耳针疗法对脑卒中后肩手综合征I期 (SHS)患者疼痛及运动功能障碍的临床疗效研究

注册号:

Registration number:

AMCTR-IOR-20000334 

注册号获得时间:

Date of releasing the registration number:

2020/4/14 14:49:06 

注册号状态:

补注册  

Registration Status:

1008002 Retrospective registration  

注册题目:

耳针疗法对脑卒中后肩手综合征I期 (SHS)患者疼痛及运动功能障碍的临床疗效研究 

Public title:

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

研究课题的正式科学名称:

耳针疗法对脑卒中后肩手综合征I期 (SHS)患者疼痛及运动功能障碍的临床疗效研究 

Scientific title:

Clinical study on the effect of auricular acupuncture for pain and motor dysfunction in patients on stage I of shoulder hand syndrome (SHS) after 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号针灸科 

研究负责人通讯地址:

北京市西城区棉花胡同83号针灸科 

Applicant address:

Acupuncture Dep.,Mianhuahutong 83#, Xicheng District, Beijing 

Study leader's address:

Acupuncture Dep.,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-20180518 

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:

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:

2018-05-18 

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针灸科 

Primary sponsor:

Acupuncture Dep.,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):

北京市西城区卫健委

具体地址:

北京市西城区枣林前街2号

Institution
hospital:

Xicheng District Health Commission of Beijing

Address:

Zaolinqianjie 2#, Xicheng District, Beijing

经费或物资来源:

北京市西城区卫健委 

Source(s) of funding:

Xicheng District Health Commission of Beijing 

研究疾病:

卒中后肩手综合征 

Target disease:

shoulder hand syndrome (SHS) after 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:

观察耳针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 auricular acupuncture 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50-76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 50-76 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缺血性脑卒中之外的脑血管病变;②丘脑部位病变所致痛阈异常患者;③合并严重内科原发性疾病者;④缺血性脑卒中后严重情志障碍患者;⑤中风次数大于3次者;⑥肩关节脱位、半脱位者;⑦卒中前患侧已诊断肩关节周围炎合并局部软组织损伤并伴随严重活动障碍;⑧严重病情变化,生命体征不平稳;⑨对治疗不耐受或不能主动配合完成治疗者。 

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 dislocation and subluxation of shoulder joint; 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:

From2018-09-01To 2020-12-31 

干预措施:

Interventions:

组别:

对照组

样本量:

36

Group:

control group

Sample size:

干预措施:

体针

干预措施代码:

Intervention:

body acupuncture

Intervention code:

组别:

假耳针组

样本量:

36

Group:

Sham ear acupuncture group

Sample size:

干预措施:

假耳针+体针

干预措施代码:

Intervention:

Sham ear acupuncture+body acupuncture

Intervention code:

组别:

耳针组

样本量:

36

Group:

ear acupuncture group

Sample size:

干预措施:

耳针+体针

干预措施代码:

Intervention:

ear acupuncture+body acupuncture

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 

Institution
hospital:

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

Level of the institution:

Triple A with specialty hospital 

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 

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FMA评分

指标类型:

主要指标 

Outcome:

Upper limbs Fugl-Meyer Assessment (FMA)

Type:

Primary indicator 

指标中文名:

基本日常生活活动能力评估表

指标类型:

次要指标 

Outcome:

Brathel Index

Type:

Secondary indicator 

指标中文名:

生活质量评分

指标类型:

次要指标 

Outcome:

quality of life (QOL)

Type:

Secondary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

病例报告表

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:

正在进行

Recruiting

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):

108例缺血性卒中后肩手综合征Ⅰ期的患者,随机分为对照组,假耳针安慰组及耳针治疗组,每组为36例。对照组采用常规体针治疗, 假耳穴安慰组在体针治疗同时,将耳针针体去除后贴于选取治疗耳穴,耳针治疗组则在体针治疗同时,将正常耳针贴于相同耳穴。每组治疗前后的观察指标分别选取疼痛视觉模拟量表VAS (visual analogue scale)评分、上肢Fugl-Meyer Assessment评分(FMA)以及BI以及QOL评分。

性别:

男女均可

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

108 patients with SHS Phase I due to ischemic stroke were randomly divided into control group, placebo ear acupuncture group and ear acupuncture treatment group, 36 cases with each. The control group was treated with routine body acupuncture, while the placebo ear acupuncture group was treated with body acupuncture, with the ear acupuncture, of which need body was removed. The ear acupuncture treatment group was treated with body acupuncture, with the normal ear acupuncture. The visual analogue

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):

以学术论文的形式

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

In the form of academic papers

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):

我们将应用病例记录表(CRF)、电子采集和管理系统对研究过程中的数据进行采集和管理.

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

We will use CRF, electronic collection and management systems to collect and manage data during the research process

创建人:

Creater Name:

 2020-03-04
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