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电针抑制膝骨关节炎患者急性痛慢性化的随机对照临床试验
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注册号:

Registration number:

ChiCTR-ICR-14005411 

最近更新日期:

Date of Last Refreshed on:

2016-11-06 

注册时间:

Date of Registration:

2014-10-31 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

电针抑制膝骨关节炎患者急性痛慢性化的随机对照临床试验 

Public title:

A randomized controlled clinical trial of electroacupuncture inhibiting chronification of the acute pain of knee osteoarthritis 

注册题目简写:

电针治疗骨性关节炎 

English Acronym:

electroacupuncture for knee osteoarthritis 

研究课题的正式科学名称:

电针通过内源性大麻素系统抑制急性痛慢性化的神经生物学机制 

Scientific title:

Neurobiological mechanisms of electroacupuncture inhibiting chronification of acute pain by endocannabinoid system 

研究课题代号(代码):

Study subject ID:

No.81473768 

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:

吕正涛 

研究负责人:

李熳 

Applicant:

Lv Zhengtao 

Study leader:

Li Man 

申请注册联系人电话:

Applicant telephone:

+86 13147104691 

研究负责人电话:

Study leader's telephone:

+86 27 83692630 

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:

630105736@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

liman73@mails.tjmu.edu.cn 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://www.hust.edu.cn 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

http://202.114.128.25/jcyxy/to.Asp?PPNewsID=272 

申请注册联系人通讯地址:

湖北省武汉市硚口区解放大道1095号 

研究负责人通讯地址:

武汉市航空路13号同济医学院神经生物学系 

Applicant address:

1095 Jiefang Avenue, Qiaokou District, Wuhan, Hubei, China 

Study leader's address:

Department of neurobiology, Tongji Medical College, 13 Hangkong Road, Wuhan 

申请注册联系人邮政编码:

Applicant postcode:

430030 

研究负责人邮政编码:

Study leader's postcode:

430030 

申请人所在单位:

华中科技大学同济医学院附属同济医院骨科 

Applicant's institution:

Department of Orthopedics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology 

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:

ChiECRCT-20140035 

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:

中国注册临床试验伦理审查委员会 

Name of the ethic committee:

Chinese Ethics Committee of Registering Clinical Trials 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-09-30 

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:

华中科技大学同济医学院基础医学院 

Primary sponsor:

School of basic medicine, Tongji medical college, Huazhong university of science and technology 

研究实施负责(组长)单位地址:

武汉市航空路13号同济医学院神经生物学系 

Primary sponsor's address:

Department of neurobiology, Tongji medical college, 13 Hangkong Road, Wuhan 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

国家自然科学基金委员会

具体地址:

北京市海淀区双清路83号

Institution
hospital:

National Natural Science Foundation of China

Address:

83 Shuangqing Road, Haidian District, Beijing

经费或物资来源:

国家自然科学基金面上项目 

Source(s) of funding:

General Grant from the National Natural Science Foundation of China 

研究疾病:

膝骨性关节炎 knee osteoarthritis 

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:

其它 

Study phase:

N/A 

研究目的:

长期以来电针治疗急性痛效果显著,但并未解决急性痛慢性化后疼痛反复发作的临床难题。弥漫性伤害抑制性控制系统(DNIC)是指作用在身体某个区域的伤害性刺激可在任何其它区域观察到镇痛效应,是目前公认的预测慢性痛发病风险的指标,急性痛慢性化的过程可能与DNIC功能的逐渐受损有关。本研究采用临床试验,研究电针能否抑制DNIC功能的减退,从而遏制膝骨关节炎急性痛慢性化,为电针治疗膝骨关节炎急性痛慢性化的临床应用提供新的思路和治疗策略。 

Objectives of Study:

Electroacupuncture (EA) has significant effect on acute pain for a long time, but it hasn't solved the clinical problem of long-term recurrent of pain after chronification of acute pain. Diffuse injury inhibitory controls (DNIC) refers to when noxious stimuli apply on a particular region of the body, the analgesic effect can be observed in any other region. It is now recognized as a reliable indicator to predict chronic pain events risk. Process of chronification of acute pain may relate to gradually impaired DNIC function. Using clinical research, we will study whether EA can inhibit the decline of DNIC function, thus supress chronification of acute pain of knee osteoarthritis. Our study will provide a new theoretical basis and therapeutic strategies for clinical applications of EA treating chronification of acute pain of 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:

根据美国风湿病学会2001年制定膝骨关节炎诊断标准:膝关节疼痛患者有下列7项中的3项:①年龄≥50岁。②晨僵<30min。③关节活动时有骨响声。④膝部检查示骨性肥大。⑤有骨压痛。⑥无明显滑膜升温。⑦放射学检查有骨赘形成。 

Inclusion criteria

The American College of Rheumatism (ACR) formulated the clinical criteria of OA at 2001. Clinical OA of the knee is defined as knee pain and at least three out of seven of the following criteria: to be aged older than 50 years, morning stiffness less than 30 min, crepitus, bony enlargement, bony tenderness, no palpable warmth, and line with radiological osteophyte. 

排除标准:

① 针刺有不良反应或不愿接受针灸治疗。 ② 符合纳入标准,未按规定治疗,无法判断疗效或资料不全等影响疗效或安全性判断者。 ③ 伴有心、脑、肝、肾及造血系统严重疾病者。 ④ 有类风湿性关节炎,痛风性关节炎等关节炎性疾病,及其它影响下肢功能的疾病的患者。 ⑤ 哺乳、妊娠或正准备妊娠的妇女。 ⑥ 精神病患者。 

Exclusion criteria:

1. Patients has adverse reactions to acupuncture or unwilling to accept acupuncture treatment; 2. Patients conform to the inclusion criteria, but didn't follow prescribed treatment, whose curative effect were unable to be judged, or patients with incomplete information which may interfere with efficacy or safety of judge; 3. Patients with accompanying severe cardiovascular, cerebral, hepatic, renal, hemopoietic diseases; 4. Patients with inflammatory arthritis such as rheumatoid arthritis, gouty arthritis, etc., or other diseases that may affect the condition of the knees; 5. Pregnant patients or women need fertilization, women in lactation period; 6. Patients with mental diseases. 

研究实施时间:

Study execute time:

From2014-09-01To 2016-03-31 

征募观察对象时间:

Recruiting time:

From2014-09-01To 2016-03-31 

干预措施:

Interventions:

组别:

强电针组

样本量:

142

Group:

strong electroacupuncture (EA) group

Sample size:

干预措施:

电针患者内膝眼、犊鼻、梁丘、血海穴,电流强度采用强电流(刺激参数:直流电,连续波,频率为2Hz,波宽0.5ms,电流强度为患者能耐受的最大强度,2mA<电流<5mA)。内膝眼与犊鼻接一对电极,血海与梁丘接一对电极。每日电针1次,5次为1个疗程,共治疗2个疗程。

干预措施代码:

Intervention:

The patients receive EA on the ipsilateral "Neixiyan" (EX-LE5), "Dubi" (ST35)," "Liangqiu" (ST34) and "Xuehai" (SP10) with high-intensity current (Stimulation index : direct current, continuous wave, frequency of 2Hz, pulse width 0.5 ms. Maximum tolerable intensity of current was delivered, 2mA less than current less t

Intervention code:

组别:

弱电针组

样本量:

75

Group:

weak EA group

Sample size:

干预措施:

刺激穴位同强电针组,电流强度采用弱电流(刺激参数:直流电,连续波,频率为2Hz,波宽0.5ms,电流强度为刚刚感受到电流刺激即可,0mA<电流<0.5mA)。内膝眼与犊鼻接一对电极,血海与梁丘接一对电极。每日电针1次,5次为1个疗程,共治疗2个疗程。

干预措施代码:

Intervention:

Intervention: Acupoints of weak EA were as same as strong EA group, and patients receives low-intensity current (Stimulation index: direct current, continuous wave, frequency of 2Hz, pulse width 0.5 ms. Patients were instructed to directly say "stop" when the sensation of current occur, 0mA, less than current l

Intervention code:

组别:

假电针组

样本量:

72

Group:

Sham EA group

Sample size:

干预措施:

假电针组针刺内膝眼、犊鼻、梁丘、血海穴分别向内外侧旁开1cm的非经非穴点,采用细针浅刺,弱电流(刺激参数:直流电,连续波,频率为2Hz,波宽0.5ms,电流强度为刚刚感受到电流刺激即可,0mA<电流<0.5mA)。每日电针1次,5次为1个疗程,共治疗2个疗程

干预措施代码:

Intervention:

Intervention: For sham control, fine needles were inserted superficially into the sites 1cm lateral to above four points with low-intensity current (Stimulation index: direct current, continuous wave, frequency of 2Hz, pulse width 0.5 ms. Patients were instructed to directly say "stop" when the sensation of c

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

华中科技大学同济医学院基础医学院 

单位级别:

教育部部属重点高校 

Institution
hospital:

School of basic medicine Tongji medical college, Huazhong university of science and technology  

Level of the institution:

Ministry of major colleges and universities 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

华中科技大学同济医学院附属协和医院 

单位级别:

教育部部属重点高校 

Institution
hospital:

Union hospital, Tongji medical college, Huazhong university of science and technology  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

华中科技大学附属中西医结合医院 

单位级别:

三级甲等医院 

Institution
hospital:

Combined traditional Chinese and western medicine hospital affiliated to Huazhong university of science and technology  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉市中心医院 

单位级别:

三级甲等医院 

Institution
hospital:

Central hospital of Wuhan  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉市第三医院 

单位级别:

三级甲等医院 

Institution
hospital:

The Third Hospital of Wuhan  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

武汉市第五医院 

单位级别:

三级甲等医院 

Institution
hospital:

The fifth Hospital of Wuhan  

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 (VAS)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

弥漫性伤害抑制性控制功能

指标类型:

主要指标 

Outcome:

Diffuse noxious inhibitory controls (DNIC) function

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

情绪评分

指标类型:

次要指标 

Outcome:

Emotional scale (ES)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

现有疼痛强度

指标类型:

次要指标 

Outcome:

Present Pain Intensity (PPI)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

骨关节炎指数

指标类型:

次要指标 

Outcome:

Western Ontario and McMaster Universities Osteoarthritis (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:

疼痛数字评价量表

指标类型:

次要指标 

Outcome:

Numerical pain rating scale (NPRS)

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:

膝关节滑液

组织:

Sample Name:

The knee joint synovial fluid

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 50 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):

符合纳入标准的患者通过电脑产生的随机序列以2:1:1的比例分配到强电针组、假电针组和弱电针组,软件是通过SAS 9.1.3实现。随机化是一个不参与试验其他环节的助手来完成的。

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

Patients who met our inclusion criteria were randomly assigned to one of three groups (strong EA, weak EA or sham EA) in a ratio of 2:1:1 using a computer-generated random allocation sequence through the stratified block randomization method of SAS version 9.1.3 (SAS Institute Inc., Cary, NC, USA). Randomiz

盲法:

患者被告知他们将要接受强电针、弱电针以及假电针三者之一的治疗,但是不知道具体是哪一种。

Blinding:

Enrolled patients participants were only informed that they would receive one of the three acupuncture therapies; consequently, they were not aware of their treatment allocation.

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

发表SCI论文

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

publication in SCI journals

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:

所有数据统计是通过R软件3.2.4版本实现。

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

All analysis was realized using R (version 3.2.4; The R Foundation, Vienna, Austria) and its mice package, with differences were considered significant if the two-tailed P-value was less than 0.05.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2014-10-31
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