舌针联合舌运动训练在鼻咽癌放疗后吞咽障碍患者中的应用

注册号:

Registration number:

AMCTR-IPR-17000097 

注册号获得时间:

Date of releasing the registration number:

2018/3/15 15:01:08 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

舌针联合舌运动训练在鼻咽癌放疗后吞咽障碍患者中的应用 

Public title:

Application of tongue acupuncture combined with tongue movement training on dysphagia patients after radiotherapy of nasopharyngeal carcinoma 

研究课题的正式科学名称:

舌针治疗鼻咽癌放疗后吞咽障碍的临床疗效研究 

Scientific title:

Clinical study on the effect of Tongue acupuncture on swallowing disorder after radiotherapy for nasopharyngeal carcinoma 

研究课题代号(代码):

Study subject ID:

20141268 

在其它机构的注册号:

Secondary ID:

ChiCTR-IPR-17012502 

申请注册联系人:

周惠嫦 

研究负责人:

周惠嫦 

Applicant:

Huichang Zhou 

Study leader:

Huichang Zhou 

申请注册联系人电话:

Applicant telephone:

+86 18038861971 

研究负责人电话:

Study leader's telephone:

+86 18038861971 

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:

13138207102@163.com 

研究负责人电子邮件:

Study leader's E-mail:

13138207102@163.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:

广东省佛山市禅城区岭南大道北81号康复科 

研究负责人通讯地址:

广东省佛山市禅城区岭南大道北81号康复科 

Applicant address:

81 Lingnan Avenue North, Chancheng District, Foshan, Guangdong, China 

Study leader's address:

81 Lingnan Avenue North, Chancheng District, Foshan, Guangdong, China 

申请注册联系人邮政编码:

Applicant postcode:

528000 

研究负责人邮政编码:

Study leader's postcode:

528000 

申请人所在单位:

佛山市第一人民医院 

Applicant's institution:

Department of Rehabilitation, The First People's Hospital of Foshan 

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:

L[2013]10 

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:

佛山市第一人民医院医学伦理委员会 

Name of the ethic committee:

Medical ethic committee in the First People's Hospital of Foshan 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-05-15 

研究实施负责(组长)单位:

佛山市第一人民医院 

Primary sponsor:

Department of Rehabilitation, The First People's Hospital of Foshan 

研究实施负责(组长)单位地址:

广东省佛山市禅城区岭南大道北81号康复科 

Primary sponsor's address:

81 Lingnan Avenue North, Chancheng District, Foshan, Guangdong, 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):

广东省

市(区县):

佛山市

Country:

China

Province:

Guangdong

City:

Foshan

单位(医院):

佛山市第一人民医院

具体地址:

广东省佛山市禅城区岭南大道北81号康复科

Institution
hospital:

Department of Rehabilitation, The First People's Hospital of Foshan

Address:

81 Lingnan Avenue North, Chancheng District, Foshan, Guangdong, China

经费或物资来源:

自筹经费 

Source(s) of funding:

Self-financing 

研究疾病:

鼻咽癌放疗后吞咽障碍 

Target disease:

Dysphagia after radiotherapy of nasopharyngeal carcinoma 

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:

探讨舌针联合舌运动训练在鼻咽癌放疗后吞咽障碍患者的临床疗效 

Objectives of Study:

To investigate the effect of tongue acupuncture combined with tongue movement training on dysphagia patients after radiotherapy of nasopharyngeal carcinoma 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

①已确诊的鼻咽癌患者且经过放射治疗;②伴有舌肌萎缩,舌运动障碍;③患者意识清醒,能配合相关临床检查及治疗,生命体征稳定;④无心、肺、肝、肾等重要脏器严重并发症;⑤既往无口腔、咽及食管结构异常等;⑥所有患者均签署知情同意书。 

Inclusion criteria

1. Diagnosed nasopharyngeal carcinoma and received radiation therapy; 2. With tongue atrophy and tongue movement disorder; 3. The patients who are conscious and stable can cooperate with the clinical examination and treatment; 4. Without serious complications of heart, lung, liver, kidney and other viscera; 5. Patients without the structure anomalies of mouth, pharynx and esophagus; 6. All had signed informed consent. 

排除标准:

①鼻咽癌复发;②合并认知障碍;③合并失语症;④张口度小于1cm;⑤凝血功能障碍;⑥年龄大于80岁;⑦舌面有溃疡。 

Exclusion criteria:

1. Recurrence of cancer; 2. Cognitive impairment; 3. Aphasia; 4. Jaw opens less than 1 cm; 5. Coagulation disorders; 6. Aged above 80; 7. Lingual surface ulcer. 

研究实施时间:

Study execute time:

From2017-10-01To 2019-09-30 

干预措施:

Interventions:

组别:

舌针组

样本量:

12

Group:

Acupuncture group

Sample size:

干预措施:

舌针+舌运动

干预措施代码:

Intervention:

Tongue acupuncture and tongue movement exercise

Intervention code:

组别:

对照组

样本量:

12

Group:

Control group

Sample size:

干预措施:

舌运动

干预措施代码:

Intervention:

tongue movement exercise

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

采集人体标本:

Collecting sample(s)
from participants:

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 20 years
最大 Max age 80 years

随机方法(请说明由何人用什么方法产生随机序列):

由陈丽珊采用随机区组随机化分组,以入院时间作为配伍因素,将入院时间相邻的4为患者作为一个区组,对24例患者分配到舌针组和对照组。

性别:

男女均可

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

Lishan Chen using randomized block design, 4 admitted patients were treated as a block. 24 patients were randomly divided into control group and acupuncture group.

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:

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):

临床试验公共管理平台ResMan http://www.medresman.org/uc/index.aspx

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

ResMan Research Manager http://www.medresman.org/uc/index.aspx

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):

ResMan

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

ResMan

创建人:

Creater Name:

 2017-08-30
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