Analgesic effect of Tuina regulation of PAG-RVM pathway in KOA patients based on fMRI

注册号:

Registration number:

ITMCTR2024000436

最近更新日期:

Date of Last Refreshed on:

2024-09-13

注册时间:

Date of Registration:

2024-09-13

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

基 于 f M R I 揭 示 推 拿 调 控 P A G - R V M 通 路 对 K O A 患 者 镇 痛 作 用 研 究

Public title:

Analgesic effect of Tuina regulation of PAG-RVM pathway in KOA patients based on fMRI

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基 于 f M R I 揭 示 推 拿 调 控 P A G - R V M 通 路 对 K O A 患 者 镇 痛 作 用 研 究

Scientific title:

Analgesic effect of Tuina regulation of PAG-RVM pathway in KOA patients based on fMRI

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:

姚书意

研究负责人:

郭光昕

Applicant:

Shuyi Yao

Study leader:

Guangxin Guo

申请注册联系人电话:

Applicant telephone:

15301727829

研究负责人电话:

Study leader's telephone:

18621831323

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:

yaoshuyihahaha@163.com

研究负责人电子邮件:

Study leader's E-mail:

gxguo9@163.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:

上海市浦东新区蔡伦路1200号11号楼4层11419

研究负责人通讯地址:

上海市浦东新区蔡伦路1200号11号楼4层11419

Applicant address:

11419, 4th Floor, Building 11, 1200 Cailun Road, Pudong New Area, Shanghai

Study leader's address:

11419, 4th Floor, Building 11, 1200 Cailun Road, Pudong New Area, Shanghai

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:

上海中医药大学

Applicant's institution:

Shanghai 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:

2024-1557-140-01

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:

上海中医药大学附属曙光医院伦理委员会

Name of the ethic committee:

Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2024/7/3 0:00:00

伦理委员会联系人:

Contact Name of the ethic committee:

Xi Geng

伦理委员会联系地址:

上海市张衡路528号

Contact Address of the ethic committee:

No. 528 Zhangheng Road, Shanghai

伦理委员会联系人电话:

Contact phone of the ethic committee:

021-20256070

伦理委员会联系人邮箱:

Contact email of the ethic committee:

sgyyllwyh@126.com

研究实施负责(组长)单位:

姚书意

Primary sponsor:

Shanghai University of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

上海市浦东新区蔡伦路1200号11号楼4层11419

Primary sponsor's address:

1200 Cailun Road Pudong New Area Shanghai

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

省(直辖市):

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

具体地址:

Institution
hospital:

Shanghai University of Traditional Chinese Medicine Affiliated Shuguang Hospital

Address:

No. 528 Zhangheng Road, Pudong New Area, Shanghai

经费或物资来源:

国家自然科学基金

Source(s) of funding:

National Natural Science Foundation of China

研究疾病:

膝骨关节炎

研究疾病代码:

Target disease:

Osteoarthritis

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:

揭示推拿通过调控KOA患者 PAG-RVM 通路脑功能活动来发挥镇痛效应,及在 PAG-RVM-DH 通路上的 PAG、NRM 是影响推拿镇痛效应的关键核团,阐明推拿调控疼痛下行抑制系统 PAG-RVM-DH 通路下行抑制信号对 KOA 发挥镇痛作用的机制,为 KOA临床提供借鉴,以便制定更合理的镇痛方案,提高患者的生活质量,并为中医理论的现代化研究提供科学示范作用。

Objectives of Study:

This study reveals that Tuina exerts its analgesic effect by regulating the brain functional activity of the PAG-RVM pathway in patients with knee osteoarthritis (KOA). It further identifies the PAG and NRM within the PAG-RVM-DH pathway as key nuclei that significantly influence the analgesic effect of tuina. By elucidating the mechanism of how tuina regulates the descending inhibitory signals within the PAG-RVM-DH pain descending inhibitory system to produce analgesia in KOA, this research provides valuable insights for clinical practice. Specifically, it can guide the development of more rational analgesic treatment plans for KOA patients, thereby improving their quality of life. Furthermore, this study serves as a scientific demonstration for the modernization of traditional Chinese medicine theories.

药物成份或治疗方案详述:

60例受试者,随机分为推拿组和健康宣教组。 推拿组:给予推拿“以痛为输”手法干预。在膝周常规推拿基础上,通过患者描述和术者触诊寻找痛点,对痛点进行推拿按揉治疗。给予 20 分钟/ 次,3 次/周的 4 周推拿治疗。手法操作:患者取合适体位。医者在患者膝周常规穴位推拿的基础上对膝周痛点进行推拿按揉操作,操作频率 120~140 次/分钟。膝周痛点检查方法:病人仰卧。检查者一手按住患者膝关节上部制动,另一手的拇指端在内、外膝眼,收肌结节,鹅足部及腘窝等处作滑动按压以寻找痛点。 健康教育组:给予健康教育。让 KOA 患者参加 3 次/周、45 分钟/次的 4周健康教育讲座(30 分钟讲座和 15 分钟讨论),纠正不良饮食习惯和生活方式等。 分别于干预前、干预 4 周后采集两组各项指标。本研究根据《赫尔辛基宣言》的指导和原则进行。全程观察并记录受试者的治疗反应;记录研究期间的不良事件,并妥善处理。

Description for medicine or protocol of treatment in detail:

60 subjects were randomly divided into a tuina group and a health education group. Tuina group: Provide massage intervention using the "pain as input" technique. On the basis of routine knee tuina, pain points are identified through patient description and operator palpation, and then treated with massage and pressure. Give 20 minutes/ Massage therapy for 4 weeks, 3 times per week. Manual operation: The patient takes an appropriate position. On the basis of routine acupoint massage around the patient's knee, doctors perform massage and kneading operations on the pain points around the knee, with a frequency of 120-140 times per minute. Knee pain point examination method: The patient lies supine. The examiner holds down the upper part of the patient's knee joint with one hand to apply pressure, while using the thumb tip of the other hand to slide and press on the inner and outer knee eyes, adductor muscle nodules, goose feet, and popliteal fossa to locate pain points. Health Education Group: Provide health education. Allow KOA patients to attend 4-week health education lectures (30 minute lectures and 15 minute discussions) 3 times per week, 45 minutes per session, to correct unhealthy eating habits and lifestyles. Collect two sets of various indicators before and 4 weeks after intervention. This study was conducted in accordance with the guidance and principles of the Helsinki Declaration. Observe and record the treatment response of the subjects throughout the entire process; Record adverse events during the research period and handle them properly.

纳入标准:

①符合 KOA 的中、西医诊断标准和瘀血阻滞证;②年龄 45~65 周岁,左膝疼痛,右利手;③Kellgren-Lawrence 放射学分级为 I-II 级;④VAS>3 分,病程不小于 3 个月;⑤近 4 周未接受过其他治疗;⑥自愿参加本研究并签署知情同意书。

Inclusion criteria

① Meets KOA's diagnostic criteria for both traditional Chinese and Western medicine, as well as the syndrome of blood stasis and obstruction; ② Age 45-65 years old, left knee pain, right handedness; ③ Kellgren Lawrence radiological grading is I-II; ④ VAS>3 points, with a course of not less than 3 months; ⑤ Not received any other treatment in the past 4 weeks; ⑥ Voluntarily participate in this study and sign the informed consent form.

排除标准:

①膝部有外伤和手术史者;②膝部有肿瘤、结核、骨髓炎等疾患者;③严重肝肾功能不全、严重心血管疾病、糖尿病及精神疾病影响推拿治疗者④有其他病引起的身体疼痛者;⑤有药物过敏史者;⑥有闭锁恐惧症、心脏起搏器、除颤器、心脏支架、宫内节育器等 MRI 禁忌症者;⑦膝关节周围皮肤破损者。

Exclusion criteria:

① Individuals with a history of knee trauma and surgery; ② Patients with tumors tuberculosis osteomyelitis and other diseases in the knee; ③ Those with severe liver and kidney dysfunction severe cardiovascular disease diabetes and mental disease that affect massage therapy ④ Those with physical pain caused by other diseases; ⑤ Individuals with a history of drug allergies; ⑥ Individuals with MRI contraindications such as locked in fear pacemakers defibrillators stents intrauterine devices etc People with skin damage around the knee joint.⑦Patients with skin damage around the knee joint.

研究实施时间:

Study execute time:

From 2024-09-15

To      2025-07-02

征募观察对象时间:

Recruiting time:

From 2024-09-15

To      2025-06-02

干预措施:

Interventions:

组别:

健康教育组

样本量:

30

Group:

Health education group

Sample size:

干预措施:

健康教育

干预措施代码:

Intervention:

Health education

Intervention code:

组别:

推拿组

样本量:

30

Group:

Tuina group

Sample size:

干预措施:

推拿

干预措施代码:

Intervention:

Tuina

Intervention code:

样本总量 Total sample size : 60

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海中医药大学附属曙光医院

单位级别:

Institution/hospital:

Shanghai University of Traditional Chinese Medicine Affiliated Shuguang Hospital

Level of the institution:

测量指标:

Outcomes:

指标中文名:

指标类型:

次要指标

Outcome:

Chinese Perceived Stress 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:

指标类型:

次要指标

Outcome:

3D gait analyzer

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

次要指标

Outcome:

Near infrared spectroscopy analysis of internal brain function

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

次要指标

Outcome:

Catastrophization of pain

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

次要指标

Outcome:

Threshold of pain

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

次要指标

Outcome:

Beck Depression 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:

指标类型:

主要指标

Outcome:

Short-Form McGill Pain Questionnaire

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

西安大略大学和麦克马斯特大学骨关节炎指数

指标类型:

次要指标

Outcome:

Western Ontario and McMaster Universities Osteoarthritis Index

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

视觉模拟评分法

指标类型:

次要指标

Outcome:

Visual analogue 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:

指标类型:

次要指标

Outcome:

Muscular tension

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

次要指标

Outcome:

Central sensitization 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:

指标类型:

次要指标

Outcome:

fMRI(parameters such as ALFF, Reho, and FC in PAG and RVM brain regions)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

次要指标

Outcome:

Isokinetic dynamometer

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 45
Min age years
最大 65
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):

用随机信封法。采用 SPSS21.0 软件产生 60 个大小不等的随机数字并依次编号,按照大小对随机数字重新排序,规定数字较小的 30 个随机数是推拿组,数字较大的是健康教育组,制作密闭不透明的随机信封,然后按照患者挂号顺序由研究者依次发放相应编号的信封,按照随机信封的分组给予相应的干预。

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

Use the random envelope method. Using SPSS21.0 software, 60 random numbers of varying sizes were generated and numbered sequentially. The random numbers were reordered according to their sizes, with the smaller 30 random numbers designated as the massage group and the larger ones as the health education group. Sealed and opaque random envelopes were created, and then the researchers distributed the corresponding numbered envelopes in the order of patient registration. Intervention was given according to the grouping of the random envelopes.

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):

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

None Applicable

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:

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

Data will be collected using Case Record Form (CRF)

数据管理委员会:

Data Managemen Committee:

No

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):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above