Today is 2019-08-21

Clinical randomized controlled trial on the effect of core stability feedback training through RUSI combined with sEMG
download

注册号:

Registration number:

ChiCTR1800014609 

最近更新日期:

Date of Last Refreshed on:

2018-01-24 

注册时间:

Date of Registration:

2018-01-24 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

超声联合表面肌电监测核心稳定训练效果的临床随机对照研究 

Public title:

Clinical randomized controlled trial on the effect of core stability feedback training through RUSI combined with sEMG 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

超声联合表面肌电监测核心稳定训练效果的临床随机对照研究 

Scientific title:

Clinical randomized controlled trial on the effect of core stability feedback training through RUSI combined with sEMG 

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:

郑耀超 

研究负责人:

伍少玲 

Applicant:

Zheng Yaochao 

Study leader:

Wu Shaoling 

申请注册联系人电话:

Applicant telephone:

+86 18819473150 

研究负责人电话:

Study leader's telephone:

+86 13660183777 

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:

zhengych3@126.com 

研究负责人电子邮件:

Study leader's E-mail:

13660183777@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:

广东省广州市越秀区中山大学北校区中山二路74号 

研究负责人通讯地址:

广东省广州市沿江西路107号 

Applicant address:

74 Second Sun Yat-Sen Road, North Campus of Sun Yat-sen University, Yuexiu district, Guangzhou, Guangdong, China 

Study leader's address:

107 Yanjiang Road West, Guangzhou, Guangdong, China 

申请注册联系人邮政编码:

Applicant postcode:

510080 

研究负责人邮政编码:

Study leader's postcode:

510120 

申请人所在单位:

中山大学孙逸仙纪念医院 

Applicant's institution:

Sun Yat-sen Memorial Hospital, Sun Yat-sen University 

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:

SYSEC-KY-KS-053 

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:

中山大学孙逸仙纪念医院医学伦理委员会 

Name of the ethic committee:

Medical ethics committee of Sun Yat-sen Memorial Hospital, Sun Yat-sen University 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-11-16 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

广东省广州市沿江西路107号 

Contact Address of the ethic committee:

107 Yanjiang Road West, Guangzhou, Guangdong, 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:

中山大学孙逸仙纪念医院 

Primary sponsor:

Sun Yat-sen Memorial Hospital, Sun Yat-sen University 

研究实施负责(组长)单位地址:

广东省广州市沿江西路107号 

Primary sponsor's address:

107 Yanjiang Road West, Guangzhou, Guangdong, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

孙逸仙纪念医院

具体地址:

广东省广州市沿江西路107号

Institution
hospital:

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Address:

107 Yanjiang Road West, Guangzhou, Guangdong, China

经费或物资来源:

广州市科技计划项目,政府合作框架下项目 

Source(s) of funding:

Science and Technology Planning Project of Guangzhou City 

研究疾病:

腰背痛 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

1. 超声联合表面肌电监测核心稳定训练效果的临床随机对照研究 2. 通过比较超声联合表面肌电监测进行反馈训练与无反馈的训练效果,在确保临床疗效的前提下,选择更有效的核心稳定训练策略进行治疗,进一步改善远期效果、缓解疼痛、减少腰椎功能障碍程度,减少复发,提高生活质量。 

Objectives of Study:

1. Determind the effect of core stability feedback training through RUSI combined with sEMG; 2. In the premise to ensure the clinical efficacy, we can choose a more effective core stability training strategy to reduce adverse reaction, improve the long-term effect and lumbar dysfunction, reduce recurrence and improve the quality of life.  

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:

(a)健康人;(b)年龄超过20-25岁;(c)愿意完成任一种治疗训练方案;(d)受试者的书面知情同意。 

Inclusion criteria

1. Healthy subject; 2. the age of 20-25 years old; 3. the willingness to comply with any one of the randomly chosen treatment programs, and 4. the written informed consent of the participants 

排除标准:

(a)腰椎间盘膨出;(b)腰椎间盘突出急性期;(c)腰椎骨折;(d)心血管疾病,或任意能导致训练无法进行的系统性疾病,(e)神经损伤;(f)精神病,或任意能影响训练依从性和症状评估的精神状况;(g)脊椎手术史;(h)怀孕;(i)炎症,感染或椎体恶性疾病;(j)严重结构性畸形。 

Exclusion criteria:

1. the presence of the herniated lumbar disk; 2. the acute phase of the lumbar disk protrusion; 3. the presence of the vertebral fracture(s); 4. cardiovascular or systemic diseases or any condition which contraindicated or made the exercise training impossible; 5. the neurological deficit; 6. the presence of the psychiatric disorder which might affect the compliance and the assessment of symptoms; 7. the history of the spinal surgery; 8. the pregnancy; 9. inflammatory, infectious or malignant diseases of the vertebra; 10. the presence of severe structural deformity. 

研究实施时间:

Study execute time:

From2017-11-01To 2018-05-31 

干预措施:

Interventions:

组别:

1

样本量:

30

Group:

one

Sample size:

干预措施:

超声联合表面肌电反馈训练

干预措施代码:

Intervention:

RUSI combined with EMG feedback training

Intervention code:

组别:

2

样本量:

30

Group:

two

Sample size:

干预措施:

相同的核心稳定训练

干预措施代码:

Intervention:

same core stability training

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

广州市 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

中山大学孙逸仙纪念医院 

单位级别:

三级甲等 

Institution
hospital:

Sun Yat-sen Memorial Hospital, Sun Yat-sen University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

腹横肌表面肌电信号

指标类型:

主要指标 

Outcome:

Trasversus abdominis sEMG characteristic

Type:

Primary indicator 

测量时间点:

训练0周、4周和8周

测量方法:

表面肌电

Measure time point of outcome:

0 week, 4 week and 8 week during training

Measure method:

sEMG

指标中文名:

腹直肌表面肌电信号

指标类型:

主要指标 

Outcome:

Rectus abdominis sEMG characteristic

Type:

Primary indicator 

测量时间点:

训练0周、4周和8周

测量方法:

表面肌电

Measure time point of outcome:

0 week, 4 week and 8 week during training

Measure method:

sEMG

指标中文名:

多裂肌表面肌电信号

指标类型:

主要指标 

Outcome:

Multifidus sEMG characteristic

Type:

Primary indicator 

测量时间点:

训练0周、4周和8周

测量方法:

表面肌电

Measure time point of outcome:

0 week, 4 week and 8 week during training

Measure method:

sEMG

指标中文名:

竖脊肌表面肌电信号

指标类型:

主要指标 

Outcome:

Erector spinae sEMG characteristic

Type:

Primary indicator 

测量时间点:

训练0周、4周和8周

测量方法:

表面肌电

Measure time point of outcome:

0 week, 4 week and 8 week during training

Measure method:

sEMG

指标中文名:

腹横肌肌肉厚度

指标类型:

主要指标 

Outcome:

Trasversus abdominis muscle thickness

Type:

Primary indicator 

测量时间点:

训练0周、4周和8周

测量方法:

康复用超声测量

Measure time point of outcome:

0 week, 4 week and 8 week during training

Measure method:

Rehabilitative Ultrasound Image

指标中文名:

腹直肌肌肉厚度

指标类型:

主要指标 

Outcome:

Rectus abdominis muscle thickness

Type:

Primary indicator 

测量时间点:

训练0周、4周和8周

测量方法:

康复用超声测量

Measure time point of outcome:

0 week, 4 week and 8 week during training

Measure method:

Rehabilitative Ultrasound Image

指标中文名:

多裂肌肌肉厚度

指标类型:

主要指标 

Outcome:

Multifidus muscle thickness

Type:

Primary indicator 

测量时间点:

训练0周、4周和8周

测量方法:

康复用超声测量

Measure time point of outcome:

0 week, 4 week and 8 week during training

Measure method:

Rehabilitative Ultrasound Image

指标中文名:

竖脊肌肌肉厚度

指标类型:

主要指标 

Outcome:

Erector spinae muscle thickness

Type:

Primary indicator 

测量时间点:

训练0周、4周和8周

测量方法:

康复用超声测量

Measure time point of outcome:

0 week, 4 week and 8 week during training

Measure method:

Rehabilitative Ultrasound Image

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

No

组织:

Sample Name:

No

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 20 years
最大 Max age 60 years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

由一名专门指定的护士负责随机分组和登记。根据电脑产生的随机数字来进行随机分组。

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

A specially designated nurse is responsible for the randomization and registration. The random numbers are generated by computer

盲法:

Blinding:

原始数据公开时间:

The time of sharing IPD:

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):

在本课题完成后6个月内公开原始数据,在“中山大学孙逸仙纪念医院--康复医学科”,http://www.syshospital.com/Category_955/Index.aspx

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

http://www.syshospital.com/Category_955/Index.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:

数据管理员采用Excel表格录入数据,统计员采用SPSS 20.0进行统计分析。

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

The date were logged by administrator useing Excel. And the dates were statistical analysis by SPSS 20.0.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-01-24
return list