针刺激痛点治疗原发性三叉神经痛的疗效观察

注册号:

Registration number:

AMCTR-IOR-18000219 

注册号获得时间:

Date of releasing the registration number:

2018/11/7 10:59:00 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

针刺激痛点治疗原发性三叉神经痛的疗效观察 

Public title:

Therapeutic effect of acupuncture myofascial trigger points on primary trigeminal neuralgia 

研究课题的正式科学名称:

针刺激痛点治疗原发性三叉神经痛的疗效观察 

Scientific title:

Therapeutic effect of acupuncture myofascial trigger points on primary trigeminal neuralgia 

研究课题代号(代码):

Study subject ID:

B5-8000-14-0008 

在其它机构的注册号:

Secondary ID:

ChiCTR1800019233 

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:

2018-03-07 

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:

三叉神经痛 

Target disease:

Trigeminal neuralgia 

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:

研究针刺头面部肌筋膜疼痛触发点治疗三叉神经痛的疗效 

Objectives of Study:

study the effect of acupuncture head facial muscle trigger point in the treatment of trigeminal neuralgia 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

1.诊断明确的原发性三叉神经痛 2.MRI检查排除继发性因素,如:感染、出血、梗塞、多发性硬化、肿瘤等 

Inclusion criteria

1. secondary factors diagnosed with primary trigeminal neuralgia; 2. MRI examination to exclude, such as: infection, bleeding, infarction, multiple sclerosis, cancer, etc. 

排除标准:

1.继发性或症状性三叉神经痛,如继发于感染、肿瘤及多发性硬化等 2.合并其他严重影响患者生存时间的疾病,如恶性肿瘤、严重心肌梗死等 3.MRI不能显示患侧三叉神经根,或三叉神经根长度<6mm 4.不愿意加入本研究,拒绝签署同意书 5.合并其他不适宜伽玛刀放射治疗的疾病,如粒细胞缺乏、血友病等 6.既往曾经接受过放射外科治疗者,如伽玛刀,Cyber刀等 

Exclusion criteria:

1. secondary or symptomatic trigeminal neuralgia, such as secondary to infection, cancer and multiple sclerosis; 2. Combined with other serious diseases affecting the survival time of patients, such as cancer, severe myocardial infarction; 3. MRI not show ipsilateral trigeminal nerve root, or the trigeminal nerve root length <6mm; 4. reluctant to join the study, refused to sign the consent form; 5. unsuitable for Gamma Knife radiation therapy combined with other diseases, such as agranulocytosis, hemophilia and other; 6. had received previous treatment radiosurgery, such as Gamma Knife, Cyber Knife, etc. 

研究实施时间:

Study execute time:

From2018-10-31To 2020-05-30 

干预措施:

Interventions:

组别:

针刺组

样本量:

20

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 trigger point

Intervention code:

组别:

对照组

样本量:

20

Group:

Control group

Sample size:

干预措施:

口服卡马西平

干预措施代码:

Intervention:

Oral carbamazepine

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:

Teriary 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:

VAS

Type:

Primary indicator 

指标中文名:

匹兹堡睡眠质量指数

指标类型:

次要指标 

Outcome:

PSQI

Type:

Secondary indicator 

指标中文名:

患者心理健康

指标类型:

次要指标 

Outcome:

Mental health of patients

Type:

Secondary indicator 

指标中文名:

焦虑自我评估

指标类型:

次要指标 

Outcome:

Anxiety self assessment

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 70 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:

 2018-11-03
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