针刺治疗颈痛的中枢机制研究

注册号:

Registration number:

ITMCTR2023000001

最近更新日期:

Date of Last Refreshed on:

2023-03-06

注册时间:

Date of Registration:

2023-03-06

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

针刺治疗颈痛的中枢机制研究

Public title:

Study on central mechanism of acupuncture treatment for neck pain

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于“以痛为输”理论针刺治疗颈痛的中枢机制研究

Scientific title:

Study on central mechanism of acupuncture treatment of neck pain based on "take the place of pain as the acupoint"

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:

高珍

研究负责人:

高珍

Applicant:

Gao Zhen

Study leader:

Gao Zhen

申请注册联系人电话:

Applicant telephone:

13546729182

研究负责人电话:

Study leader's telephone:

13546729182

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:

gz0114@126.com

研究负责人电子邮件:

Study leader's E-mail:

gz0114@126.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:

中国山西省高新园区大学街121号山西中医药大学

研究负责人通讯地址:

中国山西省高新园区大学街121号山西中医药大学

Applicant address:

Shanxi University of Traditional Chinese Medicine, 121 University Street, High-tech Zone, Shanxi Province, China

Study leader's address:

Shanxi University of Traditional Chinese Medicine, 121 University Street, High-tech Zone, Shanxi 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:

山西中医药大学

Applicant's institution:

Shanxi 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:

2023007

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:

山西省针灸医院伦理委员会

Name of the ethic committee:

Ethics Committee of Shanxi Acupuncture Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

伦理委员会联系人:

张天生

Contact Name of the ethic committee:

Zhang Tiansheng

伦理委员会联系地址:

山西省太原市平阳路北园街2号

Contact Address of the ethic committee:

2 Beiyuan Street, Pingyang Road, Taiyuan City, Shanxi Province, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

伦理委员会联系人邮箱:

Contact email of the ethic committee:

研究实施负责(组长)单位:

山西中医药大学

Primary sponsor:

Shanxi University of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

山西中医药大学

Primary sponsor's address:

Shanxi University of Traditional Chinese Medicine

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

山西省

市(区县):

Country:

China

Province:

Shanxi

City:

单位(医院):

山西中医药大学

具体地址:

山西省高新园区大学街121号山西中医药大学

Institution
hospital:

Shanxi University of Traditional Chinese Medicine

Address:

Shanxi University of Traditional Chinese Medicine, 121 University Street, High-tech Zone, Shanxi Province, China

经费或物资来源:

山西省基础研究计划

Source(s) of funding:

Basic Research Program of Shanxi Province

研究疾病:

颈痛

研究疾病代码:

Target disease:

neck pain

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:

以慢性颈痛为研究对象,在评价压痛点和假穴治疗慢性颈痛患者临床疗效的基础上采用功能磁共振技术探讨针刺治疗慢性颈痛的中枢机制。

Objectives of Study:

The trail aims to evaluate the efficacy of acupuncture at tender points and fake points and to explore the central mechanism of acupuncture in treating chronic neck pain.

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)颈痛为主要症状,视觉模拟量表(VAS)评分大于3分小于10分(范围为0-10分); (2)病程≤3个月; (3)年龄18-60岁;(4)右利手,大专以上学历;(5)愿意签署知情同意书。注:同时符合以上4项的患者,方可纳入本项研究。

Inclusion criteria

(1) Neck pain as the main complaint, and the visual analog scale (VAS) score is greater than 3 points and less than 10 points (range 0-10 points); (2) Duration ≤3 months; (3) Aged 18 - 60 years; (4) Right-handed, college degree or above(5)Voluntary signing of informed consent

排除标准:

(1)妊娠期和哺乳期女性; (2)合并有严重其他器质性疾病和情绪疾病; (3)有局部皮肤破损或严重皮肤病影响手法操作; (4)有精神神经系统疾病,无法进行正常交流者; (5)有中度或以上程度的抑郁或焦虑症状者; (6)有磁共振禁忌症者,如心脏起搏器、幽闭恐惧症等; (7)正在参加其他临床试验者。

Exclusion criteria:

(1) Pregnant or lactating women; (2) Combined with severe other organic and emotional disorders; (3) Local skin damage or severe skin disease affects manipulation; (4) People with mental and neurological disorders who cannot communicate normally; (5) Having moderate or above depression or anxiety symptoms; (6) Having MRI contraindications, such as having a heart pacemaker, having metallic foreign bodies, having severe claustrophobia, etc.; (7) Participation in other trials.

研究实施时间:

Study execute time:

From 2023-01-01

To      2025-12-31

征募观察对象时间:

Recruiting time:

From 2023-06-30

To      2025-12-31

干预措施:

Interventions:

组别:

对照组

样本量:

20

Group:

Control group

Sample size:

干预措施:

针刺假穴

干预措施代码:

Intervention:

puncturing at fake points

Intervention code:

组别:

治疗组

样本量:

20

Group:

Treatment group

Sample size:

干预措施:

针刺压痛点

干预措施代码:

Intervention:

puncturing at tender points

Intervention code:

样本总量 Total sample size : 40

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

山西省

市(区县):

Country:

China

Province:

Shanxi

City:

单位(医院):

山西省针灸医院

单位级别:

三级甲等

Institution/hospital:

Shanxi Acupuncture and moxibustion Hospital

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

焦虑自评量表

指标类型:

次要指标

Outcome:

Self-Rating Anxiety Scale (SAS)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

颈椎功能障碍指数量表

指标类型:

次要指标

Outcome:

Neck disability index (NDI)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

颈椎活动度

指标类型:

次要指标

Outcome:

cervical range of motion (ROM)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

脑功能活动变化

指标类型:

主要指标

Outcome:

Changes in brain function activity

Type:

Primary indicator

测量时间点:

测量方法:

神经影像方法

Measure time point of outcome:

Measure method:

指标中文名:

生活质量量表SF-36

指标类型:

次要指标

Outcome:

Quality of life scale SF-36

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

视觉模拟评分

指标类型:

主要指标

Outcome:

visual analogue scale (VAS)

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

压痛点压痛阈值变化

指标类型:

次要指标

Outcome:

Pressure Pain Threshords (PPT)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抑郁自评量表

指标类型:

次要指标

Outcome:

Self-Rating Depression Scale (SDS)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肌骨超声变化

指标类型:

次要指标

Outcome:

musculoskeletal ultrasound

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:

NO

Tissue:

人体标本去向

其它

说明

Fate of sample 

Others

Note:

征募研究对象情况:

尚未开始

Not yet recruiting

年龄范围:

最小 18
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):

由独立的,不知情的统计学家使用SPSS 26.0生成随机序列,将患者以1:1的比例平均分至两个治疗组。

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

An independent, blinded statistician will used SPSS 26.0 to generate a random sequence, and divided the patients into two treatment groups at a ratio of 1:1.

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):

通过发表期刊文章公开原始数据

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

by publication

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:

CRF表采集数据,数据电子存档管理

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

collect data by CRF and manage data via compute

数据管理委员会:

Data Managemen Committee:

暂未确定

Not yet

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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