Clinical Efficacy and Mechanism in the Treatment of Sensory Disorders in Patients with Limb Numbness after Stroke by Scalp Acupuncture

注册号:

Registration number:

ITMCTR2024000690

最近更新日期:

Date of Last Refreshed on:

2024-11-12

注册时间:

Date of Registration:

2024-11-12

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

头针治疗脑梗死后躯体感觉障碍疗效评价及对感觉通路的影响

Public title:

Clinical Efficacy and Mechanism in the Treatment of Sensory Disorders in Patients with Limb Numbness after Stroke by Scalp Acupuncture

注册题目简写:

English Acronym:

研究课题的正式科学名称:

头针治疗脑梗死后躯体感觉障碍疗效评价及对感觉通路的影响

Scientific title:

Clinical Efficacy and Mechanism in the Treatment of Sensory Disorders in Patients with Limb Numbness after Stroke by Scalp Acupuncture

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:

张茗佳

研究负责人:

张茗佳

Applicant:

Zhang Mingjia

Study leader:

Zhang Mingjia

申请注册联系人电话:

Applicant telephone:

16620131304

研究负责人电话:

Study leader's telephone:

16620131304

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:

13726840720@163.com

研究负责人电子邮件:

Study leader's E-mail:

13726840720@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:

广东省广州市白云区机场路12号广州中医药大学三元里校区

研究负责人通讯地址:

广东省广州市白云区机场路12号广州中医药大学三元里校区

Applicant address:

San Yuan Li Campus Guangzhou University of Chinese Medicine No. 12 Airport Road Baiyun District Guangzhou City Guangdong Province."

Study leader's address:

San Yuan Li Campus Guangzhou University of Chinese Medicine No. 12 Airport Road Baiyun District Guangzhou City Guangdong Province."

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:

广州中医药大学第二临床医学院

Applicant's institution:

The Second Clinical Medical College of Guangzhou University of 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:

YF2023-189-01

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

广东省中医院伦理委员会

Name of the ethic committee:

Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2023/7/27 0:00:00

伦理委员会联系人:

李晓彦

Contact Name of the ethic committee:

Li Xiaoyan

伦理委员会联系地址:

广东省广州市越秀区大德路111号

Contact Address of the ethic committee:

No. 111 Dadelu Yuexiu District Guangzhou City Guangdong Province China

伦理委员会联系人电话:

Contact phone of the ethic committee:

020-81887233-35943

伦理委员会联系人邮箱:

Contact email of the ethic committee:

llbgs@gzucm.edu.cn

研究实施负责(组长)单位:

广东省中医院

Primary sponsor:

Guangdong Provincial Hospital of Chinese Medicine

研究实施负责(组长)单位地址:

广东省广州市越秀区大德路111号

Primary sponsor's address:

No. 111 Dadelu Yuexiu District Guangzhou City Guangdong Province 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):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong Province

City:

Guangzhou City

单位(医院):

广东省中医院

具体地址:

广东省广州市越秀区大德路111号

Institution
hospital:

Guangdong Provincial Hospital of Chinese Medicine

Address:

No. 111 Dadelu Yuexiu District Guangzhou City Guangdong Province China

经费或物资来源:

自筹

Source(s) of funding:

Self support

研究疾病:

脑梗死

研究疾病代码:

Target disease:

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:

其它

Others

研究目的:

本研究将验证头针治疗脑梗死后躯体感觉的疗效及安全性,探究头针对于脑梗死患者感觉通路及皮层异质性的影响

Objectives of Study:

This study will verify the therapeutic efficacy and safety of scalp acupuncture for somatosensory function after cerebral infarction and explore its impact on the sensory pathways and cortical heterogeneity in patients with cerebral infarction

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)经头颅CT或MRI诊断明确,符合《中国脑卒中防治指导规范》以及中医有关脑梗死的诊断标准。 (2)单侧躯体感觉功能障碍,患侧感觉障碍评定积分表评分小于36分; (3)自身未患有可能引起躯体感觉障碍的疾病,如帕金森病、糖尿病周围神经病变等; (4)无性别限制,年龄范围为30~80岁,首次发病且发病时间为3-24周之间; (5)意识清晰,配合测试,简易智力状态检查量表(Mini-mental State Examination,MMSE)得分27分以上(MMSE分数在27~30分为正常,分数≤27为认知功能障碍);言语功能筛查听理解为二步指令以上,复述功能保留;肌张力根据改良阿什沃思量表(modified Ashworth scale,MAS)评估,分级为0~1级,无偏盲;根据《中国人利手量表》评估判断为右利手; (6)接受头针治疗。 (7)自愿签署知情同意书。

Inclusion criteria

(1) A definitive diagnosis made by cranial CT or MRI in accordance with the 'Chinese Guidelines for the Prevention and Treatment of Stroke' and the diagnostic criteria for cerebral infarction in traditional Chinese medicine. (2) Unilateral somatosensory dysfunction with a score less than 36 on the affected side sensory disturbance assessment scale; (3) No pre-existing conditions that might cause somatosensory dysfunction such as Parkinson's disease diabetic peripheral neuropathy etc.; (4) No gender restrictions age range from 30 to 80 years old with the first onset of illness and the disease duration between 3 to 48 weeks; (5) Clear consciousness and cooperation in testing with a Mini-mental State Examination (MMSE) score above 27 (MMSE scores of 27 to 30 are considered normal and a score of ≤27 indicates cognitive dysfunction); auditory comprehension is above two-step commands in speech function screening and repetition function is preserved; muscle tone is assessed by the modified Ashworth scale (MAS) graded as 0 to 1 with no hemianopia; assessed as right-handed by the 'Chinese Handedness Scale'; (6) Receiving scalp acupuncture treatment. (7) Voluntarily signing the informed consent form.

排除标准:

(1)经影像学等相关检查发现感觉障碍是由脑出血、脑肿瘤、脑外伤等疾病引起者; (2)既往有外伤、严重糖尿病、周围神经病等导致周围神经功能障碍者; (3)妊娠期女性,恶性肿瘤晚期,既往脑部手术,既往癫痫、脑肿瘤等其他中枢神经系统疾病史等。 (4)四肢缺如。 (5)颅骨不完整、头部皮肤破溃、感染等影响头针治疗及不能配合针刺治疗者。 (6)合并心、肺、肝、肾等重要器官疾病,病情危重或生命体征不稳定者。 (7)既往有认知障碍、精神病史、药物滥用及酗酒史;近期摄入或服用影响感觉功能的药物或食物等。

Exclusion criteria:

(1) Sensory disturbances found to be caused by conditions such as cerebral hemorrhage brain tumors or head trauma through imaging and other related examinations; (2) History of trauma severe diabetes peripheral neuropathy or other causes of peripheral nerve dysfunction; (3) Pregnant women advanced-stage malignant tumors history of brain surgery history of epilepsy brain tumors or other central nervous system diseases; (4) Absence of limbs. (5) Incomplete skull open sores or infections on the head that affect scalp acupuncture treatment and those who cannot cooperate with acupuncture treatment. (6) Comorbidities with severe or critical conditions of vital organs such as heart lungs liver and kidneys or with unstable vital signs. (7) History of cognitive impairment psychiatric disorders substance abuse and alcoholism; recent intake or use of drugs or foods that affect sensory function.

研究实施时间:

Study execute time:

From 2023-08-01

To      2024-12-31

征募观察对象时间:

Recruiting time:

From 2023-08-01

To      2024-10-31

干预措施:

Interventions:

组别:

对照组

样本量:

40

Group:

Control Group

Sample size:

干预措施:

基础治疗+常规针刺治疗

干预措施代码:

Intervention:

Secondary Prevention Treatment Plan for Stroke+Routine Acupuncture Protocol for Stroke Disease

Intervention code:

组别:

试验组

样本量:

40

Group:

Observation Group

Sample size:

干预措施:

基础治疗+常规针刺治疗联合头针治疗

干预措施代码:

Intervention:

Secondary Prevention Treatment Plan for Stroke+Routine Acupuncture+Scale Acupuncture

Intervention code:

样本总量 Total sample size : 80

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong Province

City:

Guangzhou City

单位(医院):

广东省中医院

单位级别:

三级甲等

Institution/hospital:

Guangdong Provincial Hospital of Chinese Medicine

Level of the institution:

Third-Class Hospital Grade A

测量指标:

Outcomes:

指标中文名:

感觉障碍积分

指标类型:

主要指标

Outcome:

Sensory Disturbance Assessment Score

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

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:

改良Barthel指数评定量表

指标类型:

次要指标

Outcome:

Modified Barthel Index

Type:

Secondary 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:

none

组织:

Sample Name:

none

Tissue:

人体标本去向

其它

说明

Fate of sample 

Others

Note:

征募研究对象情况:

结束

Completed

年龄范围:

最小 30
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):

本试验应用SPSS 26.0软件进行随机分组。根据样本量由SPSS 26.0软件生成随机数字,再采用可视化分箱功能产生新变量Group,即随机分组的结果,从而确定研究对象的随机分组情况。进行随机分配隐藏时将每个编号和相对应的随机数字及分组结果密封于单独不透光的信封内,信封表面标明纳入的顺序号码。筛选合格的受试者按照先后顺序拆开相对应的随机信封,根据分组结果接受相关治疗

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

This study utilized SPSS 26.0 software for random group allocation. Random numbers were generated by the SPSS 26.0 software based on the sample size and then the visualization binning function was used to create a new variable 'Group' which represents the outcome of the random grouping thereby determining the randomization status of the study subjects. To conceal the random allocation each subject's number along with the corresponding random number and group assignment was sealed in an individual opaque envelope with the sequence number marked on the envelope's surface. Eligible subjects in the order of their selection opened the corresponding random envelope and received the assigned treatment according to the group result.

盲法:

Blinding:

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):

/

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:

由随访人员填写病例观察表,并由数据采集人员录入数据管理软件。

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

Follow-up staff complete the case observation form and data collection personnel enter the data into the data management software

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):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above