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全身振动训练与下背痛:随机对照试验
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注册号:

Registration number:

ChiCTR-TRC-13003708 

最近更新日期:

Date of Last Refreshed on:

2016-04-30 

注册时间:

Date of Registration:

2013-10-19 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

全身振动训练与下背痛:随机对照试验 

Public title:

Whole body vibration exercise for low back pain: a randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

全身振动训练与下背痛:随机对照试验 

Scientific title:

Whole body vibration exercise for low back pain: a randomized controlled trial 

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:

王雪强 

研究负责人:

陈佩杰 

Applicant:

Xueqiang Wang 

Study leader:

Peijie Chen 

申请注册联系人电话:

Applicant telephone:

+86 02151253425 

研究负责人电话:

Study leader's telephone:

+86 02151253425 

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:

qiang897@163.com 

研究负责人电子邮件:

Study leader's E-mail:

chenpeijie@sus.edu.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:

上海市长海路399号 

研究负责人通讯地址:

上海市长海路399号 

Applicant address:

399 Changhai Road, Shanghai 

Study leader's address:

399 Changhai Road, Shanghai 

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:

上海体育学院 

Applicant's institution:

Shanghai University of Sport 

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:

2013-24 

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:

上海体育学院科学研究伦理委员会 

Name of the ethic committee:

the Ethics Committee of Shanghai University of Sport 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

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:

上海体育学院 

Primary sponsor:

Shanghai University of Sport 

研究实施负责(组长)单位地址:

上海市长海路399号 

Primary sponsor's address:

399 Changhai Road, Shanghai 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上体伤骨科医院

具体地址:

上海市长海路399号

Institution
hospital:

Shangti orthopedic hospital

Address:

399 Changhai Road, Shanghai

经费或物资来源:

运动健身科技省部共建教育部重点实验室(上海体育学院) 

Source(s) of funding:

This study was supported by the Key Laboratory of Exercise and Health Sciences (Shanghai University of Sport), Ministry of Education 

研究疾病:

下背痛 

Target disease:

low back pain 

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:

其它 

Study phase:

N/A 

研究目的:

观察全身振动训练在慢性下背痛患者的疗效 

Objectives of Study:

Whether whole body vibration exercise is effective for the treatment of low back pain; 

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:18-60岁;2)疼痛大于3个月;3)无下肢感觉、反射异常。 

Inclusion criteria

1. aged 18 to 60 years; 2. pain longer than 3 months; 3. without abnormal sense and reflection of the lower extremity. 

排除标准:

1)内脏疾病所致腰痛;2)近期接受过核心稳定性训练;3)骨折、脱位、结构异常、手术及类风湿关节炎或强直性脊柱炎;4)合并严重心血管疾病、神经系统疾病、骨质疏松及代谢性疾病等;5)妊娠或哺育期妇女。 

Exclusion criteria:

1. low back pain caused by visceral disease; 2. attended core stability training program; 3. undergone previous surgery, dislocation, fracture, structural anomalies, rheumatoid arthritis, and ankylosing spondylitis; 4. severe cardiovascular, progressive neurological deficits, severe osteoporosis,or metabolic diseases; 5. pregnancy women or lactating women. 

研究实施时间:

Study execute time:

From2013-11-01To 2014-11-01 

征募观察对象时间:

Recruiting time:

From2013-11-01To 2014-01-01 

干预措施:

Interventions:

组别:

干预组

样本量:

60

Group:

intervention group

Sample size:

干预措施:

全身振动训练

干预措施代码:

Intervention:

whole body vibration exercise

Intervention code:

组别:

对照组

样本量:

60

Group:

control group

Sample size:

干预措施:

常规训练

干预措施代码:

Intervention:

Routine exercise

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海体育学院 

单位级别:

高校 

Institution
hospital:

Shanghai University of Sport  

Level of the institution:

University 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上体伤骨科医院 

单位级别:

专科医院 

Institution
hospital:

Shangti orthopedic hospital  

Level of the institution:

special hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海浦南医院 

单位级别:

二甲 

Institution
hospital:

Shanghai Punan hospital  

Level of the institution:

Second A Hospital 

测量指标:

Outcomes:

指标中文名:

Visual Analogue Scale (VAS) score

指标类型:

主要指标 

Outcome:

Visual Analogue Scale (VAS) score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

back function

指标类型:

主要指标 

Outcome:

back function

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Adverse effect

指标类型:

主要指标 

Outcome:

Adverse effect

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

intra-abdominal pressure

指标类型:

次要指标 

Outcome:

intra-abdominal pressure

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

muscle strength of spine

指标类型:

次要指标 

Outcome:

muscle strength of spine

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SF-36

指标类型:

次要指标 

Outcome:

SF-36

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

joint position sens

指标类型:

次要指标 

Outcome:

joint position sens

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 18 years
最大 Max age 60 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):

电脑随机方法

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

computer generated random list

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

否No

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):

NA

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

NA

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:

NA

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

NA

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2013-10-19
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