Study on the effect of acupuncture on improving chronic neck pain with mild to moderate anxiety by regulating cortical excitability

注册号:

Registration number:

ITMCTR2024000174

最近更新日期:

Date of Last Refreshed on:

2024-08-05

注册时间:

Date of Registration:

2024-08-05

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

针刺调控皮层兴奋性改善慢性颈痛伴轻、中度焦虑的作用研究

Public title:

Study on the effect of acupuncture on improving chronic neck pain with mild to moderate anxiety by regulating cortical excitability

注册题目简写:

English Acronym:

研究课题的正式科学名称:

针刺调控皮层兴奋性改善慢性疼痛伴焦虑的作用研究

Scientific title:

Study on the effect of acupuncture on improving chronic pain with anxiety by regulating cortical excitability

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:

黄键澎

研究负责人:

黄键澎

Applicant:

Jianpeng Huang

Study leader:

Jianpeng Huang

申请注册联系人电话:

Applicant telephone:

13535175815

研究负责人电话:

Study leader's telephone:

13535175815

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:

hopis@sina.com

研究负责人电子邮件:

Study leader's E-mail:

hopis@sina.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:

广东省广州市越秀区大德路111号

研究负责人通讯地址:

广东省广州市越秀区大德路111号

Applicant address:

111 Dade Road, Yuexiu District, Guangzhou, Guangdong Province

Study leader's address:

111 Dade Road, Yuexiu District, Guangzhou, Guangdong 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:

广州中医药大学第二附属医院

Applicant's institution:

The Second Affiliated Hospital of Guangzhou 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:

BF2024-192-01

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

广东省中医院伦理委员会

Name of the ethic committee:

Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2024/7/19 0:00:00

伦理委员会联系人:

李晓彦

Contact Name of the ethic committee:

Xiaoyan Li

伦理委员会联系地址:

广东省广州市越秀区大德路111号

Contact Address of the ethic committee:

111 Dade Road, Yuexiu District, Guangzhou, Guangdong Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

020-81887233

伦理委员会联系人邮箱:

Contact email of the ethic committee:

llbgs@gzucm.edu.cn

研究实施负责(组长)单位:

广州中医药大学第二附属医院

Primary sponsor:

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

研究实施负责(组长)单位地址:

广东省广州市越秀区大德路111号

Primary sponsor's address:

111 Dade Road, Yuexiu District, Guangzhou, Guangdong 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):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong Province

City:

Guangzhou

单位(医院):

广州中医药大学第二附属医院

具体地址:

广东省广州市越秀区大德路111号

Institution
hospital:

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

Address:

111 Dade Road, Yuexiu District, Guangzhou, Guangdong Province

经费或物资来源:

广东省中医院中医药科学技术研究专项

Source(s) of funding:

Guangdong Provincial Hospital of Traditional Chinese Medicine Science and technology research project

研究疾病:

慢性颈痛伴轻、中度焦虑障碍

研究疾病代码:

Target disease:

Chronic neck pain with mild to moderate anxiety disorders

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:

通过观察针刺治疗慢性颈痛伴焦虑的临床疗效,采用经颅磁刺激技术,从皮层兴奋性变化的角度,初步探讨针刺通过调节DLPFC区改善疼痛伴焦虑的效应机制,为临床应用提供数据参考。

Objectives of Study:

By observing the clinical efficacy of acupuncture in the treatment of chronic neck pain with anxiety, transcranial magnetic stimulation was used to preliminatively explore the effect mechanism of acupuncture in improving pain with anxiety by regulating DLPFC region from the perspective of cortical excitatory changes, so as to provide data reference for clinical application.

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年龄在18-60 岁; ②健康志愿者:近1个月无身体不适,无基础疾病;汉密尔顿焦虑量表评分HAMA-14≤7分; ③慢性颈痛伴焦虑患者:需符合慢性颈痛及焦虑的诊断标准;视觉模拟评分VAS>3分且汉密尔顿焦虑量表评分8分<HAMA-14≤20分; ④无晕针史; ⑤近三个月内未曾接受任何外周刺激干预(如针灸、外周电刺激等)及中枢刺激(如rTMS、tDCS等); ⑥自愿参加本研究并签署知情同意书者。

Inclusion criteria

① Aged 18-60 years old; ② Healthy volunteers: no physical discomfort or underlying diseases in the past 1 month; Hamilton anxiety scale score HAMA-14≤7 points; ③ Patients with chronic neck pain and anxiety: need to meet the diagnostic criteria for chronic neck pain and anxiety; VAS score > 3 and 8< HAMA-14 score ≤20; ④ no history of needle faintness; ⑤No peripheral stimulation intervention (such as acupuncture, peripheral electrical stimulation, etc.) and central stimulation (such as rTMS, tDCS, etc.) in the past three months; ⑥ Volunteer to participate in the study and sign the informed consent.

排除标准:

①无颈痛表现的颈型颈椎病患者,或不以颈痛为主诉的患者;通过临床表现及X线片检查,排除其他类型的颈椎病; ②既往及当前有暴力行为、精神病性症状,或诊断有精神分裂症、双相障碍或其他精神障碍类疾病; ③有明显的人格障碍史; ④有酗酒或物质滥用史; ⑤既往有脑外伤、癫痫病史; ⑥合并严重心、肝、肾、脑血管疾病者; ⑦久病体弱、严重神经官能症、痴呆、重度骨质疏松、妊娠者; ⑧白血病、血小板减少等有出血倾向者。

Exclusion criteria:

① Patients with cervical spondylosis without cervical pain, or patients without cervical pain as the main complaint; Other types of cervical spondylosis were excluded through clinical manifestations and X-ray examinations. ② Have violent behavior, psychotic symptoms, or have been diagnosed with schizophrenia, bipolar disorder, or other mental disorders; ③ History of personality disorder; ④ History of alcohol or substance abuse; ⑤ History of brain trauma and epilepsy; ⑥ Patients with severe heart, liver, kidney and cerebrovascular diseases; ⑦ Chronic weakness, severe neurosis, dementia, severe osteoporosis, pregnancy; ⑧ Leukemia, thrombocytopenia and other bleeding tendency.

研究实施时间:

Study execute time:

From 2024-08-15

To      2026-08-14

征募观察对象时间:

Recruiting time:

From 2024-08-15

To      2025-02-15

干预措施:

Interventions:

组别:

治疗2组

样本量:

25

Group:

Treatment group 2

Sample size:

干预措施:

常规针刺联合疏肝调神针刺组

干预措施代码:

Intervention:

Conventional acupuncture combined with Shugan Tiaoshen acupuncture group

Intervention code:

组别:

患者组

样本量:

25

Group:

Patient group

Sample size:

干预措施:

抑制DLPFC,抑制DLPFC+针刺

干预措施代码:

Intervention:

Inhibit DLPFC, inhibit DLPFC plus acupuncture

Intervention code:

组别:

健康受试者组

样本量:

25

Group:

Healthy subject group

Sample size:

干预措施:

抑制DLPFC,抑制DLPFC+针刺

干预措施代码:

Intervention:

Inhibit DLPFC, inhibit DLPFC plus acupuncture

Intervention code:

组别:

治疗1组

样本量:

25

Group:

Treatment group 1

Sample size:

干预措施:

常规针刺组

干预措施代码:

Intervention:

Conventional acupuncture group

Intervention code:

组别:

对照组

样本量:

25

Group:

Control group

Sample size:

干预措施:

非穴浅刺

干预措施代码:

Intervention:

Non-acupoint shallow puncure

Intervention code:

样本总量 Total sample size : 125

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广州中医药大学第二附属医院

单位级别:

三甲

Institution/hospital:

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

Level of the institution:

Class A tertiary hospital

测量指标:

Outcomes:

指标中文名:

HAMA量表

指标类型:

主要指标

Outcome:

HAMA scale

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

NPQ量表

指标类型:

主要指标

Outcome:

NPQ scale

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SAS量表

指标类型:

次要指标

Outcome:

SAS scale

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

运动诱发电位MEP

指标类型:

主要指标

Outcome:

Motor evoked potentials

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

VAS量表

指标类型:

次要指标

Outcome:

VAS scale

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:

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):

由从事方法学研究的人员单独处理,通过应用SAS软件,将进行针灸治疗的75例慢性颈痛伴轻、中度焦虑患者随机分为治疗1组,治疗2组,对照组,每组25例。

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

By using SAS software, 75 patients with chronic neck pain and mild or moderate anxiety undergoing acupuncture treatment were randomly divided into treatment group 1, treatment group 2 and control group, with 25 cases in each group.

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):

研究结束后1年(2027-8-15),云存储服务共享

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

1 year after the end of the study (2027-8-15), the cloud storage service was shared

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:

病例记录表

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

Case Record Form, 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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