今天是:2022-08-12 星期五

基于多模态磁共振成像研究慢性非特异性腰痛的中枢病理机制
下载XML文档

注册号:

Registration number:

ChiCTR2200061881 

最近更新日期:

Date of Last Refreshed on:

2022-07-06 

注册时间:

Date of Registration:

2022-07-06 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于多模态磁共振成像研究慢性非特异性腰痛的中枢病理机制 

Public title:

An investigation of the central pathological mechanisms associated with chronic nonspecific low back pain based on multimodal magnetic resonance imaging 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

多模态磁共振成像、慢性非特异性腰痛的中枢病理机制 

Scientific title:

multimodal magnetic resonance imaging,the central pathological mechanisms of chronic nonspecific low back pain 

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:

江征 

研究负责人:

江征 

Applicant:

jiangzheng 

Study leader:

jiangzheng 

申请注册联系人电话:

Applicant telephone:

+86 13559458154 

研究负责人电话:

Study leader's telephone:

+86 13559458154 

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:

949273304@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

949273304@qq.com 

申请单位网址(自愿提供):

Applicant 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:

福建省福州市闽侯上街邱阳路1号 

研究负责人通讯地址:

福建省福州市闽侯上街邱阳路1号 

Applicant address:

1 Qiuyang Road, Shangjie Town, Minhou County , Fuzhou, Fujian, China 

Study leader's address:

1 Qiuyang Road, Shangjie Town, Minhou County , Fuzhou, Fujian, 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:

福建中医药大学康复医学院 

Applicant's institution:

College of Rehabilitation Medicine, Fujian University of TCM  

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2022KY-007-01 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

福建中医药大学附属康复医院临床试验伦理委员会 

Name of the ethic committee:

IEC for Clinical Research of Rehabilitation Hospital,Affiliated to Fujian University of TCM 

伦理委员会批准日期:

Date of approved by ethic committee:

2022-04-29 

伦理委员会联系人:

管祖汾 

Contact Name of the ethic committee:

Guan Zufen 

伦理委员会联系地址:

福建省福州市鼓楼区湖东支路13号 

Contact Address of the ethic committee:

13 Hudong Branch Road, Gulou District,Fuzhou Fujian,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:

福建中医药大学康复医学院 

Primary sponsor:

College of Rehabilitation Medicine, Fujian University of TCM  

研究实施负责(组长)单位地址:

福建省福州市闽侯上街邱阳路1号 

Primary sponsor's address:

1 Qiuyang Road, Shangjie Town, Minhou County , Fuzhou, Fujian, 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):

福建省

市(区县):

Country:

China

Province:

Fujian

City:

单位(医院):

福建中医药大学康复医学院

具体地址:

福建省福州市鼓楼区湖东支路13号

Institution
hospital:

College of Rehabilitation Medicine, Fujian University of TCM

Address:

13 Hudong Branch Road, Gulou District,Fuzhou Fujian,China

经费或物资来源:

福建中医药大学研究生毕业课题 

Source(s) of funding:

Graduate project of Fujian University of Traditional Chinese Medicine 

研究疾病:

慢性非特异性腰痛 

Target disease:

Chronic Nonspecific Low Back Pain 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

(1)通过临床量表评估以明确CNLBP患者与健康对照组在负性情绪和疼痛认知方面的差异。 (2)利用多模磁共振成像分析CNLBP患者与健康对照组的结构和功能脑网络的神经影像学特征差异。 (3)明确CNLBP患者异常的神经影像学特征与疼痛症状、负性情绪及疼痛认知的临床症状之间的关系,旨在阐明CNLBP潜在的中枢病理机制。 

Objectives of Study:

(1) To make clear the difference of negative emotion and pain cognition between CNLBP patients and healthy controls by clinical scale evaluation. (2) Multimode magnetic resonance imaging was used to analyze the differences of neuroimaging features of the structural and functional brain network between CNLBP patients and healthy controls. (3) To clarify the relationship between abnormal neuroimaging features of CNLBP patients and clinical symptoms such as pain symptoms, negative emotions and pain cognition, so as to clarify the potential central pathological mechanism of CNLBP. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

病例对照研究 

Study design:

Case-Control study 

纳入标准:

(1)CNLBP组纳入标准 1)符合CNLBP的诊断标准:病程持续12周以上,病因不明的、除脊柱特异性疾病及神经根性疼痛以外原因所引起的,肋缘以下、臀横纹以上及两侧腋中线之间区域内的疼痛与不适,伴或不伴大腿牵涉痛; 2)年龄18~60岁; 3)右利手(以爱丁堡利手量表为判定标准); 4)近2周内发作过至少1次; 5)近7天腰部视觉模拟评分(VAS)评分平均分≥3; 6)受试者本人同意参与本研究,签署知情同意书。 (2)健康对照组纳入标准 1)年龄18~60岁,年龄、性别需和CNLBP组大致匹配; 2)右利手(以爱丁堡利手量表作为判定标准); 3)既往健康,无慢性疼痛疾病病史; 4)贝克抑郁量表第2版(BDI-Ⅱ)评分≤13分; 5)贝克焦虑量表(BAI)评分<45分; 6)受试者本人同意参与本研究,签署知情同意书; 

Inclusion criteria

Inclusion criteria of CNLBP group 1) Meeting the diagnostic criteria of CNLBP: the course of disease lasts for more than 12 weeks, and the pain and discomfort below the costal margin, above the hip transverse line and between the midaxillary line of both sides are caused by reasons other than spine-specific disease and nerve root pain, with or without referred pain in the thigh; 2) Aged from 18 to 60; 3) Right-handedness (Using the Edinburgh handedness inventory as the criterion); 4) At least one attack in the last 2 weeks; 5) The average score of visual analog scale (VAS) ≥3 in the past 7 days; 6) The subject agrees to participate in the study and signs the informed consent. (2) Inclusion criteria of healthy control group 1) Age ranged from 18 to 60, and age and sex were roughly matched with CNLBP group; 2) Right-handedness (Using the Edinburgh Handedness Scale as the criterion); 3) Previous health, no history of chronic pain disease; 4) Beck Depression Inventory 2nd Edition (BDI-Ⅱ) score ≤13; 5) Beck Anxiety Inventory (BAI) score < 45; 6) The subject agrees to participate in the study and signs the informed consent; 

排除标准:

排除标准 1)孕妇、哺乳期的妇女; 2)简易精神状态评价量表(MMSE)得分<27分; 3)既往有手术史或腰椎骨折史、神经系统相关疾病; 4)目前存在其他慢性肌肉骨骼疼痛等疾病; 5)有酒精、精神类药物滥用史或精神障碍确诊史及家族史; 6)有幽闭恐怖症或体内有金属植入物等其他磁共振检查禁忌者; 7)近2周内服用过安眠、镇痛类、抗抑郁类或镇静类等药物; 8)其他原因不能配合评估和磁共振检测者; 9)正在参加影响本研究结果评价的其他临床试验者。 

Exclusion criteria:

Exclusion criteria 1) Pregnant and lactating women; 2) The Mini-Mental State Examination (MMSE) score < 27; 3) Previous history of surgery or lumbar fracture, or diseases related to the nervous system; 4) Presence of other chronic musculoskeletal pain disorders; 5) Previous history of alcohol or psychotropic drug abuse or diagnosed history of mental disorders and family history; 6) The subject with claustrophobia or metal implants and other contraindications for MRI examination; 7) Have taken sleeping, analgesic, antidepressant or sedative drugs in the past 2 weeks; 8) Unable to cooperate with the evaluation and MRI examination for other reasons; 9) Participants in other clinical trials that influence the evaluation of the study results. 

研究实施时间:

Study execute time:

From2022-07-01To 2024-10-01 

征募观察对象时间:

Recruiting time:

From2022-07-05To 2024-10-01 

干预措施:

Interventions:

组别:

慢性非特异性腰痛组

样本量:

31

Group:

CNLBP Group

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

Intervention code:

组别:

健康对照组

样本量:

31

Group:

Healthy controls

Sample size:

干预措施:

干预措施代码:

Intervention:

N/A

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

福建省 

市(区县):

 

Country:

China 

Province:

fujian 

City:

 

单位(医院):

福建中医药大学康复医院 

单位级别:

医院 

Institution
hospital:

College of Rehabilitation Medicine, Fujian University of TCM  

Level of the institution:

Hospital 

测量指标:

Outcomes:

指标中文名:

磁共振

指标类型:

主要指标 

Outcome:

MRI

Type:

Primary 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:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

不适用随机方法

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

Not applicable

盲法:

Blinding:

是否共享原始数据:

IPD sharing

否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):

2024/10/01通过Resman提供原始数据查询

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

2024/10/01,IPD will be public accesssable via Resman

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:

本研究通过病例记录表(Clinic Report Form,CRF)收集受试者的相关信息。完成的个案报告表审核后扫描保存为PDF文件,不可修改,如因为特殊情况需要修改,需要说明理由并保存修改痕迹。

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

In this study, the relevant information of subjects is collected through the clinical report form (CRF). The completed case report form will be scanned and saved as PDF file after review, and cannot be modified. If it needs to be modified due to special circumstances, the reasons shall be explained and the modification trace shall be saved.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2022-07-06
返回列表