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Hydro-Acupuncture Synergizes with Yi Shen Tiao Sui Formula for Liver-Kidney Deficiency in Knee Osteoarthritis

注册号：

Registration number：

ITMCTR2025000509

最近更新日期：

Date of Last Refreshed on：

2025-03-11

注册时间：

Date of Registration：

2025-03-11

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

水针刀联合益肾调髓方治疗肝肾亏虚型膝骨关节炎疗效观察

Public title：

Hydro-Acupuncture Synergizes with Yi Shen Tiao Sui Formula for Liver-Kidney Deficiency in Knee Osteoarthritis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

水针刀联合益肾调髓方治疗肝肾亏虚型膝骨关节炎疗效观察

Scientific title：

Hydro-Acupuncture Synergizes with Yi Shen Tiao Sui Formula for Liver-Kidney Deficiency in Knee Osteoarthritis

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：

郭克淳

研究负责人：

王萧枫

Applicant：

Kechun GUO

Study leader：

Xiaofeng Wang

申请注册联系人电话：

Applicant telephone：

+86 138 5773 4085

研究负责人电话：

Study leader's telephone：

+86 189 8979 9903

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：

9167649172@qq.com

研究负责人电子邮件：

Study leader's E-mail：

1139165152@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：

中国浙江省温州市鹿城区锦绣路75号‌‌

研究负责人通讯地址：

中国浙江省温州市鹿城区锦绣路75号‌‌

Applicant address：

No.75 Jinxiu Road Lucheng District Wenzhou City Zhejiang Province China

Study leader's address：

No.75 Jinxiu Road Lucheng District Wenzhou City Zhejiang 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：

浙江中医药大学附属温州中西医结合医院

Applicant's institution：

Wenzhou Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Zhejiang Chinese Medical University

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：

伦研批第(2024-L120)号

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：

温州市中西医结合医院医学伦理委员会

Name of the ethic committee：

Wenzhou Integrated Traditional Chinese and Western Medicine Hospital Medical Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2024/11/12 0:00:00

伦理委员会联系人：

王萧枫

Contact Name of the ethic committee：

Xiaofeng Wang

伦理委员会联系地址：

中国浙江省温州市鹿城区温州市中西医结合医院锦绣路75号

Contact Address of the ethic committee：

No. 75 Jinxiu Road Lucheng District Wenzhou City Wenzhou Integrated Traditional Chinese and Western Medicine Hospital Zhejiang Province China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 577 8891 8725

伦理委员会联系人邮箱：

Contact email of the ethic committee：

1139165152@qq.com

研究实施负责（组长）单位：

温州市中西医结合医院

Primary sponsor：

Wenzhou Integrated Traditional Chinese and Western Medicine Hospital

研究实施负责（组长）单位地址：

中国浙江省温州市鹿城区温州市中西医结合医院锦绣路75号

Primary sponsor's address：

No. 75 Jinxiu Road Lucheng District Wenzhou City Wenzhou Integrated Traditional Chinese and Western Medicine Hospital Zhejiang Province 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)：

浙江

市(区县)：

Country：

China

Province：

Zhejiang Province

City：

单位(医院)：

温州市中西医结合医院

具体地址：

中国浙江省温州市鹿城区温州市中西医结合医院锦绣路75号

Institution
hospital：

Wenzhou Integrated Traditional Chinese and Western Medicine Hospital

Address：

No. 75 Jinxiu Road Lucheng District Wenzhou City Wenzhou Integrated Traditional Chinese and Western Medicine Hospital Zhejiang Province China

经费或物资来源：

国家中医药管理局科技司-浙江省中医药管理局共建重点项目（项目号：GZY-ZJ-KJ-23093）；浙江省自然基金项目（项目号：Y23H270001）

Source(s) of funding：

-(National Administration ncial Administration of Traditional Chinese Medicine GZY-ZJ-KJ-23093);(Zhejiang Provincial Natural Science Fund project Y23H270001)

研究疾病：

膝骨关节炎

研究疾病代码：

Target disease：

osteoarthritis of the knee

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：

其它

Others

研究目的：

骨关节炎是一种骨伤科常见的退行性疾病，据统计全球约有 2.5 亿人患有不同程度的 OA，中国作为人口大国，目前已有约 1.2 亿 关节炎患者。 而 关节炎又以膝关节受累最为多见，同时随着我国人口老龄化现象的日益加剧，膝骨关节炎将波及越来越多的人群，这无疑将进一步加重我国社会及医疗经济负担。其涉及病理生理过程复杂，其中炎症细胞因子（诸如白介素IL-1β、白介素IL-6、肿瘤坏死因子TNF-α等）和蛋白水解分子(基质金属蛋白酶MMP、蛋白聚糖酶Aggrecanase-1)是被认为是导致KOA的主要物质。中医学认为，KOA是一种筋骨共病、痿痹共存的疾病，属“痹证”“骨痹”“筋痹”“骨痿”“筋痿”等范畴，发病机制总属肝肾不足，加之风寒湿邪气外侵，证属本虚标实、本痿标痹。尽管现今对于KOA的研究不断深入，但是针对导致残疾症状和关节结构改变的长期有效的治疗策略却仍旧缺乏，也因此现阶段针对KOA的治疗目标仍是以减少疼痛，改善关节活动度，减少功能损害为重点，治疗策略强调症状控制，仍无法达到长期的病理改变治疗。作为中医骨伤科的优势病种之一，中医药治疗方法在 KOA 的临床治疗中发挥了重要作用。本研究拟通过观察水针刀联合益肾调髓方中药治疗肝肾亏虚型膝骨关节炎患者的临床疗效，为膝骨关节炎临床诊治提供新的治疗方案参考。

Objectives of Study：

Osteoarthritis is a common degenerative disease in orthopedics and traumatology. According to the statistics there are about 250 million people in the world suffering from different degrees of OA and China as a large country with a large population has about 120 million arthritis patients at present. Arthritis is most common in the knee joint and with the aging of China's population osteoarthritis of the knee will affect more and more people which will undoubtedly further aggravate China's social and medical economic burden. It involves complex pathophysiological processes among which inflammatory cytokines (such as interleukin IL-1β interleukin IL-6 tumor necrosis factor TNF-α etc.) and protein hydrolysis molecules (matrix metalloproteinase MMP proteoglycanase Aggrecanase-1) are the main substances believed to cause KOA. According to Chinese medicine KOA is a co-morbidity of tendon and bone impotence and paralysis and belongs to the category of "paralysis" "bone paralysis" "tendon paralysis" "bone impotence " "tendon impotence" and other categories the pathogenesis always belongs to the deficiency of the liver and kidney coupled with the wind cold and dampness evil invasion the evidence of this deficiency this impotence this paralysis. Although the research on KOA has been deepening there is still a lack of long-term effective treatment strategies for the symptoms and structural changes of the joints that lead to disability and therefore the goal of treatment for KOA at this stage still focuses on the reduction of pain the improvement of joint mobility and the reduction of functional impairment and the treatment strategy emphasizes symptom control which is not able to reach the long-term treatment of pathological changes. As one of the dominant diseases in Chinese orthopedics and traumatology TCM therapeutic methods play an important role in the clinical treatment of KOA. In this study we intend to observe the clinical efficacy of hydroentanglement combined with Yi Kidney Medullary Regulation Formula of traditional Chinese medicine in the treatment of knee osteoarthritis patients with deficiency of liver and kidney so as to provide a new therapeutic program reference for the clinical diagnosis and treatment of knee osteoarthritis.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

治疗前3个月未接受任何治疗，并同意在治疗期间不接受其他治疗方诊断标准 参照膝骨关节炎中医诊疗指南(2020年版)西医诊断：①近 1个月内反复膝关节疼痛；②年龄≥50岁；③晨僵≤30 min；④活动时有骨摩擦音(感) ；⑤X线片( 站立位或负重位) 示关节间隙变窄、软骨下骨硬化和(或) 囊性变、关节缘骨赘形成。符合①和②③④⑤中任意2条即可诊断。X线分级：参照 Kellgren-Lawrence影像分级方法：① 0 级无改变(正常) ；②Ⅰ级 可疑骨赘，关节间隙正常；③Ⅱ级 明确骨赘，关节间隙可疑变窄；④Ⅲ级 中等量骨赘，关节间隙明确变窄，有硬化性改变；⑤Ⅳ级 大量骨赘，关节间隙明显变窄，有严重硬化。中医诊断：KOA中医辩证分型肝肾亏虚型：（主症关节隐隐作痛。次症腰膝酸软无力, 酸困疼痛, 遇劳更甚。舌象与脉象舌质红, 少苔; 脉沉细无力。） 纳入标准 所有纳入患者均符合以下三点：①符合上述KOA西医诊断和中医诊断；②X线分级为Ⅱ-Ⅲ级，③同意加入本实验，并签署相应式者。

Inclusion criteria

The diagnostic criteria Refer to the Chinese Medicine Treatment Guidelines for Osteoarthritis of the Knee (2020 edition) for western medical diagnosis: ① recurrent knee pain in the past month; ② age ≥50 years; ③ morning stiffness ≤30 min; ④ bone friction sound (sensation) during activity; ⑤ X-ray (standing or weight-bearing position) shows narrowing of joint space subchondral bone sclerosis and/or cystic degeneration and formation of bone capillaries at the joint margins. X-ray (standing or weight-bearing position) shows narrowing of the joint space subchondral bone sclerosis and/or cystic degeneration and formation of bone capillaries at the joint margin. The diagnosis can be made if any two of ① and ② ③ ④ ⑤ are met. X-ray grading: refer to the Kellgren-Lawrence grading method: ① grade 0 no change (normal); ② grade Ⅰ suspected bony encumbrance normal joint space; ③ grade Ⅱ definite bony encumbrance suspected narrowing of the joint space; ④ grade Ⅲ moderate amount of bony encumbrance definite narrowing of the joint space sclerosis; ⑤ grade Ⅳ large amount of bony encumbrance definite narrowing of the joint space severe sclerosis. ⑤ Grade IV Large amount of bony redundancy clear narrowing of joint space serious sclerosis. Diagnosis in TCM: KOA: Liver and kidney deficiency type (primary symptom: vague pain in the joints. secondary symptom: lumbar and knee pain and weakness). Secondary symptoms: lumbar and knee weakness soreness and pain worse with exertion. Tongue and pulse: red tongue with little moss; pulse is thin and weak). Inclusion Criteria All included patients met the following three points: ① met the above KOA western medical diagnosis and Chinese medical diagnosis; ② X-ray grading of grade II-III and ③ those who agreed to enroll in this experiment and signed the corresponding formula.

排除标准：

①属于肝肾亏虚型KOA但存在并发病影响到关节者；②合并心血管、脑血管、肝、肾、造血系统、内分泌系统等严重原发性疾病及精神病患者；③病情危重，难以对治疗方式的有效性和安全性作出确切评价者；④既往晕针、晕血者；⑤已接受其他相关治疗，可能影响本研究的效应指标观测者；⑤过去6个月内受累关节的创伤、手术或任何侵入性手术史、下肢对线不良患者；⑥明确水针刀治疗禁忌症或既往有水针刀治疗史的患者；⑦过敏体质及对多种药物存在过敏者。

Exclusion criteria：

① Those who belong to the liver and kidney deficiency type of KOA but with the presence of co-morbidities affecting the joints; ② Patients with combined cardiovascular cerebrovascular hepatic renal hematopoietic endocrine system and other serious primary diseases and psychiatric disorders; ③ Those whose condition is critical making it difficult to make a definitive evaluation of the effectiveness and safety of the treatment modality; ④ Those who have had previous needle-sickness or blood-sickness; ⑤ Those who have already received other related treatments that may affect the observation of the effect indexes of the present study; ⑤ Patients with trauma surgery or any history of invasive surgery of the affected joints within the past 6 months or poor alignment of the lower limbs; ⑥ Patients with clear contraindications to hydroentanglement therapy or previous history of hydroentanglement therapy; ⑦ Allergy and the presence of allergies to a variety of drugs.

研究实施时间：

Study execute time：

从From 2024-12-01

至To      2025-03-01

征募观察对象时间：

Recruiting time：

从From 2024-12-01

至To      2025-03-01

干预措施：

Interventions：

组别：

观察组

样本量：

36

Group：

Observation Group

Sample size：

干预措施：

对照组水针刀治疗基础上益肾调髓方内服 每日一帖，于每一次水针刀治疗结束后开始服用，每周7贴，4周为1疗程。

干预措施代码：

Intervention：

In the control group, the internal administration of Kidney Regulating Medulla Formula on the basis of hydro-acupuncture knife treatment was carried out One post per day, started at the end of each hydro-acupuncture knife treatment, 7 posts per week, 4 weeks for 1 course of treatment.

Intervention code：

组别：

对照组

样本量：

36

Group：

Control Group

Sample size：

干预措施：

水针刀治疗 水针刀治疗1周行1次，连续治疗4次，4周为1疗程。

干预措施代码：

Intervention：

Hydro-acupuncture treatment Hydro-acupuncture treatment is performed once a week, 4 consecutive treatments, 4 weeks as a course of treatment.

Intervention code：

样本总量 Total sample size ： 72

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

浙江

市(区县)：

Country：

China

Province：

Zhejiang Province

City：

单位(医院)：

浙江省温州市中西医结合医院

单位级别：

三甲

Institution/hospital：

Wenzhou Integrated Traditional Chinese and Western Medicine Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

西安大略大学和麦克马斯特大学关节炎指数

指标类型：

次要指标

Outcome：

Western Ontario and McMaster Universities Arthritis Index,(WOMAC)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

预后比较

指标类型：

主要指标

Outcome：

Prognostic comparison

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

疼痛视觉模拟评分

指标类型：

次要指标

Outcome：

Visual analog score (VAS score)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

炎症因子指标（血清中肿瘤坏死因子-α、白细胞介素-1β、白细胞介素-6水平）

指标类型：

次要指标

Outcome：

Indicators of inflammatory factors:(tumor necrosis factor α,TNF-α)(interleukin 1,IL-1β)-6(interleukin 1,IL-6)

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：

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：

结束

Completed

年龄范围：

最小 50 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）：

随机数字表法

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

random number table method

盲法：

开放标签，对评估者隐藏分组

Blinding：

Open-label study with blinded-evaluators

是否共享原始数据：

IPD sharing：

是

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）：

ResMan临床试验公共管理平台“http://www.medresman.org.cn/uc/index.aspx”

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

ResMan Clinical Trial Public Management Platform：“http://www.medresman.org.cn/uc/index.aspx”

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：

本研究采用纸质病例记录表 (CRF) 和 RedCap 电子数据采集系统。数据首先记录在 CRF 上，随后录入安全的 RedCap 系统。RedCap 因其安全性、易用性和数据验证功能而被选用。数据由两名研究者独立录入并核对，RedCap 系统也会进行数据质量检查。所有数据安全存储于 RedCap，仅授权人员可访问。数据将定期备份，研究结束后按伦理要求存档。

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

This study will utilize paper-based Case Record Forms (CRFs) and the RedCap electronic data capture system. Data will be initially recorded on CRFs and subsequently entered into the secure RedCap system. RedCap was chosen for its security, user-friendliness, and data validation capabilities. Data will be entered independently by two researchers and cross-checked. RedCap will also implement data quality checks. All data will be securely stored in RedCap, accessible only to authorized personnel. Data will be regularly backed up and archived according to ethical guidelines upon study completion.

数据管理委员会：

Data Managemen Committee：

暂未确定

Not yet

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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