基于“经筋”理论肌骨超声可视下射频热凝治疗早中期膝骨关节炎的临床研究

注册号:

Registration number:

AMCTR-IPR-20000325 

注册号获得时间:

Date of releasing the registration number:

2020/1/20 15:59:45 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

基于“经筋”理论肌骨超声可视下射频热凝治疗早中期膝骨关节炎的临床研究 

Public title:

Clinical study of Radiofrequency Thermocoagulation in the treatment of Knee Osteoarthritis in the early and middle period by applying ultrasound visualization of musculoskeletal based on the muscle meridian theory 

研究课题的正式科学名称:

基于“经筋”理论肌骨超声可视下射频热凝治疗早中期膝骨关节炎的临床研究 

Scientific title:

Clinical study of Radiofrequency Thermocoagulation in the treatment of Knee Osteoarthritis in the early and middle period by applying ultrasound visualization of musculoskeletal based on the muscle meridian theory 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

何波 

研究负责人:

王平 

Applicant:

He Bo 

Study leader:

Wang Ping 

申请注册联系人电话:

Applicant telephone:

15196369716 

研究负责人电话:

Study leader's telephone:

13602179933 

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:

369345053@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

shenzheng201@163.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:

德阳市旌阳区天山南路159号 

研究负责人通讯地址:

天津市西青区昌凌路88号 

Applicant address:

159, Tianshan South Road, Jingyang District, Deyang 

Study leader's address:

No.88,changling,xiqingDistrict,Tianjing300391,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:

德阳市中西医结合医院 

Applicant's institution:

Deyang integrative medicine hospital 

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:

德阳市中西医医院伦审(2020-009) 

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:

德阳市中西医结合医院医学伦理委员会 

Name of the ethic committee:

The Ethics committee of Deyang integrative medicine hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-01-10 

研究实施负责(组长)单位:

德阳市中西医结合医院 

Primary sponsor:

Deyang integrative medicine hospital 

研究实施负责(组长)单位地址:

德阳市旌阳区天山南路159号 

Primary sponsor's address:

159, Tianshan South Road, Jingyang District, Deyang 

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

市(区县):

Country:

China

Province:

Sichuan

City:

单位(医院):

德阳市中西医结合医院

具体地址:

德阳市旌阳区天山南路159号

Institution
hospital:

Deyang integrative medicine hospital

Address:

159 Tianshan South Road, Jingyang District, Deyang

经费或物资来源:

自筹以及德阳市中西医结合医院科研基金资助 

Source(s) of funding:

Self-raised and Deyang integrative medicine hospital scientific research funds 

研究疾病:

膝骨关节炎 

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 

研究所处阶段:

I期临床试验 

Study phase:

Phase I 

研究目的:

目的一:评估基于“经筋”理论肌骨超声可视下射频热凝改善早中期膝骨关节炎患者疼痛,关节活动度及生活质量的有效性和安全性;目的二:对比肌骨超声可视下射频热凝和传统电针在改善早中期膝骨关节患者疼痛,关节活动度,生活质量及膝周软组织弹力的疗效差异。 

Objectives of Study:

Objective 1: To evaluate the effectiveness and safety of radiofrequency thermocoagulation in the treatment of pain, joint mobility, and quality of life in patients with knee osteoarthritis in the early and middle stages by applying ultrasound visualization of musculoskeletal based on the muscle meridian theory.Objective two: To compare the therapeutic effect of radiofrequency thermocoagulation and traditional electroacupuncture on pain, joint activity, quality of life and soft tissue elasticity of knee joint in early and middle stage. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

(1) 符合西医诊断标准且病情分期为早期和中期、K-L 影像诊断分级在 0~Ⅲ级的早、中期患者; (2)符合中医诊断标准; (3)年龄 40~75岁的患者; (4)自愿接受本次研究并签署知情同意书的患者。 

Inclusion criteria

⑴ Meet the diagnostic standard of Western Medicine and accord with patients with early and intermediate stage of disease and early and middle stage patients with K-L image diagnosis grade of 0-III ; ⑵ Meet the diagnostic standard oftraditional Chinese medical; ⑶ Patients aged 40-75; ⑷ Patients who voluntarily accepted the study and signed the informed consent. 

排除标准:

(1)小于 40 岁或者大于 75 岁的膝骨关节炎患者; (2)关节腔内有大量积液,浮髌试验或膨胀征阳性; (3)膝关节及周围软组织红肿; (4)膝关节周围皮肤有破损或皮肤疾病; (5)膝关节其他炎性疼痛性疾病,如创伤性膝骨关节炎、感染性关节炎、痛风性关节炎、风湿及类风湿性关节炎等。 (6)膝骨关节炎以外的膝关节疼痛性疾病,关节内肿瘤,关节创伤(骨折、半月板损伤、韧带损伤及骨软骨挫伤等),色素绒毛结节性滑膜炎等。 (7)合并有严重的心、脑、肝、肾等内脏病变者或其他严重代谢异常疾病及骨肿瘤患者; (8)精神病患者、智力障碍者; (9)试验前3周接受过免疫抑制剂、肾上腺皮质激素局部或全身治疗者; (10)怀疑或确有酒精、药物滥用病史,或者根据研究者的判断,容易造成失访情况者; (11)正在参加其他临床试验的患者; (12)既往有盐酸利多卡因过敏、不良反应史。 

Exclusion criteria:

⑴ Patients under 40 years old or over 75 years old with knee osteoarthritis; ⑵ There is a large amount of effusion in the articular cavity and floating patella test or expansion sign was positive; (3) Swelling of knee joint and surrounding soft tissue; (4) The skin around the knee joint is damaged or has skin diseases; (5) Other inflammatory and painful diseases of the knee joint, such as traumatic knee osteoarthritis, infectious arthritis, gouty arthritis, rheumatism and rheumatoid arthritis; (6) Painful diseases of the knee joint other than osteoarthritis of the knee, such as intra-articular tumor, joint trauma (fracture, meniscus injury, ligament injury, bone cartilage contusion, etc.), pigmented villonodular synovitis, etc; (7) Patients with severe heart, brain, liver, kidney and other visceral diseases or other serious metabolic disorders and bone tumors; (8) Mentally ill and mentally retarded; (9) Patients who received immunosuppressant, corticosteroid or systemic therapy 3 weeks before the trial; (10)Patients who are suspected or have a history of alcohol or drug abuse, or those who are likely to lose the interview according to the judgment of the researcher; (11) Patients in other clinical trials; (12) Previous allergic and adverse reactions of lidocaine hydrochloride. 

研究实施时间:

Study execute time:

From2020-01-20To 2021-02-28 

干预措施:

Interventions:

组别:

治疗组

样本量:

53

Group:

treatment group

Sample size:

干预措施:

射频热凝联合康复锻炼

干预措施代码:

Intervention:

Radiofrequency Thermocoagulation combined physical training

Intervention code:

组别:

对照组

样本量:

53

Group:

control group

Sample size:

干预措施:

电针联合康复训练

干预措施代码:

Intervention:

Electroacupuncture combined physical training

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

德阳市中西医结合医院 

单位级别:

三乙医院 

Institution
hospital:

Deyang integrative medicine hospital  

Level of the institution:

Tertiary b hospital 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

青白江鑫朋康复医院 

单位级别:

一级医院 

Institution
hospital:

Qingbaijiang Xinpeng rehabilitation hospital  

Level of the institution:

community level hospital 

测量指标:

Outcomes:

指标中文名:

视觉模拟评分法

指标类型:

主要指标 

Outcome:

Visual Analogue Scale

Type:

Primary indicator 

指标中文名:

关节活动度

指标类型:

主要指标 

Outcome:

Range of joint motion

Type:

Primary indicator 

指标中文名:

痛阈测定(PPT)和耐痛阈测定(PTT)

指标类型:

次要指标 

Outcome:

痛阈测定(PPT)和耐痛阈测定(PTT)

Type:

Secondary indicator 

指标中文名:

患者满意度

指标类型:

次要指标 

Outcome:

Patient satisfaction evaluation

Type:

Secondary indicator 

指标中文名:

WOMA骨关节炎指数评分

指标类型:

次要指标 

Outcome:

WOMAC Index of OA

Type:

Secondary indicator 

指标中文名:

步态分析

指标类型:

次要指标 

Outcome:

Gait analysis

Type:

Secondary indicator 

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:

标本中文名:

关节液

组织:

Sample Name:

joint liqu

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:

Recruiting status:

尚未开始

Pending

年龄范围:

Participant age:

最小 Min age 40 years
最大 Max age 75 years

随机方法(请说明由何人用什么方法产生随机序列):

由统计专业人员采用随机数字表法进行分组

性别:

男女均可

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

Statistical professionnals were grouped using a table of random numbers

Gender:

Both

盲法:

采用盲法评价,由不知分组情况的第三者进行疗效评价,资料总结阶段采集用盲法统计分析、实行研究者、操作者、统计者三分离。

Blinding:

Blind method for evaluators and statisticians

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

通过发表期刊文章公布原始数据

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

by publication

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

CRF表采集数据,数据电子存档管理

The repository and management of the data(Please specify what repository will be used for management of the metadata):

Collect date by CRF and manage date via computer

创建人:

Creater Name:

 2020-01-19
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