今天是:2022-01-28 星期五

电针治疗腰椎术后综合征的临床随机对照研究
下载XML文档

注册号:

Registration number:

ChiCTR2000040144 

最近更新日期:

Date of Last Refreshed on:

2021-01-11 

注册时间:

Date of Registration:

2020-11-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

电针治疗腰椎术后综合征的临床随机对照研究  

Public title:

Efficacy of electroacupuncture in patients with failed back surgery syndrome: study protocol for a randomized controlled trail 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

电针治疗腰椎术后综合征的临床随机对照研究  

Scientific title:

Efficacy of electroacupuncture in patients with failed back surgery syndrome: study protocol for a randomized controlled trail 

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:

ChiMCTR2000004070 

申请注册联系人:

陈林 

研究负责人:

陈林 

Applicant:

Chen Lin 

Study leader:

Chen Lin 

申请注册联系人电话:

Applicant telephone:

+86 13482541533 

研究负责人电话:

Study leader's telephone:

+86 13482541533 

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:

f0540104@126.com 

研究负责人电子邮件:

Study leader's E-mail:

f0540104@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:

上海市静安区芷江中路274号 

研究负责人通讯地址:

上海市静安区芷江中路274号 

Applicant address:

274 Zhijiang Middle Road, Jing'an District, Shanghai, China 

Study leader's address:

274 Zhijiang Middle Road, Jing'an District, Shanghai, 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:

上海市中医医院 

Applicant's institution:

Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine 

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:

2020SHL-KY-40 

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:

上海市中医医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-11-04 

伦理委员会联系人:

凌丽 

Contact Name of the ethic committee:

Ling Li 

伦理委员会联系地址:

上海市静安区芷江中路274号 

Contact Address of the ethic committee:

274 Zhijiang Middle Road, Jing'an District, Shanghai, 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:

上海市中医医院 

Primary sponsor:

Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

上海市静安区芷江中路274号 

Primary sponsor's address:

274 Zhijiang Middle Road, Jing'an District, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市中医医院

具体地址:

上海市静安区芷江中路274号

Institution
hospital:

Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine

Address:

274 Zhijiang Middle Road, Jing'an District, Shanghai

经费或物资来源:

自筹 

Source(s) of funding:

Self-funded 

研究疾病:

腰椎术后综合征 

Target disease:

failed back surgery syndrome 

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:

探索性研究/预试验 

Study phase:

研究目的:

拟采用随机对照的研究设计,观察电针、针灸、安慰剂针灸三种方法治疗前后腰椎术后综合征患者NRS、ODI、BDI-Ⅱ、PSQI、止痛药使用量等相关情况。旨在通过对比三种方法对腰椎术后综合征的治疗效果,探索出一种更安全、更有效的治疗腰椎术后综合征的方案。 

Objectives of Study:

It is planned to adopt a randomized controlled research design to observe the related conditions of patients with postoperative lumbar syndrome including NRS, ODI, BDI-Ⅱ, PSQI, and analgesic consumption before and after the three methods of electroacupuncture, acupuncture, and placebo acupuncture. The aim is to compare the therapeutic effects of the three methods on the postoperative lumbar syndrome, and explore a safer and more effective treatment for postoperative lumbar syndrome. 

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)年龄一般18-80岁; 2)符合腰椎术后综合征诊断标准; 3)从未接受过针灸治疗; 4)治疗前愿意停止任何物理治疗、止痛药物2周且2周后NRS评估≥6分; 5)了解研究目的并愿意遵守随机选择治疗计划; 

Inclusion criteria

1) Aged 18 to 80 years old; 2) Meet the diagnostic criteria for postoperative lumbar syndrome; 3) Have never received acupuncture treatment; 4) Willing to stop any physical therapy and analgesics for 2 weeks before treatment and NRS assessment >=6 points after 2 weeks; 5) Understand the purpose of the study and be willing to follow the randomized treatment plan. 

排除标准:

1)腰椎术后并发术区感染、脑脊液漏或腰椎行二次手术者; 2)有腰椎肿瘤、腰椎结核、腰椎外伤、腰椎感染、强直性脊柱炎或腰椎畸形病史; 3)有凝血障碍,红斑狼疮,糖尿病性神经病,类风湿性关节炎病史或其他严重内科疾病史; 4)孕妇、精神药物依赖或认知障碍者; 

Exclusion criteria:

1) Patients who have complicated operation area infection, cerebrospinal fluid leakage or second lumbar operation after lumbar spine surgery; 2) History of lumbar spine tumor, lumbar spine tuberculosis, lumbar spine trauma, lumbar spine infection, ankylosing spondylitis or lumbar deformity; 3) History of coagulopathy, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis or other serious medical diseases; 4) Pregnant women, people with psychotropic drug dependence or cognitive impairment. 

研究实施时间:

Study execute time:

From2020-12-01To 2022-12-31 

征募观察对象时间:

Recruiting time:

From2020-12-01To 2022-11-30 

干预措施:

Interventions:

组别:

电针组

样本量:

48

Group:

Electroacupuncture Group

Sample size:

干预措施:

电针治疗

干预措施代码:

Intervention:

electroacupuncture

Intervention code:

组别:

针灸组

样本量:

48

Group:

Manual acupuncture Group

Sample size:

干预措施:

针灸

干预措施代码:

Intervention:

Manual acupuncture

Intervention code:

组别:

模拟针灸组

样本量:

48

Group:

Sham acupuncture Group

Sample size:

干预措施:

模拟针灸

干预措施代码:

Intervention:

Sham acupuncture

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):

上海市中医医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine  

Level of the institution:

Grade III Level A 

测量指标:

Outcomes:

指标中文名:

数字评定量表

指标类型:

主要指标 

Outcome:

numerical rating scale

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

指标类型:

次要指标 

Outcome:

The Oswestry Disability Index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

贝克抑郁量表Ⅱ

指标类型:

次要指标 

Outcome:

Beck depression inventory-Ⅱ

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

匹兹堡睡眠质量指数

指标类型:

次要指标 

Outcome:

Pittsburgh Sleep Quality Index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

止痛药使用量

指标类型:

次要指标 

Outcome:

Analgesic consumption

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:

标本中文名:

影像学资料

组织:

Sample Name:

Imaging data

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:

尚未开始

Not yet recruiting

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):

本临床研究为随机平行对照试验,采用变化区组随机化方法,区组长度设为2、4和6,通过SPSS 22.0统计软件产生随机数字表,符合条件受试者按1:1:1比例随机分配。

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

This clinical study is a randomized parallel controlled trial, using the randomization method of changing blocks, the block length is set to 2, 4, and 6, the random number table is generated through SPSS 22.0 statistical software, and the eligible subjects are in a ratio of 1:1:1 Randomly assigned.

盲法:

未说明

Blinding:

Not stated

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

是Yes

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):

论文支持材料

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

supporting materials of the artical

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:

病例记录表(Case Record Form, CRF)

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

Management Case Record Form (CRF)

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2020-11-22
返回列表