Road,Dongzhimen, Dongcheng District, Beijing 

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:

中国中医科学院中医临床基础医学研究所 

Applicant's institution:

Institute Of Basic Research In Clinical Medicine,China Academy Of Chinese Medical Sciences 

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:

BF2019-232-01 

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:

广东省中医院伦理委员会 

Name of the ethic committee:

Ethics committee of Guangdong hospital of traditional Chinese medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-01-17 

研究实施负责(组长)单位:

广东省中医院 

Primary sponsor:

Guangdong Hospital of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

广东省中医院 

Primary sponsor's address:

Guangdong Hospital of Traditional Chinese Medicine 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院中医临床基础医学研究所

具体地址:

北京市东直门内南小街16号

Institution
hospital:

Institute Of Basic Research In Clinical Medicine,China Academy Of Chinese Medical Sciences

Address:

No. 16, Nanxiao Road,Dongzhimen, Dongcheng District, Beijing

经费或物资来源:

中国中医科学院中医临床基础医学研究所自选课题 

Source(s) of funding:

Optional Subjects of Institute Of Basic Research In Clinical Medicine,China Academy Of Chinese Medical Sciences 

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:

其它 

Study phase:

Other 

研究目的:

通过高技能、初级技能浮针医师治疗膝骨关节炎的临床研究,对比不同技能浮针医师的临床疗效,并分析疗效影响因素。 

Objectives of Study:

To compare the clinical efficacy of Fu’s subcutaneous needling doctors with different skills and the influencing factors of curative effect by clinical study on the treatment of knee osteoarthritis of doctors with high skill and primary skil. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

(1)符合膝骨关节炎诊断标准者; (2)膝关节X线分级符合Kellgren-Lawrence I—III级; (3)年龄在45-75岁之间者; 

Inclusion criteria

(1) Those who meet the diagnostic criteria for knee osteoarthritis (2) The X-ray grade of the knee is kellgren-Lawrence I-III; (3) persons between 45 and 75 years old; 

排除标准:

(1)患膝局部急性炎症反应,有红肿热痛症状; (2)患膝关节严重畸形、下肢力线不良者; (3)合并有心脑血管、肝、肾和造血系统等严重危及生命的疾病患者;患有急性传染病或严重皮肤病而不宜治疗者; (4)合并其他骨关节病:痛风性关节炎;类风湿性关节炎;髌骨软化症;大骨节病;膝关节特发骨坏死;膝关节发育畸形等; (5)并发症影响到关节者,如牛皮癣、梅毒性神经病、褐黄病、代谢性骨病、急性创伤等。 (6)恶性肿瘤、精神病患者;难以随访者; (7)目标膝关节在近1年内有手术史,或严重创伤史; (8)服用抗凝药等具有自发性出血倾向者; (9)孕妇、哺乳期妇女; (10)拒绝签署知情同意者。 

Exclusion criteria:

(1) Acute local inflammatory reaction of the affected knee, with symptoms of redness, swelling, heat and pain; (2) Severe deformity of knee joint and malformation of lower limb (3) Patients with serious life-threatening diseases such as cardiovascular and cerebrovascular diseases, liver, kidney and hematopoietic systems; Persons suffering from acute infectious diseases or serious skin diseases and unfit for treatment (4) Other joint diseases: gout arthritis; Rheumatoid arthritis; Patellar malacia; Kashin-beck disease; Osteonecrosis of knee joint; Knee joint development malformation, etc (5) Complications affecting the joints, such as psoriasis, plum toxic neuropathy, brown yellow disease, metabolic bone disease, acute trauma, etc. (6) patients with malignant tumors or mental diseases; Difficult to follow visitors; (7) Target knee has a history of surgery or severe trauma in the past 1 year; (8) Patients with spontaneous bleeding tendency, such as taking anticoagulants; (9) Pregnant and lactating women; (10) Those who refuse to sign informed consent 

研究实施时间:

Study execute time:

From2020-01-01To 2021-12-31 

干预措施:

Interventions:

组别:

高技能浮针医师组

样本量:

40

Group:

High skill Fu’s subcutaneous needling

Sample size:

干预措施:

高技能浮针医师浮针治疗

干预措施代码:

1

Intervention:

treatment conducted by high skill Fu's subcutaneous needing

Intervention code:

组别:

低技能浮针医师组

样本量:

40

Group:

Primary skill Fu's subcutaneous needing

Sample size:

干预措施:

低技能浮针医师浮针治疗

干预措施代码:

2

Intervention:

treatment conducted by primary skill Fu's subcutaneous needing

Intervention code:

组别:

空白对照组

样本量:

40

Group:

Blank control group

Sample size:

干预措施:

空白等待,入组7天后开始浮针治疗

干预措施代码:

3

Intervention:

Treatment was resumed 7 days after enrollment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

广州市 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广东省中医院 

单位级别:

三级甲等 

Institution
hospital:

Guangdong hospital of traditional Chinese medicine  

Level of the institution:

Third-class hospital 

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):

南京浮针医学研究所 

单位级别:

私立医院 

Institution
hospital:

Nanjing Institute of Fu’s subcutaneous needle Medicine  

Level of the institution:

Private hospita 

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 

指标中文名:

即刻疼痛改善

指标类型:

次要指标 

Outcome:

Immediate pain improvement

Type:

Secondary indicator 

指标中文名:

安全性指标

指标类型:

次要指标 

Outcome:

Security indicators

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):

中央随机系统

性别:

男女均可

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

Interactive Web Response System

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):

数据库,试验完成6个月后

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

Database, 6 months after completion of the trial

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):

病例报告表,临床研究数据管理系统

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

Case report form, clinical research data management system

创建人:

Creater Name:

 2020-05-25
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