三维平衡正脊技术治疗椎动脉型颈椎病的临床疗效及对Piezo1的影响

注册号:

Registration number:

ITMCTR2025000254

最近更新日期:

Date of Last Refreshed on:

2025-02-13

注册时间:

Date of Registration:

2025-02-13

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

三维平衡正脊技术治疗椎动脉型颈椎病的临床疗效及对Piezo1的影响

Public title:

Clinical efficacy of Three-Dimensional Balancing Chiropractic Technique in the treatment of cervical spondylosis of vertebral artery type and its effect on Piezo1

注册题目简写:

English Acronym:

研究课题的正式科学名称:

三维平衡正脊技术治疗椎动脉型颈椎病的临床疗效及对Piezo1的影响

Scientific title:

Clinical efficacy of Three-Dimensional Balancing Chiropractic Technique in the treatment of vertebral artery-type cervical spondylosis and its effect on Piezo1

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:

王义善

研究负责人:

王义善

Applicant:

wangyishan

Study leader:

wangyishan

申请注册联系人电话:

Applicant telephone:

15232397841

研究负责人电话:

Study leader's telephone:

15232397841

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:

wangyishan@163.com

研究负责人电子邮件:

Study leader's E-mail:

wangyishan@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:

山东省济南市历下区经十路16369号山东中医药大学

研究负责人通讯地址:

山东省济南市历下区经十路16369号山东中医药大学

Applicant address:

Shandong University of Traditional Chinese Medicine No. 16369 Jingshi Road Lixia District Jinan Shandong Province China

Study leader's address:

Shandong University of Traditional Chinese Medicine No. 16369 Jingshi Road Lixia District Jinan 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:

山东第一医科大学附属颈肩腰腿痛医院

Applicant's institution:

Neck Shoulder Back and Leg Pain Hospital of Shandong First Medical University

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:

202401028

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:

山东第一医科大学附属颈肩腰腿痛医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee Affiliated Neck Shoulder and Back Pain Hospital Shandong First Medical University China

伦理委员会批准日期:

Date of approved by ethic committee:

2024/11/7 0:00:00

伦理委员会联系人:

温雅

Contact Name of the ethic committee:

wenya

伦理委员会联系地址:

山东第一医科大学附属颈肩腰腿痛医院

Contact Address of the ethic committee:

Neck Shoulder Back and Leg Pain Hospital of Shandong First Medical University

伦理委员会联系人电话:

Contact phone of the ethic committee:

0531-82595716

伦理委员会联系人邮箱:

Contact email of the ethic committee:

sykyjjyttyy@126.com

研究实施负责(组长)单位:

山东第一医科大学附属颈肩腰腿痛医院

Primary sponsor:

Neck Shoulder Back and Leg Pain Hospital of Shandong First Medical University

研究实施负责(组长)单位地址:

山东省济南市历下区经十路18877号

Primary sponsor's address:

No. 18877 Jingshi Road Lixia 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):

山东省

市(区县):

济南市

Country:

China

Province:

Shandong Province

City:

Jinan City

单位(医院):

山东第一医科大学附属颈肩腰腿痛医院

具体地址:

山东省济南市历下区经十路18877号

Institution
hospital:

Neck Shoulder Back and Leg Pain Hospital of Shandong First Medical University

Address:

No. 18877 Jingshi Road Lixia District Jinan City Shandong Province China

经费或物资来源:

山东第一医科大学附属颈肩腰腿痛医院

Source(s) of funding:

Neck Shoulder Back and Leg Pain Hospital of Shandong First Medical University

研究疾病:

椎动脉型颈椎病

研究疾病代码:

Target disease:

cervical spondylosis of vertebral artery type

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:

评价三维平衡正脊技术治疗椎动脉型颈椎病的临床疗效,同时通过检测机械敏感性离子通道Piezo1在治疗前后的表达差异,验证三维平衡正脊技术对Piezo1的影响,为后续研究推拿压力信号转化为电信号及化学信号提供一定参考。

Objectives of Study:

To evaluate the clinical efficacy of Three-Dimensional Balancing Chiropractic Technique in the treatment of cervical spondylosis of vertebral artery type and at the same time to verify the effect of Three-Dimensional Balancing Chiropractic Technique on Piezo1 by detecting the difference in the expression of mechanically sensitive ion channel Piezo1 before and after the treatment so as to provide a certain reference for the subsequent research on the conversion of push-pressure signals into electrical signals and chemical signals.

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)符合国家中医药管理局颁布的《中医病证诊断疗效标准》[1]的诊断标准; (2)年龄20~60岁; (3)愿意接受本方案治疗并签署知情同意书,能如实提供病情变化,并按时来我院复诊; (4)自2024年10月以后有经颅彩色多普勒(TCD)及X线片检查,影像学资料保存完整者。

Inclusion criteria

(1) Meet the diagnostic criteria of the Diagnostic and Therapeutic Criteria for Chinese Medicine Diseases issued by the State Administration of Traditional Chinese Medicine; (2) Aged 20 to 60 years old; (3) Willing to accept the treatment of this programme and sign the informed consent can truthfully provide the changes in the condition and come to our hospital for follow-up on time; (4) Having transcranial colour Doppler (TCD) and X-ray examination since October 2024 with complete preservation of imaging data.

排除标准:

(1)其他疾病(梅尼埃病、颅内疾病等)引起的相关症状(眩晕、耳鸣等); (2)颈部病变(肿瘤、颈椎骨折、颈椎间盘脱出、椎体结核等)引起的相关症状; (3)存在神经内科系统疾病(帕金森病、阿尔茨海默病)及其他诱导产生认知障碍的疾病(甲状腺功能低下等); (4)颈部存在严重皮肤破溃的患者; (5)颈部血管病变(大量斑块及血栓形成); (6)影像学资料保存不完整、无法正常进行检查者; (7)妊娠及哺乳期妇女。

Exclusion criteria:

(1) Symptoms associated with other diseases (Meniere's disease intracranial diseases etc.) (vertigo tinnitus etc.). (2) Symptoms associated with cervical lesions (tumours cervical fractures cervical disc prolapse vertebral tuberculosis etc.). (3) Presence of neurological disorders (Parkinson's disease Alzheimer's disease) and other cognitive disorders (hypothyroidism etc.). (4) Patients with severe skin breakdown in the neck; and (5) Vascular lesions in the neck (massive plaque and thrombosis). (6) Patients with incomplete preservation of imaging data who are unable to perform the examination properly; (7) Pregnant and lactating women.

研究实施时间:

Study execute time:

From 2024-10-15

To      2027-03-01

征募观察对象时间:

Recruiting time:

From 2025-03-01

To      2027-03-01

干预措施:

Interventions:

组别:

治疗组

样本量:

42

Group:

treatment group

Sample size:

干预措施:

针刺结合药物+三维平衡正脊手法

干预措施代码:

Intervention:

Acupuncture combined with medicine + Three-Dimensional Balancing Chiropractic Technique

Intervention code:

组别:

对照组

样本量:

42

Group:

control group

Sample size:

干预措施:

针刺结合药物

干预措施代码:

Intervention:

Acupuncture combined with medicine

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 Province

City:

Jinan City

单位(医院):

山东第一医科大学附属颈肩腰腿痛医院

单位级别:

二级甲等

Institution/hospital:

Neck Shoulder Back and Leg Pain Hospital of Shandong First Medical University

Level of the institution:

2A

测量指标:

Outcomes:

指标中文名:

机械敏感性离子通道Piezo1

指标类型:

次要指标

Outcome:

Piezo1

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医证候积分

指标类型:

主要指标

Outcome:

Chinese Medicine 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:

副作用指标

指标类型:

次要指标

Outcome:

Side effect index

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

颈性眩晕症状与功能评估量表

指标类型:

次要指标

Outcome:

evaluation scale for cervical vertigo

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:

血液

组织:

Sample Name:

blood

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:

尚未开始

Not yet recruiting

年龄范围:

最小 20
Min age years
最大 60
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):

由研究者采用SPSS软件生成随机数进行随机分组

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

Randomised groups were generated by the researcher using SPSS software to generate random numbers

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):

不共享原始数据

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

Raw data is not shared

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:

选取山东第一医科大学附属颈肩腰腿痛医院门诊及住院进行治疗的CSA患者为研究对象,应用SPSS软件生成随机数,对纳入病例进行分组,使用EXCEL软件进行病例数据统计及汇总,对所收集的结局指标应用SPSS软件进行统计分析。

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

CSA patients who were treated in the outpatient department and inpatient department of Neck Shoulder and Back Pain Hospital affiliated to Shandong First Medical University were selected as the research objects. SPSS software was used to generate random numbers the included cases were grouped the case data were counted and summarized by EXCEL software and the collected outcome indicators were statistically analyzed by SPSS 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):

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