电针治疗骨肉瘤患者术后幻肢痛的疗效观察

注册号:

Registration number:

AMCTR-IOC-19000241 

注册号获得时间:

Date of releasing the registration number:

2019/1/2 14:37:50 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

电针治疗骨肉瘤患者术后幻肢痛的疗效观察 

Public title:

Effectiveness of electroacupuncture for phantom limb pain in patients with osteosarcoma after surgery 

研究课题的正式科学名称:

电针治疗骨肉瘤患者术后幻肢痛的疗效观察 

Scientific title:

Effectiveness of electroacupuncture for phantom limb pain in patients with osteosarcoma after surgery 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

ChiCTR1800020399 

申请注册联系人:

候志凌 

研究负责人:

候志凌 

Applicant:

Zhi-ling Hou 

Study leader:

Zhi-ling Hou 

申请注册联系人电话:

Applicant telephone:

+86 13903681477 

研究负责人电话:

Study leader's telephone:

+86 13903681477 

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:

zhiling198303@outlook.com 

研究负责人电子邮件:

Study leader's E-mail:

zhiling198303@outlook.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:

黑龙江省佳木斯市向阳区德祥街348号 

研究负责人通讯地址:

黑龙江省佳木斯市向阳区德祥街348号 

Applicant address:

348 Dexiang Street, Xiangyang District, Jiamusi, Heilongjiang, China 

Study leader's address:

348 Dexiang Street, Xiangyang District, Jiamusi, Heilongjiang, 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:

佳木斯大学附属第一医院 

Applicant's institution:

First Affiliated Hospital of Jiamusi 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:

JMS201812 

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:

佳木斯大学附属第一医院伦理委员会 

Name of the ethic committee:

Ethics Committee of First Affiliated Hospital of Jiamusi University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-12-11 

研究实施负责(组长)单位:

佳木斯大学附属第一医院 

Primary sponsor:

First Affiliated Hospital of Jiamusi University 

研究实施负责(组长)单位地址:

黑龙江省佳木斯市向阳区德祥街348号 

Primary sponsor's address:

348 Dexiang Street, Xiangyang District, Jiamusi, Heilongjiang, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

黑龙江

市(区县):

Country:

China

Province:

Heilongjiang

City:

单位(医院):

佳木斯大学附属第一医院

具体地址:

黑龙江省佳木斯市向阳区德祥街348号

Institution
hospital:

First Affiliated Hospital of Jiamusi University

Address:

348 Dexiang Street, Xiangyang District, Jiamusi, Heilongjiang, China

经费或物资来源:

佳木斯大学附属第一医院 

Source(s) of funding:

First Affiliated Hospital of Jiamusi University 

研究疾病:

骨肿瘤 

Target disease:

osteosarcoma 

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:

其它 

Study phase:

Other 

研究目的:

该试验旨在评估电针(EA)对手术后骨肉瘤患者幻肢痛(PLP)的有效性 

Objectives of Study:

This trial aims to assess the effectiveness of electroacupuncture (EA) for phantom limb pain (PLP) in patients with osteosarcoma after surgery. 

研究设计:

横断面 

Study design:

Cross-sectional 

纳入标准:

纳入标准将包括新诊断为组织学证实的骨肉瘤的30岁或以下的患者,但3岁以上所有接受手术的患者。此外,在本研究之前,所有患者都经历了PLP(视觉模拟评分,VAS≥4,范围为0-10)。所有登记的患者同意提供知情同意书。 

Inclusion criteria

Patient aged 3 to 30 years old; newly diagnosed with histologically confirmed osteosarcoma, and all of received surgery. Experienced PLP test (Visual Analogue Scale, VAS≥4, at the range of 0-10) before this study. All enrolled patients agree to provide informed consent. 

排除标准:

如果患者在服用止痛药并且不愿停药,母乳喂养,怀孕,其他疾病引起的疼痛,参加其他临床试验,研究前一个月接受EA或针灸,将被排除在外。 

Exclusion criteria:

Using anti pain medications and unwilling to stop; breast feeding; pregnant; pain caused by other conditions, participating other clinical trials; or receiving EA; acupuncture one month prior to the study. 

研究实施时间:

Study execute time:

From2019-01-01To 2021-12-31 

干预措施:

Interventions:

组别:

电针组

样本量:

48

Group:

EA group

Sample size:

干预措施:

电针治疗

干预措施代码:

Intervention:

EA treatment

Intervention code:

组别:

假电针组

样本量:

48

Group:

Sham EA group

Sample size:

干预措施:

假电针治疗

干预措施代码:

Intervention:

Sham EA treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

疼痛程度

指标类型:

主要指标 

Outcome:

Pain intensity

Type:

Primary indicator 

指标中文名:

生活质量

指标类型:

次要指标 

Outcome:

Quality of life

Type:

Secondary indicator 

指标中文名:

术后并发症

指标类型:

次要指标 

Outcome:

Postoperative complications

Type:

Secondary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液、尿液

组织:

Sample Name:

Blood, Urine

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 3 years
最大 Max age 30 years

随机方法(请说明由何人用什么方法产生随机序列):

在治疗开始之前,患者将被分别随机分配到EA组或假EA组。随机化分配序列将由不参与招募和评估患者的统计学家实施,并且将通过使用SAS 9.3包(SAS Institute Inc.,Cary,North Carolina,USA)生成。

性别:

男女均可

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

Before the treatment begins, the patients will be randomly allocated to the EA group or sham EA group, respectively. The randomization allocation sequence will be implemented by a statistician who will not involved with the recruiting and evaluating the patients, and will be generated by using SAS 9.3 packa

Gender:

Both

盲法:

Blinding:

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):

原始数据将于2022年6月30日公开

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

Raw data will be released on June 30, 2022

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):

所有数据将从病例报告表(CRF)中收集。它将由专业研究人员根据佳木斯大学第一附属医院的标准操作程序进行专门预先设计。将输入所有数据值并将其存储到研究计算机系统的特定电子数据库中。此外,任何相关的纸质文件也将保存在上锁的柜子中。

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

All data will be collected from a case report form (CRF). It will be specifically pre-designed by the professional researchers based on the standard operating procedures of the First Affiliated Hospital of Jiamusi University. All data values will be entered and stored into specific electronic database of the research computer system. Additionally, any related paper documents will also be kept in locked cabinets.

创建人:

Creater Name:

 2018-12-29
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