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Resting-state functional research of Balance Acupuncture therapeutic central mechanism for lumbar intervertebral disc herniation by magnetic resonance imaging
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注册号:

Registration number:

ChiCTR-TRC-09000519 

最近更新日期:

Date of Last Refreshed on:

2015-05-15 

注册时间:

Date of Registration:

2009-08-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

运用磁共振脑功能成像技术探索平衡针治疗腰椎间盘突出症的中枢机制 

Public title:

Resting-state functional research of Balance Acupuncture therapeutic central mechanism for lumbar intervertebral disc herniation by magnetic resonance imaging 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

运用磁共振脑功能成像技术探索平衡针治疗腰椎间盘突出症的中枢机制 

Scientific title:

Resting-state functional research of Balance Acupuncture therapeutic central mechanism for lumbar intervertebral disc herniation by magnetic resonance imaging 

研究课题代号(代码):

Study subject ID:

09CX068 

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:

叶泳松 

研究负责人:

叶泳松 

Applicant:

Yongsong Ye 

Study leader:

Yongsong Ye 

申请注册联系人电话:

Applicant telephone:

+86 020 81887233-38112 

研究负责人电话:

Study leader's telephone:

+86 020 81887233-38112 

申请注册联系人传真 :

Applicant Fax:

+86 020 81887233 

研究负责人传真:

Study leader's fax:

+86 020 81887233 

申请注册联系人电子邮件:

Applicant E-mail:

ye7yong7song@163.com 

研究负责人电子邮件:

Study leader's E-mail:

ye7yong7song@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

www.gdhtcm.com 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

www.gdhtcm.com 

申请注册联系人通讯地址:

广东省广州市越秀区大德路111号广东省中医院影像科 

研究负责人通讯地址:

广东省广州市越秀区大德路111号广东省中医院影像科 

Applicant address:

No.111, Dade Road, Guangzhou City, Guangdong Province, China 

Study leader's address:

No.111, Dade Road, Guangzhou City, Guangdong Province, China 

申请注册联系人邮政编码:

Applicant postcode:

510120 

研究负责人邮政编码:

Study leader's postcode:

510120 

申请人所在单位:

广东省中医院 

Applicant's institution:

Guangdong Provincial Hospital 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:

2008GL-42 

伦理委员会批件附件:

Approved file of Ethical Committee:

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 Provincial Hospital of Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

广东省中医院(广州中医药大学附属第二医院) 

Primary sponsor:

Guangdong Provincial Hospital of Chinese Medicine 

研究实施负责(组长)单位地址:

广东省广州市越秀区大德路111号 

Primary sponsor's address:

No.111, Dade Road, Guangzhou City, Guangdong Province, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

广州中医药大学中医药科研创新基金项目 

Source(s) of funding:

Guangzhou university of Traditional Chinese Medicine Creative research fund 

研究疾病:

腰椎间盘突出 

Target disease:

Lumbar intervertebral disc herniation 

研究疾病代码:

M51.202 

Target disease code:

M51.202 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

IV期临床试验 

Study phase:

研究目的:

平衡针治疗腰椎间盘突出的起效机理 

Objectives of Study:

To research the central mechanism of Balance Acupuncture therapeutic for lumbar intervertebral disc herniation 

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:

腰椎间盘突出组:①起病或病情发作不超过1个月者;②均为右利手;③有腰部外伤、慢性劳损急性发作史;④年龄在20-40岁;⑤VAS法疼痛评分积分5分以上患者;⑥腰部向臀部及下肢放射痛,腹压增加(咳嗽、打喷嚏等)疼痛加剧;⑦直腿抬高及拾物试验均为阳性,膝、跟腱反射减弱或消失;⑧CT或MR证实有腰椎间盘突出;⑨签署知情同意书者。 

Inclusion criteria

1. Pathogenesis within one month; 2. Right handedness; 3. History of external injury in the lumbar part or acute stage with chronic lumbar muscle strain; 4. Between the age from 20 to 40 years old; 5. Above 5 score of angelic grading; 6. Radiating pain from lumbar part to haunch and lower limb, which was intensified by augmented abdominal pressure, such as cough and sneeze and so on; 7. Positive result in the straight leg raising test and pick-up test; weaken or vanish of the knee jerk reflex and Achilles reflex; 8. Lumbar intervertebral disc herniation was diagnosed by CT or MR; 9. The subjects who have already signed the informed consent. 

排除标准:

腰椎间盘突出组:①妊娠或哺乳期妇女;②合并严重心脑血管、肝、肾、造血系统等疾病者;③神经官能症及精神病患者;④腰椎间盘突出物钙化、侧隐窝狭窄、椎管狭窄、梨状肌综合征、干性坐骨神经痛、腰椎肿瘤、腰椎结核、腰椎骨折、腰椎滑脱者;⑤服用镇痛药者;⑥确诊为腰椎间盘突出症但无临床症状者;⑦对治疗不配合者。 

Exclusion criteria:

1. The women who were in the process of pregnancy or lactation; 2. History of serious diseases of Cardiac, Cerebrovascular, hepatic, renal, hematopoietic system and so on; 3. History of neurosis or psychosis; 4. History of calcification, lateral recess stenosis, vertebral canal stenosis, pyriformis syndrome, ischioneuralgia of trunk type, tumor, tuberculosis, fracture, olisthe of lumbar vertebrae; 5. History of having taken pain-killer; 6. No clinical symptom of Lumbar intervertebral disc herniation was diagnosed; 7. Not the partner treatment. 

研究实施时间:

Study execute time:

From2009-10-01To 2011-10-31 

征募观察对象时间:

Recruiting time:

From2009-10-01To  

干预措施:

Interventions:

组别:

A

样本量:

50

Group:

Group A

Sample size:

干预措施:

平衡针

干预措施代码:

Intervention:

Balance Acupuncture

Intervention code:

组别:

B

样本量:

50

Group:

Group B

Sample size:

干预措施:

常规针刺

干预措施代码:

Intervention:

Normal Acupuncture

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广东省中医院 

单位级别:

三甲医院 

Institution
hospital:

Guangdong Provincial Hospital of Chinese Medicine  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

脑部局部一致性

指标类型:

主要指标 

Outcome:

Regional homogeneity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

脑部低频振幅

指标类型:

主要指标 

Outcome:

Amplitude of low-frequency fluctuation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

脑功能连接

指标类型:

主要指标 

Outcome:

Functional Connectivity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Oswestry功能障碍指数

指标类型:

次要指标 

Outcome:

Oswestry Disability 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:

简式疼痛问卷表(MPQ)

指标类型:

次要指标 

Outcome:

McGill pain questionnaire, MPQ

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

现在疼痛状况(PPI)

指标类型:

次要指标 

Outcome:

Present Pain Intensity scale, PPI

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

目测类比疼痛评分(VAS)

指标类型:

次要指标 

Outcome:

Visual Analogue Scale, VAS

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:

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 40 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):

计算机软件

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

Computer Software

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

广东省中医院影像科

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

Guangdong Provincial Hospital of Chinese Medicine

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:

广东省中医院影像科

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

Guangdong Provincial Hospital of Chinese Medicine

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2009-08-26
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