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超声与低剂量CT引导腰椎小关节注射
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注册号:

Registration number:

ChiCTR1800018819 

最近更新日期:

Date of Last Refreshed on:

2018-10-11 

注册时间:

Date of Registration:

2018-10-11 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

超声与低剂量CT引导腰椎小关节注射 

Public title:

Ultrasound-Guided versus low dose Computed Tomography Scanning Guidance for Lumbar Facet Joint Injections 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

超声与低剂量CT引导腰椎小关节注射的临床研究 

Scientific title:

Clinical research of ultrasound-Guided versus low dose Computed Tomography Scanning Guidance for Lumbar Facet Joint Injections 

研究课题代号(代码):

Study subject ID:

中国国家自然科学基金 项目编号:81200865 

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:

文传兵 

研究负责人:

刘慧 

Applicant:

Chuanbing Wen 

Study leader:

Hui Liu 

申请注册联系人电话:

Applicant telephone:

+86 17708130259 

研究负责人电话:

Study leader's telephone:

+86 18980601547 

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:

chunbingwen@163.com 

研究负责人电子邮件:

Study leader's E-mail:

595472345@qq.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:

四川省成都市一环路西二段32号 

研究负责人通讯地址:

四川省成都市武侯区国学巷37号 

Applicant address:

32 West Section 2, First Ring Road, Chengdu, Sichuan, China 

Study leader's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China 

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:

四川省医学科学院.四川省人民医院 

Applicant's institution:

Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

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:

四川大学华西医院 

Primary sponsor:

West China Hospital, Sichuan University 

研究实施负责(组长)单位地址:

四川省成都市武侯区国学巷37号 

Primary sponsor's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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):

四川省

市(区县):

Country:

China

Province:

Sichuan

City:

单位(医院):

四川大学华西医院

具体地址:

四川省成都市武侯区国学巷37号

Institution
hospital:

West China Hospital, Sichuan University

Address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China

国家:

中国

省(直辖市):

四川省

市(区县):

Country:

China

Province:

Sichuan Province

City:

单位(医院):

四川省医学科学院.四川省人民医院

具体地址:

四川省成都市一环路西二段32号

Institution
hospital:

Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

Address:

32 West Section 2, First Ring Road, Chengdu, Sichuan, China

经费或物资来源:

中国国家自然科学基金 项目编号:81200865 

Source(s) of funding:

National Natural Science Foundation of China Project number 81200865 

研究疾病:

腰椎小关节源性疼痛 

Target disease:

The Lumbar facet joint-related 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:

本研究的目的是研究超声引导下腰椎小关节注射与低剂量CT引导下腰椎小关节注射的可行性、准确性和效率 

Objectives of Study:

The purpose of this study was to investigate the feasibility, accuracy and efficiency of the facet joint injections in the lumbar spine by ultrasound guided versus lose dose computed tomography (CT) guidance 

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:

第一部分纳入标准:18-80岁成年人 第二部分纳入标准:18-80岁成年人;腰椎进行了CT或MRI检查,可见腰椎小关节间隙。 

Inclusion criteria

The first part: aged 18-80 years old; The second part: aged 18-80 years old; having undergone CT or MRI of their lumbar spine, with the visible lumbar facet joint spaces.  

排除标准:

第一部分:排除标准:体重指数(BMI)≥25kg/m2;脊柱畸形包括先天性脊柱侧凸和后凸,继发性畸形如强直性脊柱炎、脊柱结核、神经肌肉侧凸、Scheumann病和骨质疏松症。 第二部分:排除标准:任何潜在的禁忌症,如脊柱肿瘤、脊柱畸形、脊柱不稳定、椎间盘炎和骨折;局部或全身感染或脊柱感染;对类固醇或麻醉剂过敏;腰椎手术史;无法纠正的凝血功能障碍;怀孕者 体重指数≥25 kg/m2. 。 

Exclusion criteria:

The first part: the body mass index (BMI) ≥ 25 kg/m2; spinal deformities including congenital scoliosis and kyphosis, secondary deformities such as ankylosing spondylitis, spinal tuberculosis, neuromuscular scoliosis, Scheumann disease and osteoporosis; The second part: any potential contraindications, such as a spinal tumor, spinal deformities, spinal instability, discitis, and fracture; local or systemic infection or spinal infections; allergy to steroids or anesthetics; previous surgery; uncorrectable coagulopathy; pregnant BMI ≥ 25 kg/m2.  

研究实施时间:

Study execute time:

From2016-01-03To 2016-12-20 

干预措施:

Interventions:

组别:

超声引导组

样本量:

20

Group:

Group 1

Sample size:

干预措施:

超声引导

干预措施代码:

Intervention:

ultrasound guide

Intervention code:

组别:

CT引导组

样本量:

20

Group:

Group 2

Sample size:

干预措施:

CT引导

干预措施代码:

Intervention:

CT guide

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川省 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

四川省成都市武侯区国学巷37号 

单位级别:

三级甲等医院 

Institution
hospital:

37 Guoxue Lane, Wuhou District, Chengdu  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

旁开距离(A):从棘突尖端的中间到参考点的水平距离

指标类型:

主要指标 

Outcome:

The lateral distance (A): the horizontal distance from the middle of the tip of the spinous process to the reference point

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

深度(B):从棘突尖端的中间点到参考点的垂直距离

指标类型:

主要指标 

Outcome:

the depth (B): the vertical distance from the middle point between the tips of the spinous processes to the reference point

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

斜线(c):从棘突尖到参考点之间的中间点的距离

指标类型:

主要指标 

Outcome:

the oblique line (C):the distance from the middle point between the tips of the spinous processes to the reference point

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

视觉模拟评分

指标类型:

主要指标 

Outcome:

VAS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

缓解率

指标类型:

主要指标 

Outcome:

remission rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

准确率

指标类型:

主要指标 

Outcome:

accuracy rate

Type:

Primary 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:

标本中文名:

组织:

Sample Name:

none

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 80 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):

根据计算机生成的随机表,将患者随机分成两组:第一组为超声引导组(US组),第二组为低剂量CT引导组(CT组,低剂量组,100例,35毫安

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

Based on the computer-generated randomization table, the patients were randomized assigned to two groups: patients in the group 1 were scheduled for the ultrasound-guided infiltrations (the US group), patients in the group 2 were scheduled for the lose dose CT guidance (the CT group, low dose, 100 kV, 35

盲法:

未说明

Blinding:

Not stated

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/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):

2019.5.电子化临床数据管理系统 https://edc713.drugchina.org/main_menu.jsp

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

https://edc713.drugchina.org/main_menu.jsp

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:

试验数据管理采用电子化数据管理系统

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

The experimental data management uses DAS for EDC

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-10-11
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