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Is Platelet Rich Plasma Superior to Local Steroids Injection in Lateral Epicondylitis at 24 months? A multicenter randomized controlled trial
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注册号：

Registration number：

 ChiCTR2000038828 

最近更新日期：

Date of Last Refreshed on：

 2020-12-27 18:15:14 

注册时间：

Date of Registration：

 2020-10-05 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Is Platelet Rich Plasma Superior to Local Steroids Injection in Lateral Epicondylitis at 24 months? A multicenter randomized controlled trial

Public title：

Is Platelet Rich Plasma Superior to Local Steroids Injection in Lateral Epicondylitis at 24 months? A multicenter randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Is Platelet Rich Plasma Superior to Local Steroids Injection in Lateral Epicondylitis at 24 months? A multicenter randomized controlled trial

Scientific title：

Is Platelet Rich Plasma Superior to Local Steroids Injection in Lateral Epicondylitis at 24 months? A multicenter randomized controlled trial

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：

Muhammad Tahir 

研究负责人：

Ejaz Ali Chaudhry 

Applicant：

Muhammad Tahir 

Study leader：

Ejaz Ali Chaudhry 

申请注册联系人电话：

Applicant telephone：

 +92 33 32343828

研究负责人电话：

Study leader's
telephone：

+44 73 09026936

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：

 doctor.muhammad.tahir@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 dr.aliejaz84@gmail.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 Jinnah Postgraduate Medical Centre

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：

Department of Orthopaedics JPMC, Karachi, Pakistan

研究负责人通讯地址：

Ghurki Trust and Teaching hospital, Lahore, Pakistan

Applicant address：

Department of Orthopaedics JPMC, Karachi, Pakistan

Study leader's address：

Ghurki Trust and Teaching hospital, Lahore, Pakistan

申请注册联系人邮政编码：

Applicant postcode：

 75500

研究负责人邮政编码：

Study leader's postcode：

 53400

申请人所在单位：

巴基斯坦卡拉齐真纳教学医学中心研究生医学中心

Applicant's institution：

Jinnah Postgraduate Medical Centre

研究负责人所在单位：

巴基斯坦拉合尔Ghurki Trust and Teaching hospital

Affiliation of the Leader：

Ghurki Trust and Teaching 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：

 NO.F.2-81/2015-GENL/108 /JPMC

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：

Medical Ethics Review Board

Name of the ethic committee：

Medical Ethics Review Board

伦理委员会批准日期：

Date of approved by ethic committee：

 2014-12-12 00:00:00

伦理委员会联系人：

Medical Ethics Review Board, JPMC

Contact Name of the ethic committee：

Medical Ethics Review Board JPMC

伦理委员会联系地址：

Medical Ethics Review Board JPMC

Contact Address of the ethic committee：

Medical Ethics Review Board JPMC

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：

Ghurki Trust and Teaching hospital, Lahore, Pakistan

Primary sponsor：

Ghurki Trust and Teaching hospital, Lahore, Pakistan

研究实施负责（组长）单位地址：

JALLO MORR, LAHORE-Pakistan

Primary sponsor's address：

JALLO MORR, LAHORE-Pakistan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

巴基斯坦

省(直辖市)：

信德

市(区县)：

卡拉奇

Country：

Pakistan

Province：

Sindh

City：

Karachi

单位(医院)：

Jinnah Postgraduate Medical Centre

具体地址：

Department of Orthopaedics

Institution
hospital：

Jinnah Postgraduate Medical Centre

Address：

Department of Orthopaedics

国家：

巴基斯坦

省(直辖市)：

阿萨德.克什米尔

市(区县)：

Mirpurkhas

Country：

Pakistan

Province：

Azad Kashmir

City：

Mirpurkhas

单位(医院)：

Shaheed Mohtarma Benazir Bhutto University

具体地址：

Mirpurkhas

Institution
hospital：

Shaheed Mohtarma Benazir Bhutto University

Address：

Mirpurkhas

经费或物资来源：

Nil

Source(s) of funding：

nil

研究疾病：

肱骨外上髁炎  

Target disease：

Lateral Epicondylitis

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：

 I期临床试验 

Study phase：

1

研究设计：

半随机对照 

Study design：

Quasi-randomized controlled 

研究目的：

The null hypothesis of the study was that platelet rich plasma (PRP) will significantly relieve pain in patients of lateral epicondylitis from the 4 weeks to 24 months as compared to steroid injections.  

Objectives of Study：

The null hypothesis of the study was that platelet rich plasma (PRP) will significantly relieve pain in patients of lateral epicondylitis from the 4 weeks to 24 months as compared to steroid injections.

药物成份或治疗方案详述：

Patients were allocated either to the steroids group (control arm) or the PRP group (experimental arm). For the PRP group, 15 milliliters of venous blood collected from the cephalic vein under aseptic measures and was then centrifuged till plasma concentrates were obtained. After centrifugation, a smaller syringe kit with 25G needle was used to fill 5 milliliters of PRP. For the steroid group of patients, participants received one local injection with either 1 ml triamcinolonacetonide 10 mg/ml with 1 milliliter of 1% lidocaine. After aseptic measures, the researchers injected PRP or corticosteroid into the insertion of the affected ECRB tendon with a 22G needle. No specific postoperative regimen was advised to the participants. However, if they experienced pain, they could consume over the counter analgesics. 

Description for medicine or protocol of treatment in detail：

Patients were allocated either to the steroids group (control arm) or the PRP group (experimental arm). For the PRP group, 15 milliliters of venous blood collected from the cephalic vein under aseptic measures and was then centrifuged till plasma concentrates were obtained. After centrifugation, a smaller syringe kit with 25G needle was used to fill 5 milliliters of PRP. For the steroid group of patients, participants received one local injection with either 1 ml triamcinolonacetonide 10 mg/ml with 1 milliliter of 1% lidocaine. After aseptic measures, the researchers injected PRP or corticosteroid into the insertion of the affected ECRB tendon with a 22G needle. No specific postoperative regimen was advised to the participants. However, if they experienced pain, they could consume over the counter analgesics. 

纳入标准：

Inclusion criteria

排除标准：

Patients were excluded if they had previous surgery on the affected elbow or a traumatic injury on the affected limb, patients with pain around the medial epicondyle, patient not willing to participate in the study and history of alcohol or patient not able to follow commands due to any neurological issue or psychiatric issue.

Exclusion criteria：

Patients were excluded if they had previous surgery on the affected elbow or a traumatic injury on the affected limb, patients with pain around the medial epicondyle, patient not willing to participate in the study and history of alcohol or patient not able to follow commands due to any neurological issue or psychiatric issue.

研究实施时间：

Study execute time：

从 From 2015-01-21 00:00:00至 To 2019-08-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2015-02-03 00:00:00 至 To 2017-04-18 00:00:00

干预措施：

Interventions：

组别：

1

样本量：

 66

Group：

1

Sample size：

干预措施：

PRP

干预措施代码：

Intervention：

PRP

Intervention code：

组别：

2

样本量：

 73

Group：

2

Sample size：

干预措施：

Steroid injection

干预措施代码：

Intervention：

Steroid injection

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 巴基斯坦

省(直辖市)：

 信德 

市(区县)：

 卡拉齐 

Country：

Pakistan

Province：

Sindh

City：

Karachi

单位(医院)：

 真纳教学医学中心 

单位级别：

  

Institution
hospital：

Jinnah Postgraduate Medical Centre

Level of the institution：

国家：

 巴基斯坦

省(直辖市)：

 旁遮普 

市(区县)：

 拉合尔 

Country：

Pakistan

Province：

Punjab

City：

Lahore

单位(医院)：

 Ghurki Teaching Trust Hospital 

单位级别：

  

Institution
hospital：

Ghurki Teaching Trust Hospital

Level of the institution：

国家：

 巴基斯坦

省(直辖市)：

 阿萨德.克什米尔 

市(区县)：

 Mirpurkhas 

Country：

Pakistan

Province：

Azad Kashmir

City：

Mirpurkhas

单位(医院)：

 Shaheed Mohtarma Benazir Bhutto University 

单位级别：

  

Institution
hospital：

Shaheed Mohtarma Benazir Bhutto University

Level of the institution：

测量指标：

Outcomes：

指标中文名：

VAS

指标类型：

主要指标

Outcome：

VAS

Type：

Primary indicator

测量时间点：

24 months

测量方法：

Measure time point of outcome：

24 months

Measure method：

指标中文名：

SF-12

指标类型：

次要指标

Outcome：

SF-12

Type：

Secondary indicator

测量时间点：

24 months

测量方法：

SF-12

Measure time point of outcome：

24 months

Measure method：

SF-12

指标中文名：

qDASH

指标类型：

次要指标

Outcome：

qDASH

Type：

Secondary indicator

测量时间点：

24 months

测量方法：

Measure time point of outcome：

24 months

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

lateral epicondylitis

组织：

tendon

Sample Name：

lateral epicondylitis

Tissue：

tendon

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation 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 18 岁 years
最大 Max age 90 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）：

Computer software

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

Eligible patients were informed about the study protocol and after informed consent patients were included in the trial and their baseline data were collected. Sequential randomization of patients was performed by a computer and later stored in a sealed, opaque envelope by an independent research officer.

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：

Blinding：

computerized

是否共享原始数据：

IPD sharing

是Yes

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）：

private message only

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

private message only

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：

SPSS

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

spss

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2020-10-05 04:48:22
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