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The Clinical Efficacy Observation of A New Type of Silver - Warm Needle in Treating Lumbar Intervertebra Disc Herniation
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注册号:

Registration number:

ChiCTR1800019051 

最近更新日期:

Date of Last Refreshed on:

2018-10-29 

注册时间:

Date of Registration:

2018-10-24 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

新型银质针温针灸治疗腰椎间盘突出临床疗效评价 

Public title:

The Clinical Efficacy Observation of A New Type of Silver - Warm Needle in Treating Lumbar Intervertebra Disc Herniation  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

新型银质针温针灸治疗腰椎间盘突出症临床疗效评价 

Scientific title:

The Clinical Efficacy Observation of A New Type of Silver - Warm Needle in Treating Lumbar Intervertebra Disc Herniation  

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:

AMCTR-IOR-18000217 

申请注册联系人:

李甜 

研究负责人:

黄奏琴 

Applicant:

Li Tian 

Study leader:

Huang Zouqin 

申请注册联系人电话:

Applicant telephone:

+86 15216715185 

研究负责人电话:

Study leader's telephone:

+86 13564599607 

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:

alasoka@163.com 

研究负责人电子邮件:

Study leader's E-mail:

hzqmusic@yeah.net 

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:

上海市浦东新区平川路399号 

研究负责人通讯地址:

上海市浦东新区平川路399号 

Applicant address:

399 Pingchuan Road, Pudong New Area, China 

Study leader's address:

399 Pingchuan Road, Pudong New Area, 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:

上海市浦东新区中医医院 

Applicant's institution:

Pudong New Area TCM 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:

pdzyyy-2018-21 

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:

上海浦东新区中医医院医学伦理委员会c 

Name of the ethic committee:

IRB of Pudong New Area TCM Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-10-15 

伦理委员会联系人:

蒋鲁仪 

Contact Name of the ethic committee:

LuYi Jiang 

伦理委员会联系地址:

上海市浦东新区平川路399号 

Contact Address of the ethic committee:

399 Pingchuan Road, Pudong New Area, China 

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:

上海市浦东新区中医医院 

Primary sponsor:

Pudong New Area TCM Hospital 

研究实施负责(组长)单位地址:

上海市浦东新区平川路399号 

Primary sponsor's address:

399 Pingchuan Road, Pudong New Area, 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):

上海

市(区县):

浦东新区

Country:

China

Province:

Shanghai

City:

Pudong New Area

单位(医院):

上海市浦东新区中医医院

具体地址:

上海市浦东新区平川路399号

Institution
hospital:

Pudong New Area TCM Hospital

Address:

399 Pingchuan Road, Pudong New Area, China

经费或物资来源:

上海市浦东新区卫生和计划生育委员会 

Source(s) of funding:

Pudong New Area commission of health and family planning, Shanghai 

研究疾病:

腰椎间盘突出 

Target disease:

Lumbar Intervertebra Disc Herniation  

研究疾病代码:

M51.202 

Target disease code:

M51.202 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

通过对临床较为常见的寒湿型LDH进行新型银质针温针灸治疗的疗效评价研究,进一步探索新型银质针温针灸治疗LDH的作用规律. 

Objectives of Study:

In this RCT we tend to assess the clinical efficacy of silver-needles warm acupuncture versus conventional warm acupuncture on LDH by comparing the change of the Oswestry Disability Index (ODI), Visual Analogue Scale (VAS) and lumbar spine dysfunction score of Japanese Orthopedic Association Back Pain Evaluation Questionnaire (JOABPEQ). Our hypothesis is that LDH patients treated with silver-needles warm acupuncture will receive a better improvement considering to the severity of pain, physical dysfunction and quality of life. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

年龄20-60岁之间。 具备相关症状、体征(以下至少满足两项): a. 腰背痛合并根性下肢痛,腹压增加疼痛加剧; b. 脊柱侧凸,在L4/5或L5/S1症状侧椎板间隙有压痛; c. 脊柱前屈受限,直腿抬高试验(+),直腿抬高加强试验(+);或股神经牵拉试验(+); d. 肌肉萎缩、肌力减弱、感觉障碍和反射异常。 病程小于12周。 X线摄片显示腰椎生理前凸减少或消失,椎间隙变窄并能排除脊柱结核、脊柱关节炎等其它骨性疾病者;或CT检查、MRI检查可提示准确的责任病灶。 VAS评分≥5。 中医辩证属寒湿痹阻证。 

Inclusion criteria

We intend to include patients aged 20-60 if they: 1. have two of the following symptoms and signs: (1) low back with or without lower extremity pain, lasting no more than 12 weeks and exacerbating with the abdominal pressure increased; (2) scoliosis, paravertebral tenderness; (3) limited range of forward bending and a positive Lasegue s sign or Mackiewicz s sign; (4) paresthesia, dysreflexia, myodynamia or even muscle atrophy in a lower extremity; 2. have imaging evidence (X-ray, computed tomography scan or magnetic resonance imaging) supporting a confirmed diagnosis of LDH; 3. with a VAS≥ 5 at the first visit; 4. meet the criteria for the Cold-Dampness-Bi syndrome based on Traditional Chinese Medicine (TCM) theory determined by medical history review and examination (cardinal symptoms such as recurrent ache, heaviness or soreness in the lower back, cold limbs, restricted lumbar function; physical examination shown as pale tongue with white or even thick coat, sunken and tight pulse). 

排除标准:

有以下病情的患者: a. 症状严重,有马尾神经损害,或有部分或完全截瘫者。 b. 严重间歇性跛行者,同时合并椎管狭窄症,合并腰椎峡部不连及脊椎滑脱。 c. 脊柱各部位骨折及脱位者,肿瘤,严重骨质疏松、畸形者。 d. 脊柱炎症性病变如结核、强直性脊柱炎。 e.合并有干性坐骨神经痛及梨状肌损伤综合症。 合并心脑血管、肝、肾和造血系统严重疾病者。 妊娠及哺乳期妇女。 三个月内正在参加或参加过其他针对腰椎间盘突出诊治的临床试验的患者。 

Exclusion criteria:

1. suffering from the damage of cauda equina nerve, manifested as saddle anesthesia, bladder and bowel dysfunction, sexual dysfunction; or suffer from LDH complicated by sciatica of nerve trunk, piriformis syndrome, or other spinal diseases such as lumbar spinal stenosis, lumbar spondylolisthesis, ankylosing spondylitis, or spinal tuberculosis; 2. appear life-threatening complication or contradiction to acupuncture therapy such as heart diseases, liver or kidney dysfunction, poorly controlled diabetes mellitus, coagulation dysfunction; 3. pregnant or lactate woman; 4. have had experience with other therapy or treatment related to LDH in the past three months. 

研究实施时间:

Study execute time:

From2018-12-01To 2021-11-30 

征募观察对象时间:

Recruiting time:

From2018-12-01To 2020-11-30 

干预措施:

Interventions:

组别:

治疗组

样本量:

80

Group:

Group 1

Sample size:

干预措施:

银质针温针疗法

干预措施代码:

Intervention:

warm acupuncture with silver-needle

Intervention code:

组别:

对照组

样本量:

80

Group:

Group 2

Sample size:

干预措施:

不锈钢针温针疗法

干预措施代码:

Intervention:

common warm acupuncture

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):

浦东新区 

Country:

China 

Province:

Shanghai 

City:

Pudong New Area 

单位(医院):

上海市浦东新区中医医院 

单位级别:

公立二级甲等医院 

Institution
hospital:

Pudong New Area TCM Hospital  

Level of the institution:

Second A Hospital 

测量指标:

Outcomes:

指标中文名:

汉化版Oswestry功能障碍指数问卷表

指标类型:

主要指标 

Outcome:

Oswestry Dability Index (Chinese Version)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疼痛视觉模拟评分法

指标类型:

次要指标 

Outcome:

visual analogue scale

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

日本骨科协会评估治疗分数(腰椎)

指标类型:

附加指标 

Outcome:

Japanese Orthopaedic Association Scores

Type:

Additional indicator 

测量时间点:

测量方法:

只提取腰椎JOA表中临床体征评估项进行数据统计与分析

Measure time point of outcome:

Measure method:

For JOA score, only the 3 items evaluating the physical sign will be extracted for statistical analysis in this study

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

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 20 years
最大 Max age 60 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):

项目负责人黄奏琴采用SAS软件包生成随机数组成编码表,由研究员王曙负责将编码表加密保护,确保每例受试者严格按照时间顺序得到一个治疗编号,在研究员王思瑶帮助下随机分配进入治疗组和对照组。

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

The chief coordinator (HZQ) who takes charge of the study design and coordination, will create a list of randomization sequence by using Statistical Analysis System. Then, an independent researcher (WS) without any involvement in intervention nor assessment procedure will transform this list into a password-protected r

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

通过临床试验公共管理平台ResMan公布

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

we will upload and share the IPD through www.medresman.org

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:

采用ResMan平台对原始记录、病例记录表等数据进行记录和整合

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

IPD such as raw records, case records will be uploaded, stored and managed in The ResMan database.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-10-24
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