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基于血清代谢组学探讨“腰膝同治”刮痧法对寒湿痹阻型膝骨关节炎临床疗效及机制研究

注册号：

Registration number：

ITMCTR2025000620

最近更新日期：

Date of Last Refreshed on：

2025-04-01

注册时间：

Date of Registration：

2025-04-01

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

基于血清代谢组学探讨“腰膝同治”刮痧法对寒湿痹阻型膝骨关节炎临床疗效及机制研究

Public title：

Clinical Efficacy and Mechanism Study of 'Waist-Knee Co-Treatment' Gua Sha Therapy for Cold-Dampness Obstruction Pattern Knee Osteoarthritis Based on Serum Metabolomics

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于血清代谢组学探讨“腰膝同治”刮痧法对寒湿痹阻型膝骨关节炎临床疗效及机制研究

Scientific title：

Clinical Efficacy and Mechanism Study of 'Waist-Knee Co-Treatment' Gua Sha Therapy for Cold-Dampness Obstruction Pattern Knee Osteoarthritis Based on Serum Metabolomics

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：

邱戈

研究负责人：

朱燕

Applicant：

Ge Qiu

Study leader：

Yan Zhu

申请注册联系人电话：

Applicant telephone：

18145442043

研究负责人电话：

Study leader's telephone：

17715271177

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：

20231001@njucm.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

965457837@qq.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：

中国江苏省南京市鼓楼区汉中路155号江苏省中医院

研究负责人通讯地址：

中国江苏省南京市鼓楼区汉中路155号江苏省中医院

Applicant address：

Jiangsu Provincial Hospital of Traditional Chinese Medicine No. 155 Hanzhong Road Gulou District Nanjing Jiangsu Province 210029 China

Study leader's address：

Jiangsu Provincial Hospital of Traditional Chinese Medicine No. 155 Hanzhong Road Gulou District Nanjing Jiangsu Province 210029 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：

南京中医药大学

Applicant's institution：

Nanjing University of Chinese Medicine (NJUCM)

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：

2025NL-030-02

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：

江苏省中医院伦理审查委员会

Name of the ethic committee：

Ethics Committee of Jiangsu Provincial Hospital of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2025/3/20 0:00:00

伦理委员会联系人：

王卯

Contact Name of the ethic committee：

Wang Mao

伦理委员会联系地址：

中国江苏省南京市鼓楼区汉中路155号江苏省中医院

Contact Address of the ethic committee：

Jiangsu Provincial Hospital of Traditional Chinese Medicine No. 155 Hanzhong Road Gulou District Nanjing Jiangsu Province 210029 China

伦理委员会联系人电话：

Contact phone of the ethic committee：

025-86560515

伦理委员会联系人邮箱：

Contact email of the ethic committee：

LLWYHBGS@qq.com

研究实施负责（组长）单位：

江苏省中医院

Primary sponsor：

Jiangsu Provincial Hospital of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

江苏省南京市鼓楼区汉中路155号江苏省中医院

Primary sponsor's address：

Jiangsu Provincial Hospital of Traditional Chinese Medicine No. 155 Hanzhong Road Gulou District Nanjing Jiangsu Province 210029 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)：

江苏省

市(区县)：

南京市

Country：

China

Province：

Jiangsu Provincial

City：

Nanjing

单位(医院)：

江苏省中医院

具体地址：

江苏省南京市鼓楼区汉中路155号江苏省中医院

Institution
hospital：

Jiangsu Provincial Hospital of Traditional Chinese Medicine

Address：

Jiangsu Provincial Hospital of Traditional Chinese Medicine No. 155 Hanzhong Road Gulou District Nanjing Jiangsu Province 210029 China

经费或物资来源：

江苏省中医院中医膝骨关节炎临床医学创新中心

Source(s) of funding：

Clinical Innovation Center for Knee Osteoarthritis of Traditional Chinese Medicine Jiangsu Provincial Hospital of TCM

研究疾病：

膝骨关节炎

研究疾病代码：

Target disease：

knee 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：

膝骨关节炎（KOA）是一种常见的退行性关节疾病，严重影响患者的生活质量。寒湿痹阻型KOA是中医常见的证型之一，其主要特征为关节疼痛、活动受限，遇寒加重，得温则减。刮痧作为传统中医外治法，具有活血化瘀、疏通经络的作用，但其对KOA的具体疗效及机制尚未完全阐明。代谢组学作为系统生物学的重要组成部分，能够全面反映机体的代谢状态，为揭示刮痧治疗KOA的作用机制提供了新的视角。 本研究通过血清代谢组学技术，探索“腰膝同治”刮痧法对寒湿痹阻型KOA的临床疗效及其潜在的代谢调控机制，为中医药治疗KOA提供科学依据，推动中医药现代化和国际化发展。

Objectives of Study：

Knee Osteoarthritis (KOA) a prevalent degenerative joint disease significantly impairs patients' quality of life. In Traditional Chinese Medicine (TCM) practice the cold-dampness obstruction syndrome is a common clinical pattern of KOA characterized by joint pain limited mobility cold-aggravated symptoms and warmth-induced relief. Gua sha therapy a traditional TCM external treatment demonstrates therapeutic effects through blood circulation promotion and meridian regulation. However its specific efficacy and mechanisms in KOA management remain insufficiently elucidated. Metabolomics as a crucial component of systems biology provides comprehensive metabolic profiling capabilities. This approach offers novel perspectives for deciphering the mechanistic basis of Gua sha in KOA treatment. This study investigates the clinical efficacy and metabolic regulatory mechanisms of "lumboknee co-treatment" Gua sha therapy in cold-dampness obstruction KOA through serum metabolomics analysis. The research aims to: 1.Establish scientific evidence for TCM approaches in KOA management 2.Identify potential metabolic biomarkers and pathways 3.Promote TCM modernization and global integration through mechanism-driven validation

药物成份或治疗方案详述：

1. 研究思路与方法 临床研究：采用随机对照试验设计，将寒湿痹阻型KOA患者分为试验组（腰膝同治刮痧）和对照组（双氯芬酸二乙胺乳胶剂），观察两组的临床疗效。 代谢组学研究：利用UPLC-Q-TOF-MS技术分析KOA患者与健康志愿者的血清代谢谱差异，并通过多元统计分析筛选出与刮痧治疗相关的潜在生物标志物及代谢通路。 2. 技术路线 受试者招募与分组：随机纳入68例寒湿痹阻型KOA患者，分为试验组和对照组，另招募34例健康志愿者作为空白对照。 干预措施：试验组接受“腰膝同治”刮痧治疗，对照组接受双氯芬酸二乙胺乳胶剂治疗，疗程为4周。 样本采集：分别在治疗前、治疗后采集受试者血清样本，进行代谢组学分析。 数据统计：通过主成分分析（PCA）、偏最小二乘法判别分析（PLS-DA）等多元统计方法分析代谢组学数据，筛选出差异代谢物及代谢通路。 3. 试验方案 干预措施： 对照组：双氯芬酸二乙胺乳胶剂外用，每日3-4次，连续4周。 试验组：腰膝同治刮痧，每周1次，连续4周。刮痧部位包括膝关节周围穴位及腰部经络。 观察指标： 主要疗效指标：WOMAC评分。 次要疗效指标：VAS评分、Lequesne评分、中医证候积分。 安全性评价：记录刮痧过程中是否出现皮肤损伤、晕痧等不良反应。

Description for medicine or protocol of treatment in detail：

1. Research Approach and Methods Clinical Study: A randomized controlled trial (RCT) design was adopted. Patients with cold-dampness obstruction type knee osteoarthritis (KOA) were divided into an experimental group (treated with waist-knee co-treatment scraping therapy) and a control group (treated with diclofenac diethylamine emulsion). The clinical efficacy of the two groups was observed. Metabolomics Study: Ultra-performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry (UPLC-Q-TOF-MS) was used to analyze the differences in serum metabolic profiles between KOA patients and healthy volunteers. Multivariate statistical analysis was employed to identify potential biomarkers and metabolic pathways associated with scraping therapy. 2. Technical Route Subject Recruitment and Grouping: A total of 68 patients with cold-dampness obstruction type KOA were randomly enrolled and divided into an experimental group and a control group. Additionally 34 healthy volunteers were recruited as a blank control group. Intervention Measures: The experimental group received "waist-knee co-treatment" scraping therapy while the control group was treated with diclofenac diethylamine emulsion. The treatment duration was 4 weeks. Sample Collection: Serum samples were collected from the participants before and after the treatment for metabolomics analysis. Data Analysis: Multivariate statistical methods including principal component analysis (PCA) and partial least squares discriminant analysis (PLS-DA) were used to analyze the metabolomics data to identify differential metabolites and metabolic pathways. 3. Experimental Protocol Intervention Measures: Control Group: Diclofenac diethylamine emulsion was applied topically 3-4 times daily for 4 weeks. Experimental Group: Waist-knee co-treatment scraping therapy was administered once a week for 4 weeks. The scraping areas included acupoints around the knee joint and meridians in the waist region. Observation Indicators: Primary Efficacy Indicator: WOMAC score. Secondary Efficacy Indicators: VAS score Lequesne score and TCM syndrome score. Safety Evaluation: Adverse reactions such as skin damage or dizziness during scraping were recorded.

纳入标准：

寒湿痹阻型KOA患者： （寒湿痹阻型膝骨关节炎患者纳入标准： (1)符合KOA西医诊断和中医辨证分型标准； (2)年龄≥40岁且≤80岁，性别不限； (3)KL分级为Ⅰ-Ⅱ级； (4)患者未接受其他关于KOA的非手术治疗，或曾接受其他非手术疗法，愿意经7日的洗脱期； (5)愿意参与研究，依从性好并自愿签署知情同意书 (6) 正在服用止痛药的患者，需符合以下条件： 允许使用的止痛药种类： Ⅰ.对乙酰氨基酚（Paracetamol）：每日最大剂量不超过4000 mg，且每日服用次数不超过4次。 Ⅱ.非甾体类抗炎药（NSAIDs）：如布洛芬（Ibuprofen，每日最大剂量不超过1200 mg）、Ⅲ.双氯芬酸（Diclofenac，每日最大剂量不超过150 mg）、塞来昔布（Celecoxib，每日最大剂量不超过200 mg）等，每日服用次数不超过2次。 Ⅳ.局部止痛药：如双氯芬酸凝胶、酮洛芬凝胶等，每日使用次数不超过3次。 健康志愿者： (1) 在本院体检的健康志愿者； (2) 年龄≥40岁且≤80岁，性别不限； (3) 从未有膝关节疼痛或不适者； (4) 愿意参与研究，依从性好并自愿签署知情同意书

Inclusion criteria

Patients with Cold-Dampness Obstruction Type KOA: (1) Meet the diagnostic criteria for KOA in Western medicine (refer to the Diagnosis and Treatment Guidelines for Osteoarthritis (2018 Edition) formulated by the Orthopaedic Branch of the Chinese Medical Association) and the TCM syndrome differentiation criteria (Guidelines for TCM Diagnosis and Treatment of Knee Osteoarthritis (2020 Edition)); (2) Aged 40-80 years regardless of gender; (3) KL grade I-II; (4) Patients who have not received other non-surgical treatments for KOA or who have received other non-surgical therapies and are willing to undergo a 7-day washout period; (5) Willing to participate in the study with good compliance and voluntary signing of the informed consent form. Healthy Volunteers: (1) Healthy volunteers undergoing physical examinations at our hospital; (2) Aged 40-80 years regardless of gender; (3) No history of knee pain or discomfort; (4) Willing to participate in the study with good compliance and voluntary signing of the informed consent form.

排除标准：

寒湿痹阻型KOA患者： (1) KOA伴有急性滑膜炎或急性感染者； (2) 膝部骨关节结核、肿瘤、风湿性关节炎、类风湿性关节炎者； (3) 存在并发症影响膝关节者，如牛皮癣、梅毒性神经病、褐黄病、代谢性骨病、急性创伤等； (4) 2个月内接受全身或者关节腔内的激素治疗，3月内对膝关节进行过关节腔内注射或关节镜检查； (5) 既往有膝关节手术史、3个月内刮痧区域有严重外伤史或皮肤破损及其他疾病，影响到局部刮痧者； (6) 正在或准备参加其他临床试验者； (7) 除KOA外，由于其他慢性或复发性疼痛而需使用止痛药，如阿片类镇痛药、具有止痛效果的复方非处方药物或中药（如含有阿司匹林、对乙酰氨基酚等成分的中成药），或未按规定使用允许的止痛药者; (8) 合并妊娠期、月经期、严重肝肾疾病、心血管疾病、代谢性疾病、皮肤病、精神疾病、出血倾向及凝血功能障碍者； (9) 认知或语言功能障碍者； (10) 易过敏体质或患有免疫系统疾病者； (11) 研究人员认为不适合本研究的病例，如工作环境经常变动等易造成失访的情况。 健康志愿者 （1）妊娠期、脯乳期妇女； （2）具有严重的原发性心肺功能不全、肝肾功能疾病及造血系统疾病； （3）认知或语言功能障碍者； （4）具有原发性或继发性感染疾病，如肺炎、尿路感染、胆囊炎等； （5）患有或既往有代谢类疾病病史，如代谢综合征等； （6）精神或智力障碍者。

Exclusion criteria：

Patients with Cold-Dampness Obstruction Type KOA: (1) KOA accompanied by acute synovitis or acute infection; (2) Patients with knee joint tuberculosis tumors rheumatic arthritis or rheumatoid arthritis; (3) Patients with complications affecting the knee joint such as psoriasis syphilitic neuropathy ochronosis metabolic bone disease acute trauma etc.; (4) Patients who have received systemic or intra-articular hormone therapy within the past 2 months or who have undergone intra-articular injections or arthroscopy of the knee joint within the past 3 months; (5) Patients with a history of knee surgery severe trauma or skin lesions in the scraping area within the past 3 months or other conditions affecting local scraping; (6) Patients who are currently participating in or planning to participate in other clinical trials; (7) Patients who require painkillers for chronic or recurrent pain other than KOA such as acetaminophen non-steroidal anti-inflammatory drugs opioid analgesics compound over-the-counter drugs with analgesic effects or traditional Chinese medicine or topical analgesics; (8) Patients who are pregnant menstruating or have severe liver or kidney diseases cardiovascular diseases metabolic diseases skin diseases mental illnesses bleeding tendencies or coagulation disorders; (9) Patients with cognitive or language dysfunction; (10) Patients with allergic constitutions or immune system diseases; (11) Cases deemed unsuitable for the study by researchers such as those with frequently changing work environments that may lead to loss to follow-up. Healthy Volunteers: (1) Pregnant or lactating women; (2) Individuals with severe primary cardiopulmonary insufficiency liver or kidney diseases or hematopoietic system diseases; (3) Individuals with cognitive or language dysfunction; (4) Individuals with primary or secondary infectious diseases such as pneumonia urinary tract infections cholecystitis etc.; (5) Individuals with a history of metabolic diseases such as metabolic syndrome; (6) Individuals with mental or intellectual disabilities.

研究实施时间：

Study execute time：

从From 2025-03-20

至To      2025-09-20

征募观察对象时间：

Recruiting time：

从From 2025-04-06

至To      2025-09-20

干预措施：

Interventions：

组别：

实验组

样本量：

34

Group：

Experimental Group

Sample size：

干预措施：

刮痧

干预措施代码：

Intervention：

Gua sha

Intervention code：

组别：

对照组

样本量：

34

Group：

Control Group

Sample size：

干预措施：

双氯芬酸二乙胺乳胶剂

干预措施代码：

Intervention：

Diclofenac Diethylamine Emulgel

Intervention code：

样本总量 Total sample size ： 64

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

江苏省

市(区县)：

南京市

Country：

China

Province：

Jiangsu

City：

Nanjing

单位(医院)：

江苏省中医院

单位级别：

三级甲等

Institution/hospital：

Jiangsu Provincial Hospital of Traditional Chinese Medicine

Level of the institution：

Grade III Level A Hospital

测量指标：

Outcomes：

指标中文名：

中医证候积分

指标类型：

次要指标

Outcome：

TCM Syndrome Score

Type：

Secondary indicator

测量时间点：

入组第0天、28天和60天

测量方法：

问卷

Measure time point of outcome：

Day 0 Day 28 and Day 60 of Enrollment

Measure method：

Questionnaire

指标中文名：

膝关节骨性关节炎严重度指数

指标类型：

次要指标

Outcome：

Lequesne

Type：

Secondary indicator

测量时间点：

入组第0天、28天和60天

测量方法：

问卷

Measure time point of outcome：

Day 0 Day 28 and Day 60 of Enrollment

Measure method：

Questionnaire

指标中文名：

血清代谢物

指标类型：

附加指标

Outcome：

Serum Metabolites

Type：

Additional indicator

测量时间点：

入组第0、28天

测量方法：

血清代谢检测

Measure time point of outcome：

Day 0 and Day 28 of Enrollment

Measure method：

Serum Metabolic Testing

指标中文名：

疼痛视觉模拟评分法

指标类型：

次要指标

Outcome：

VAS

Type：

Secondary indicator

测量时间点：

入组第0天、28天和60天

测量方法：

问卷

Measure time point of outcome：

Day 0 Day 28 and Day 60 of Enrollment

Measure method：

Questionnaire

指标中文名：

西安大略和麦克马斯特大学骨关节炎指数评分

指标类型：

主要指标

Outcome：

WOMAC

Type：

Primary indicator

测量时间点：

入组第0天、28天和60天

测量方法：

问卷

Measure time point of outcome：

Day 0 Day 28 and Day 60 of Enrollment

Measure method：

Questionnaire

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 40 岁
Min age years
最大 80 岁
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）：

随机序列由独立的第三方人员使用SPSS 27.0软件生成，为1至68编号的受试者分配随机序列号。随机化采用区组随机化方法，按照1:1的比例将受试者分为对照组和试验组。生成的随机分配结果被密封在不透光的信封中，信封上标注受试者的入组顺序编号。受试者入组时，研究人员按照顺序依次打开对应的信封，以确定其分组。

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

The random sequence was generated by an independent third party using SPSS 27.0 software assigning random sequence numbers to participants numbered from 1 to 68. Randomization was performed using a block randomization method allocating participants into the control group and the experimental group in a 1:1 ratio. The generated random allocation results were sealed in opaque envelopes with each envelope labeled with the participant's enrollment sequence number. Upon enrollment the researchers opened the corresponding envelopes in sequential order to determine the participant's group assignment.

盲法：

本研究为非盲法研究，采用盲态评价。委托第三方对研究结果进行评估。

Blinding：

This study is an open-label trial with blinded outcome assessment. The evaluation of the study results was delegated to an independent third party.

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）：

无

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

no

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：

有

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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