针刺肌筋膜触发点治疗肩周炎的疗效观察

注册号:

Registration number:

AMCTR-IOR-18000230 

注册号获得时间:

Date of releasing the registration number:

2018/12/20 9:43:43 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

针刺肌筋膜触发点治疗肩周炎的疗效观察 

Public title:

Effect of acupuncture the myofascial trigger point in the treatment of periarthritis of shoulder 

研究课题的正式科学名称:

针刺肌筋膜触发点治疗肩周炎的疗效观察 

Scientific title:

Effect of acupuncture the myofascial trigger point in the treatment of periarthritis of shoulder 

研究课题代号(代码):

Study subject ID:

国家自然科学基金(B5-8000-14-0008) 

在其它机构的注册号:

Secondary ID:

ChiCTR1800020134 

申请注册联系人:

马彦韬 

研究负责人:

马彦韬 

Applicant:

Yantao Ma 

Study leader:

Yantao Ma 

申请注册联系人电话:

Applicant telephone:

+86 15800859381 

研究负责人电话:

Study leader's telephone:

+86 15800859381 

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:

mayantao1102@163.com 

研究负责人电子邮件:

Study leader's E-mail:

mayantao1102@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:

上海市杨浦区长海路399号 

研究负责人通讯地址:

上海市杨浦区长海路399号 

Applicant address:

399 Changhai Road, Shanghai, China 

Study leader's address:

399 Changhai Road, 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:

上海体育学院 

Applicant's institution:

Shanghai University of Sport 

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:

2017017 

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:

上海体育学院科学研究伦理委员会 

Name of the ethic committee:

the Ethics Committee of Shanghai University of Sport 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-03-07 

研究实施负责(组长)单位:

上海体育学院 

Primary sponsor:

Shanghai University of Sport 

研究实施负责(组长)单位地址:

上海市杨浦区长海路399号 

Primary sponsor's address:

399 Changhai Road, 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):

华东医院

具体地址:

上海市静安区延安西路221号

Institution
hospital:

East China Hospital

Address:

221 West Yan'an Road, Jing'an District, Shanghai

经费或物资来源:

国家自然科学基金(B5-8000-14-0008) 

Source(s) of funding:

National Natural Science Foundation of China (B5-8000-14-0008) 

研究疾病:

肩周炎 

Target disease:

shoulder periarthritis 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional 

研究所处阶段:

其它 

Study phase:

Other 

研究目的:

采用单中心、随机临床试验,观察针刺肩周炎关联肌筋膜触发点治疗肩周炎的临床效果。 

Objectives of Study:

A single-center, randomized clinical trial was conducted to observe the clinical effect of acupuncture periarthritis associated with myofascial trigger points in the treatment of frozen shoulder. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

1.年龄在40-75岁,病程≥3个月,能够并愿意配合治疗;2. 均符合1991年全国第二届肩关节周围炎学术研讨会制定的肩关节周围炎诊断标准;3.经过数次理疗或口服药物治疗,效果不佳;4. 均签署知情同意书。 

Inclusion criteria

1. Aged 40-75 years old, course more than 3 months, able and willing to cooperate with the treatment; 2. consistent with the diagnostic criteria of periarthritis of shoulder joint in 1991 of the second National Symposium on periarthritis of shoulder making; 3. ineffective after several physiotherapy or oral medications;4 .have signed an informed consent form. 

排除标准:

1.肩关节x线片显示骨折、结核、肿瘤者;2.凝血功能障碍者;3.因各种原因未完成本研究或观察记录数据不完整者;4.近3个月内接受过肩关节激素注射者;5.完整的肩袖撕裂;6.全身性炎症疾病 

Exclusion criteria:

1. shoulder joint X-ray showed fracture, tuberculosis, tumor; 2. coagulation dysfunction; 3. for various reasons do not complete the study or observe and record the data is not complete; 4. in the past 3 months received shoulder hormone injection; 5. complete rotator cuff tear; 6. systemic inflammatory diseases. 

研究实施时间:

Study execute time:

From2018-12-15To 2019-12-15 

干预措施:

Interventions:

组别:

针刺组

样本量:

30

Group:

Acupuncture group

Sample size:

干预措施:

针刺肌筋膜疼痛触发点

干预措施代码:

Intervention:

Acupuncture myofascial pain trigger point

Intervention code:

组别:

对照组

样本量:

30

Group:

Control group

Sample size:

干预措施:

常规拉伸和康复理疗

干预措施代码:

Intervention:

Stretching and conventional rehabilitation therapy

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):

华东医院 

单位级别:

三甲医院 

Institution
hospital:

East China Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

视觉模拟评分

指标类型:

主要指标 

Outcome:

NPRS

Type:

Primary indicator 

指标中文名:

肩关节功能评分

指标类型:

次要指标 

Outcome:

Melle评分

Type:

Secondary indicator 

指标中文名:

日常生活能力

指标类型:

次要指标 

Outcome:

ADL

Type:

Secondary indicator 

采集人体标本:

Collecting sample(s)
from participants:

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 40 years
最大 Max age 75 years

随机方法(请说明由何人用什么方法产生随机序列):

随机数字表

性别:

男女均可

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

Random number table

Gender:

Both

盲法:

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

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):

原始数据将在试验完成后6个月内公布于中国临床试验注册中心网站(http://www.chictr.org.cn)

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

Original records will be shared on the Chinese Clinical Trial Registry website (http://www.chictr.org.cn)within 6 months after the trial completed.

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

原始数据记录采用SPSS 22.0数据库进行保存。

The repository and management of the data(Please specify what repository will be used for management of the metadata):

All of the original data records will be stored via SPSS 22.0.

创建人:

Creater Name:

 2018-12-17
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