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基于膝骨关节炎探讨针刺特异性和非特异性效应的脑功能连接机制
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注册号:

Registration number:

ChiCTR1900025799 

最近更新日期:

Date of Last Refreshed on:

2020-01-26 

注册时间:

Date of Registration:

2019-09-09 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于膝骨关节炎探讨针刺特异性和非特异性效应的脑功能连接机制 

Public title:

The cerebral mechanism of the specific and nonspecific Effects of Acupuncture Based on Knee Osteoarthritis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于膝骨关节炎探讨针刺特异性和非特异性效应的脑功能连接机制 

Scientific title:

The cerebral mechanism of the specific and nonspecific Effects of Acupuncture Based on 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:

 

申请注册联系人:

张娜 

研究负责人:

刘存志 

Applicant:

Na Zhang 

Study leader:

Cunzhi Liu 

申请注册联系人电话:

Applicant telephone:

+86 18615639141 

研究负责人电话:

Study leader's telephone:

+86 010-53912201 

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:

zhangna2008zhentui@163.com 

研究负责人电子邮件:

Study leader's E-mail:

lcz623780@126.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:

北京市朝阳区北三环东路11号 

研究负责人通讯地址:

北京市朝阳区北三环东路11号 

Applicant address:

11 North Third Ring Road East, Chaoyang District, Beijing 

Study leader's address:

11 North Third Ring Road East, Chaoyang District, Beijing 

申请注册联系人邮政编码:

Applicant postcode:

100029 

研究负责人邮政编码:

Study leader's postcode:

100029 

申请人所在单位:

北京中医药大学针灸推拿学院 

Applicant's institution:

School of Acupuncture-Moxibustion and Tuina, Beijing 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:

DZMEC-KY-2017-53-02 

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:

北京中医药大学东直门医院医学伦理委员会 

Name of the ethic committee:

Ethics Committee of Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-08-29 

伦理委员会联系人:

尚建伟 

Contact Name of the ethic committee:

Jianwei Shang 

伦理委员会联系地址:

北京市东城区海运仓5号 

Contact Address of the ethic committee:

5 Haiyuncang, Dongcheng District, Beijing, 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:

北京中医药大学针灸推拿学院 

Primary sponsor:

School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine. 

研究实施负责(组长)单位地址:

北京市朝阳区北三环东路11号 

Primary sponsor's address:

11 North Third Ring Road East, 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):

北京

市(区县):

朝阳区

Country:

China

Province:

Beijing

City:

Chaoyang District

单位(医院):

北京中医药大学针灸推拿学院

具体地址:

朝阳区北三环东路11号

Institution
hospital:

School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine.

Address:

11 North Third Ring Road East, Chaoyang District

经费或物资来源:

北京市科委重大项目(项目编号:D171100003217003)资助 

Source(s) of funding:

Beijing Municipal Science & Technology Commission (D171100003217003) 

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 study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

基于膝骨关节炎,结合功能磁共振成像技术和血液检查,探讨针刺特异性和非特异性效应机制。 

Objectives of Study:

Based on knee osteoarthritis, the mechanism of specific and non-specific effects of acupuncture will be explored by combining functional magnetic resonance imaging and blood examination.  

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. 年龄45-65岁之间,男女不限; 2. 膝关节疼痛,病程超过6个月; 3. 12个月以内的放射检查显示KL分级为Ⅱ或Ⅲ级; 4. 过去一周内疼痛数字评分法(NRS)≥4; 5. 右利手; 6. 签署知情同意书者。 

Inclusion criteria

1. Aged 45-65 years, male or female; 2. Knee pain more than 6 months;; 3. KL (Kellgren-Lawrence) grade II or III in recent 12 months; 4. NRS >= 4 in the past one week; 5. Right handedness; 6. Signed 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. 评价关节1年之内有关节镜检查史、近6个月有关节腔注射史; 3. 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); 4. 严重的急性或慢性器质性或精神类疾病; 5. 凝血功能障碍疾病(如血友病等); 6. 备孕、妊娠期及哺乳期妇女; 7. 幽闭恐惧症者或体内携带心脏起搏器、金属制品等其他MRI检查禁忌者; 8. MRI扫描中发现有明确器质性病变或严重头部解剖结构不对称者; 9. 近1月内接受推拿或针灸治疗; 10. 对针具和酒精过敏或者恐惧扎针者; 11. 近3个月内参加其他临床研究者。 

Exclusion criteria:

1. Surgery history of knee or waiting for surgery (knee replacement or knee arthroscopy); 2. History of arthroscopy within 1 year or intra-articular injection within 6 months; 3. Knee pain caused by other diseases (such as joint bodies, severe effusion of joint cavity, infection, malignant tumors, autoimmune diseases, trauma, etc.); 4. Severe acute/chronic organic or mental diseases; 5. Coagulation disorders (such as hemophilia, etc.): 6. Pregnant women, pregnant and lactating women; 7. Claustrophobia or with a cardiac pacemaker, metal products and other contraindicated by MRI examinations; 8. Severe skull anatomical asymmetry or definite lesions were found in magnetic resonance scanning; 9. History of receiving acupuncture or massage treatment within 1 month; 10. Allergy to needles and alcohol, or fear acupuncture needles; 11. Participation in another clinical study in the past 3 months. 

研究实施时间:

Study execute time:

From2019-09-01To 2021-12-31 

征募观察对象时间:

Recruiting time:

From2019-09-01To 2021-12-31 

干预措施:

Interventions:

组别:

针刺组

样本量:

30

Group:

acupuncture group

Sample size:

干预措施:

每周3次针刺干预

干预措施代码:

Intervention:

patients will receive manual acupuncture 3 sessions per week for 4 weeks

Intervention code:

组别:

安慰针组

样本量:

30

Group:

placebo acupuncture group

Sample size:

干预措施:

每周3次安慰针干预

干预措施代码:

Intervention:

patients will receive placebo acupuncture 3 sessions per week for 4 weeks

Intervention code:

组别:

等待治疗组

样本量:

30

Group:

waiting group

Sample size:

干预措施:

4周内不接受任何干预。观察4周后,患者将接受12次针刺治疗作为免费补偿。

干预措施代码:

Intervention:

Patients in the waiting group will not be treated within 4 weeks. After 4 weeks of observation, patients will receive 12 times of acupuncture treatment as free compensation.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

东城区 

Country:

China 

Province:

Beijing 

City:

Dongcheng District 

单位(医院):

北京中医药大学东直门医院 

单位级别:

三级甲等 

Institution
hospital:

Dongzhimen Hospital, Beijing University of Chinese Medicine  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

有效应答率

指标类型:

主要指标 

Outcome:

Response rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

脑功能活动

指标类型:

主要指标 

Outcome:

Brain Functional Activity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

WOMAC量表

指标类型:

次要指标 

Outcome:

Western Ontario and McMaster Universities Osteoarthritis Index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

斯坦福期望治疗量表

指标类型:

次要指标 

Outcome:

Stanford Expectations of Treatment Scale

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

状态-特质焦虑-状态量表

指标类型:

次要指标 

Outcome:

State-Trait Anxiety Inventory-State

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

服用抢救药物人数

指标类型:

次要指标 

Outcome:

Number of people taking rescue medications

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

针刺不良反应

指标类型:

次要指标 

Outcome:

Adverse events about acupuncture

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

盲法评价

指标类型:

次要指标 

Outcome:

Blind evaluation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

催产素检测

指标类型:

次要指标 

Outcome:

Oxytocin

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

基因多态性

指标类型:

次要指标 

Outcome:

Gene polymorphism

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:

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:

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 45 years
最大 Max age 65 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):

采用区组随机,随机序列由一位专业的统计学家用SAS 9.3软件产生,该统计学家不参与试验评价、治疗或分析。

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

The blocked randomization sequence was prepared by a professional statistician with the SAS 9.3 software, who is not involved in assessment, treatment or analysis.

盲法:

对结局评价者和数据统计分析者设盲。

Blinding:

Blind method for evaluators and statisticians.

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:

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):

试验完成后6个月内,通过中国临床试验注册中心的ResMan平台进行原始数据的共享(http://www.medresman.org/login.aspx)

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

Within 6 months after the trial complete, we will share IPD based on the ResMan platform (http://www.medresman.org/login.aspx)

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:

通过纸质CRF表格记录元数据,再由两人交叉核对将数据转录到epidata建立的数据库。数据管理由专人负责。

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

The records of metadata are recorded through a CRF form, and then cross-checked and transcribed to an electronic database file based on Epidata software. All the data management is handled by an independent person.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-09-09
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