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艾克热木·吾斯曼医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 骶管硬膜外注射与选择性椎间孔注射治疗单节段腰椎管狭窄症临床随机对照试验
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注册号:

Registration number:

ChiCTR1900028038 

最近更新日期:

Date of Last Refreshed on:

2019-12-08 

注册时间:

Date of Registration:

2019-12-08 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

艾克热木·吾斯曼医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 骶管硬膜外注射与选择性椎间孔注射治疗单节段腰椎管狭窄症临床随机对照试验 

Public title:

A randomized controlled trial of sacral epidural injection and selective intervertebral foraminal injection in the treatment of single-segment lumbar spinal stenosis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

骶管硬膜外注射与选择性椎间孔注射治疗单节段腰椎管狭窄症临床随机对照试验 

Scientific title:

A randomized controlled trial of sacral epidural injection and selective intervertebral foraminal injection in the treatment of single-segment lumbar spinal stenosis 

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:

艾克热木·吾斯曼 

研究负责人:

胡炜 

Applicant:

Wusiman·Aykeremu 

Study leader:

Wei Hu 

申请注册联系人电话:

Applicant telephone:

+86 13201212014 

研究负责人电话:

Study leader's telephone:

+86 18199848111 

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:

575265454@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

realhuwei@163.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:

新疆维吾尔自治区乌鲁木齐市黄河路116号 

研究负责人通讯地址:

新疆维吾尔自治区乌鲁木齐市黄河路116号 

Applicant address:

116 Huanghe Road, Urumqi, Xinjiang Uygur Autonomous Region, China 

Study leader's address:

116 Huanghe Road, Urumqi, Xinjiang Uygur Autonomous Region, 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:

新疆维吾尔自治区中医医院脊柱二科 

Applicant's institution:

Second Department of Spine, Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine 

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:

新疆维吾尔自治区中医医院 

Primary sponsor:

Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

新疆维吾尔自治区乌鲁木齐市黄河路116号 

Primary sponsor's address:

116 Huanghe Road, Urumqi, Xinjiang Uygur Autonomous Region, 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):

新疆维吾尔自治区

市(区县):

乌鲁木齐

Country:

China

Province:

Xinjiang Uygur Autonomous Region

City:

Urumqi

单位(医院):

新疆维吾尔自治区中医医院

具体地址:

黄河路116号

Institution
hospital:

Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine

Address:

116 Huanghe Road

经费或物资来源:

研究所需设备、物资等由新疆维吾尔自治区中医医院提供 

Source(s) of funding:

The equipment and materials needed for the research will be provided by the hospital of traditional Chinese medicine of xinjiang uygur autonomous region 

研究疾病:

腰椎管狭窄症 

Target disease:

Lumbar spinal stenosis 

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:

骶管硬膜外注射与选择性椎间孔注射在改善单节段腰椎管狭窄症患者临床症状的作用,并且对比两种手术方法对患者疗效的差异。  

Objectives of Study:

The effect of acral epidural injection and selective intervertebral foraminal injection in improving the clinical symptoms of patients with single-segment lumbar spinal stenosis was compared. 

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) 腰椎MRI示单节段腰椎管狭窄, 不伴其他明显退变性改变、脱出或游离组织; (2) 有反复发作的间歇性跛行,独立行走距离受限病史; (3) 需要减轻自身疼痛的患者; (4) 对其他非手术治疗无效的患者; (5) 需要手术干预的患者; (6) 可能有炎症基础的疼痛患者; (7) 下肢疼痛≤3个月 ; (8) 利兹神经病理性症状和体征评分(LANSS评分)≥12分。 

Inclusion criteria

(1) MRI of the lumbar spine showed single-segment lumbar canal stenosis without other significant degenerative changes, prolapse or free tissues; (2) a history of recurrent intermittent claudication and limited independent walking distance; (3) patients who need to relieve their own pain; (4) patients who fail to respond to other non-surgical treatments; (5) patients requiring surgical intervention; (6) patients with pain that may have an inflammatory basis; (7) lower limb pain <= 3 months; (8) LANSS score >= 12. 

排除标准:

(1) 病人不能或不愿意接受这个手术; (2) 由于已知的过敏反应,造影剂不能使用; (3) 病人有证据表明在手术部位有未治疗的局部感染; (4) 病人在手术过程中不能合作; (5) 对任何一种将要使用的药物过敏; (6) 怀孕; (7) 同时使用抗凝血剂; (8) 危及手术安全和成功进行的先天性或外科性解剖学上的紊乱; (9) 已知的全身感染; (10) 同时存在的疾病,造成明显的呼吸或心血管损害; (11) 免疫抑制。 

Exclusion criteria:

(1) the patient is unable or unwilling to undergo the operation; (2) the contrast agent should not be used due to a known allergic reaction; (3) the patient has evidence of untreated local infection at the surgical site; (4) the patient cannot cooperate during the operation; (5) allergy to any drug to be used; (6) pregnancy; (7) use anticoagulant at the same time; (8) congenital or exogenous anatomical disorders that threaten the safety and success of the operation; (9) known systemic infections; (10) co-existing diseases causing significant respiratory or cardiovascular damage; (11) immunosuppression; 

研究实施时间:

Study execute time:

From2020-01-01To 2021-01-01 

征募观察对象时间:

Recruiting time:

From2020-01-01To 2021-01-01 

干预措施:

Interventions:

组别:

1组

样本量:

31

Group:

Group 1

Sample size:

干预措施:

骶管硬膜外注射

干预措施代码:

Intervention:

Epidural injection of the sacral canal

Intervention code:

组别:

2组

样本量:

31

Group:

Group 2

Sample size:

干预措施:

选择性椎间孔注射

干预措施代码:

Intervention:

Selective intervertebral foramen injection

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

新疆维吾尔自治区 

市(区县):

乌鲁木齐 

Country:

China 

Province:

Xinjiang Uygur Autonomous Region 

City:

Urumqi 

单位(医院):

新疆维吾尔自治区中医医院 

单位级别:

三甲 

Institution
hospital:

Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

疼痛数字评分表

指标类型:

主要指标 

Outcome:

NRS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

腰痛ODI评分标准

指标类型:

主要指标 

Outcome:

ODI

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:

N/A

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

新疆维吾尔自治区中医医院脊柱二科硕士研究生伊克沙使用计算机产生不可预测的随机序列,使骶管硬膜外注射和选择性椎间孔注射组按约1:1的比列进行随机分配。

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

Yiksha, a postgraduate student from the second department of spine, xinjiang uygur autonomous region hospital of traditional Chinese medicine, used computers to generate unpredictable random sequences to randomly assign the epidural injection of the sacral canal and the selective intervertebral foramina injection group at

盲法:

对受试者与观察者设盲

Blinding:

Blind method for subjects and observers.

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):

实验结束半年内,需与主要研究者取得联系后获取

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

Within half a year after the end of the experiment, it should be obtained after contacting with the main researcher

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:

患者入院时进行RNS、ODI、LANSS评分量表填写,初步评估实施干预前评定;术后第一天、术后2周、术后三月、术后六月、术后一年再次完成上述量表(除了LANSS)填写,以评估疗效。受试者其他基线资料可用医院住院信息系统查询。 每个患者术前、术后及随访时收集到的所有数据进行分类、整理,将骶管硬膜外注射组患者相关数据分为一类,选择性椎间孔注射组数据分为一类;将每组每个患者姓名、性别、年龄等基线资料以及收集到的所有评分量表数据整理为两种手术方法、随访时间、症状改善情况等内容以表格对比形式贮存在专门的硬盘中并设置密码。

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

RNS, ODI and LANSS scales were completed on admission, and preliminary assessment was made before intervention. On the first day after surgery, 2 weeks after surgery, 3 months after surgery, 6 months after surgery, and 1 year after surgery, the above scales (except LANSS) were again completed to evaluate the efficacy. Other baseline data of the subjects can be obtained from the hospital admission information system. All the data collected before, after and during the follow-up of each patient were classified and sorted. Relevant data of patients in the epidural injection group of the sacral canal were divided into one category, and data of the selective intervertebral foraminal injection group were divided into one category. The baseline data of each patient in each group, including name, gender, age and all the data collected from the scoring scale, were arranged into two surgical methods, follow-up time, symptom improvement, etc. and stored in a special hard disk in the form of table comparison and password was set.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2019-12-08
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