激光针灸治疗臂丛神经损伤后引起上肢水肿的疗效观察

注册号:

Registration number:

AMCTR-IPR-19000279 

注册号获得时间:

Date of releasing the registration number:

2019/7/3 20:12:43 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

激光针灸治疗臂丛神经损伤后引起上肢水肿的疗效观察 

Public title:

An observation on the effect of laser acupuncture treatment on upper-limb edema after brachial plexus injury 

研究课题的正式科学名称:

激光针灸治疗臂丛神经损伤后引起上肢水肿的疗效观察 

Scientific title:

An observation on the effect of laser acupuncture treatment on upper-limb edema after brachial plexus injury 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

ChiCTR1900024198 

申请注册联系人:

王丽祯 

研究负责人:

王丽祯 

Applicant:

Wang Lizhen 

Study leader:

Wang Lizhen 

申请注册联系人电话:

Applicant telephone:

+86 13817280004 

研究负责人电话:

Study leader's telephone:

+86 13817280004 

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:

wlz@shutcm.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

wlz@shutcm.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:

上海市浦东新区蔡伦路1200号 

研究负责人通讯地址:

上海市浦东新区蔡伦路1200号 

Applicant address:

1200 Cailun Road, Pudong District, Shanghai 

Study leader's address:

1200 Cailun Road, Pudong District, Shanghai 

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:

上海中医药大学 

Applicant's institution:

Shanghai University of Traditional Chinese Medicine 

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:

2019-647-02-01 

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:

上海中医药大学附属曙光医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-03-27 

研究实施负责(组长)单位:

上海中医药大学附属曙光医院 

Primary sponsor:

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

上海市浦东新区张衡路528号 

Primary sponsor's address:

528 Zhangheng Road, Pudong District, Shanghai 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海中医药大学附属曙光医院

具体地址:

上海市浦东新区张衡路528号

Institution
hospital:

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Address:

528 Zhangheng Road, Pudong District, Shanghai

经费或物资来源:

上海中医药大学 

Source(s) of funding:

Shanghai University of Traditional Chinese Medicine 

研究疾病:

臂丛神经损伤 

Target disease:

brachial plexus injury 

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:

预实验 

Study phase:

Polit 

研究目的:

观察激光针灸对臂丛神经损伤引起的上肢水肿的临床疗效 

Objectives of Study:

To observe the clinical effect of laser acupuncture treatment on upper-limb edema caused by brachial plexus injury. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

1. 由于上肢臂丛神经受损引起的单侧或双侧上肢水肿患者,18周岁-70周岁; 2. 上肢水肿分级为轻到中度,发生于上臂近端或影响到整个上肢,包括前臂和手背。 

Inclusion criteria

1. Patients with unilateral or bilateral upper-limb edema due to impaired upper limb brachial plexus, aged 18 to 70 years; 2. Upper-limb edema is graded as mild to moderate, occurring at the proximal end of the upper arm or affecting the entire upper limb, including the forearm and the back of the hand. 

排除标准:

1. 患侧上肢的平均周径比健侧粗8 cm以上,皮肤硬韧,水肿波及整个上肢包括手指,使患者整个上臂和肩关节活动严重受限; 2. 上肢水肿经超声检查是由锁骨下静脉、腋静脉血栓或狭窄引起者; 3. 目前有肿瘤转移、蜂窝性组织炎、静脉血栓形成、慢性炎症性疾病或严重外伤史者; 4. 前6个月内接受过针灸治疗; 5. 有光敏性病史不能接受激光治疗者。 6. 怀孕和准备怀孕的妇女。 

Exclusion criteria:

1. The average circumference of the upper limb of the affected side is more than 8 cm thicker than the healthy side. The skin is hard and tough, and the edema affects the entire upper limb including the finger, which makes the whole upper arm and shoulder joint activity of the patient severely restricted; 2. upper extremity edema is caused by subclavian vein, iliac vein thrombosis or stenosis; 3. Currently there is a history of tumor metastasis, cellulitis, venous thrombosis, chronic inflammatory disease or severe trauma; 4. Acupuncture treatment in the first 6 months; 5. Those who have a history of photosensitivity cannot receive laser treatment. 6. Pregnant and pregnant women. 

研究实施时间:

Study execute time:

From2019-04-01To 2020-06-30 

干预措施:

Interventions:

组别:

激光组

样本量:

20

Group:

laser acupuncture treatment

Sample size:

干预措施:

激光穴位照射

干预措施代码:

Intervention:

laser radiation on acupoint

Intervention code:

组别:

等待组

样本量:

20

Group:

waiting-list

Sample size:

干预措施:

等待10周后行激光穴位照射

干预措施代码:

Intervention:

laser radiation on acupoint after waiting for 10 weeks

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海中医药大学附属曙光医院 

单位级别:

三级甲等 

Institution
hospital:

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

上肢臂围

指标类型:

主要指标 

Outcome:

Upper limb circumference

Type:

Primary indicator 

指标中文名:

神经电生理检查

指标类型:

主要指标 

Outcome:

Neurophysiological examination

Type:

Primary indicator 

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 70 years

随机方法(请说明由何人用什么方法产生随机序列):

Excel表格随机数字

性别:

男女均可

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

random number in Excel table

Gender:

Both

盲法:

单盲

Blinding:

single blind

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):

中国临床试验注册中心的网络平台

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

China Clinical Trial Registration Center's network platform

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):

病例记录表

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

Case Record Form, CRF

创建人:

Creater Name:

 2019-07-03
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