艾灸对缺血性脑卒中后肩手综合征(SHS)Ⅰ期患者疼痛及运动障碍的临床疗效研究

注册号:

Registration number:

AMCTR-IOR-20000336 

注册号获得时间:

Date of releasing the registration number:

2020/4/14 14:52:02 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

艾灸对缺血性脑卒中后肩手综合征(SHS)Ⅰ期患者疼痛及运动障碍的临床疗效研究 

Public title:

Clinical study on the effect of moxibustion for pain and motor dysfunction in patients on stage I of shoulder hand syndrome (SHS) after ischemic stroke 

研究课题的正式科学名称:

艾灸对脑卒中后肩手综合征(SHS)Ⅰ期患者疼痛及运动障碍的临床疗效研究 

Scientific title:

Clinical study on the effect of moxibustion for pain and motor dysfunction in patients on stage I of shoulder hand syndrome (SHS) after ischemic stroke 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

孟笑男 

研究负责人:

孟笑男 

Applicant:

Xiaonan Meng 

Study leader:

Xiaonan Meng 

申请注册联系人电话:

Applicant telephone:

+86 13810988685 

研究负责人电话:

Study leader's telephone:

+86 13810988685 

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:

mengxiaonan.cn@gmail.com 

研究负责人电子邮件:

Study leader's E-mail:

mengxiaonan.cn@gmail.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:

北京市西城区棉花胡同83号 

研究负责人通讯地址:

北京市西城区棉花胡同83号 

Applicant address:

Mianhuahutong 83#, Xicheng District,Beijing 

Study leader's address:

Mianhuahutong 83#, Xicheng District,Beijing 

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:

北京中医药大学附属护国寺中医医院 

Applicant's institution:

Beijing Huguosi TCM Hospital,affiliated to Beijing University of 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:

HZ-20200309 

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:

北京中医药大学附属护国寺中医医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Beijing Huguosi TCM Hospital,affiliated to Beijing University of Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-03-09 

研究实施负责(组长)单位:

北京中医药大学附属护国寺中医医院 

Primary sponsor:

Beijing Huguosi TCM Hospital,affiliated to Beijing University of Chinese Medicine 

研究实施负责(组长)单位地址:

北京市西城区棉花胡同83号 

Primary sponsor's address:

Mianhuahutong 83#, Xicheng District,Beijing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京中医药大学附属护国寺中医医院

具体地址:

北京市西城区棉花胡同83号

Institution
hospital:

Beijing Huguosi TCM Hospital,affiliated to Beijing University of Chinese Medicine

Address:

Mianhuahutong 83#, Xicheng District,Beijing

经费或物资来源:

经费项目申请中 

Source(s) of funding:

Applying program funding in process 

研究疾病:

缺血性脑卒中后肩手综合征 

Target disease:

shoulder hand syndrome (SHS) after ischemic stroke 

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:

观察艾灸治疗缺血性卒中后肩手综合征Ⅰ期患者的临床疗效。 

Objectives of Study:

To observe the clinical effect of moxibustion on shoulder-hand syndrome (SHS) PhaseⅠpatients due to ischemic stroke. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

①符合西医脑梗死诊断标准; ②符合SHSⅠ期诊断标准;脑血管病变经影像学证实(包括但不仅限于头CT或MRI); ③两次以内的中风,且此次发病后收治时间介于两周到三个月; ④性别不限; ⑤年龄35-76岁; ⑥患者生命体征平稳,且志愿参加并积极配合完成课题; ⑦意识清楚并签署同意书。 

Inclusion criteria

①Conformed by the diagnostic standards of Western medicine for cerebral infarction; ②conformed by the diagnostic standards of SHS stage I; ③cerebrovascular diseases confirmed by imaging (including but not limited to head CT or MRI); ischemic stroke within two times, and the treatment time after the onset is between two weeks and three months; ④the gender unlimited; ⑤the age between 35-76 years old; ⑥the patient's vital signs are stable, and they volunteer to participate in and actively cooperate to complete the project; ⑦they are full awareness of study and sign the consent form 

排除标准:

①除外脑出血; ②丘脑病变和卒中前明显神经肌肉病变致肩关节疼痛或运动障碍者; ③合并心血管、肺、肝、肾和造血系统等严重的原发性疾病者; ④精神病患者或严重智力障碍; ⑤中风次数大于3次者; ⑥脑外伤、脑寄生虫病、严重并发症,采用过溶栓治疗的患者; ⑦上肢局部感染者,肩关节脱位、半脱位者; ⑧生命体征不平稳; ⑨对治疗不耐受者。 

Exclusion criteria:

①Cerebrovascular diseases other than ischemic stroke; ② patients with abnormal pain threshold caused by lesions in thalamus; ③ patients with other serious internal diseases; ④ patients with serious emotional disorders after ischemic stroke; ⑤ patients suffered more than three times of stroke; ⑥ patients with brain injury, brain parasitosis and serious complications who have been treated with thrombolysis; ; ⑦ patients with peri-arthritis of shoulder and local soft tissue injury with serious activities have been diagnosed before stroke; ⑧ unstable vital signs; ⑨ intolerant of treatment or unable to actively cooperate to complete the treatment. 

研究实施时间:

Study execute time:

From2020-07-01To 2022-06-30 

干预措施:

Interventions:

组别:

对照组

样本量:

23

Group:

control group

Sample size:

干预措施:

体针

干预措施代码:

Intervention:

body acupuncture

Intervention code:

组别:

艾灸组

样本量:

23

Group:

moxibustion group

Sample size:

干预措施:

体针+艾灸

干预措施代码:

Intervention:

body acupuncture+moxibustion

Intervention code:

组别:

假艾灸组

样本量:

23

Group:

sham moxibustion group

Sample size:

干预措施:

体针+假艾灸组

干预措施代码:

Intervention:

body acupuncture+sham moxibustion

Intervention code:

组别:

无烟艾灸组

样本量:

23

Group:

smokeless moxibustion group

Sample size:

干预措施:

体针+无烟艾灸

干预措施代码:

Intervention:

body acupuncture+smokeless moxibustion

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京中医药大学附属护国寺中医医院 

单位级别:

三级甲等专科医院 

Institution
hospital:

Beijing Huguosi TCM Hospital,affiliated to Beijing University of Chinese Medicine  

Level of the institution:

Triple A Hospital with Specialty 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京小汤山医院 

单位级别:

三级医院 

Institution
hospital:

Beijing Xiaotangshan Hospital  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学宣武医院 

单位级别:

三级甲等医院 

Institution
hospital:

Xuanwu Hospital Capital Medical Universtiy  

Level of the institution:

Triple A Hospital 

测量指标:

Outcomes:

指标中文名:

视觉模拟评分法

指标类型:

主要指标 

Outcome:

(visual analogue scale,VAS

Type:

Primary indicator 

指标中文名:

上肢Fugl-Meyer运动功能评分量表

指标类型:

主要指标 

Outcome:

Upper limbsFugl-Meyer assessment

Type:

Primary indicator 

指标中文名:

改良Barthel指数评定量表

指标类型:

次要指标 

Outcome:

modified Barthel index,MBI

Type:

Secondary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

病例观察表

组织:

Sample Name:

case report form

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

Pending

年龄范围:

Participant age:

最小 Min age 35 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):

92例缺血性卒中后肩手综合征Ⅰ期的患者,根据随机数字表随机分为对照组,艾灸组,假艾灸组及无烟艾灸组,每组为23例。

性别:

男女均可

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

Based on computer-generated randomization charts,92 patients with SHS PhaseⅠ after ischemic stroke would be randomly divided into control group,moxibustion group, sham moxibustion group and smokeless moxibustion group, 36 cases in each.

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):

数据由论文形式公开发表后通讯作者负责。

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

Obtained by contacting the corresponding author after the paper is published.

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):

由医师对患者的数据进行采集并登记于病例记录表,由本单位研究人员对数据进行管理及保存。

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

The doctor collects and registers the patients' data in the case record form, and the scientific researchers of the unit manages and saves the data.

创建人:

Creater Name:

 2020-03-09
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