Research on the Development and Promotion of Mulligan Technique Combined with Ladder Suspension Training for the Treatment of Non-specific Low Back Pain

注册号:

Registration number:

ITMCTR2024000849

最近更新日期:

Date of Last Refreshed on:

2024-12-21

注册时间:

Date of Registration:

2024-12-21

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

Mulligan技术结合阶梯式悬吊训练治疗非特异性下腰疼的开发与推广研究

Public title:

Research on the Development and Promotion of Mulligan Technique Combined with Ladder Suspension Training for the Treatment of Non-specific Low Back Pain

注册题目简写:

English Acronym:

研究课题的正式科学名称:

Mulligan技术结合阶梯式悬吊训练治疗非特异性下腰疼的开发与推广研究

Scientific title:

Research on the Development and Promotion of Mulligan Technique Combined with Ladder Suspension Training for the Treatment of Non-specific Low Back Pain

研究课题的正式科学名称简写:

Scientific title acronym:

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:

申请注册联系人:

罗振宇

研究负责人:

高新

Applicant:

Luo zhenyu

Study leader:

Gao xin

申请注册联系人电话:

Applicant telephone:

13076707124

研究负责人电话:

Study leader's telephone:

13737096931

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:

862050871@qq.com

研究负责人电子邮件:

Study leader's E-mail:

1027790131@qq.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:

广西壮族自治区南宁市青秀区仙葫大道西327号

研究负责人通讯地址:

广西壮族自治区南宁市青秀区仙葫大道西327号

Applicant address:

No. 327 Xianhu Avenue West Qingxiu District Nanning City Guangxi Zhuang Autonomous Region People's Republic of China.

Study leader's address:

No. 327 Xianhu Avenue West Qingxiu District Nanning City Guangxi Zhuang Autonomous Region People's Republic of 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:

广西中医药大学第一附属医院

Applicant's institution:

The First Affiliated Hospital of Guangxi University of 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:

2023-004-02

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:

广西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 Guangxi University of Chinese Medicine.

伦理委员会批准日期:

Date of approved by ethic committee:

2023/5/8 0:00:00

伦理委员会联系人:

黎军宏

Contact Name of the ethic committee:

Li junhong

伦理委员会联系地址:

广西壮族自治区南宁市青秀区东葛路89-9号

Contact Address of the ethic committee:

No. 89-9 Dongge Road Qingxiu District Nanning City Guangxi Zhuang Autonomous Region People's Republic of China.

伦理委员会联系人电话:

Contact phone of the ethic committee:

0771-5623553

伦理委员会联系人邮箱:

Contact email of the ethic committee:

862050871@qq.com

研究实施负责(组长)单位:

广西壮族自治区南宁市青秀区东葛路89-9号

Primary sponsor:

No. 89-9 Dongge Road Qingxiu District Nanning City Guangxi Zhuang Autonomous Region People's Republic of China.

研究实施负责(组长)单位地址:

广西壮族自治区南宁市青秀区仙葫大道西327号

Primary sponsor's address:

Ethics Committee of The First Affiliated Hospital of Guangxi 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):

广西壮族自治区

市(区县):

Country:

china

Province:

Nanning City Guangxi Zhuang Autonomous Region People's Republic of China

City:

单位(医院):

广西中医药大学第一附属医院

具体地址:

广西壮族自治区南宁市青秀区东葛路89-9号

Institution
hospital:

The First Affiliated Hospital of Guangxi University of Chinese Medicine.

Address:

No. 89-9 Dongge Road Qingxiu District Nanning City Guangxi Zhuang Autonomous Region People's Republic of China.

经费或物资来源:

广西医疗卫生适宜技术开发与推广应用,基金号S2022052

Source(s) of funding:

Guangxi Medical and Health Appropriate Technology Development and Promotion Application Grant Number S2022052.

研究疾病:

非特异性下腰痛

研究疾病代码:

Target disease:

nonspecific low back pain

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:

其它

Others

研究目的:

本研究使用Mulligan技术与阶梯式悬吊训练相结合治疗非特异性下腰痛,评估临床疗效,以提高疗效、改善腰部的运动功能和降低复发率

Objectives of Study:

This study uses a combination of Mulligan technique and stepwise suspension training to treat nonspecific low back pain evaluating clinical efficacy to enhance effectiveness improve lumbar function and reduce recurrence rates.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

①18~70岁符合非特异性下腰痛诊断的患者。 ②疼痛来源于躯体牵涉痛或非根性痛(膝盖以上)。

Inclusion criteria

① Patients aged 18 to 70 who meet the diagnosis criteria for non-specific lower back pain. ② The pain originates from somatic referred pain or non-radicular pain (above the knee).

排除标准:

1、18 岁以下患者; 2、特异性下腰痛(肿瘤、感染、代谢性疾病、类风湿性关节炎、骨折); 3、脊柱畸形(脊柱滑脱、峡部裂或脊柱侧弯); 4、膝盖以下部位疼痛; 5、脊髓外疾病(例如血管、泌尿生殖系统疾病); 6、有腰椎手术史; 7、存在根性症状; 8、腰痛伴 2 个或以上其他部位疼痛; 9、妊娠。

Exclusion criteria:

1. Patients under 18 years old; 2. Specific low back pain (tumors infections metabolic diseases rheumatoid arthritis fractures); 3. Spinal deformities (spondylolisthesis spondylolysis or scoliosis); 4. Pain below the knees; 5. Extramedullary diseases (e.g. vascular urogenital system diseases); 6. History of lumbar surgery; 7. Presence of radicular symptoms; 8. Low back pain accompanied by pain in two or more other areas; 9. Pregnancy.

研究实施时间:

Study execute time:

From 2023-01-01

To      2025-12-31

征募观察对象时间:

Recruiting time:

From 2023-05-09

To      2024-06-30

干预措施:

Interventions:

组别:

对照组

样本量:

47

Group:

Control group

Sample size:

干预措施:

Mulligan技术结合普通腰背肌锻炼

干预措施代码:

Intervention:

Mulligan technique combined with general lumbar and back muscle exercises.

Intervention code:

组别:

治疗组

样本量:

47

Group:

Treatment group

Sample size:

干预措施:

Mulligan技术结合阶梯式悬吊训练

干预措施代码:

Intervention:

Mulligan technique combined with stepwise suspension training

Intervention code:

样本总量 Total sample size : 94

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

广西壮族自治区

市(区县):

Country:

china

Province:

Nanning City Guangxi Zhuang Autonomous Region People's Republic of China

City:

单位(医院):

广西中医药大学第一附属医院

单位级别:

广西壮族自治区南宁市青秀区东葛路89-9号

Institution/hospital:

The First Affiliated Hospital of Guangxi University of Chinese Medicine.

Level of the institution:

No. 89-9 Dongge Road Qingxiu District Nanning City Guangxi Zhuang Autonomous Region People's Republic of China.

测量指标:

Outcomes:

指标中文名:

JOA评分

指标类型:

次要指标

Outcome:

JOA score

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

vas评分

指标类型:

次要指标

Outcome:

VAS score:

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

表面肌电图记录的治疗前后两侧竖脊肌RMS值

指标类型:

主要指标

Outcome:

RMS values of the bilateral erector spinae muscles recorded by surface electromyography before and after treatment.

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

有效率

指标类型:

主要指标

Outcome:

Effective rate

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:

组织:

Sample Name:

Not collected

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:

正在进行

Recruiting

年龄范围:

最小 18
Min age years
最大 70
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):

选取2023年1月至2024年6月至广西中医药大学第一附属医院康复科招募的非特异性下腰痛患者94例,使用随机数字表法,由电脑生成随机数字表,分为治疗组及对照组各47例,所有受试者均签署知情同意书,并符合诊断标准、纳入标准、排除标准,剔除标准。

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

A total of 94 patients with non-specific low back pain recruited from the Rehabilitation Department of the First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine between January 2023 and June 2024 were selected. Using a random number table method generated by the computer they were divided into a treatment group and a control group with 47 cases in each group. All participants signed informed consent forms and met the diagnostic criteria inclusion criteria exclusion criteria and disqualification criteria.

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):

http://itmctr.ccebtcm.org.cn/

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

http://itmctr.ccebtcm.org.cn/

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:

病例记录表

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

Case record form

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):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above