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低强度脉冲超声治疗膝骨关节炎安全性和有效性的前瞻、随机对照临床试验
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注册号:

Registration number:

ChiCTR-IPR-14005748 

最近更新日期:

Date of Last Refreshed on:

2016-08-07 

注册时间:

Date of Registration:

2014-12-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

低强度脉冲超声治疗膝骨关节炎安全性和有效性的前瞻、随机对照临床试验 

Public title:

Efficacy and safety of low intensity pulsed ultrasound for knee osteoarthritis: a prospective, randomized controlled trial protocol 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

低强度脉冲超声治疗膝骨关节炎安全性和有效性的前瞻、随机对照临床试验 

Scientific title:

Efficacy and safety of low intensity pulsed ultrasound for knee osteoarthritis: a prospective, randomized controlled trial protocol 

研究课题代号(代码):

Study subject ID:

2013BAI03B06 

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:

贾朗 

研究负责人:

陈文直 

Applicant:

Jia Lang 

Study leader:

Chen Wen-zhi 

申请注册联系人电话:

Applicant telephone:

+86 13677690535 

研究负责人电话:

Study leader's telephone:

+86 13608335926 

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:

93348047@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

chenwz@cqmu.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:

重庆市渝中区临江路76号 

研究负责人通讯地址:

重庆市渝中区临江路76号 

Applicant address:

No.76, Linjiang Road, Yuzhong District, Chongqing 

Study leader's address:

No.76, Linjiang Road, Yuzhong District, Chongqing 

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:

重庆医科大学附属第二医院 

Applicant's institution:

The Second Affiliated Hospital of Chongqing Medical 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:

2014年审(2014005)号 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

重庆医科大学理论委员会 

Name of the ethic committee:

The Ethics Committee of Chongqing Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-04-03 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

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:

重庆医科大学附属第二医院 

Primary sponsor:

The Second Affiliated Hospital of Chongqing Medical University 

研究实施负责(组长)单位地址:

重庆市渝中区临江路76号 

Primary sponsor's address:

No.76, Linjiang Road, Yuzhong District, Chongqing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

重庆

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆医科大学附属第二医院

具体地址:

重庆市渝中区临江路76号

Institution
hospital:

The Second Affiliated Hospital of Chongqing Medical University

Address:

No.76, Linjiang Road, Yuzhong District, Chongqing

经费或物资来源:

国家科技支撑计划课题——“物理治疗新技术及基层适宜产品开发(2013BAI03B06)” 

Source(s) of funding:

The national science and technology support program 

研究疾病:

骨性关节炎 

Target disease:

osteoarthritis 

研究疾病代码:

ICD-10:M17 

Target disease code:

ICD-10:M17 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

本课题旨在评估低强度脉冲超声在膝关节骨关节炎疾病治疗中的安全性及有效性。 

Objectives of Study:

The aim of the study was to observe whether low intensity pulsed ultrasound could effectively relieve pain and improve the function of knee in patients with knee osteoarthritis. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

① 符合1995年美国风湿病协会制定的膝骨性关节炎诊断标准;② 患者年龄40-80岁,性别不限;③ 符合放射学病情分级标准(KelIgren&Lawrence法)I-III级;④ 6个月内未使用过皮质激素类药物;⑤ 2周内未使用非甾体抗炎药、玻璃酸钠、全身慢作用药(SYSADOA)或采用相关治疗方案者;⑥ 签署知情同意书;⑦ 自愿作为受试对象能接受试验方法治疗,志愿完成疗程者。 

Inclusion criteria

1. According to American College of Rheumatology (ACR) criteria for symptomatic knee OA assessed by a rheumatologist; 2. Men and women aged between 40 and 80; 3. KelIgren-Lawrence grade rating of I, II and III; 4. Not receiving corticosteroids for more than six months; 5. Not receiving NSAIDs, intraarticular hyaluronan, SYSADOA and other treatment for more than two weeks; 6. Signed informed consent; 7. Able to attend 1 intervention sessions(10 days). 

排除标准:

① 风湿和类风湿关节炎、感染性关节炎、痛风性关节炎等其他关节疾患;② 合并严重神经、精神疾病不能配合医生治疗的患者;③ 膝关节局部皮肤破溃、皮肤感染、严重手术或外伤性瘢痕、关节局部恶性肿瘤及关节置换术患者;④ 伴有活动性消化道溃疡及出血、严重肾、肝功能不全或凝血功能障碍出血倾向、严重器质性心脏病,如心肌梗塞、心力衰竭、严重心律失常、心脏起搏器植入的患者及未经治疗或药物不能控制的高血压患者;⑤ 排除其他原因引起的关节疼痛及功能障碍的患者;⑥ 合并全身胶原结缔组织疾病患者,如系统性红斑狼疮等;⑦无法理解问卷调查的患者。 

Exclusion criteria:

1. Rheumatoid and rheumatic arthritis, infectional arthritis, gouty arthritis diseases; 2. Patients with severe mental and neurologic diseases; 3. Patients with knee skin ulceration and infections, serious operation or traumatic scar, joint local malignant tumor and joint replacement; 4. Patients with gastrointestinal ulcer and bleeding, severe liver and kidney dysfunction, cardiovascular disease, artificial heart pacemaker and uncontrolled hypertension; 5. Knee pain and disfunction caused by other diseases; 6. Patients with connective tissue disease (e.g.SLE); 7. unable to fulfil the forms. 

研究实施时间:

Study execute time:

From2015-02-01To 2016-02-01 

干预措施:

Interventions:

组别:

治疗组

样本量:

50

Group:

treatment group

Sample size:

干预措施:

低强度脉冲超声+双氯芬酸钠

干预措施代码:

Intervention:

LIPUS+diclofenac

Intervention code:

组别:

对照组

样本量:

50

Group:

control group

Sample size:

干预措施:

假超声+双氯芬酸钠

干预措施代码:

Intervention:

sham LIPUS+diclofenac

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆医科大学附属第二医院 

单位级别:

三甲医院 

Institution
hospital:

The Second Affiliated Hospital of Chongqing Medical University  

Level of the institution:

Tertiary A 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 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

西安大略和麦克马斯特大学骨关节炎调查量表

指标类型:

主要指标 

Outcome:

WOMAC-VA3.1

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

膝骨关节炎病情严重指数评价

指标类型:

次要指标 

Outcome:

Lequesne index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SF-36健康调查简表

指标类型:

次要指标 

Outcome:

SF-36

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:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 40 years
最大 Max age 80 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):

随机数字表

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

random number table

盲法:

单盲

Blinding:

Single-Blind

试验完成后的统计结果(上传文件):

点击下载

Calculated Results after
the Study Completed(upload file):

download

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

重庆医科大学附属第二医院

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

The Second Affiliated Hospital of Chongqing Medical University

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:

重庆医科大学附属第二医院

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

The Second Affiliated Hospital of Chongqing Medical University

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2014-12-26
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