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: |
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English Acronym: |
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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: |
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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: |
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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): |
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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: |
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申请人所在单位: |
上海体育学院 |
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Applicant's institution: |
Shanghai University of Sport |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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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: |
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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 |
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Name of the ethic committee: |
the Ethics Committee of Shanghai University of Sport |
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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: |
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Contact Name of the ethic committee: |
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伦理委员会联系地址: |
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Contact Address of the ethic committee: |
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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 |
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Primary sponsor: |
Shanghai University of Sport |
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研究实施负责(组长)单位地址: |
上海市长海路399号 |
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Primary sponsor's address: |
399 Changhai Road, Shanghai |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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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) |
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Source(s) of funding: |
This study was supported by the Key Laboratory of Exercise and Health Sciences (Shanghai University of Sport), Ministry of Education |
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研究疾病: |
下背痛 |
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Target disease: |
low back pain |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
其它 | ||||||||||||||||||||||
Study phase: |
N/A |
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研究目的: |
观察全身振动训练在慢性下背痛患者的疗效 |
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Objectives of Study: |
Whether whole body vibration exercise is effective for the treatment of low back pain; |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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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。 |
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Inclusion criteria |
1. aged 18 to 60 years; 2. pain longer than 3 months; 3. without abnormal sense and reflection of the lower extremity. |
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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。 |
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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: |
从From2013-11-01至To 2014-11-01 |
征募观察对象时间: Recruiting time: |
从From2013-11-01至To 2014-01-01 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
结束 Completed |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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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 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
computer generated random list |
盲法: |
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Blinding: |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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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 |