我要注册
立即登录
中文/English
平台介绍|试验检索|关于我们|新闻公告
基于静息态功能磁共振成像（rs-fMRI）探讨项七针治疗颈性眩晕的临床疗效与作用机制

注册号：

Registration number：

ITMCTR2025001259

最近更新日期：

Date of Last Refreshed on：

2025-06-26

注册时间：

Date of Registration：

2025-06-26

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

基于静息态功能磁共振成像（rs-fMRI）探讨项七针治疗颈性眩晕的临床疗效与作用机制

Public title：

Exploring the clinical efficacy and mechanism of action of Nape Seven Needles in treating Cervical Vertigo based on resting-state functional Magnetic Resonance Imaging (rs-fMRI)

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于静息态功能磁共振成像（rs-fMRI）探讨项七针治疗颈性眩晕的临床疗效与作用机制

Scientific title：

Exploring the clinical efficacy and mechanism of action of Nape Seven Needles in treating Cervical Vertigo based on resting-state functional Magnetic Resonance Imaging (rs-fMRI)

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：

贾雨琦

研究负责人：

贾红玲

Applicant：

Jia Yuqi

Study leader：

Jia Hongling

申请注册联系人电话：

Applicant telephone：

18963232586

研究负责人电话：

Study leader's telephone：

18254178199

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：

jyq0406x@163.com

研究负责人电子邮件：

Study leader's E-mail：

jiahl1969@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：

山东省济南市市中区经八路1号

研究负责人通讯地址：

山东省济南市市中区经八路1号

Applicant address：

No. 1 Jingba Road Shizhong District Jinan City Shandong Province China

Study leader's address：

No. 1 Jingba Road Shizhong District Jinan City Shandong Province 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：

山东中医药大学

Applicant's institution：

Shandong 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：

2023 伦审-KY-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：

山东中医药大学第二附属医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2023/9/21 0:00:00

伦理委员会联系人：

袁媛

Contact Name of the ethic committee：

Yuan Yuan

伦理委员会联系地址：

山东省济南市市中区经八路1号

Contact Address of the ethic committee：

No. 1 Jingba Road Shizhong District Jinan City Shandong Province China

伦理委员会联系人电话：

Contact phone of the ethic committee：

0531-82436062

伦理委员会联系人邮箱：

Contact email of the ethic committee：

zdeyllwyh@163.com

研究实施负责（组长）单位：

山东中医药大学第二附属医院

Primary sponsor：

The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

山东省济南市市中区经八路1号

Primary sponsor's address：

No. 1 Jingba Road Shizhong District Jinan City Shandong 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)：

山东

市(区县)：

济南

Country：

China

Province：

Shandong

City：

Jinan

单位(医院)：

山东中医药大学第二附属医院

具体地址：

山东省济南市市中区经八路1号

Institution
hospital：

The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Address：

No. 1 Jingba Road Shizhong District Jinan City Shandong Province China

经费或物资来源：

研究者及患者自费

Source(s) of funding：

The investigator and the patient are self-paying

研究疾病：

颈性眩晕

研究疾病代码：

Target disease：

Cervical Vertigo

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：

项七针是全国老中医药专家学术经验继承工作指导老师单秋华教授腧穴配伍处方的经验总结，贾红玲教授团队自 2004 年起，陆续开展了项七针治疗椎动脉型颈椎病的相关文献、临床观察和实验研究。本课题将继续观察项七针治疗颈性眩晕(Cervical Vertigo，CV)的临床疗效，探讨项七针治疗 CV 的疗效与安全性，同时结合静息态 fMRI 技术分析脑区局部神经元活动强度及活动同步性变化，探讨项七针治疗颈性眩晕的作用机制，为项七针治疗颈性眩晕提供科学依据，为临床针灸治疗颈性眩晕提供更多的思路与方法，对于提高颈性眩晕的诊断和治疗水平，为患者提供更好的医疗服务具有重要意义。

Objectives of Study：

The Nape Seven Needles is an empirical summary of acupoint combination prescriptions developed by Professor Shan Qiuhua a mentor in the National Inheritance Program for the Academic Experience of Veteran Traditional Chinese Medicine (TCM) Experts. Since 2004 Professor Jia Hongling's research team has sequentially conducted relevant literature reviews clinical observations and experimental studies on the treatment of vertebral artery type cervical spondylosis using the Nape Seven Needles technique. This current study aims to further evaluate the clinical efficacy of the "Nape Seven Needles" in treating cervical vertigo (CV) investigate both its therapeutic effects and safety profile. Additionally by integrating resting-state functional magnetic resonance imaging (fMRI) technology the study will analyze changes in the intensity and synchronicity of local neuronal activity within brain regions. The objective is to elucidate the underlying mechanisms of the "Nape Seven Needles" in the treatment of cervical vertigo thereby providing a scientific basis for its application and offering additional insights and methodologies for clinical acupuncture treatment of cervical vertigo. This research holds significant importance for enhancing the diagnostic and therapeutic standards of cervical vertigo ultimately leading to improved medical services for patients.

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）符合上述中西医诊断标准；（2）性别不限，年龄 18 至 65 岁；（3）生命体征平稳，意识清楚，能够独立完成各项量表；（4）自愿作为受试对象，配合针刺治疗，知情并签订同意书，自愿承担相应风险。凡纳入本研究的患者需同时满足上述条件。

Inclusion criteria

(1) Meet the above diagnostic criteria for both Traditional Chinese Medicine (TCM) and Western Medicine;(2) No restriction on gender aged between 18 and 65 years old;(3) Have stable vital signs be conscious and capable of independently completing various assessment scales;(4) Volunteer to participate as a study subject cooperate with acupuncture treatment provide informed consent after being fully informed and voluntarily assume the corresponding risks.Patients included in this study must meet all of the above criteria simultaneously.

排除标准：

（1）其他原因导致的眩晕：中枢性、前庭性、精神心理性以及全身疾病相关性的眩晕；（2）严重的基础疾病包括心、脑、肾血管疾病及精神类疾病；（3）既往颈部手术或外伤史，或先天脊椎发育异常；（4）椎动脉重度狭窄、椎动脉或颈动脉粥样斑块形成；（5）妊娠期及哺乳期妇女；（6）不能耐受针刺治疗，感染性疾病或严重皮肤病；（7）凝血功能障碍，或有出血倾向。凡具备上述任意一项的患者，均予以排除。

Exclusion criteria：

(1) Vertigo caused by other reasons: central vestibular psychogenic or associated with systemic diseases;(2) Severe underlying diseases including cardiovascular cerebrovascular renal vascular diseases and psychiatric disorders;(3) Previous history of cervical surgery or trauma or congenital spinal developmental abnormalities;(4) Severe stenosis of the vertebral artery formation of atherosclerotic plaques in the vertebral or carotid arteries;(5) Women who are pregnant or lactating;(6) Inability to tolerate acupuncture treatment presence of infectious diseases or severe skin conditions;(7) Coagulation dysfunction or bleeding tendency. Patients who meet any of the above criteria shall be excluded from the study.

研究实施时间：

Study execute time：

从From 2023-09-21

至To      2024-09-20

征募观察对象时间：

Recruiting time：

从From 2023-09-21

至To      2024-09-20

干预措施：

Interventions：

组别：

治疗组

样本量：

42

Group：

Treatment group

Sample size：

干预措施：

项七针

干预措施代码：

Intervention：

Nape Seven Needles

Intervention code：

组别：

对照组

样本量：

42

Group：

Control Group

Sample size：

干预措施：

常规针刺

干预措施代码：

Intervention：

Conventional acupuncture treatment

Intervention code：

样本总量 Total sample size ： 84

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

山东

市(区县)：

济南

Country：

China

Province：

Shandong

City：

Jinan

单位(医院)：

山东中医药大学第二附属医院

单位级别：

三级甲等

Institution/hospital：

The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Level of the institution：

Tertiary Grade A

测量指标：

Outcomes：

指标中文名：

颈性眩晕症状与功能评估量表

指标类型：

主要指标

Outcome：

Evaluation Scale for Cervical Vertigo

Type：

Primary indicator

测量时间点：

第一次治疗前、最后一次治疗结束后及治疗结束一个月后

测量方法：

Measure time point of outcome：

Before the start of the treatment course, after the treatment course ends and one month after the treatment course ends.

Measure method：

指标中文名：

影像学指标

指标类型：

附加指标

Outcome：

Imaging indices

Type：

Additional indicator

测量时间点：

疗程开始前、疗程结束后

测量方法：

Measure time point of outcome：

Before the start of the treatment course and after it ends.

Measure method：

指标中文名：

血流动力学指标

指标类型：

次要指标

Outcome：

Hemodynamic indices

Type：

Secondary indicator

测量时间点：

疗程开始前、疗程结束后及疗程结束一个月后

测量方法：

Measure time point of outcome：

Before the start of the treatment course, after the treatment course ends and one month after the treatment course ends.

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

结束

Completed

年龄范围：

最小 18 岁
Min age years
最大 65 岁
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）：

随机方案委托第三方机构进行实施。使用SAS软件PROCPLAN过程语句进行区组随机分组，纳入符合上述标准的患者84例，按照试验患者入组顺序将研究对象编为1～84号。采用密闭信封法，进行区组随机，得出与纳入顺序相应的随机号和分配组别并密封于不透光的信封内，纳入顺序号贴在信封表面。按照1：1的比例随机分为常规针刺组42例，治疗组42例。随机信封和分配由不参与治疗和评价的专人负责。

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

The randomization protocol was entrusted to a third-party agency for implementation. The PROC PLAN procedure statement in SAS software was utilized to perform block randomization. A total of 84 patients who met the aforementioned criteria were included in the study. The research subjects were numbered from 1 to 84 according to the order of their enrollment in the trial. Using the sealed envelope method block randomization was conducted to generate random numbers and allocation groups corresponding to the enrollment order which were then sealed in opaque envelopes. The enrollment sequence numbers were affixed to the surface of the envelopes. The patients were randomly divided into two groups in a 1:1 ratio with 42 patients in the Control group and 42 patients in the Treatment group. The randomization envelopes and group allocations were managed by a designated individual who was not involved in the treatment or evaluation processes.

盲法：

Blinding：

是否共享原始数据：

IPD sharing：

是

Yes

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）：

通过邮件向研究负责人索要，项目组根据情况提供。

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

Data can be requested from the research director by email and the project team will provide it according to the situation.

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：

数据采集用CRF表，研究者根据受试者的原始观察记录，将数据及时、完整、正确、清晰的载入病例报告表，录入采用相应的数据库系统双人双机录入，之后对数据库进行两边比对。电子数据文件分类保存，并有多个备份保存于不同磁盘或记录介质上，妥善保存，防止损坏。

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

Data collection was performed using Case Report Forms (CRFs). Researchers transferred data from the subjects original observation records to the CRFs in a timely complete accurate and clear manner. Data entry was conducted using a double-entry method with two individuals and two separate systems. The database entries were then cross-checked for consistency. Electronic data files were categorized and saved with multiple backups stored on different disks or recording media to ensure proper preservation and prevent damage.

数据管理委员会：

Data Managemen Committee：

有

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):

返回
平台信息
平台简介
关于我们
试验注册
常见问题
伦理审查
公共服务
试验检索
参与我们
国际传统医学临床试验注册平台 京ICP备07032215号-5 提示：推荐使用IE8.0以上版本 宽屏显示分辨率下使用系统