Today is 2022-01-28

Efficacy of combining intra-articular prolotherapy with transcranial direct current stimulation for pain with knee osteoarthritis
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注册号:

Registration number:

ChiCTR2200055650 

最近更新日期:

Date of Last Refreshed on:

2022-01-15 

注册时间:

Date of Registration:

2022-01-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

增生疗法联合经颅直流电治疗膝骨性关节炎疼痛的临床疗效观察 

Public title:

Efficacy of combining intra-articular prolotherapy with transcranial direct current stimulation for pain with knee osteoarthritis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

增生疗法联合经颅直流电治疗膝骨性关节炎疼痛的临床疗效观察 

Scientific title:

Efficacy of combining intra-articular prolotherapy with transcranial direct current stimulation for pain with knee osteoarthritis 

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:

李娟 

研究负责人:

李铁山 

Applicant:

lijuan 

Study leader:

litieshan 

申请注册联系人电话:

Applicant telephone:

15621418182 

研究负责人电话:

Study leader's telephone:

13964282582 

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:

lijuan980308@163.com 

研究负责人电子邮件:

Study leader's E-mail:

tieshanl@126.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:

山东省青岛市青岛大学附属医院 

研究负责人通讯地址:

青岛大学附属医院 

Applicant address:

The Affiliated Hospital of Qingdao University,Shandong Province 

Study leader's address:

The Affiliated Hospital of Qingdao University 

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:

青岛大学附属医院 

Applicant's institution:

The Affiliated Hospital of Qingdao 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:

QYFY WZLL 26765 

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:

青岛大学附属医院医学伦理委员 

Name of the ethic committee:

Medical Ethics Committee of the affiliated Hospital of Qingdao University 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

朱婕 

Contact Name of the ethic committee:

zhujie 

伦理委员会联系地址:

山东省青岛市青岛大学附属医院市南院区江苏路16号 

Contact Address of the ethic committee:

16 Jiangsu Road, Shinanyuan District, Affiliated Hospital of Qingdao University, Qingdao, Shandong  

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:

青岛大学附属医院 

Primary sponsor:

The Affiliated Hospital of Qingdao University 

研究实施负责(组长)单位地址:

山东省青岛市青岛大学附属医院市南院区江苏路16号 

Primary sponsor's address:

16 Jiangsu Road, Shinanyuan District, Affiliated Hospital of Qingdao University, Qingdao, Shandong  

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

山东省

市(区县):

Country:

China

Province:

Shandong Province

City:

青岛

单位(医院):

青岛大学附属医院

具体地址:

青岛大学附属医院

Institution
hospital:

The Affiliated Hospital of Qingdao University

Address:

The Affiliated Hospital of Qingdao University

经费或物资来源:

研究生经费 

Source(s) of funding:

Postgraduate funds 

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:

研究目的:

在前期的研究中我们已经证实了增生疗法对于KOA疼痛的缓解作用,本课题的研究目的是观察关节内增生疗法+经颅直流电刺激联合治疗对于缓解KOA疼痛是否优于单纯增生疗法,并探讨其可能的作用机制。 

Objectives of Study:

In previous studies, we have confirmed the effect of prolotherapy on pain relief in KOA. The purpose of this study is to observe whether the combination of intra-articular hypertonic dextrose and transcranial direct current stimulation is superior to simple prolotherapy in relieving KOA pain, and to explore its possible mechanism. 

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根据美国风湿病学会的制定的临床和放射学标准,符合下列中的A+B或A+C+E+F;A+D+E+F,可诊断为KOA(A:近1个月内反复膝关节疼痛;B:X线片(站立或负重位)示关节间隙变窄、软骨下硬化(或)囊性变、关节缘骨赘形成;C:骨性关节炎典型的滑膜积液:清亮、粘稠,WBC<2000个/ml;D:中老年患者(≥40岁);E:晨僵≤30min;F:活动时有骨摩擦音。)②自愿接受关节内注射和tdcs的患者。 

Inclusion criteria

(1)According to the clinical and radiological standards established by the American Society of Rheumatology,if the participants meet the following A+B or A+C+E+F or A+D+E+F ,they can be diagnosed as KOA (A: recurrent knee pain within 1 month; B: X-ray (standing or weight-bearing position) shows narrowing of joint space, subchondral sclerosis (or) cystic degeneration, and formation of marginal osteophytes; C: Synovial fl uid typical of osteoarthritis: clear, sticky, WBC < 2000 / ml. D: middle-aged and elderly patients (≥ 40 years old); E: Morning stiff ness lasting 30 min or less; F:Crepitus on active joint motion. (2) patients who voluntarily received intra-articular injection and tdcs. 

排除标准:

如果参与者同时患有可能阻碍方案完成的疾病,包括:①病变膝关节合并局部皮肤感染、关节肿瘤或结核;②既往膝关节手术史或近3个月内接受过膝关节内或周围注射治疗;③严重的基础疾病、凝血障碍;④脑外科手术、脑瘤、癫痫、中风或颅内金属植入史;⑤合并认知障碍及精神障碍,不能配合治疗及随访,则将参与者排除在外。 

Exclusion criteria:

If the participant also suffers from diseases that may hinder the completion of the program, including: (1) local skin infection, joint tumor or tuberculosis of the diseased knee joint; (2) previous knee joint surgery or treatment within or around the knee joint within the last 3 months; (3) severe underlying diseases, blood clotting disorders; (4) history of brain surgery, brain tumor, epilepsy, stroke or intracranial metal implantation. (5) if they were complicated with cognitive and mental disorders and could not cooperate with treatment and follow-up, the participants were excluded. 

研究实施时间:

Study execute time:

From2022-01-10To 2022-04-30 

征募观察对象时间:

Recruiting time:

From2022-01-10To 2022-03-31 

干预措施:

Interventions:

组别:

实验组

样本量:

20

Group:

Experimental group

Sample size:

干预措施:

增生疗法+经颅直流电真刺激

干预措施代码:

Intervention:

prolotherapy+active tDCS

Intervention code:

组别:

对照组

样本量:

20

Group:

control group

Sample size:

干预措施:

增生疗法+经颅直流电假刺激

干预措施代码:

Intervention:

prolotherapy+sham tDCS

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

山东省 

市(区县):

 

Country:

China 

Province:

Shandong Province 

City:

 

单位(医院):

青岛大学附属医院 

单位级别:

三甲医院 

Institution
hospital:

The Affiliated Hospital of Qingdao University  

Level of the institution:

Third-class 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 Analog Scale/Score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

WOMAC骨关节炎指数评分

指标类型:

主要指标 

Outcome:

the Western Ontario and McMaster Universities Osteoarthritis Index

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

压痛阈

指标类型:

主要指标 

Outcome:

pressure pain thresholds

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

条件性疼痛调制

指标类型:

主要指标 

Outcome:

Conditioned Pain Modulation

Type:

Primary 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:

-

组织:

Sample Name:

-

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

Not yet recruiting

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):

李娟使用SPSS统计分析软件产生随机数列

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

Li Juan used SPSS statistical analysis software to generate random numbers

盲法:

Blinding:

是否共享原始数据:

IPD sharing

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):

2023-01 共享原始数据方式:https://store.creativecommons.org/ creative commons

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

2023-01 The way of sharing IPD:https://store.creativecommons.org/ creative commons

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、电子采集和管理系统

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

Case Record Form, CRF Electronic Data Capture, EDC

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2022-01-15
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