浮针浅刺治疗卒中后肩痛的临床疗效研究

注册号:

Registration number:

AMCTR-IOR-19000258 

注册号获得时间:

Date of releasing the registration number:

2019/3/12 9:50:47 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

浮针浅刺治疗卒中后肩痛的临床疗效研究 

Public title:

Therapeutic Effect of Superficial Acupuncture for Hemiplegic Shoulder Pain Among Stroke Survivors: A Randomized Controlled Trial 

研究课题的正式科学名称:

浮针浅刺治疗卒中后肩痛的临床疗效研究 

Scientific title:

Therapeutic Effect of Superficial Acupuncture for Hemiplegic Shoulder Pain Among Stroke Survivors: A Randomized Controlled Trial 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

ChiCTR1900021644 

申请注册联系人:

刘通 

研究负责人:

刘悦 

Applicant:

Liu Tong 

Study leader:

Liu Yue 

申请注册联系人电话:

Applicant telephone:

+86 18319673139 

研究负责人电话:

Study leader's telephone:

+86 18319673139 

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:

liutongmama@163.com 

研究负责人电子邮件:

Study leader's E-mail:

liuyue2288@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:

广东省广州市越秀区恒福路60号 

研究负责人通讯地址:

广东省广州市越秀区恒福路60号 

Applicant address:

60 Hengfu Road, Guangzhou, Yuexiu District, Guangdong, China 

Study leader's address:

60 Hengfu Road, Guangzhou, Yuexiu District, Guangdong, 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:

广东省第二中医院 

Applicant's institution:

Guangdong Second Hospital of Traditional 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:

粤二中医(2019)伦审第03号 

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:

广东省第二中医院伦理委员会 

Name of the ethic committee:

Ethics Committee of the Guangdong Second Hospital of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-02-22 

研究实施负责(组长)单位:

广东省第二中医院 

Primary sponsor:

Guangdong Second Hospital of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

广东省广州市越秀区恒福路60号 

Primary sponsor's address:

60 Hengfu Road, Guangzhou, Yuexiu District, Guangdong, 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):

广东

市(区县):

Country:

China

Province:

Guangdong

City:

单位(医院):

广东省第二中医院

具体地址:

广东省广州市越秀区恒福路60号

Institution
hospital:

Guangdong Second Hospital of Traditional Chinese Medicine

Address:

60 Hengfu Road, Guangzhou, Yuexiu District, Guangdong, China

经费或物资来源:

自筹经费 

Source(s) of funding:

self-financing 

研究疾病:

卒中后肩痛 

Target disease:

Hemiplegic Shoulder Pain 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:

明确浮针浅刺治疗卒中后肩痛的临床疗效。 

Objectives of Study:

To evaluate the therapeutic effect of superficial acupuncture for hemiplegic shoulder pain among stroke survivors. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

1. 卒中后肩痛患者; 2. 病程在2周-6个月之间; 3. 年龄在20-80之间; 4. 入组时疼痛评分(NRS>1); 5. 认知功能正常; 6. 知情同意并签署知情同意书。 

Inclusion criteria

(1) HPS induced by stroke; (2) Duration ranges from two weeks to six months at time of recruitment; (3) Aged 20 to 80 years; (4) intensity of HSP evaluated by Numerical Rating Scale score above 1; (5) adequate communication ability and intact cognitive function (Mini-Mental Status Examination scores ≥ 24 points); (6) Signed informed consent. 

排除标准:

1. 非卒中引发的肩痛患者; 2. 伴有失语的患者; 3. 严重心、肝、肾功能不全可随时危及生命安全者; 4. 不接受针刺治疗者; 5. 妊娠期、哺乳期妇女; 6. 患者同时参与其他研究者; 7.有严重认知障碍者。 

Exclusion criteria:

(1) HPS not induced by stroke; (2) Combination of heart, liver or kidney failure endanger the safety of life at any time; (3) Those who do not receive acupuncture therapy; (4) Women with pregnancy and lactation; (5) participate in other studies; (6) aphasia; (7) severe cognitive deficits. 

研究实施时间:

Study execute time:

From2019-03-01To 2019-12-31 

干预措施:

Interventions:

组别:

传统针刺组

样本量:

30

Group:

Group 1

Sample size:

干预措施:

传统针刺

干预措施代码:

Intervention:

Traditional acupuncture

Intervention code:

组别:

浮针浅刺组

样本量:

30

Group:

Group 2

Sample size:

干预措施:

浮针浅刺

干预措施代码:

Intervention:

Superficial acupuncture

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广东省第二中医院 

单位级别:

三甲 

Institution
hospital:

Guangdong Second Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

NRS评分

指标类型:

主要指标 

Outcome:

NRS score

Type:

Primary indicator 

指标中文名:

FuglMeyer评分

指标类型:

次要指标 

Outcome:

FuglMeyer

Type:

Secondary indicator 

指标中文名:

Constant

指标类型:

次要指标 

Outcome:

Constant 评分

Type:

Secondary indicator 

指标中文名:

MPQ-SF评分

指标类型:

次要指标 

Outcome:

MPQ-SF

Type:

Secondary indicator 

指标中文名:

Qol评分

指标类型:

次要指标 

Outcome:

Qol

Type:

Secondary indicator 

指标中文名:

ROM评分

指标类型:

次要指标 

Outcome:

ROM

Type:

Secondary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

None

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

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 0 years
最大 Max age 0 years

随机方法(请说明由何人用什么方法产生随机序列):

由中心计算机产生随机方案,并由专人负责保管。随机方案除设计者之外,其他研究人员均不能知晓。临床医师根据患者的入组序号向中心随机员索取随机号及该患者所纳入的组别编号,然后按照事先确定好的各组的治疗方案进行临床研究

性别:

男女均可

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

Random numbers were generated by central computer program and were kept by the special person. Besides the designer,other researchers were not aware of the random program.The clinician requests the random number and the group number according to the serial number of the patient, and then conducts the clinical.

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):

在实验结束、论文完成并发表后,可以以电子文件的形式将原始数据在中国临床试验注册中心临床试验公共管理平台ResMan公开

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

IPD will be public accessable via ResMan After completion of this clinical trial and finish the paper publication, the stata of the trial can be obtained on the web of chinese clinical registry.

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):

数据包括原始记录、病例记录等,采用spss软件及ResMan数据库

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

Original records, case records and other data, using the spss software and resman database

创建人:

Creater Name:

 2019-03-06
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