石氏经筋刺法治疗脑卒中后痉挛性瘫痪的随机对照研究

注册号:

Registration number:

ITMCTR2024000247

最近更新日期:

Date of Last Refreshed on:

2024-08-16

注册时间:

Date of Registration:

2024-08-16

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

石氏经筋刺法治疗脑卒中后痉挛性瘫痪的随机对照研究

Public title:

A randomized controlled study on the treatment of spastic paralysis after stroke with Shi's muscle meridian acupuncture therapy

注册题目简写:

English Acronym:

研究课题的正式科学名称:

石氏经筋刺法治疗脑卒中后痉挛性瘫痪的随机对照研究

Scientific title:

A randomized controlled study on the treatment of spastic paralysis after stroke with Shi's muscle meridian acupuncture therapy

研究课题的正式科学名称简写:

Scientific title acronym:

研究课题代号(代码):

Study subject ID:

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

申请注册联系人:

王兆庆

研究负责人:

尹丽丽

Applicant:

Wang Zhaoqing

Study leader:

Yin Lili

申请注册联系人电话:

Applicant telephone:

+86 131 3468 0144

研究负责人电话:

Study leader's telephone:

+86 137 5236 2670

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:

wangzhaoqing121@163.com

研究负责人电子邮件:

Study leader's E-mail:

kintelili@163.com

申请单位网址(自愿提供):

Study leader's 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:

天津市西青区昌凌路88号

研究负责人通讯地址:

天津市西青区昌凌路88号

Applicant address:

88 Changling Road, Xiqing District, Tianjin

Study leader's address:

88 Changling Road, Xiqing District, Tianjin

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:

天津中医药大学第一附属医院

Applicant's institution:

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

TYLL2024[K]字 035

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

天津中医药大学第一附属医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2024/6/19 0:00:00

伦理委员会联系人:

郑子琦

Contact Name of the ethic committee:

Zheng Ziqi

伦理委员会联系地址:

天津市西青区昌凌路88号

Contact Address of the ethic committee:

88 Changling Road, Xiqing District, Tianjin

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 022 2798 6258

伦理委员会联系人邮箱:

Contact email of the ethic committee:

yfeyfyiec@163.com

研究实施负责(组长)单位:

天津中医药大学第一附属医院

Primary sponsor:

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

天津市西青区昌凌路88号

Primary sponsor's address:

88 Changling Road, Xiqing District, Tianjin

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

天津市

市(区县):

Country:

China

Province:

Tianjin

City:

单位(医院):

天津中医药大学第一附属医院

具体地址:

天津市西青区昌凌路88号

Institution
hospital:

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Address:

88 Changling Road, Xiqing District, Tianjin

经费或物资来源:

国家中医针灸临床医学研究中心开放课题

Source(s) of funding:

National Clinical medical Research center of TCM acupuncture and moxibustion open subject

研究疾病:

脑卒中后痉挛性瘫痪

研究疾病代码:

Target disease:

spastic paralysis after stroke

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

治疗新技术临床试验

New Treatment Measure Clinical Study

研究目的:

本研究旨在观察经筋刺法治疗卒中后痉挛性瘫痪的临床疗效,及经筋刺法对不同程度、不同性质、不同部位的脑血管病所致痉挛疗效的差异,为卒中后痉挛性瘫痪患者提供更加有效的治疗方案。本研究采用随机对照研究设计,在研究过程中,充分利用大数据时代的发展契机,依托国家针灸临床研究中心的医渡云专科数据库平台,发放电子问卷完成CRF表数据采集及汇总,全程使用无纸化办公,初步探索网络平台临床科学研究的方案。

Objectives of Study:

The purpose of this study was to observe the clinical efficacy of transmuscular acupuncture in the treatment of spastic paralysis after stroke, and the difference in the efficacy of transmuscular acupuncture in the treatment of spastic paralysis caused by different degrees, different properties and different parts of cerebrovascular diseases, so as to provide more effective treatment for patients with spastic paralysis after stroke. This study adopts a randomized controlled study design. In the process of the study, making full use of the development opportunity of the era of big data, relying on the medical cloud specialty database platform of the National Clinical Research Center of Acupuncture and Moximotion, issuing electronic questionnaires to complete the data collection and summary of CRF table, using paperless office throughout the process, and initially exploring the scheme of clinical science research on the network platform.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

(1)符合下述诊断标准,存在肢体肌力下降,肌力评分<5级; ①西医诊断标准:缺血性脑卒中参照《中国急性缺血性脑卒中诊治指南2018》;出血性脑卒中参照《中国脑出血诊治指南2019》; ②中医诊断标准:参照《中医内科病症诊断疗效标准》中关于中风病的诊断; ③痉挛性瘫痪的诊断标准:参照《脑卒中康复治疗技术》中“脑血管疾病的康复评定”,即具有肌张力增高、腱反射异常、阵挛等临床特点,改良Ashworth量表评级≥1级。 (2)中风病病程6个月之内。 (3)年龄在35岁-80岁之间; (4)发病后经治疗病情平稳,能配合治疗并能完成相关功能评定者; (5)患者自愿参与,知情并签署知情同意书。

Inclusion criteria

(1) Meet the following diagnostic criteria, there is a decline in limb muscle strength, muscle strength score < 5; Diagnostic criteria for Western medicine: for ischemic stroke, refer to Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018; For hemorrhagic stroke, refer to the Chinese Guidelines for Diagnosis and Treatment of Cerebral Hemorrhage 2019. ② TCM diagnostic criteria: refer to the "TCM internal medicine diagnosis and Curative effect criteria" on the diagnosis of stroke; ③ Diagnostic criteria for spastic paralysis: refer to "Rehabilitation Assessment of cerebrovascular diseases" in "Stroke Rehabilitation Treatment Technology", that is, it has clinical characteristics such as increased muscle tone, abnormal tendon reflex, and clonus, and the modified Ashworth scale rating is ≥1 level. (2) Stroke course within 6 months. (3) Aged between 35 and 80 years old; (4) patients with stable condition after treatment, who can cooperate with treatment and complete relevant functional evaluation; (5) The patient voluntarily participated, informed and signed the informed consent.

排除标准:

(1)由骨折、骨质疏松症、关节炎等其他原因所引起的肢体功能障碍; (2)伴脑外伤、动脉瘤、神经肿瘤、动静脉畸形患者; (3)合并心肝肾功能严重损伤者; (4)大面积脑梗死,伴严重脑水肿,脑疝形成等患者。

Exclusion criteria:

(1) Limb dysfunction caused by fracture, osteoporosis, arthritis and other causes; (2) Patients with brain trauma, aneurysm, nerve tumor, arteriovenous malformation; (3) Patients with severe injury of heart, liver and kidney function; (4) Patients with large cerebral infarction, severe cerebral edema, cerebral hernia formation, etc.

研究实施时间:

Study execute time:

From 2023-12-01

To      2025-11-30

征募观察对象时间:

Recruiting time:

From 2024-08-20

To      2025-10-31

干预措施:

Interventions:

组别:

治疗组

样本量:

100

Group:

Treatment group

Sample size:

干预措施:

石氏经筋刺法结合基础治疗(西医常规治疗+醒脑开窍针刺法)

干预措施代码:

Intervention:

On the basis of conventional Western medicine treatment, Shi's muscle meridian acupuncture therapy is used.

Intervention code:

组别:

对照组

样本量:

100

Group:

Control group

Sample size:

干预措施:

不采用经筋刺法,仅使用基础治疗(西医常规治疗+醒脑开窍针刺法)

干预措施代码:

Intervention:

It does not use the muscle meridian acupuncture therapy, but only uses the conventional Western medicine treatment and "Xing Nao Kai Qiao" acupuncture therapy.

Intervention code:

样本总量 Total sample size : 200

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

天津市

市(区县):

Country:

China

Province:

Tianjin

City:

单位(医院):

天津中医药大学第一附属医院

单位级别:

三甲

Institution/hospital:

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

简式Fugl-Meyer评分法(FMA)

指标类型:

次要指标

Outcome:

Fugl-Meyer rating scale(FMA)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

神经功能NIHSS评分

指标类型:

次要指标

Outcome:

National Institutes of Health Stroke Scale

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Barthel指数评分(BI)

指标类型:

次要指标

Outcome:

Barthel Index(BI)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

超声剪切波弹性成像

指标类型:

次要指标

Outcome:

Ultrasonic shear wave elastic imaging

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

改良Ashworth量表(MAS)

指标类型:

主要指标

Outcome:

Modified Ashworth Scale (MAS)

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

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:

正在进行

Recruiting

年龄范围:

最小 35
Min age years
最大 80
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

非课题成员用SPSS27.0软件生成随机数字表

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

A table of random numbers is generated by a non-project member using SPSS27.0 software

盲法:

单盲法

Blinding:

Single blind method

是否共享原始数据:

IPD sharing:

No

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):

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

none

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

病例记录表:患者的一般项目资料如姓名、性别、年龄、民族、出生日期、身高、体重、住诊号、本人电话、职业、婚姻状况、吸烟史、饮酒史、发病时间、病程、合并症、脑梗死或脑出血部位、治疗史、体格检查、肌力、肌张力、化验检查等基线资料,并采集改良Ashworth量表(MAS)、简式Fugl-Meyer评分法(FMA)、Barthel指数(BI)评分、神经功能NIHSS评分、超声剪切波弹性成像的数据。 电子采集和管理系统:针灸优势病种科研专病库、医渡云随访系统(nova.tjtcm.yiducloud.cn)。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Case record form: The patient's general project information, such as name, sex, age, nationality, date of birth, height, weight, hospitalization number, personal telephone number, occupation, marital status, smoking history, drinking history, time of onset, course of disease, comorbidities, site of cerebral infarction or cerebral hemorrhage, treatment history, physical examination, muscle strength, muscle tension, laboratory examination and other baseline data, The data of modified Ashworth Scale (MAS), Fugl-Meyer score (FMA), Barthel index (BI), NIHSS score and ultrasonic shear wave elastic imaging were collected. Electronic collection and management system: acupuncture and moxibustion advantageous diseases research disease database, medical cloud follow-up system (nova.tjtcm.yiducloud.cn).

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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