不同穴区组织结构在产生得气针感中的作用及其脑功能效应的初步探讨

注册号:

Registration number:

AMCTR-IOR-20000314 

注册号获得时间:

Date of releasing the registration number:

2020/1/2 1:22:58 

注册号状态:

补注册  

Registration Status:

1008002 Retrospective registration  

注册题目:

不同穴区组织结构在产生得气针感中的作用及其脑功能效应的初步探讨 

Public title:

The role of different tissues under acupoints in the production of various needling sensations and the brain responses detected by fMRI 

研究课题的正式科学名称:

不同穴区组织结构在产生得气针感中的作用及其脑功能效应的初步探讨 

Scientific title:

The role of different tissues under acupoints in the production of various needling sensations and the brain responses detected by fMRI 

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:

高俊虹 

研究负责人:

高俊虹 

Applicant:

Gao Junhong 

Study leader:

Gao Junhong 

申请注册联系人电话:

Applicant telephone:

18518093378 

研究负责人电话:

Study leader's telephone:

18518093378 

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:

gaojh@mail.cintcm.ac.cn 

研究负责人电子邮件:

Study leader's E-mail:

gaojh@mail.cintcm.ac.cn 

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:

北京市东城区东直门内南小街16号 

研究负责人通讯地址:

北京市东城区东直门内南小街16号 

Applicant address:

No.16 Nanxiao Street, Dongzhimen Nei, Dongcheng District, Beijing 

Study leader's address:

No.16 Nanxiao Street, Dongzhimen Nei, Dongcheng District, Beijing 

申请注册联系人邮政编码:

Applicant postcode:

1007100 

研究负责人邮政编码:

Study leader's postcode:

100700 

申请人所在单位:

中国中医科学院针灸研究所 

Applicant's institution:

Institute of Acupuncture and Moxibusion, 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:

中科针伦(2018-03-08) 

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:

中国中医科学院针灸研究所伦理委员会 

Name of the ethic committee:

Ethics Committee of Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-03-08 

研究实施负责(组长)单位:

中国中医科学院针灸研究所 

Primary sponsor:

Institute of Acupuncture and Moxibusion, China Academy of Chinese Medical Sciences 

研究实施负责(组长)单位地址:

北京市东城区东直门内南小街16号 

Primary sponsor's address:

No.16 Nanxiao Street, Dongzhimen Nei, Dongcheng 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):

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院针灸研究所

具体地址:

北京市东城区东直门内南小街16号

Institution
hospital:

Institute of Acupuncture and Moxibusion, China Academy of Chinese Medical Sciences

Address:

No.16 Nanxiao Street, Dongzhimen Nei, Dongcheng District, Beijing

经费或物资来源:

中国中医科学院 

Source(s) of funding:

China Academy of Chinese Medical Sciences 

研究疾病:

健康人 

Target disease:

Healthy participant 

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:

本项目拟研究探讨穴区不同组织结构(肌肉、皮肤、结缔组织等)在引起不同得气针感(受针者得气感与施针者针感)中的作用及其与穴区肌电和fMRI脑功能变化的关系,为针刺得气针感理论提供科学解释,并藉此为其临床应用、提高临床疗效提供科学依据。 

Objectives of Study:

This project intends to explore the effects on Deqi sensations, myoelectricity around the acupoint and brain effects by needling at different tissues (muscle, skin and connective tissue, etc.) of the acupoint. The completion of the study is expected to provide a scientific explanation for the theory of Deqi and a scientific basis for its clinical application and improvement of clinical curative effect. 

研究设计:

随机交叉对照 

Study design:

Randomized cross-over control 

纳入标准:

1 右利手; 2 年龄20~30岁,身体健康,男女不限; 3 中等身材:体重50-80 kg,体重指数19-24; 4 学历:本科及以上学历; 5 作息规律,无吸烟、嗜酒等不良嗜好; 6 无重大身体疾病和精神病,无怀孕,无右腿外伤史或皮损; 7 试验前四周内、试验期间不服用其它任何药物。 

Inclusion criteria

1 Right handedness; 2 Healthy participant with ages of 20-30 years, male or female; 3 Body weight of 50-80 kg and BMI of 19-24; 4 Bachelor degree or above; 5 Have regular schedule, no consuming of cigarettes and alcohol or other bad habits; 6 No mental or medical disorders, no pregnancy, no history of right-leg hurt or skin damage; 7 No medications within 4 weeks before the trial and during the trial. 

排除标准:

1 体内金属器件植入者(金属假牙、骨折固定钢板等); 2 心、肝、脑、肾等重要器官严重疾病者; 3 精神疾病者; 4 妊娠期; 5 右腿外伤、皮损等。 

Exclusion criteria:

1 Participant with metal in body (such as metal dentures, Fracture fixation plate, etc. ) 2 Serious diseases of heart, liver, brain, kidney and other organs; 3 Mental disorders; 4 Pregnancy; 5 History of right-leg hurt or skin damage. 

研究实施时间:

Study execute time:

From2018-01-01To 2019-12-31 

干预措施:

Interventions:

组别:

足三里穴皮肤层针刺组

样本量:

44

Group:

Skin needling at ST36

Sample size:

干预措施:

针刺

干预措施代码:

Intervention:

Needling

Intervention code:

组别:

足三里穴肌肉层针刺组

样本量:

44

Group:

Muscle needling at ST36

Sample size:

干预措施:

表皮麻醉,针刺

干预措施代码:

Intervention:

Surface anesthesia, Needling

Intervention code:

组别:

足三里全穴针刺组

样本量:

44

Group:

Needling at ST36

Sample size:

干预措施:

针刺

干预措施代码:

Intervention:

Needling

Intervention code:

组别:

犊鼻穴针刺组

样本量:

44

Group:

Needling at ST35

Sample size:

干预措施:

针刺

干预措施代码:

Intervention:

Needling

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):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国中医科学院广安门医院 

单位级别:

国家级 

Institution
hospital:

Guang An Men hospital, China Academy of Chinese Medical Sciences  

Level of the institution:

National level 

测量指标:

Outcomes:

指标中文名:

得气针感

指标类型:

主要指标 

Outcome:

Needling sensations

Type:

Primary indicator 

指标中文名:

头颅fMRI

指标类型:

主要指标 

Outcome:

Brain fMRI

Type:

Primary indicator 

指标中文名:

穴区表面肌电

指标类型:

主要指标 

Outcome:

Surface myoelectricity

Type:

Primary indicator 

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 20 years
最大 Max age 30 years

随机方法(请说明由何人用什么方法产生随机序列):

由研究负责人采用随机抽签法决定受试者针刺组别的顺序。

性别:

男女均可

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

Random lottery method was adopted by study leader.

Gender:

Both

盲法:

本试验采用单盲法:受试者不知道自己接受的是何种针刺方法。

Blinding:

Single blind was used in the study to prevent the participant know which needling manipulation he/she accepted.

试验完成后的统计结果:

统计针感的强度、频率,肌电积分值,激活与负激活脑区。

Calculated Results ater
the Study Completed:

The needling sensations' intensity and frequency, the integrated EMG values, the activated and deactivated brain areas.

研究负责(组长)单位:

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):

数据在实验过程中通过纸质版表格、excel表格和光盘共享。

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

Data are shared by paper and office excel during study.

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):

数据通过纸质版表格,excel表格和光盘保存。

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

Data are saved by paper, office excel and CD.

创建人:

Creater Name:

 2019-12-13
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