ChiCTR2400082288 版本V1.0 版本创建时间2024/03/26 10:40:22 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2400082288 

最近更新日期：

Date of Last Refreshed on：

2024-03-26 10:40:12 

注册时间：

Date of Registration：

2024-03-26 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

原发性失眠穴位痛敏化现象及其规律的临床病例对照研究

Public title：

A clinical case-control study of the phenomenon of pain sensitization at primary insomnia acupuncture points and its patterns

注册题目简写：

English Acronym：

研究课题的正式科学名称：

原发性失眠穴位痛敏化现象及其规律的临床病例对照研究

Scientific title：

A clinical case-control study of the phenomenon of pain sensitization at primary insomnia acupuncture points and its patterns

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：

余笑帅 

研究负责人：

余笑帅; 梁宜 

Applicant：

Xiaoshuai Yu 

Study leader：

Xiaoshuai Yu; Yi Liang 

申请注册联系人电话：

Applicant telephone：

+86 178 5731 5605

研究负责人电话：

Study leader's telephone：

+86 178 5731 5605

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：

yusunshine0108@126.com

研究负责人电子邮件：

Study leader's E-mail：

yusunshine0108@126.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：

浙江省杭州市西湖区教工路118号

研究负责人通讯地址：

浙江省杭州市西湖区教工路118号

Applicant address：

No. 118, Jiaogong Road, Xihu District, Hangzhou, Zhejiang, China

Study leader's address：

No. 118, Jiaogong Road, Xihu District, Hangzhou, Zhejiang, China

申请注册联系人邮政编码：

Applicant postcode：

310005

研究负责人邮政编码：

Study leader's postcode：

310005

申请人所在单位：

浙江中医药大学附属第三医院

Applicant's institution：

The Third Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine

研究负责人所在单位：

浙江中医药大学附属第三医院

Affiliation of the Leader：

The Third Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

ZSLL-ZN-2024-017-01

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：

浙江中医药大学附属第三医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the Third Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2024-01-29 00:00:00

伦理委员会联系人：

闫坤

Contact Name of the ethic committee：

Kun Yan

伦理委员会联系地址：

浙江省杭州市西湖区莫干山路219号

Contact Address of the ethic committee：

No.219 Moganshan Road, West Lake District, Hangzhou, Zhejiang Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 87238255

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：

浙江中医药大学附属第三医院

Primary sponsor：

The Third Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

浙江省杭州市西湖区莫干山路219号

Primary sponsor's address：

No.219 Moganshan Road, West Lake District, Hangzhou, Zhejiang 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)：

浙江省

市(区县)：

Country：

China

Province：

Zhejiang Province

City：

单位(医院)：

浙江中医药大学附属第三医院

具体地址：

浙江省杭州市西湖区莫干山路219号

Institution
hospital：

The Third Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine

Address：

No.219 Moganshan Road, West Lake District, Hangzhou, Zhejiang Province

经费或物资来源：

浙江中医药大学附属第三医院及课题组

Source(s) of funding：

The Third Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine and Subject Groups

Target disease：

Insomnia

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

病例对照研究 

Study design：

Case-Control study 

研究目的：

主要目的：确定穴位敏化诊断界值，计算PI患者穴位压痛敏化率； 次要目的：探讨和阐述穴位压痛敏化率与PI患者睡眠量表评分、睡眠参数及自主神经功能等主客观数据的相关性；探究不同表现形式PI患者的穴位压痛敏化率的差异；用现代方法解释PI患者穴位敏化的临床诊疗价值及规律。  

Objectives of Study：

Primary objective: to determine the diagnostic threshold of acupoint sensitization and calculate the rate of acupoint pressure pain sensitization in patients with PI; Secondary objectives: to explore and elaborate the correlation between the acupoint pressure-pain sensitization rate and the subjective and objective data such as sleep scale scores, sleep parameters and autonomic functions of PI patients; to explore the differences in the acupoint pressure-pain sensitization rate of PI patients with different manifestations; to explain the clinical diagnostic and therapeutic value and the law of the acupoint sensitization of PI patients with modern methods.

药物成份或治疗方案详述：

相关穴位压痛阈值检测：研究者将使用测力仪(Force TenTM Digital Force Gage, Wagner Instruments, Greenwich, CT, USA)在身体区域的17个穴位依次进行2次PPT测量，两次间隔时间为2min。如果在一个穴位进行的两次PPT测量之间的差异超过500gf，则将在该穴位进行第三次PPT测量，取相近两个PPT计算均值。 每个穴位以100gf /s的速度逐级加压，计算平均PPT。  

Description for medicine or protocol of treatment in detail：

Pressure Pain Threshold Testing at Relevant Acupuncture Points: the investigator will perform 2 PPT measurements sequentially at 17 acupoints in the body region using an dynamometer (Force TenTM Digital Force Gage, Wagner Instruments, Greenwich, CT, USA) at 2 min intervals. if the difference between the two PPT measurements performed at one acupoint is more than 500 gf, a third PPT will be performed at that acupoint. PPT measurements differed by more than 500 gf, a third PPT measurement would be performed at that acupoint, and the mean value would be calculated by taking the two similar PPTs. Each acupoint was pressurized stepwise at 100 gf /s and the average PPT was calculated. 

纳入标准：

（1）符合失眠障碍诊断标准：依据美国精神科协会(American Psychological Association，APA)所制定的《精神障碍诊断和统计手册（第Ⅴ版）》的描述，本研究中PI患者的诊断标准如下： A. 主诉对睡眠数量和质量不满意，并伴有以下一种或多种失眠症状：睡眠潜伏期增加、维持睡眠困难（频繁地觉醒或醒后再入睡困难）、早醒（且不能再入睡）; B. 该睡眠障碍引起有临床意义的痛苦，或导致社交、职业、教育、学业、行为或其他重要功能方面的损害; C. 每周至少出现3晚睡眠困难，并持续至少1个月; D. 排除躯体疾病或精神疾病导致的继发性失眠。 （2）18≤年龄≤80岁，性别不限；（3）无沟通及认知功能障碍；（4）一个月内无使用或已停用抗焦虑等精神类药物；（5）无重大躯体疾病；（6）自愿接受研究内容,可完成各项量表评估及多导睡眠监测者；（7）在研究开始前签署知情同意书者。

Inclusion criteria

(1) Compliance with the diagnostic criteria for insomnia disorder: based on the description of the Diagnostic and Statistical Manual of Mental Disorders (5th edition) developed by the American Psychological Association (APA), the diagnostic criteria for the PI patients in this study were as follows: A. complaints of dissatisfaction with the quantity and quality of sleep, accompanied by one or more of the following symptoms of insomnia: increased sleep latency, difficulty in maintaining sleep (frequent awakenings or difficulty in falling back to sleep after awakening), and early awakenings (and the inability to fall back to sleep); and B. the sleep disorder causes clinically significant distress or results in impairment of social, occupational, educational, academic, behavioral, or other important aspects of functioning. C. the sleep difficulty occurs at least 3 nights per week and persists for at least 1 month. D. exclude secondary insomnia due to physical or mental illness. (2) 18 ≤ age ≤ 80 years, gender is not limited; (3) no communication and cognitive dysfunction; (4) no use or discontinued use of psychotropic drugs such as anxiolytics within one month; (5) no major physical diseases; (6) voluntary acceptance of the study content, can complete the various scales assessment and polysomnography monitoring; (7) signed the informed consent form prior to the start of the study.

排除标准：

（1）不符合纳入标准者；（2）患有严重精神疾患、严重头部外伤史且伴有明显意识障碍者；（3）有严重肝、肾功能不全和出血倾向者；（4）酗酒（白酒≥100ml/日）、嗜烟（≥15支/日）、吸毒或者正在服用精神类药物者；（5）患有其他睡眠障碍，如睡眠呼吸暂停低通气综合征、发作性睡病、快动眼睡眠行为障碍者；（6）妊娠或哺乳者；（7）存在其他重大疾病且控制不佳者；（8）穴位处皮肤受损；（9）其他不愿签署知情同意者。

Exclusion criteria：

(1) those who did not meet the inclusion criteria; (2) those who suffered from severe mental disorders, history of severe head trauma with obvious consciousness disorders; (3) those who had severe hepatic or renal insufficiency and bleeding tendency; (4) those who were alcoholics (liquor ≥100ml/day), smokers (≥15 cigarettes/day), drug addicts, or those who were taking psychotropic drugs; (5) those who suffered from other sleep disorders, such as sleep apnea hyperventilation syndrome, episodic sleep disorder, rapid eye movement sleep behavior disorder; (6) pregnant or breastfeeding; (7) the existence of other major diseases and poorly controlled; (8) the skin at the acupoints is damaged; (9) other people who do not want to sign the informed consent.

研究实施时间：

Study execute time：

从 From 2024-04-01 00:00:00至 To 2025-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-04-01 00:00:00 至 To 2025-06-30 00:00:00  

干预措施：

Interventions：

组别：

原发性失眠患者组

样本量：

73

Group：

Primary insomnia patient group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

组别：

健康受试者组

样本量：

73

Group：

Healthy subjects group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江省 

市(区县)：

  

Country：

China 

Province：

Zhejiang Province 

City：

 

单位(医院)：

浙江中医药大学附属第三医院 

单位级别：

三甲 

Institution
hospital：

The Third Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

穴位压痛阈值

指标类型：

主要指标

Outcome：

Pressure pain threshold at acupoints

Type：

Primary indicator

测量时间点：

量表评估、睡眠监测、心率变异率检测后

测量方法：

测力仪(Force TenTM Digital Force Gage, Wagner Instruments, Greenwich, CT, USA)

Measure time point of outcome：

After scale assessment, sleep monitoring, and heart rate variability testing

Measure method：

Dynamometer (Force TenTM Digital Force Gage, Wagner Instruments, Greenwich, CT, USA)

指标中文名：

匹兹堡睡眠质量评分（PSQI）

指标类型：

次要指标

Outcome：

Pittsburgh Sleep Quality Index (PSQI)

Type：

Secondary indicator

测量时间点：

基线数据采集后

测量方法：

失眠患者根据自己情况填写量表

Measure time point of outcome：

After baseline data collection

Measure method：

Insomnia patients fill out the scale according to their situation

指标中文名：

焦虑评分量表（SAS）

指标类型：

次要指标

Outcome：

Anxiety Rating Scale (SAS)

Type：

Secondary indicator

测量时间点：

基线数据采集后

测量方法：

失眠患者根据自己情况填写量表

Measure time point of outcome：

After baseline data collection

Measure method：

Insomnia patients fill out the scale according to their situation

指标中文名：

抑郁评分量表（SDS）

指标类型：

次要指标

Outcome：

Depression Rating Scale (SDS)

Type：

Secondary indicator

测量时间点：

基线数据采集后

测量方法：

失眠患者根据自己情况填写量表

Measure time point of outcome：

After baseline data collection

Measure method：

Insomnia patients fill out the scale according to their situation

指标中文名：

多导睡眠监测（PSG）

指标类型：

次要指标

Outcome：

Polysomnography (PSG)

Type：

Secondary indicator

测量时间点：

基线数据采集后

测量方法：

PSG监测

Measure time point of outcome：

After baseline data collection

Measure method：

PSG monitoring

指标中文名：

心率变异率检测（HRV）

指标类型：

次要指标

Outcome：

Heart Rate Variability Testing (HRV)

Type：

Secondary indicator

测量时间点：

基线数据采集后

测量方法：

动态数字心电记录仪（型号：Seer12）记录自主神经功能的变动，采用GE MARS软件测量HRV有关数据，来评估治疗人体自主神经功能变化。

Measure time point of outcome：

After baseline data collection

Measure method：

Changes in autonomic function recorded by an ambulatory digital electrocardiograph (model: Seer12) and measuring HRV-related data using GE MARS software.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

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 18 岁 years
最大 Max age 80 岁 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）：

无

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Blinding：

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

2025-6-30 通过社交媒体分享数据

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

2025-6-30 Sharing data via social media

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, EpiData V.3.1软件

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

CRF, EpiData V.3.1 software

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：

  2024-03-26 10:40:12