穴位注射改善颈椎后路术后早期轴性症状的随机对照研究

注册号:

Registration number:

ITMCTR2025000253

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:

补注册

Retrospective registration

注册题目:

穴位注射改善颈椎后路术后早期轴性症状的随机对照研究

Public title:

Randomized controlled study on acupoint injection for improving early post-operative axial symptoms after posterior cervical surgery

注册题目简写:

English Acronym:

研究课题的正式科学名称:

穴位注射改善颈椎后路术后早期轴性症状的随机对照研究

Scientific title:

Randomized controlled study on acupoint injection for improving early post-operative axial symptoms after posterior cervical surgery

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:

周文超

研究负责人:

周文超

Applicant:

wenchao zhou

Study leader:

wenchao zhou

申请注册联系人电话:

Applicant telephone:

+86 15618395979

研究负责人电话:

Study leader's telephone:

+86 15618395979

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:

spinezhou@yeah.net

研究负责人电子邮件:

Study leader's E-mail:

spinezhou@yeah.net

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:

上海市长宁区华山路1328号中国人民解放军海军第九〇五医院

研究负责人通讯地址:

上海市长宁区华山路1328号中国人民解放军海军第九〇五医院

Applicant address:

No.905 Hospital of PLA Navy 1328 Huashan Road Changning District Shanghai China

Study leader's address:

No.905 Hospital of PLA Navy 1328 Huashan Road Changning District Shanghai 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:

中国人民解放军海军第九O五医院

Applicant's institution:

No.905 Hospital of PLA Navy Shanghai China

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:

2024-伦理意见-LW10

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:

中国人民解放军海军第九O五医院

Name of the ethic committee:

No.905 Hospital of PLA Navy Shanghai China

伦理委员会批准日期:

Date of approved by ethic committee:

2025/1/3 0:00:00

伦理委员会联系人:

张璇

Contact Name of the ethic committee:

xuan zhang

伦理委员会联系地址:

上海市长宁区华山路1328号中国人民解放军海军第九〇五医院

Contact Address of the ethic committee:

No.905 Hospital of PLA Navy 1328 Huashan Road Changning District Shanghai China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 19916934515

伦理委员会联系人邮箱:

Contact email of the ethic committee:

511276312@qq.com

研究实施负责(组长)单位:

中国人民解放军海军第九O五医院

Primary sponsor:

No.905 Hospital of PLA Navy Shanghai China

研究实施负责(组长)单位地址:

上海市长宁区华山路1328号中国人民解放军海军第九〇五医院

Primary sponsor's address:

No.905 Hospital of PLA Navy 1328 Huashan Road Changning District Shanghai 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):

上海市

市(区县):

上海市

Country:

china

Province:

shanghai

City:

shanghai

单位(医院):

中国人民解放军海军第九O五医院

具体地址:

上海市长宁区华山路1328号中国人民解放军海军第九〇五医院

Institution
hospital:

No.905 Hospital of PLA Navy Shanghai China

Address:

No.905 Hospital of PLA Navy 1328 Huashan Road Changning District Shanghai China

经费或物资来源:

中国人民解放军海军第九O五医院科研处

Source(s) of funding:

Department of Scientific Research No.905 Hospital of PLA Navy

研究疾病:

颈椎后路术后轴性症状

研究疾病代码:

Target disease:

post-operative axial symptoms after posterior cervical surgery

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:

探索性研究/预试验

Pilot clinical trial

研究目的:

本研究拟通过前瞻性临床随机对照试验,探讨穴位注射是否可以改善颈后路术后早期颈部轴性症状,为临床治疗提供简单、有效的治疗途径。

Objectives of Study:

This study aims to explore through a prospective clinical randomized controlled trial whether acupoint injection can improve early axial symptoms in the neck following posterior cervical surgery providing a simple and effective treatment approach for clinical practice.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

符合以下5项者,可纳入研究,若有任何一项不符合,则患者不能进入研究: 1、颈后路单开门椎管扩大成形术患者 2、颈部VAS评分≥6分 3、年龄18-80岁 4、符合颈后路术后AS诊断的Takeuchi 标准 5、同意参与本研究并且交流配合者

Inclusion criteria

Those who meet the following 5 items can be included in the study. If there is any inconformity the patient cannot enter the study 1.Patients who have undergone posterior cervical single-door decompression surgery 2.Cervical VAS score of ≥6 aged 3.Between 18 and 80 years 4.Meet the Takeuchi criteria for the diagnosis of post-operative axial symptoms (AS) 5.Patients agree to participate in this study and cooperate in communication.

排除标准:

如果以下任何一项符合,则患者不能进入研究 1、既往颈椎手术史患者 2、孕妇 3、颈椎感染患者 4、合并焦虑、抑郁、失眠等神经系统或心理疾病及肿瘤病史的患者 5、年龄大于80岁的患者

Exclusion criteria:

Patients cannot enter the study if any of the following are met: 1.Patients with a history of cervical spine surgery; 2.Pregnant women; 3.Patients with cervical spine infections conditions; 4.Patients with comorbid neurological or psychological disorders such as anxiety depression insomnia or a history of tumors; 5.Patients older than 80 years.

研究实施时间:

Study execute time:

From 2025-01-04

To      2025-07-04

征募观察对象时间:

Recruiting time:

From 2025-01-04

To      2025-07-04

干预措施:

Interventions:

组别:

对照组

样本量:

60

Group:

Control Group

Sample size:

干预措施:

穴位旁2cm注射

干预措施代码:

Intervention:

Injection of 2cm paracupoint

Intervention code:

组别:

实验组

样本量:

60

Group:

Experimental Group

Sample size:

干预措施:

穴位注射

干预措施代码:

Intervention:

acupoint injection

Intervention code:

样本总量 Total sample size : 120

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

上海市

市(区县):

上海市

Country:

china

Province:

shanghai

City:

shanghai

单位(医院):

上海长征医院

单位级别:

三级甲等

Institution/hospital:

Changzheng Hospital Affiliated to Navy Medical University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

上海市

市(区县):

上海市

Country:

china

Province:

shanghai

City:

shanghai

单位(医院):

中国人民解放军海军第九O五医院

单位级别:

三级甲等

Institution/hospital:

No.905 Hospital of PLA Navy Shanghai China

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

“有效”患者率

指标类型:

主要指标

Outcome:

"effective" patient rate

Type:

Primary indicator

测量时间点:

3周

测量方法:

Measure time point of outcome:

3 week

Measure method:

指标中文名:

VAS评分变化

指标类型:

次要指标

Outcome:

Changes in VAS scores

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

轴性症状分级变化

指标类型:

次要指标

Outcome:

Changes in AS grading

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

是否口服非甾体类消炎药及数量

指标类型:

次要指标

Outcome:

Oral intake of non-steroidal anti-inflammatory drugs (NSAIDs) and their quantity

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疼痛时是否有伴随症状:僵硬、沉重

指标类型:

次要指标

Outcome:

Accompanying symptoms during pain: stiffness, heaviness

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:

组织:

Sample Name:

non

Tissue:

人体标本去向

其它

说明

Fate of sample 

Others

Note:

征募研究对象情况:

正在进行

Recruiting

年龄范围:

最小 18
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):

参与的医生及护士负责纳入病人,由(第三方数据管理)计算机产生随机数,按随机数排列的编号给予病人。

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

The participating doctors and nurses are responsible for enrolling patients with random numbers generated by a computer from a third-party data management system assigned to the patients according to the arranged sequence.

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):

试验完成6个月内在本平台公开原始数据

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

The original data will be disclosed on this platform within 6 months after the completion of the test

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:

采用病例记录表方式采集数据和管理数据

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

The data will be collected and managed in the form of CRF

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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