易筋经单势锻炼对大学生颈痛伴活动受限的临床研究

注册号:

Registration number:

ITMCTR2025001302

最近更新日期:

Date of Last Refreshed on:

2025-06-30

注册时间:

Date of Registration:

2025-06-30

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

易筋经单势锻炼对大学生颈痛伴活动受限的临床研究

Public title:

Clinical Study on Single - posture Exercise of Yijinjing for College Students with Neck Pain and Limited Mobility

注册题目简写:

English Acronym:

研究课题的正式科学名称:

易筋经单势锻炼对大学生颈痛伴活动受限的临床研究

Scientific title:

Clinical Study on Single - posture Exercise of Yijinjing for College Students with Neck Pain and Limited Mobility

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:

马梦娟

研究负责人:

李江山

Applicant:

MaMengjuan

Study leader:

LiJiangshan

申请注册联系人电话:

Applicant telephone:

15516194227

研究负责人电话:

Study leader's telephone:

13707315642

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:

1490439075@qq.com

研究负责人电子邮件:

Study leader's E-mail:

001316@hnucm.edu.cn

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:

湖南省长沙市岳麓区含浦科教园300号

研究负责人通讯地址:

湖南省长沙市岳麓区含浦科教园300号

Applicant address:

No. 300 Hanpu Science and Education Park Yuelu District Changsha City Hunan Province

Study leader's address:

No. 300 Hanpu Science and Education Park Yuelu District Changsha City Hunan 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:

湖南中医药大学

Applicant's institution:

Hunan 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:

2025-kt-104

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:

湖南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 Hunan University of Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2025/3/31 0:00:00

伦理委员会联系人:

林宏远

Contact Name of the ethic committee:

Lin Hongyuan

伦理委员会联系地址:

湖南省长沙市蔡锷北路233号

Contact Address of the ethic committee:

No. 233 Cai'e North Road Changsha City Hunan Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

15084894144

伦理委员会联系人邮箱:

Contact email of the ethic committee:

jwb2025@126.com

研究实施负责(组长)单位:

湖南中医药大学第二附属医院

Primary sponsor:

The Second Affiliated Hospital of Hunan University of Chinese Medicine

研究实施负责(组长)单位地址:

湖南省长沙市蔡锷北路233号

Primary sponsor's address:

No. 233 Cai'e North Road Changsha City Hunan Province

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

湖南

市(区县):

长沙

Country:

China

Province:

Hunan

City:

Changsha

单位(医院):

湖南中医药大学第二附属医院

具体地址:

湖南省长沙市蔡锷北路233号

Institution
hospital:

Medical Ethics Committee of the Second Affiliated Hospital of Hunan University of Chinese Medicine

Address:

No. 233 Cai'e North Road Changsha City Hunan Province

经费或物资来源:

自筹

Source(s) of funding:

self - raised funds

研究疾病:

颈痛伴活动受限

研究疾病代码:

Target disease:

Neck pain accompanied by limited mobility

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:

以麦肯基疗法作为对照,观察易筋经功法中颈肩部活动为主的横担降魔杵势、掌托天门势、九鬼拔马刀势、青龙探爪势、打躬击鼓势、吊尾摇头势的单式练习对颈椎活动度、疼痛以及肌张力的影响,通过对比易筋经六式对颈椎前屈、后伸、旋转、侧屈功能障碍的疗效差异,总结出对各颈椎活动功能障碍改善效果最佳的易筋经动作。

Objectives of Study:

Taking the McKenzie Method as a control this study aims to observe the effects of the single - style exercises of the Yijinjing Qigong mainly including the postures of Horizontal Pole to Subdue Demons Holding the Heavenly Gate with Palms Nine Ghosts Pulling the Horse's Saber Green Dragon Probing the Claw Bowing and Beating the Drum and Hanging the Tail and Shaking the Head which focus on the activities of the neck and shoulders on the range of motion of the cervical spine pain and muscle tension. By comparing the curative effect differences of these six postures of the Yijinjing on the dysfunction of cervical flexion extension rotation and lateral flexion the best Yijinjing movements for improving each dysfunction of cervical spine movement function are summarized.

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)符合上述诊断标准; (2)18-30岁的在校大学生; (3)无规律锻炼; (4)2≤首次VAS评分≤6分; (5)自愿参加本研究,配合研究中的操作并且签署知情同意书

Inclusion criteria

(1) Meeting the above diagnostic criteria; (2) Being undergraduate students aged between 18 and 30 years old; (3) Having no regular exercise; (4) The initial Visual Analogue Scale (VAS) score being between 2 and 6 points (inclusive); (5) Volunteering to participate in this study cooperating with the operations in the study and signing the informed consent form.

排除标准:

(1)不符合上述诊断标准; (2)有外伤或畸形等引起的肌肉、骨骼系统疾病或脊柱病变; (3)有糖尿病等全身系统性疾病、神经系统疾病或精神病; (4)有明显的脊柱侧弯; (5)妊娠期女性或准妊娠女性; (6)符合上述任何一项即可排除。

Exclusion criteria:

(1) Not meeting the above diagnostic criteria; (2) Having musculoskeletal system diseases or spinal lesions caused by trauma deformity etc.; (3) Having systemic diseases such as diabetes neurological diseases or mental illnesses; (4) Having obvious scoliosis of the spine; (5) Being pregnant women or women preparing for pregnancy; (6) Those who meet any one of the above items will be excluded.

研究实施时间:

Study execute time:

From 2025-04-01

To      2026-07-01

征募观察对象时间:

Recruiting time:

From 2025-04-01

To      2026-07-01

干预措施:

Interventions:

组别:

7组

样本量:

23

Group:

seven group

Sample size:

干预措施:

麦肯基疗法

干预措施代码:

Intervention:

McKenzie

Intervention code:

组别:

4组

样本量:

23

Group:

four group

Sample size:

干预措施:

青龙探爪势

干预措施代码:

Intervention:

qinglongtanzhua

Intervention code:

组别:

5组

样本量:

23

Group:

five group

Sample size:

干预措施:

打躬击鼓势

干预措施代码:

Intervention:

dagongjigu

Intervention code:

组别:

6组

样本量:

23

Group:

six group

Sample size:

干预措施:

掉尾摇头势

干预措施代码:

Intervention:

diaoweiyaotou

Intervention code:

组别:

3组

样本量:

23

Group:

three group

Sample size:

干预措施:

九鬼拔马刀势

干预措施代码:

Intervention:

jiuguibamadao

Intervention code:

组别:

1组

样本量:

23

Group:

one group

Sample size:

干预措施:

横担降魔杵势

干预措施代码:

Intervention:

hedanxiangmochu

Intervention code:

组别:

2组

样本量:

23

Group:

two group

Sample size:

干预措施:

掌托天门势

干预措施代码:

Intervention:

zhangtuotianmen

Intervention code:

样本总量 Total sample size : 161

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

湖南省

市(区县):

长沙市

Country:

China

Province:

Hunan

City:

Changshang

单位(医院):

湖南中医药大学第二附属医院

单位级别:

省级综合性三级甲等中医院

Institution/hospital:

The Second Affiliated Hospital of Hunan University of Chinese Medicine

Level of the institution:

Provincial-level comprehensive Class-A Grade-III traditional Chinese medicine hospital

测量指标:

Outcomes:

指标中文名:

颈椎功能障碍指数

指标类型:

主要指标

Outcome:

neck disability index

Type:

Primary indicator

测量时间点:

干预前一天、干预后一天

测量方法:

量表填写

Measure time point of outcome:

One day before the intervention One day after the intervention

Measure method:

Scale Completion

指标中文名:

颈椎活动度

指标类型:

主要指标

Outcome:

Cervical Range of Motion

Type:

Primary indicator

测量时间点:

干预前一天、干预后一天

测量方法:

使用量角尺和数显倾角仪

Measure time point of outcome:

One day before the intervention 、One day after the intervention

Measure method:

protractor、Digital inclinometer

指标中文名:

上斜方肌标记点肌肉特性

指标类型:

次要指标

Outcome:

Muscle characteristics at the marked point of the upper trapezius muscle

Type:

Secondary indicator

测量时间点:

干预前一天、干预后一天

测量方法:

PRO数字触诊仪(爱沙尼亚MyotonAS)

Measure time point of outcome:

One day before the intervention One day after the intervention

Measure method:

PRO Digital Palpation Instrument (MyotonAS Estonia)

指标中文名:

视觉模拟评分法

指标类型:

主要指标

Outcome:

Visual Analogue Scale (VAS)

Type:

Primary indicator

测量时间点:

干预前一天、干预后一天

测量方法:

量表填写

Measure time point of outcome:

One day before the intervention One day after the intervention

Measure method:

Scale Completion

指标中文名:

胸锁乳突肌标记点肌肉特性

指标类型:

次要指标

Outcome:

The muscle characteristics of the marking points of the sternocleidomastoid muscle

Type:

Secondary indicator

测量时间点:

干预前一天、干预后一天

测量方法:

PRO数字触诊仪(爱沙尼亚MyotonAS)

Measure time point of outcome:

One day before the intervention One day after the intervention

Measure method:

PRO Digital Palpation Instrument (MyotonAS Estonia)

采集人体标本:

Collecting sample(s)
from participants:

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 30
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):

由统计人员使用excel表格生成随机数

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

Random numbers are generated by statisticians using Excel spreadsheets.

盲法:

因物理干预特性,所以无法对受试者和易筋经带练者进行盲法,对评估者、统计者、数据分析员盲法

Blinding:

Due to the characteristics of physical intervention it is impossible to implement blinding for the subjects and the Yijinjing exercise instructors. However blinding is applied to the evaluators statisticians and data analysts.

是否共享原始数据:

IPD sharing:

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):

2026.7.1在redcap系统上传原始数据

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

Upload the original data to the REDCap system on July 1, 2026.

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CRF表和Excel表格,以及redcap系统(https://www.redhat.com/zh)

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

Use the Case Report Form (CRF) and Excel spreadsheet and REDCap system(https://www.redhat.com/zh)

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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