Evaluation of curative effect base on the theory of jingjin and myofascial meridian treatment for Low Back Muscle Fasciitis.

注册号:

Registration number:

ITMCTR2022000107

最近更新日期:

Date of Last Refreshed on:

2022-11-11

注册时间:

Date of Registration:

2022-06-28

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

基于经筋、肌筋膜链理论的综合疗法治疗腰背肌筋膜炎的疗效评价研究临床研究

Public title:

Evaluation of curative effect base on the theory of jingjin and myofascial meridian treatment for Low Back Muscle Fasciitis.

注册题目简写:

背肌筋膜炎的疗效评价研究

English Acronym:

Evaluation of curative effectfor Low Back Muscle Fasciitis.

研究课题的正式科学名称:

基于经筋、肌筋膜链理论的综合疗法治疗腰背肌筋膜炎的疗效评价研究

Scientific title:

Evaluation of curative effect base on the theory of jingjin and myofascial meridian treatment for Low Back Muscle Fasciitis.

研究课题的正式科学名称简写:

背肌筋膜炎的疗效评价研究

Scientific title acronym:

Evaluation of curative effectfor Low Back Muscle Fasciitis.

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:

ChiCTR2200065657 ; ChiMCTR2200006763

申请注册联系人:

耿涛

研究负责人:

耿涛

Applicant:

Tao Geng

Study leader:

Tao Geng

申请注册联系人电话:

Applicant telephone:

13581919728

研究负责人电话:

Study leader's telephone:

13581919728

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:

gamgengtao@126.com

研究负责人电子邮件:

Study leader's E-mail:

gamgengtao@126.com

申请单位网址(自愿提供):

Study leader's 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:

北京市西城区北线阁5号

研究负责人通讯地址:

北京市西城区北线阁5号

Applicant address:

No.5, Beixian Pavilion, Xicheng District, Beijing

Study leader's address:

No.5, Beixian Pavilion, Xicheng District, Beijing

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:

中国中医科学院广安门医院

Applicant's institution:

Guang'anmen Hospital of Chinese Academy of traditional Chinese medicine

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

2022-185-KY-01

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

中国中医科学院广安门医院伦理委员会

Name of the ethic committee:

Ethics Committee of Guang'anmen Hospital, Chinese Academy of Traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2022/10/13 0:00:00

伦理委员会联系人:

乔洁

Contact Name of the ethic committee:

Jie Qiao

伦理委员会联系地址:

中国中医科学院广安门医院

Contact Address of the ethic committee:

Guang'anmen Hospital of Chinese Academy of traditional Chinese medicine

伦理委员会联系人电话:

Contact phone of the ethic committee:

010-88001552

伦理委员会联系人邮箱:

Contact email of the ethic committee:

gamhec@126.com

研究实施负责(组长)单位:

中国中医科学院广安门医院

Primary sponsor:

Guang'anmen Hospital of Chinese Academy of traditional Chinese medicine

研究实施负责(组长)单位地址:

北京市西城区北线阁5号

Primary sponsor's address:

No.5, Beixian Pavilion, Xicheng District, Beijing

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京市

市(区县):

西城区

Country:

China

Province:

BeiJing

City:

Xicheng District

单位(医院):

中国中医科学院广安门医院

具体地址:

北京市西城区北线阁5号

Institution
hospital:

Guanganmen Hospital, Chinese Academy of Chinese Medical Sciences

Address:

No. 5, North Line Pavilion, Xicheng District, Beijing

经费或物资来源:

中国中医科学院

Source(s) of funding:

China Academy of Chinese Medical Sciences

研究疾病:

腰背肌筋膜炎

研究疾病代码:

Target disease:

low back muscle fasciitis

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

I期临床试验

Phase I clinical trial

研究目的:

本实验的研究目的是完成基于经筋、肌筋膜链理论的综合疗法治疗腰背肌筋膜炎的疗效评价研究,形成综合疗法治疗腰背肌筋膜炎的循证临床证据。

Objectives of Study:

The purpose of this study is to evaluate the efficacy of combining therapy based on the theory of jingjin and myofascial meridian treatment for low back muscle fasciitis, and to form evidence-based clinical evidence of combining therapy in the treatment of low back muscle fasciitis.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

1.符合上述西医诊断标准和中医诊断标准的腰背肌筋膜炎的受试者; 2.自愿作为受试对象者,自愿签署知情同意书并能根据医师的指导接受本研究试验方法治疗; 3.年龄20-60岁; 4.病程在3个月以上,并且受试者在自发病后的2周内未曾使用过任何有关治疗手段及药物者。

Inclusion criteria

1. Patients with low back muscle fasciitis who met the diagnostic criteria of Western medicine and traditional Chinese medicine; 2. Willing to participate in the study and sign the consent forms; 3. Aged 20–60 years; 4. The course of disease is more than 3 months, and the patients has not used any relevant treatment means or drugs within 2 weeks of onset.

排除标准:

1.不符合上述西医、中医诊断标准及其他纳入标准的受试者; 2.合并有严重的原发性疾病的受试者,例如心血管系统、肝脏、肾脏、脑血管及淋巴免疫系统等严重受损者,及影响本研究的其他疾病,如内分泌系统疾病、骨结核、骨肿瘤、严重骨质疏松症、周围神经病变、严重精神病受试者等; 3.孕妇及哺乳期妇女; 4.发病后的两周接受其他治疗(包括药物治疗)的受试者,或既往行腰部相关手术者; 5.腰背部牵扯痛受试者,如妇科疾病、泌尿系统疾病等疾病引起的腰背部牵扯痛及影像学诊断为中、重度椎间盘脱垂受试者;怀疑或已经确认以往有药物、酒精等滥用史者,或研究中不听从研究者的合理治疗安排,或失联,或不愿配合,或拒绝签署CRF表、知情同意书的受试者。

Exclusion criteria:

1. Patients who do not meet the above diagnostic criteria of Western medicine and traditional Chinese medicine and other inclusion criteria; 2. Patients with serious primary diseases, such as those with serious impairment of cardiovascular system, liver, kidney, cerebrovascular and lymphatic immune system, and other diseases affecting the study, such as endocrine system diseases, bone tuberculosis, bone tumors, severe osteoporosis, peripheral neuropathy, and severe psychosis; 3. Pregnant or lactating women; 4. Patients who received other treatment (including medication) two weeks after the onset of the disease, or who had previously undergone lumbar surgery; 5. Patients with low back pain, such as subjects with low back pain caused by gynecological diseases, urinary system diseases and other diseases, and subjects with moderate and severe intervertebral disc prolapse diagnosed by imaging diagnosis; Patients who suspect or have confirmed that they have a history of drug, alcohol and other abuse in the past, or do not follow the reasonable treatment arrangement of the researcher during the study, or lose contact, or are unwilling to cooperate, or refuse to sign CRF form and informed consent.

研究实施时间:

Study execute time:

From 2021-10-01

To      2024-10-01

征募观察对象时间:

Recruiting time:

From 2022-11-10

To      2023-03-31

干预措施:

Interventions:

组别:

对照组

样本量:

75

Group:

control group

Sample size:

干预措施:

口服双氯芬酸钠肠溶片

干预措施代码:

Intervention:

oral diclofenac sodium enteric-coated tablets

Intervention code:

组别:

治疗组

样本量:

75

Group:

Treatment group

Sample size:

干预措施:

运动拉伸+针刺治疗+手法治疗

干预措施代码:

Intervention:

Sports stretching + acupuncture + manual therapy

Intervention code:

样本总量 Total sample size : 150

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

北京市

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院广安门医院

单位级别:

三级甲等医院

Institution/hospital:

Guang'anmen Hospital of Chinese Academy of traditional Chinese medicine

Level of the institution:

3A grade hospita

测量指标:

Outcomes:

指标中文名:

日本骨科学会下腰痛评估表

指标类型:

主要指标

Outcome:

Japanese Orthopaedic Association,JOA

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:

主要指标

Outcome:

Visual Analogue Scale,VAS

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

超声探查

指标类型:

主要指标

Outcome:

Ultrasonic exploration

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

腰背肌筋膜炎的临床疗效评定

指标类型:

主要指标

Outcome:

Clinical evaluation of low back muscle fasciitis

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

blood

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:

尚未开始

Not yet recruiting

年龄范围:

最小 20
Min age years
最大 60
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

在本研究中,我们将按照SAS软件(SAS Institute Inc., Cary, NC, USA)生成的顺序,按1:1的比例进行分组随机。随机分配的信息将被密封在不透明的信封中。

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

In this study, we will carry out block randomization in a 1:1 ratio according to the sequence generated with SAS software (SAS Institute Inc., Cary, NC, USA). Randomly allocated information will be sealed in opaque envelopes.

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

No

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):

-

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

-

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:

受试者由特定的治疗者(研究者 A)进行治疗、数据采集者(研究者 B)采集数据、专业统计人员进行统计分析;临床治疗者、数据采集者、统计分析者独立进行工作,确保研究结果真实可靠。统计分析由统计专业人员与主要研究者负责,根据临床试验方案共同制订统计计划书,在数据库锁定前定稿,并制定出供统计分析所用表格。

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

The patients will be treated by a specific therapist (researcher a), collected by a data collector (researcher b), and statistically analyzed by professional statisticians; Clinical therapists, data collectors and statistical analysts work independently to ensure that the research results are true and reliable. Statistical professionals and main researchers are responsible for statistical analysis. According to the clinical trial scheme, the statistical plan is jointly formulated, finalized before the database is locked, and the tables for statistical analysis are developed.

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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