Today is 2019-11-17

Clinical study on the treatment of rotator cuff injury by Electroacupuncture at Tiaokou point combined with joint mobilization
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注册号:

Registration number:

ChiCTR1900026780 

最近更新日期:

Date of Last Refreshed on:

2019-10-21 

注册时间:

Date of Registration:

2019-10-21 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

李岩峰医师: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。 电针条口穴联合关节松动术治疗肩袖损伤的临床研究 

Public title:

Clinical study on the treatment of rotator cuff injury by Electroacupuncture at Tiaokou point combined with joint mobilization 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

电针条口穴联合关节松动术治疗肩袖损伤的临床研究 

Scientific title:

Clinical study on the treatment of rotator cuff injury by Electroacupuncture at Tiaokou point combined with joint mobilization 

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:

李岩峰 

研究负责人:

李岩峰 

Applicant:

Li Yanfeng 

Study leader:

Li Yanfeng 

申请注册联系人电话:

Applicant telephone:

+86 13641657444 

研究负责人电话:

Study leader's telephone:

+86 13641657444 

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:

gogo1st@163.com 

研究负责人电子邮件:

Study leader's E-mail:

gogo1st@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:

上海市芷江中路274号 

研究负责人通讯地址:

上海市芷江中路274号 

Applicant address:

274 Middle Zhijiang Road, Shanghai 

Study leader's address:

274 Middle Zhijiang 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:

 

申请人所在单位:

上海市中医医院 

Applicant's institution:

Shanghai 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:

上海市中医医院 

Primary sponsor:

Shanghai Hospital of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

上海市芷江中路274号 

Primary sponsor's address:

274 Middle Zhijiang Road, Shanghai 

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

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市中医医院

具体地址:

芷江中路274号

Institution
hospital:

Shanghai Hospital of Traditional Chinese Medicine

Address:

274 Middle Zhijiang Road

经费或物资来源:

上海申康医院发展中心 

Source(s) of funding:

Shanghai Shenkang Hospital Development Center 

研究疾病:

肩袖损伤 

Target disease:

rotator cuff injury 

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:

收集临床病例,进行临床观察,总结诊疗经验,评价电针条口穴治疗肩袖损伤的有效性及安全性,明确电针条口穴治疗肩袖损伤的具体指征,形成一套规范化的诊疗方案。 

Objectives of Study:

Collect clinical cases, carry out clinical observation, summarize experience, evaluate the effectiveness and safety of electroacupuncture at Tiaokou point in the treatment of rotator cuff injury, clarify the specific indications of electroacupuncture at Tiaokou point in the treatment of rotator cuff injury, and form a set of standardized diagnosis and treatment plan. 

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:

符合诊断标准,病程超过1个月,入组时年龄在18-75岁之间,并且入组前2周未进行任何治疗的门诊病人,理解并签订知情同意书,能够配合完成研究,遵照医嘱按时复诊者。 

Inclusion criteria

Those outpatients who meet the diagnostic criteria, have a course of more than one month, aged between 18-75 years at the time of enrollment, and have no treatment in the first two weeks before enrollment, understand and sign the informed consent, can cooperate with the completion of the study, and follow the doctor's advice to return to the clinic on time. 

排除标准:

患有严重骨质疏松症者;肩关节合并有风湿免疫性、感染性等特异性疾病者;合并既往外伤史者,如肩关节内骨折、陈旧性肌腱断裂等;合并心脑血管疾病及肝肾功能不全者;精神、心理疾病患者。 

Exclusion criteria:

Patients with severe osteoporosis, shoulder joint with rheumatic immune, infectious and other specific diseases, shoulder joint with previous history of trauma, such as intra-articular fracture, old tendon rupture, etc., with cardiovascular and cerebrovascular diseases and liver and kidney dysfunction, mental and psychological diseases. 

研究实施时间:

Study execute time:

From2019-11-30To 2022-11-30 

干预措施:

Interventions:

组别:

治疗组

样本量:

70

Group:

Treatment group

Sample size:

干预措施:

电针条口穴

干预措施代码:

Intervention:

Electroacupuncture at Tiao Kou

Intervention code:

组别:

对照组

样本量:

70

Group:

Control group

Sample size:

干预措施:

肩三针

干预措施代码:

Intervention:

Shoulder-three-points

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 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市中医医院 

单位级别:

三甲 

Institution
hospital:

Shanghai Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

临床疗效

指标类型:

主要指标 

Outcome:

Clinical efficacy

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疼痛视觉模拟评分

指标类型:

次要指标 

Outcome:

Visual simulation score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肩关节功能评分

指标类型:

次要指标 

Outcome:

Constant-Murley score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

AE/严重不良事件(SAE)发生频率、类型和严重程度

指标类型:

副作用指标 

Outcome:

The frequency, type and severity of AE/severe adverse events (SAE)

Type:

Adverse events 

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):

用SPSS23.0软件生成140个随机数,纳入的患者按就诊先后顺序每人对照一个随机数;将140个随机数按升序进行编序号( 1~140号 ),其中序号1~70号为治疗组,71~140号为对照组。

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

140 random numbers were generated by SPSS23.0 software, and each patient was compared with one random number according to the order of treatment; 140 random numbers were numbered in ascending order (No. 1-140), among which No. 1-70 was the treatment group and No. 71-140 was the control group.

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

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):

医院保存

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

saved in hospital

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

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

Case Record Form,

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-10-21
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