ChiCTR2500100182 版本V1.0 版本创建时间2025/04/03 15:00:19 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：

ChiCTR2500100182 

最近更新日期：

Date of Last Refreshed on：

2025-04-03 15:00:14 

注册时间：

Date of Registration：

2025-04-03 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

针刺治疗膝骨关节炎的随机对照试验及其代谢机制研究

Public title：

Randomized controlled trial of acupuncture in the treatment of knee osteoarthritis and its metabolic mechanism

注册题目简写：

English Acronym：

研究课题的正式科学名称：

针刺治疗膝骨关节炎的随机对照试验及其代谢机制研究

Scientific title：

Randomized controlled trial of acupuncture in the treatment of knee osteoarthritis and its metabolic mechanism

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：

吴柳 

研究负责人：

满天明 

Applicant：

Liu Wu 

Study leader：

Tianming Man 

申请注册联系人电话：

Applicant telephone：

+86 151 8442 0680

研究负责人电话：

Study leader's telephone：

+86 186 0466 3520

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：

854492330@qq.com

研究负责人电子邮件：

Study leader's E-mail：

1368163630@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：

四川省成都市温江区柳台大道1166号

研究负责人通讯地址：

四川省成都市青羊区武都路3号

Applicant address：

Chengdu University of Traditional Chinese Medicine, No. 1166 Liutai Avenue, Wenjiang District, Chengdu City, Sichuan Province, China

Study leader's address：

Chengdu Bayi Orthopedic Hospital, No. 3 Wudu Road, Qingyang District, Chengdu City, Sichuan Province, 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：

成都中医药大学

Applicant's institution：

Chengdu University of Traditional Chinese Medicine

研究负责人所在单位：

成都八一骨科医院

Affiliation of the Leader：

Chengdu Bayi Orthopedics hospital

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：

CDBYGK-20240001

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：

八一骨科医院医学伦理委员会

Name of the ethic committee：

Medical ethics committee of Bayi Orthopedic Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2024-09-27 00:00:00

伦理委员会联系人：

赵育刚

Contact Name of the ethic committee：

YuGang Zhao

伦理委员会联系地址：

四川省成都市青羊区武都路3号

Contact Address of the ethic committee：

No.3 Wudu Road, Qingyang District, Chengdu, Sichuan, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 166 1280 4516

伦理委员会联系人邮箱：

Contact email of the ethic committee：

2693396122@qq.com

研究实施负责（组长）单位：

成都八一骨科医院

Primary sponsor：

Chengdu Bayi Orthopedics hospital

研究实施负责（组长）单位地址：

四川省成都市青羊区武都路3号

Primary sponsor's address：

No. 3 Wudu Road, Qingyang District, Chengdu, Sichuan, 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)：

四川省

市(区县)：

成都市

Country：

China

Province：

Sichuan

City：

Chengdu

单位(医院)：

成都八一骨科医院

具体地址：

四川省成都市青羊区武都路3号

Institution
hospital：

Chengdu Bayi Orthopedics hospital

Address：

No. 3 Wudu Road, Qingyang District, Chengdu, Sichuan, China

经费或物资来源：

国家中医优势专科建设项目

Source(s) of funding：

National TCM Advantageous Specialty Construction Project

Target disease：

knee osteoarthritis

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究将通过代谢组学技术和肌骨超声，全面评估KOA的机制和针刺治疗的疗效。具体来说，代谢组学技术将用于分析针刺治疗前后患者体内代谢物的变化，识别与KOA发病和针刺疗效相关的关键代谢物和代谢途径。肌骨超声将用于实时动态观察膝关节结构变化，包括膝关节微循环、滑膜炎症、关节积液、关节间隙和软组织病变等指标。通过结合代谢组学和肌骨超声技术系统评估针刺治疗的临床效果，深入探讨其生物学机制，为针刺疗法在膝骨关节炎中的应用提供科学依据，推动个体化治疗的发展。  

Objectives of Study：

In this study, the mechanisms of KOA and the efficacy of acupuncture treatment will be comprehensively evaluated by metabolomics techniques and musculoskeletal ultrasound.Specifically, metabolomics technology will be used to analyze the changes of metabolites in patients before and after acupuncture treatment, and to identify the key metabolites and metabolic pathways associated with the pathogenesis of KOA and the efficacy of acupuncture. Musculoskeletal ultrasound will be used to dynamically observe structural changes in the knee joint in real time, including indicators of knee microcirculation, synovial inflammation, joint effusion, joint space and soft tissue lesions. By combining metabolomics and musculoskeletal ultrasound technology to systematically evaluate the clinical effects of acupuncture therapy and to deeply explore its biological mechanisms, we will provide scientific basis for the application of acupuncture therapy in knee osteoarthritis and promote the development of individualized treatment.

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、符合美国风湿病学会（ACR）制定的膝骨关节炎（KOA）诊断标准： （1）年龄>=40岁且<=75岁； （2）膝关节疼痛持续时间>=6个月； （3）X线检查（Kellgren-Lawrence分级）为II-III级。 2、视觉模拟评分（VAS）>=4分且<=7分（疼痛程度中度）。 3、近1个月内未接受过其他针灸、推拿或关节腔注射治疗。 4、自愿签署知情同意书，并承诺完成全部疗程及随访。

Inclusion criteria

1. Meet the diagnostic criteria for knee osteoarthritis (KOA) formulated by the American College of Rheumatology (ACR): (1) Age>=40 years and <=75 years; (2) duration of knee pain>=6 months; (3) X-ray examination (Kellgren-Lawrence classification) is grade II-III. 2. Visual analogue score (VAS) > = 4 points and < = 7 points (moderate pain level). 3. Have not received other acupuncture, massage or intra-articular injection treatment in the past 1 month. 4. Voluntarily sign the informed consent form and promise to complete the full course of treatment and follow-up.

排除标准：

1、继发性膝骨关节炎（如类风湿性关节炎、创伤性关节炎、痛风性关节炎等）。 2、合并严重心脑血管疾病（如NYHA心功能分级>=III级）、肝肾功能不全（ALT/AST>=2倍正常值上限，Cr>=1.5 mg/dL）或恶性肿瘤。 3、膝关节手术史或计划6个月内接受手术者。 4、妊娠或哺乳期妇女。 5、凝血功能障碍（INR>=1.5或血小板计数<100×10?/L）。 6、皮肤局部感染或破损（针刺部位禁忌）。 7、长期服用糖皮质激素（>=5 mg/d泼尼松等效剂量）或免疫抑制剂。 8、精神疾病或认知障碍无法配合治疗者。 9、参与其他临床试验可能干扰本研究结果者。

Exclusion criteria：

1. Secondary knee osteoarthritis (such as rheumatoid arthritis, traumatic arthritis, gouty arthritis, etc.). 2. Combined with severe cardiovascular and cerebrovascular diseases (such as NYHA cardiac function classification >=grade III), liver and kidney insufficiency (ALT/AST>=2 times the upper limit of normal value, Cr>=1.5 mg/dL) or malignant tumor. 3. Those who have a history of knee surgery or plan to undergo surgery within 6 months. 4. Pregnant or lactating women. 5. Coagulation dysfunction (INR>=1.5 or platelet count <100×10?/L). 6. Local infection or damage to the skin (contraindication at acupuncture site). 7. Long-term use of glucocorticoids (>=5 mg/d prednisone equivalent) or immunosuppressants. 8. Those with mental illness or cognitive impairment who cannot cooperate with treatment. 9. Those who participate in other clinical trials that may interfere with the results of this study.

研究实施时间：

Study execute time：

从 From 2024-10-01 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-05-01 00:00:00 至 To 2025-09-01 00:00:00  

干预措施：

Interventions：

组别：

针刺组

样本量：

52

Group：

acupuncture group

Sample size：

干预措施：

选取内膝眼、血海、梁丘、阳陵泉、大杼、太冲、阿是穴。每周进行3次针刺治疗，连续治疗8周，一共治疗24次，随访2周。

干预措施代码：

Intervention：

The Inner Knee Eye, Sea of Blood, Liangqiu, Yanglingquan, Da Loom, Taichong, and Ah Yes points were selected. Acupuncture treatment was performed 3 times a week for 8 weeks, for a total of 24 treatments, with a 2-week follow-up.

Intervention code：

组别：

假针刺组

样本量：

52

Group：

sham acupuncture group

Sample size：

干预措施：

选取非经非穴进行浅刺，针刺深度约2mm，不进行手法操作，不求得气，非穴参考来源于刘存志教授。每周进行3次针刺治疗，连续治疗8周，一共治疗24次，随访2周。

干预措施代码：

Intervention：

Non-meridian and non-acupuncture points were selected for shallow stabbing with a depth of about 2 mm, without manipulation, without seeking to obtain qi, and the non-acupuncture points were referenced from Prof. Liu Cunzhi. Acupuncture treatment was performed 3 times per week for 8 weeks, totalling 24 treatments, with a 2-week follow-up.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 四川省 

市(区县)：

  

Country：

China 

Province：

Sichuan 

City：

 

单位(医院)：

成都八一骨科医院 

单位级别：

三甲 

Institution
hospital：

Chengdu Bayi Orthopedics hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

骨关节炎指数

指标类型：

主要指标

Outcome：

Osteoarthritis index

Type：

Primary indicator

测量时间点：

测量方法：

WOMAC评分

Measure time point of outcome：

Measure method：

WOMAC score

指标中文名：

骨关节炎指数

指标类型：

次要指标

Outcome：

Osteoarthritis index

Type：

Secondary indicator

测量时间点：

测量方法：

PainVision疼痛测试；HSS膝关节评分量表；KOOS量表；Lequesne指数

Measure time point of outcome：

Measure method：

PainVision Pain Test; HSS Knee Rating Scale; Knee injury and Osteoarthritis Outcome Score Sclae; Lequesne Algofunctional Index

指标中文名：

肌骨超声分析指标

指标类型：

主要指标

Outcome：

Musculoskeletal ultrasound analysis metrics

Type：

Primary indicator

测量时间点：

测量方法：

肌骨超声

Measure time point of outcome：

Measure method：

Musculoskeletal ultrasound

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

静脉血

Sample Name：

Blood

Tissue：

Venous blood

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：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 45 岁 years
最大 Max age 70 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）：

本研究由不参与招募和治疗的研究人员根据SPSS26.0软件制作随机数字表，将104例受试者随机分为2组，每组52例，因此共生成104个随机数字。该研究人员使用不透明的牛皮信封，将序列号、随机数和组别信息装进信封中，密封好，最后再给信封外层编上序号。当KOA受试者符合纳入标准后，由该研究人员按照入组顺序拆开信封，并且告知对应分配治疗的治疗人员。

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

In this study, a researcher who was not involved in the recruitment and treatment created a table of random numbers based on SPSS 26.0 software, and 104 subjects were randomly divided into 2 groups of 52 subjects each, thus generating a total of 104 random numbers. The researcher used opaque cowhide envelopes into which the serial numbers, random numbers, and group information were placed, sealed, and then finally serial numbered the outer layer of the envelope. Once the KOA subjects met the inclusion criteria, the envelopes were opened by this researcher in the order of enrollment, and the treatment staff corresponding to the assigned treatment was informed.

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：

本研究遵循盲法原则。在研究过程和数据分析阶段实行研究人员、操作人员、统计人员三盲、三分离的原则。在操作过程中，对受试者采用单独的隔离进行治疗，以最大程度地对受试者实施盲法。在疗效评价阶段，由经过培训的评价人员进行评价，评价人员不知晓受试者分组情况，评价人员不得参与治疗过程。统计分析人员不知晓试验方案及具体分组情况。

Blinding：

This study followed the principle of blinding. The principle of triple blinding and separation of researchers, operators, and statisticians was applied during the study process and data analysis phase. During the operation process, subjects were treated using separate isolation to maximise the blinding of the subjects. In the efficacy evaluation phase, the evaluation was conducted by trained evaluators who were not aware of the subject grouping, and the evaluators were not allowed to participate in the treatment process. Statistical analysts were unaware of the trial protocol and specific subgroups.

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）：

预计于2026年12月份前以发表论文及申报课题方式共享，或者联系研究者邮箱

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

It is expected to be shared by December 2026 by publishing papers and applying for topics, or contact the investigator's email

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：

在试验开展前，课题组通过多次方案研讨会议制定本研究的工作手册。研究者需严格按照工作手册的要求，严格控制入组的受试者的基线资料，让两组受试者在年龄、性别、身高、体重等方面保持一致。在填写量表过程中，需让受试者在安静的环境中进行填写，填写结束时也应当检查，对未填完的量表数据需提醒受试者进行填写。之后，所有的量表评分均用SPSS 25.0统计软件进行分析。定性指标以构成比或百分率表示，定量指标以“均数±标准差”（Mean ± SD）表示，非参数检验的结果展示形式为“中位数（四分位数）”（Median（P25, P75））。组间比较，定性资料采用卡方检验或Fisher精确概率法，定量资料符合正态分布用双样本t检验，不符合正态分布用非参数检验。组内比较，定量资料符合正态分布用配对t检验，不符合正态分布用非参数检验。假设检验统一使用双侧检验，给出检验统计量及其对应的P值，以P＜0.05作为有显著性统计学意义。

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

Before the trial was conducted, the subject group developed the workbook for this study through several protocol seminar meetings. The researcher should strictly follow the requirements of the workbook, strictly control the baseline information of the enrolled subjects, and keep the age, gender, height, and weight of the subjects in both groups consistent. In the process of filling out the scales, the subjects should be allowed to fill out the scales in a quiet environment and should be checked at the end of filling out the scales, and the subjects should be reminded to fill out the unfinished data of the scales. Afterwards, all scale scores were analyzed using SPSS 25.0 statistical software. Qualitative indicators were expressed as component ratios or percentages, quantitative indicators were expressed as "Mean ± Standard Deviation" (Mean ± SD), and the results of nonparametric tests were presented in the form of "Median (Quartiles)" (Median (P25, P75)). For between-group comparisons, the chi-square test or Fisher's exact probability method was used for qualitative data, and the two-sample t-test was used for quantitative data that conformed to normal distribution, and the nonparametric test was used for data that did not conform to normal distribution. For within-group comparisons, paired t-tests were used for quantitative data conforming to normal distribution, and nonparametric tests were used for those not conforming to normal distribution. Hypothesis testing was uniformly performed using two-sided tests, giving the test statistic and its corresponding P-value, with P < 0.05 as statistically significant.

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：

  2025-04-03 15:00:14