ChiCTR2300076651 版本V1.1 版本创建时间2024/04/01 17:06:20 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：

 ChiCTR2300076651 

最近更新日期：

Date of Last Refreshed on：

 2023-10-13 16:50:41 

注册时间：

Date of Registration：

 2023-10-13 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

B超弹性呈象评估电针对退行性膝关节病患者股四头肌近、远期收缩效率的影响

Public title：

Effect of Electroacupuncture on short and long-term contraction efficiency of quadriceps femoris in knee osteoarthritis Evaluated by SWE

注册题目简写：

English Acronym：

研究课题的正式科学名称：

B超弹性呈象评估电针对退行性膝关节病患者股四头肌近、远期收缩效率的影响

Scientific title：

Effect of Electroacupuncture on short and long-term contraction efficiency of quadriceps femoris in knee osteoarthritis Evaluated by SWE

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：

周歆 

研究负责人：

周歆 

Applicant：

Zhou xin 

Study leader：

Zhou xin 

申请注册联系人电话：

Applicant telephone：

 +86 135 3325 9616

研究负责人电话：

Study leader's
telephone：

+86 135 3325 9616

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：

 zhouxin23@mail.sysu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

 zhouxin23@mail.sysu.edu.cn

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：

广州市越秀区百子横路3号百子大厦1410房

研究负责人通讯地址：

广州市越秀区百子横路3号百子大厦1410房

Applicant address：

Room 1410, Baizi building, No. 3, baiziheng Road, Yuexiu District, Guangzhou

Study leader's address：

Room 1410, Baizi building, No. 3, baiziheng Road, Yuexiu District, Guangzhou

申请注册联系人邮政编码：

Applicant postcode：

 510080

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

中山大学附属第一医院

Applicant's institution：

the first affiliated hospital, Sun yat-sen University

研究负责人所在单位：

中山大学附属第一医院

Affiliation of the Leader：

the first affiliated hospital, Sun yat-sen University

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 [2023]005

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：

中山大学附属第一医院临床科研和实验动物伦理委员会

Name of the ethic committee：

IEC for Clinical Research and Animal Trials of the First Affiliated Hospital of Sun Yat-sen University

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-02-28 00:00:00

伦理委员会联系人：

颜楚荣

Contact Name of the ethic committee：

Churong Yan

伦理委员会联系地址：

广州市中山二路58号，中山大学附属第一医院临床科研和实验动物伦理委员会

Contact Address of the ethic committee：

Clinical Research and Experimental Animal Ethics Committee of the First Affiliated Hospital of Sun Yat-sen University, No. 58, Zhongshan Second Road, Guangzhou

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 20 8733 4871

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

中山大学附属第一医院

Primary sponsor：

the first affiliated hospital, Sun yat-sen University

研究实施负责（组长）单位地址：

广州市越秀区中山二路58号

Primary sponsor's address：

No. 58, Zhongshan 2nd Road, Yuexiu District, Guangzhou

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东省

市(区县)：

广州市

Country：

China

Province：

GuangDong

City：

GuangZhou

单位(医院)：

中山大学附属第一医院

具体地址：

广州市越秀区中山二路58号

Institution
hospital：

the first affiliated hospital, Sun yat-sen University

Address：

No. 58, Zhongshan 2nd Road, Yuexiu District, Guangzhou

经费或物资来源：

广东省中医药管理局

Source(s) of funding：

Guangdong Administration of traditional Chinese Medicine

研究疾病：

膝骨性关节炎  

Target disease：

Knee osteoarthritis

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究在原有工作基础上，观察电针对退行性膝关节病中股四头肌质量减少及收缩效率的下降的近、远期疗效，促进该病膝关节功能恢复，改善躯体、社会生活功能及心理状态，说明电针是OA患者优选的治疗策略，值得应用于临床以帮助患者早日康复及提高生活质量。  

Objectives of Study：

Based on the original work, this study observed the short-term and long-term effects of Electroacupuncture on the decrease of quadriceps femoris mass and contraction efficiency in degenerative knee disease, promoted the recovery of knee function, and improved physical, social life function and psychological state, indicating that electroacupuncture is the preferred treatment strategy for patients with OA, It is worthy of clinical application to help patients recover as soon as possible and improve the quality of life

药物成份或治疗方案详述：

（1）对照组 采用股四头肌等长收缩锻炼,每周三次,每次30分钟,总共进行4周。具体方法如下：患者采取仰卧位，下肢后侧紧贴床面，尽力收缩股四头肌，伸展膝关节，背伸踝关节，保持5秒钟后放松，连续进行30分钟。 （2）治疗组 治疗组采用下肢穴位电针，穴位选取：风市、中渎、扶兔、鹤顶、百虫窝、血海，其中风市、中渎为一组，扶兔、鹤顶为一组，百虫窝、血海为一组，总共三组电针。针灸针采用一次性穗鑫牌针灸针（苏州华伦医疗，0.35*40mm））电针机采用KWD-808I脉冲针灸治疗仪，电流强度10ma，使用疏密波，每周3次，每次30分钟并结合股四头肌等长收缩锻炼。总共进行4周。 

Description for medicine or protocol of treatment in detail：

(1) Control group Quadriceps femoris isometric contraction exercise was used for 30 minutes three times a week for a total of 4 weeks. The specific methods are as follows: the patient is in the supine position, the back of the lower limbs is close to the bed surface, try to contract the quadriceps femoris, extend the knee and back ankle, and relax after 5 seconds for 30 minutes. (2) Treatment group The treatment group was treated with lower limb acupoint electroacupuncture. The acupoints were selected as Fengshi, Zhongdu, futu, heding, Baichong nest and Xuehai, of which Fengshi and Zhongdu were one group, futu and heding were one group, Baichong nest and Xuehai were one group, with a total of three groups of electroacupuncture. The acupuncture needle adopts disposable Suixin brand acupuncture needle (Suzhou Hualun medical, 0.35 * 40MM)) and the electroacupuncture machine adopts kwd-808i pulse acupuncture therapeutic instrument with current intensity of 10mA. The density wave is used for 30 minutes three times a week, combined with isometric contraction exercise of quadriceps femoris. A total of 4 weeks. 

纳入标准：

（1）符合退行性关节病诊断标准：A、西医诊断标准 ①年龄≥50 岁；②晨僵＜30 min；③膝部检查提示骨性肥大；④关节活动时有骨响声；⑤有骨压痛；⑥放射学检查有骨赘形成；⑦无明显滑膜升温。有以上7项中的 3 项的患者则被诊断为膝骨关节炎。B、中医诊断标准（按国家中医药管理局发布的《中医病症诊断疗效标准》和卫生部发布的《中药新药临床研究指导原则》）；①初起多见膝关节隐隐作痛，活动中关节不能很顺利的完成屈伸动作，转侧动作的完成也欠佳，休息或者轻微活动后疼痛可稍微减轻，遇气温下降则反复发病，经久难愈；②膝关节局部肿胀是不难被发现的，在活动时可以听到关节间的骨擦音或者有明显的骨擦感，在严重的时候可以见到比较明显的关节畸形；③起病发病皆缓慢，中老年人比较常见；④骨质疏松存在，X 线片可显示关节间隙变窄，还有软骨下骨的骨质增生，并可看到骨赘形成；⑤检测血沉、抗“O”未见异常，也未检测出异常的类风湿因子及粘蛋白。 （2）自愿加入本随机对照试验研究并签署知情同意书的患者。

Inclusion criteria

(1) It meets the diagnostic criteria of degenerative arthropathy: A. Diagnostic criteria for Western medicine ① Age ≥ 50 years old; ② Morning stiffness < 30 min; ③ Knee examination indicates bone hypertrophy; ④ There is bone noise during joint movement; ⑤ Bone tenderness; ⑥ Radiological examination showed osteophyte formation; ⑦ No obvious synovial temperature rise. Patients with 3 of the above 7 items were diagnosed as knee osteoarthritis. B. Diagnostic criteria of traditional Chinese medicine (according to the Criteria for the Diagnosis and Curative Effect of Traditional Chinese Medicine issued by the State Administration of Traditional Chinese Medicine and the Guiding Principles for Clinical Research of New Chinese Medicines issued by the Ministry of Health); ① At the beginning, it is common to see faint pain in the knee joint. During the activity, the joint can not smoothly complete the flexion and extension movement, and the completion of the lateral movement is also poor. The pain can be slightly relieved after rest or slight activity, and it will recur when the temperature drops, which is difficult to recover for a long time; ② Local swelling of the knee joint is not difficult to be found. During movement, you can hear bone frictions between joints or have obvious bone friction feeling. In severe cases, you can see obvious joint deformities; ③ The onset of disease is slow, and the middle-aged and elderly are more common; ④ Osteoporosis exists. The X-ray film can show the narrowing of joint space, the hyperplasia of subchondral bone, and the formation of osteophytes; ⑤ There was no abnormality in ESR and anti-O, and no abnormal rheumatoid factor and mucin were detected. (2) Patients who voluntarily participated in this randomized controlled trial and signed informed consent.

排除标准：

（1）合并中枢及外周神经损伤受累膝关节患者。
（2）BMI指数≥28
（3）线粒体肌病、周期性瘫痪等原发性肌肉病
（4）严重的肾或甲状旁腺功能紊乱
（5）精神异常不能配合治疗或检查者
（6）怀孕

Exclusion criteria：

(1) Knee patients with central and peripheral nerve injury.
(2) BMI index ≥ 28
(3) Mitochondrial myopathy, periodic paralysis and other primary muscle diseases
(4) Severe renal or parathyroid dysfunction
(5) Those with mental disorders who cannot cooperate with treatment or examination
(6) Pregnant

研究实施时间：

Study execute time：

从 From 2022-03-01 00:00:00至 To 2023-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-02-28 00:00:00 至 To 2023-09-30 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 16

Group：

Experimental group

Sample size：

干预措施：

电针及锻炼处方

干预措施代码：

Intervention：

Electroacupuncture and exercise prescription

Intervention code：

组别：

对照组

样本量：

 16

Group：

Control group

Sample size：

干预措施：

锻炼处方

干预措施代码：

Intervention：

Exercise prescription

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

 广州市 

Country：

China

Province：

GuangDong

City：

GuangZhou

单位(医院)：

 中山大学附属第一医院 

单位级别：

 省部级 

Institution
hospital：

the first affiliated hospital, Sun yat-sen University

Level of the institution：

Provincial and ministerial level

测量指标：

Outcomes：

指标中文名：

关节活动度

指标类型：

次要指标

Outcome：

Range of motion（ROM）

Type：

Secondary indicator

测量时间点：

干预前、4周，12周，24周

测量方法：

关节量角器测量

Measure time point of outcome：

Before intervention, 4 weeks, 12 weeks, 24 weeks

Measure method：

Joint protractor measurement

指标中文名：

WOMAC评分

指标类型：

主要指标

Outcome：

WOMAC score

Type：

Primary indicator

测量时间点：

干预前、4周，12周，24周

测量方法：

量表填写

Measure time point of outcome：

Before intervention, 4 weeks, 12 weeks, 24 weeks

Measure method：

Fill in the scale

指标中文名：

不同角度屈膝股四头肌刚度

指标类型：

主要指标

Outcome：

Quadriceps femoris contraction efficiency

Type：

Primary indicator

测量时间点：

干预前、4周，12周，24周

测量方法：

弹性B超呈象（SWE）

Measure time point of outcome：

Before intervention, 4 weeks, 12 weeks, 24 weeks

Measure method：

SWE

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 50 岁 years
最大 Max age 80 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）：

招募患者按来诊先后生成序列号，再利用spss随机数生成器将序列号患者随机分配到治疗组及对照组

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

Recruit patients to generate serial numbers according to the order of arrival, and then use spss random number generator to randomly assign patients with serial numbers to treatment group and control group

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

对咨询锻炼方法的患者的医生设盲：由于两组均需要提供锻炼方案，首诊医生在得知患者的分组后，可将两组患者直接分配给提供锻炼方法的医生。然后再单独电话联系治疗组患者告知需要参与针灸治疗。

Blinding：

Blind doctors of patients who consult with exercise methods: since both groups need to provide exercise programs, the first doctor can directly assign the two groups of patients to the doctors who provide exercise methods after knowing the grouping of patients. Then, the patients in the treatment group were contacted individually by telephone to inform them that they needed to participate in acupuncture and moxibustion treatment.

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）：

Resman

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

Resman

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：

数据采集和管理采用病例记录表（CRF）和ResMan完成

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

Data collection and management are completed using CRF and ResMan

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-10-13 16:50:31