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A randomized controlled study of tuina therapy for patellofemoral arthritis

注册号：

Registration number：

ITMCTR2025000098

最近更新日期：

Date of Last Refreshed on：

2025-01-14

注册时间：

Date of Registration：

2025-01-14

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

推拿治疗髌股关节炎的随机对照研究

Public title：

A randomized controlled study of tuina therapy for patellofemoral arthritis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

推拿治疗髌股关节炎的随机对照研究

Scientific title：

A randomized controlled study of tuina therapy for patellofemoral arthritis

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：

陈军涛

研究负责人：

陈军涛

Applicant：

CHEN juntao

Study leader：

CHEN juntao

申请注册联系人电话：

Applicant telephone：

17839966492

研究负责人电话：

Study leader's telephone：

17839966492

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：

3164985899@qq.com

研究负责人电子邮件：

Study leader's E-mail：

3164985899@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：

河南省郑州市金水区东明路63号

研究负责人通讯地址：

河南省郑州市金水区东明路63号

Applicant address：

63 Dongming Road Jinshui District Zhengzhou City Henan Province

Study leader's address：

63 Dongming Road Jinshui District Zhengzhou City Henan Province

申请注册联系人邮政编码：

Applicant postcode：

450000

研究负责人邮政编码：

Study leader's postcode：

450000

申请人所在单位：

河南中医药大学第三附属医院

Applicant's institution：

The Third Affiliated Hospital of Henan 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：

2023SH-096

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：

河南中医药大学第三附属医院伦理委员会

Name of the ethic committee：

Ethics Committee of Henan University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2024/9/18 0:00:00

伦理委员会联系人：

张晓东

Contact Name of the ethic committee：

ZHANG Xiaodong

伦理委员会联系地址：

河南省郑州市金水区东明路63号

Contact Address of the ethic committee：

63 Dongming Road Jinshui District Zhengzhou City Henan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

15036065036

伦理委员会联系人邮箱：

Contact email of the ethic committee：

15036065036@163.com

研究实施负责（组长）单位：

河南中医药大学第三附属医院

Primary sponsor：

The Third Affiliated Hospital of Henan University of Chinese Medicine

研究实施负责（组长）单位地址：

河南省郑州市金水区东明路63号

Primary sponsor's address：

63 Dongming Road Jinshui District Zhengzhou City Henan 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)：

河南

市(区县)：

郑州

Country：

china

Province：

henan

City：

zhengzhou

单位(医院)：

河南中医药大学第三附属医院

具体地址：

河南省郑州市金水区东明路63号

Institution
hospital：

The Third Affiliated Hospital of Henan University of Chinese Medicine

Address：

63 Dongming Road Jinshui District Zhengzhou City Henan Province

经费或物资来源：

河南省高层次人才特殊支持计划中原千人计划—中原名医(No.ZYQR201912120)

Source(s) of funding：

Henan Special Support Program for High-level Talents Central Plains Thousand Talents Program - Central Plains Famous Doctor (No.ZYQR201912120)

研究疾病：

髌股关节炎

研究疾病代码：

Target disease：

Patellofemoral arthritis

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：

目的：评价推拿治疗髌股关节炎的临床疗效。方法：将符合入选标准的患者进入随机化过程，研究人员根据随机系统产生的分组信息，将患者分配到治疗组及对照组，使用便携式肌力测试仪测量PFOA患者坐位膝关节屈伸时下肢屈肌群、伸肌群及股直肌和股外侧肌在膝关节屈伸时的最大肌力，使用便携式测痛仪测量患者膝前区的压痛点痛阈。同时统计患者的改良版30s坐站试验、WOMAC评分、总有效率、患者满意率、不良事件发生率。观察时间为患者治疗前、治疗一周、治疗后、随访15天及随访30天。预期结果：推拿治疗髌股关节炎有较好的临床疗效，能有效改善患者的疼痛。且症状的好转与膝关节附近的软组织肌力改善存在密切联系。

Objectives of Study：

Objective: To evaluate the clinical efficacy of massage in the treatment of patellofemoral arthritis. Methods: will meet the inclusion criteria into the randomization process the researchers according to the randomization system generated group information patients assigned to the treatment group and the control group using the portable muscle strength tester to measure the lower limb flexors and extensors and maximal knee flexion and extension of the lateral muscle strength in the patient. At the same time the modified 30s sit-up test WOMAC score total response rate patient satisfaction rate and incidence of adverse reactions were counted. The observation time was before treatment one week after treatment 15 days and 30 days. Expected results: Massage treatment of patellofemoral arthritis has a good clinical effect can effectively improve the pain of patients. And the improvement of symptoms is closely related to the improvement of soft tissue muscle strength near the knee joint.

药物成份或治疗方案详述：

将患者分配到治疗组及对照组，两组均给与健康宣教干预。在健康宣教的基础上，治疗组给与推拿治疗，对照组不加用任何治疗。健康宣教内容如下：1)向患者宣教KOA的发病机制使患者正确认识KOA，消除患者的思想顾虑；2)要调整日常的生活方式，尽量避免长时间的走路，爬山，上下高层楼梯，长时间的站立、蹲位、跪位等；3)对于体重超重的患者，告知其尽量调整饮食结构，适当减轻体重；4)平时尽量避免穿高跟鞋，可适当采取佩戴护膝、保护关节的弹性套，穿柔软的平底鞋，拄手杖等对膝关节有保护作用的措施；5)根据患者向自身的情况可选择适当的运 动方式进行关节肌肉的锻炼，例如适量的步行、游泳、骑自行车、太极拳、八段锦及在非负重状态下做关节的屈伸活动等以改善关节的活动度。 治疗组推拿操作如下： 1) 松解足太阳膀胱经经筋（解痉）：患者首先取仰卧位，屈膝，患者用双手环抱小腿，左手、右手四指横向拨动足太阳膀胱经经筋，操作2分钟； 2) 强化足太阴脾经经筋、足阳明胃经经筋：患者取仰卧位，施术者沿股直肌、胫前肌部点按，同时嘱患者关节背伸并与术者手掌对抗，操作4分钟； 3) 对患者患膝的股四头肌使用点法、弹拨法、滚法进行松解。操作5分钟；

Description for medicine or protocol of treatment in detail：

Patients were assigned to treatment group and control group and both groups were given health education intervention. On the basis of health education the treatment group was given massage treatment and the control group was not given any treatment. The contents of health education are as follows: 1) Educate patients about the pathogenesis of KOA so that patients can correctly understand KOA and eliminate their ideological concerns; 2) To adjust the daily lifestyle try to avoid long walking climbing up and down high stairs long standing squatting kneeling etc.; 3) For overweight patients inform them to adjust their diet as much as possible and appropriately reduce their weight; 4) Usually try to avoid wearing high heels can be appropriate to wear knee pads elastic sleeves to protect the joint wear soft flat shoes cane and other measures to protect the knee; 5) According to the patient's own conditions appropriate movement methods can be selected for joint muscle exercise such as an appropriate amount of walking swimming cycling Taijiquan Badanjin and joint flexion and extension activities in non-weight-bearing state to improve joint motion. 1) Educate patients about the pathogenesis of KOA so that patients can correctly understand KOA and eliminate their ideological concerns; 2) To adjust the daily lifestyle try to avoid long walking climbing up and down high stairs long standing squatting kneeling etc.; 3) For overweight patients inform them to adjust their diet as much as possible and appropriately reduce their weight; 4) Usually try to avoid wearing high heels can be appropriate to wear knee pads elastic sleeves to protect the joint wear soft flat shoes cane and other measures to protect the knee; 5) According to the patient's own conditions appropriate movement methods can be selected for joint muscle exercise such as an appropriate amount of walking swimming cycling Taijiquan Badanjin and joint flexion and extension activities in non-weight-bearing state to improve joint motion. Massage operations in the treatment group were as follows: 1) Release the foot Sun bladder meridian tendon (antispasmodic) : The patient first takes the supine position knees down the patient with both hands around the calf left hand right hand four fingers to move the foot sun bladder meridian tendon operation for 2 minutes; 2) Strengthen foot Taiyin spleen meridian tendon and foot Yangming stomach meridian tendon: the patient is supine the operator points along the femoris rectus muscle and the anterior tibial muscle and asks the patient to stretch the back of the joint and oppose the operator's hand for 4 minutes; 3) The quadriceps muscle of the patient's knee was released by point method plucking method and rolling method. Operate for 5 minutes;

纳入标准：

诊断标准： 1)近一个月内反复膝关节疼痛，以膝前疼痛为主； 2) 年龄：≥50岁； 3) 晨僵时间≤30 min； 4) 活动时有骨摩擦音（感）； 5) X线片（站立或负重位）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； 6) MRI示软骨损伤、骨赘形成、软骨下骨骨髓水肿和（或）囊性变、半月板退行性撕裂、软骨部分或全层缺失。 满足诊断标准1+2+3+4或1+5或1+6可诊断为膝骨关节炎。在满足以上诊断标准的同时具有以下任意一个临床症状或体征的患者即可诊断为PFOA。 1)膝前区疼痛，以髌骨边缘疼痛为主； 2)膝关节屈曲运动时髌股关节发出捻发音或磨擦感 3)髌骨研磨试验阳性； 4)下蹲试验阳性； 5)股四头肌抗阻试验阳性。 纳入标准 符合以上诊断标准的同时符合以下要求的患者方可纳入本研究 1) 已知晓试验要求及注意事项，并签署知情同意书； 2) K-L分级：Ⅰ、Ⅱ级者； 3) 近一月未接受膝骨关节炎及髌股关节炎药物及其它治疗； 4) 年龄在50到75之间（含50岁及75岁)。

Inclusion criteria

Diagnostic criteria: 1) Recurrent knee pain in the past month mainly in front of the knee; 2) Age: ≥50 years old; 3) Morning stiffness time ≤30 min; 4) There is bone friction sound (feeling) during activity; 5) Radiographs (standing or weight-bearing position) show narrowing of joint space subchondral sclerosis and/or cystic degeneration and osteophyte formation at the joint margin; 6) MRI showed cartilage injury osteophyte formation subchondral bone marrow edema and/or cystic change degenerative tears of meniscus partial or full cartilage loss. Meeting the diagnostic criteria 1+2+3+4 or 1+5 or 1+6 can be diagnosed as knee osteoarthritis. Patients who meet the above diagnostic criteria and have any of the following clinical signs or symptoms can be diagnosed with PFOA. 1) Anterior knee pain mainly patellar edge pain; 2) The patellofemoral joint produces a crepitating or grinding sensation during knee flexion 3) Patella grinding test positive; 4) Squat test positive; 5) Quadriceps resistance test is positive. Inclusion criteria Patients who meet the above diagnostic criteria and meet the following requirements can be included in this study 1) Have known the test requirements and precautions and signed the informed consent; 2) K-L classification: Ⅰ Ⅱ; 3) Did not receive knee osteoarthritis and patellofemoral arthritis drugs and other treatment in the past month 4) Aged between 50 and 75 (including 50 and 75 years old).

排除标准：

凡符合下列任意一条的患者，应予以排除： 1) 并发有其它严重膝关节疾病如膝关节结核、肿瘤、风湿和类风湿性关节炎、髌骨脱位、膝关节滑膜炎、严重的心血管疾病、肝肾功能损伤、免疫缺陷、糖尿病、痛风、血液病、皮肤病等不仅仅局限于单纯PFOA的患者； 2) 近端时间因下肢关节扭挫伤、足部畸形或疼痛、膝关节局部创伤或其它因素影响正常步行的病变者； 3) 有精神障碍及智能障碍不能配合问卷调查者； 4) 近一个月使用贴敷或理疗等其他治疗手段干预的PFOA及KOA患者； 5) 接受过全膝关节置换术及髌股关节置换术的患者； 6) 孕妇、哺乳期或近半年内有妊娠计划的妇女； 7) 髌股关节炎K/L分级为0级及3、4级或影像学检查发现有关节畸形、关节软骨破坏严重者； 8) 正在参与其它临床试验者。

Exclusion criteria：

Patients who meet any of the following criteria should be excluded: 1) Other serious knee joint diseases such as knee joint tuberculosis tumor rheumatism and rheumatoid arthritis patellar dislocation synovitis of knee joint serious cardiovascular disease liver and kidney function injury immune deficiency diabetes gout blood disease skin disease etc. are not limited to patients with PFOA alone; 2) Patients with proximal lesions that affect normal walking due to contusion of lower limb joint foot deformity or pain local trauma of knee joint or other factors; 3) Have mental disorders and mental disorders can not cooperate with the questionnaire investigators; 4) Patients with PFOA and KOA who have been treated with other therapeutic means such as patch or physiotherapy in the past month; 5) Patients who have undergone total knee replacement and patellofemoral joint replacement; 6) Women who are pregnant breastfeeding or have a pregnancy plan within the last six months; 7) patellofemoral arthritis K/L grade 0 3 4 or imaging findings of joint malformation articular cartilage destruction serious; 8) Those who are participating in other clinical trials.

研究实施时间：

Study execute time：

从From 2024-10-23

至To      2025-09-17

征募观察对象时间：

Recruiting time：

从From 2024-10-23

至To      2025-06-01

干预措施：

Interventions：

组别：

对照组

样本量：

54

Group：

Control group

Sample size：

干预措施：

健康宣教

干预措施代码：

Intervention：

Health education

Intervention code：

组别：

治疗组

样本量：

54

Group：

treatment group

Sample size：

干预措施：

推拿结合健康宣教

干预措施代码：

Intervention：

Tuina combined with health education

Intervention code：

样本总量 Total sample size ： 108

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

河南

市(区县)：

--请选择--

Country：

China

Province：

Henan

City：

----

单位(医院)：

河南中医药大学第三附属医院

单位级别：

省级三级甲等医院，大学附属医院。

Institution/hospital：

The Third Affiliated Hospital of Henan University of Chinese Medicine

Level of the institution：

Provincial level Three class A hospital university affiliated hospital.

测量指标：

Outcomes：

指标中文名：

患者满意率

指标类型：

附加指标

Outcome：

Patient satisfaction rate

Type：

Additional indicator

测量时间点：

分别在治疗1周后、治疗后、随访15天、随访30天进行记录。

测量方法：

患者将按5分制对治疗结果的满意率进行评分（1=非常不满意；2=不满意；3=中立；4=满意；5=非常满意），“非常满意”的频率决定了最后的满意率

Measure time point of outcome：

Records were recorded after 1 week of treatment, after treatment, 15 days of follow-up and 30 days of follow-up.

Measure method：

Patients will be rated on a 5-point scale for their satisfaction with the treatment outcome (1= very dissatisfied; 2= not satisfied; 3= neutral; 4= satisfied; 5= very satisfied), the frequency of "very satisfied" determines the final satisfaction rate

指标中文名：

总有效率

指标类型：

次要指标

Outcome：

Total effective rate

Type：

Secondary indicator

测量时间点：

分别在治疗后、随访15天随访30天进行记录。

测量方法：

参考《中药新药临床研究指导原则》软组织损伤疗效评定有关内容拟定

Measure time point of outcome：

Records were recorded after treatment, 15 days follow-up and 30 days follow-up.

Measure method：

Reference "Guiding Principles for Clinical Research of New Chinese Medicine" soft tissue injury efficacy evaluation related content

指标中文名：

不良事件发生率

指标类型：

附加指标

Outcome：

Adverse event rate

Type：

Additional indicator

测量时间点：

治疗结束当天。

测量方法：

数据统计人员通过询问推拿操作人员及患者获得相关结果

Measure time point of outcome：

The day the treatment ends.

Measure method：

Data statisticians obtained relevant results by asking massage operators and patients

指标中文名：

西部安大略麦马斯特大学骨关节炎指标（WOMAC)评分

指标类型：

次要指标

Outcome：

McMaster University of Western Ontario Osteoarthritis Indicator (WOMAC) score

Type：

Secondary indicator

测量时间点：

治疗前、治疗6天、治疗后、随访15天及随访30天

测量方法：

分别在测量时询问患者该评分表上的相关内容，并记录。

Measure time point of outcome：

Before treatment 6 days after treatment 15 days and 30 days after treatment

Measure method：

At the time of measurement, the patients were asked about the relevant contents of the score scale and recorded.

指标中文名：

坐位膝关节下肢屈肌群、伸肌群及股直肌、股外侧肌在屈伸时的最大肌力

指标类型：

主要指标

Outcome：

The maximum strength of flexor and extensor muscles rectus femoris and lateral femoris muscles during flexion and extension of knee joint in sitting position

Type：

Primary indicator

测量时间点：

治疗前、治疗6天、治疗后、随访15天及随访30天

测量方法：

MicroFET3便携式数字化肌力测量仪

Measure time point of outcome：

Before treatment 6 days after treatment 15 days and 30 days after treatment

Measure method：

MicroFET3 portable digital muscle strength measuring instrument

指标中文名：

髌骨边缘压痛点的痛阈值

指标类型：

主要指标

Outcome：

The pain threshold of the tenderness point of the patella margin

Type：

Primary indicator

测量时间点：

治疗前、治疗6天、治疗后、随访15天及随访30天

测量方法：

便携式痛觉测试仪

Measure time point of outcome：

Before treatment 6 days after treatment 15 days and 30 days after treatment

Measure method：

Portable pain tester

指标中文名：

改良版30s坐站实验

指标类型：

次要指标

Outcome：

Modified version of 30s sitting and standing experiment

Type：

Secondary indicator

测量时间点：

治疗前、治疗6天、治疗后、随访15天及随访30天

测量方法：

嘱患者在30S内双腿均匀用力并下蹲，观察人员计时并记录患者30S内下蹲次数。

Measure time point of outcome：

Before treatment 6 days after treatment 15 days and 30 days after treatment

Measure method：

The patient was asked to exert even force with both legs and squat within 30S, and the observers timed and recorded the number of squat times of the patient within 30S.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

no

Tissue：

人体标本去向

其它

说明

Fate of sample 

Others

Note：

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 50 岁
Min age years
最大 75 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）：

使用计算机随机方法，采用SPSS26.0软件，治疗、数据收集及处理人员之外的研究人员用计算机产生随机数字，每组病例数54例，比例为1:1。随机编码，编码表按病例入选的顺序排列，随机分配方案的隐藏用完全的分配方案隐藏方法，即按顺序编码、密封、不透光的信封，将符合入选标准的患者进入随机化过程，根据随机系统产生的分组信息，将患者分配到观察组（推拿结合健康宣教）或对照组（健康宣教）。

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

Using the computer randomization method researchers outside the treatment data collection and processing staff used the software SPSS26.0 to generate random numbers with 54 cases in each group at a 1:1 ratio. Random coding the coding table is arranged according to the order of case selection and the hiding of random assignment scheme is carried out by a complete allocation scheme hiding method that is sequentially-coded sealed and opaque envelopes. Patients who meet the inclusion criteria are randomized into the process and patients are assigned to the observation group (massage combined with health education) or the control group (health education) according to the grouping information generated by the random system.

盲法：

本研究遵循盲法精神，对推拿治疗人员、健康宣教操作者、数据收集人员及数据处理人员设盲。即推拿治疗人员和健康宣教人员不参与分组和数据收集及处理。数据收集人员不参与患者分组且不参与数据处理，数据处理人员仅将收集到的数据进行处理，并不参与数据收集。

Blinding：

In accordance with the spirit of the blind method the massage therapy personnel health education operators data collection personnel and data processing personnel were blind. That is massage therapy personnel and health education personnel do not participate in grouping and data collection and processing. Data collectors do not participate in patient grouping and data processing. Data processors only process the collected data and do not participate in data collection.

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）：

从数据管理及处理人员处获得，联系人为姚灿，邮箱：2413267245@qq.com。

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

Obtained from data management and processing personnel, Contact Yao Can, email: 2413267245@qq.com.

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

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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