灵龟神灸治疗肾阳虚型腰痛的随机对照试

注册号:

Registration number:

AMCTR-IPR-20000337 

注册号获得时间:

Date of releasing the registration number:

2020/4/29 16:32:42 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

灵龟神灸治疗肾阳虚型腰痛的随机对照试 

Public title:

Linggui-Moxibustion for Low Back Pain of Kidney-Yang Deficiency: a randomized controlled trial 

研究课题的正式科学名称:

灵龟神灸相关灸具的研发及应用 

Scientific title:

Research , development and application of related Linggui-moxibustion tools 

研究课题代号(代码):

Study subject ID:

2019ZWB14 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

王澍欣 

研究负责人:

王澍欣 

Applicant:

Shuxin Wang 

Study leader:

Shuxin Wang 

申请注册联系人电话:

Applicant telephone:

13660285076 

研究负责人电话:

Study leader's telephone:

13660285076 

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:

widiot@126.com 

研究负责人电子邮件:

Study leader's E-mail:

widiot@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:

广东省广州市机场路16号大院广州中医药大学第一附属医院康复中心 

研究负责人通讯地址:

广东省广州市机场路16号大院广州中医药大学第一附属医院康复中心 

Applicant address:

Department of Rehabilitation Center, First Affiliated Hospital of Guangzhou University of Chinese Medicine, No. 16, Ji Chang Road, Baiyun District, Guangzhou city,Guangdong province 

Study leader's address:

Department of Rehabilitation Center, First Affiliated Hospital of Guangzhou University of Chinese Medicine, No. 16, Ji Chang Road, Baiyun District, Guangzhou city,Guangdong province 

申请注册联系人邮政编码:

Applicant postcode:

510405 

研究负责人邮政编码:

Study leader's postcode:

510405 

申请人所在单位:

广州中医药大学第一附属医院 

Applicant's institution:

First Affiliated Hospital of Guangzhou University of 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:

ZYYECK【2020】14 

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:

广州中医药大学第一附属医院伦理委员会 

Name of the ethic committee:

Ethics committee of the First Affiliated Hospital of Guangzhou University of Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-03-30 

研究实施负责(组长)单位:

广州中医药大学第一附属医院 

Primary sponsor:

First Affiliated Hospital of Guangzhou University of Chinese Medicine 

研究实施负责(组长)单位地址:

广东省广州市机场路16号大院广州中医药大学第一附属医院 

Primary sponsor's address:

First Affiliated Hospital of Guangzhou University of Chinese Medicine 

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):

广州市

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广州中医药大学第一附属医院

具体地址:

广东省广州市机场路16号大院广州中医药大学第一附属医院

Institution
hospital:

Address:

经费或物资来源:

广州中医药大学第一附属医院课题 

Source(s) of funding:

Project of the First Affiliated Hospital of Guangzhou University of Chinese Medicine 

研究疾病:

肾阳虚型腰痛 

Target disease:

Low Back Pain of Kidney-Yang Deficiency 

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:

I期临床试验 

Study phase:

Phase I 

研究目的:

验证灵龟神灸法治疗肾阳虚型腰痛的疗效及安全性 

Objectives of Study:

Verification of the efficacy and safety of the Linggui-Moxibustion in the treatment of low back pain caused by kidney-yang deficiency 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

①符合国家卫生部制定的2002版《中药新药临床研究指导原则》中的肾阳虚型腰痛标准: 中医诊断标准:①典型的单侧或双侧腰部疼痛。②可有反复发作的腰痛病史。③排除淋证、水肿、肿瘤及妇科、妊娠等有腰痛症状的疾患者。肾阳虚型:腰部隐痛,腰膝酸软无力,迁延难愈,局部不温,喜揉喜按,劳累加重,卧则痛减,神疲乏力,畏寒肢冷。舌淡,脉沉,细弱无力。 西医诊断指以下几种疾病: ①腰椎退行性变;②腰肌劳损;③腰椎间盘突出、膨出或脱出;④第三腰椎横突综合征;⑤椎管狭窄;⑥腰椎滑脱;⑦腰椎压缩性骨折。 ②年龄在30~75 岁之间; ③自愿参与本研究,能按计划坚持治疗并签署知情同意书。 

Inclusion criteria

①Meeting the criteria of low back pain of kidney-yang deficiency in the 2002 edition of "Guiding Principles of Clinical Study on New Drugs of Traditional Chinese Medicine" formulated by the Ministry of Health: Diagnostic criteria for traditional Chinese medicine: ① Typical unilateral or bilateral lumbar pain. ② May have a medical history of recurrent low back pain. ③Patients with back pain symptoms such as shower syndrome, edema, tumor and gynecology, pregnancy are excluded. Kidney-yang deficiency type: Dull pain in the lower back; weakness in the lower back and knees; difficult to heal after prolonging; partially unheated; like rubbing and pressing; increased fatigue after moving; reduced pain when lying down; lassitude of spirit and lack of strength; fear of cold; cold of the extremities; pale tongue; sunken, fine and weak pulse. Western medicine diagnosis refers to the following diseases: ①Degeneration of lumbar spine; ②Lumbar muscle strain; ③Lumbar disc herniation, bulging or prolapse; ④Transverse process syndrome of the third lumbar vertebra; ⑤Spinal stenosis; ⑥Lumbar spondylolisthesis; ⑦Compression fracture of lumbar vertebra. ②The age is between 30 and 75 years old. ③Participate voluntarily in this study, be able to sign an informed consent and adhere to treatment as planned. 

排除标准:

①易过敏体质及对艾烟熏过敏,对艾烟过敏或有哮喘病史、慢性阻塞性肺疾病、肺心病等急、慢性肺部疾病的患者;②长期口服其它的与本疾病相关的药物,不能立即停用的患者;③有严重内分泌疾病、代谢性疾病或肿瘤的患者;④合并有严重心脑血管、肝、肾及造血系统等疾病及精神病的患者;⑤患者难以沟通,不配合治疗及不配合医师评分调查者;⑥有明显皮肤疾病或皮肤破损及凝血功能障碍等血液疾病的患者;⑦脊髓结核、肿瘤等引起的腰痛,严重椎管狭窄、严重腰椎间盘突出已具有手术指征者;⑧妊娠及哺乳期妇女;⑨局部皮肤有感觉障碍者;⑩患者或家属不同意接受试验,未签署知情同意书者。 

Exclusion criteria:

①People with allergic constitution and hypersensitivity to moxa smoke or acute and chronic lung diseases such as asthma, chronic obstructive pulmonary disease, pulmonary heart disease, etc; ②Long-term oral administration of other drugs related to this disease, which cannot be stopped immediately; ③Patients with severe endocrine diseases, metabolic diseases or tumors; ④Patients with serious cardiovascular and cerebrovascular diseases, liver, kidney and hematopoietic system diseases and mental illness; ⑤Patients difficult to communicate or refuse to cooperate with the treatment; ⑥ Patients with obvious skin diseases or skin damage and blood disorders such as coagulation dysfunction; ⑦ Low back pain caused by spinal tuberculosis, tumors, etc or severe spinal stenosis, severe lumbar disc herniation with surgical indications. ⑧ Pregnant and lactating women; ⑨ Local skin with sensory impairment; ⑩ Patients or family members do not agree to accept the test or sign the informed consent. 

研究实施时间:

Study execute time:

From2019-06-01To 2022-05-31 

干预措施:

Interventions:

组别:

灵龟神灸组

样本量:

30

Group:

Linggui-Moxibustion group

Sample size:

干预措施:

灵龟神灸

干预措施代码:

Intervention:

Linggui-Moxibustion

Intervention code:

组别:

清艾条灸组

样本量:

30

Group:

Moxibustion group

Sample size:

干预措施:

清艾条灸

干预措施代码:

Intervention:

Moxibustion

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

广州市 

Country:

China 

Province:

Guangdong 

City:

Guagnzhou 

单位(医院):

广州中医药大学第一附属医院 

单位级别:

3A 

Institution
hospital:

First Affiliated Hospital of Guangzhou University of Chinese Medicine  

Level of the institution:

3A 

测量指标:

Outcomes:

指标中文名:

视觉疼痛模拟评分方案

指标类型:

主要指标 

Outcome:

Visual Analogue Scale

Type:

Primary indicator 

指标中文名:

中医体质辨识标准评分

指标类型:

主要指标 

Outcome:

traditional Chinese medicine dialectical factor score

Type:

Primary indicator 

指标中文名:

腰椎功能评价

指标类型:

次要指标 

Outcome:

Japanese Orthopaedic Association Scores

Type:

Secondary indicator 

指标中文名:

肺功能

指标类型:

附加指标 

Outcome:

Pulmonary function

Type:

Additional indicator 

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 30 years
最大 Max age 75 years

随机方法(请说明由何人用什么方法产生随机序列):

由华南针灸研究中心工作人员用计算机生成随机数字。通过计算机生成100个随机数字,将所得的随机数字按1、2……100顺序排列,令末位为单数的随机数字相应序号的受试对象分配至灵龟神灸法组,双数和零者进入清艾条组。

性别:

男女均可

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

Random numbers are generated by the staff of South China Acupuncture Research Center using computer.100 random numbers were generated by computer, arranged in the order of 1, 2, ... 100 and assigned to the subjects. Subjects with random numbers ending in the singular number and corresponding serial numbers were assigned to the Linggui- moxibustion method group, and those with even numbers and zeros entered the moxibustion method 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:

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):

始数据将于试验完成后6个月内公开, 纸质形式共享

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

The initial data will be published within 6 months after the completion of the test, and shared in paper form

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):

数据采用纸质病例报告表保存,然后输入SPSS数据库。

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

Original Case report form will be preserved and will be input in the SPSS database

创建人:

Creater Name:

 2020-04-13
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