今天是:2022-08-12 星期五

冯氏正骨与麦特兰德关节松动术对慢性腰痛患者的疗效比较
下载XML文档

注册号:

Registration number:

ChiCTR2200061884 

最近更新日期:

Date of Last Refreshed on:

2022-07-27 

注册时间:

Date of Registration:

2022-07-06 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

冯氏正骨与麦特兰德关节松动术对慢性腰痛患者的疗效比较 

Public title:

Comparison of Chinese Osteopathy with Maitland mobilization in management of chronic non-specific low back pain 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

冯氏正骨与麦特兰德关节松动术对慢性腰痛患者的疗效比较 

Scientific title:

Comparison of Chinese Osteopathy with Maitland mobilization in management of chronic non-specific low back pain 

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:

龚成 

研究负责人:

龚成 

Applicant:

ChengGong 

Study leader:

ChengGong 

申请注册联系人电话:

Applicant telephone:

18600213168 

研究负责人电话:

Study leader's telephone:

18600213168 

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:

234108386@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

234108386@qq.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:

北京市西城区永安路95号首都医科大学附属北京友谊医院康复医学科 

研究负责人通讯地址:

北京市西城区永安路95号首都医科大学附属北京友谊医院康复医学科 

Applicant address:

Department of Rehabilitation Medicine, Beijing Friendship Hospital, Capital Medical University, No. 95, Yong An Street, Xi Cheng District, Beijing 

Study leader's address:

Department of Rehabilitation Medicine, Beijing Friendship Hospital, Capital Medical University, No. 95, Yong An Street, Xi Cheng 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:

首都医科大学附属北京友谊医院 

Applicant's institution:

Beijing Friendship Hospital, Capital Medical University 

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:

2022-P2-190-01 

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:

首都医科大学附属北京友谊医院生命伦理委员会 

Name of the ethic committee:

Bioethics Committee of Beijing Friendship Hospital ,Capital Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2022-06-14 

伦理委员会联系人:

李悦 

Contact Name of the ethic committee:

Yue Li 

伦理委员会联系地址:

北京市西城区永安路95号首都医科大学附属北京友谊医院 

Contact Address of the ethic committee:

Beijing Friendship Hospital, Capital Medical University, No. 95, Yong An Street, Xi Cheng District, Beijing 

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:

龚成 

Primary sponsor:

ChengGong 

研究实施负责(组长)单位地址:

北京市西城区永安路95号首都医科大学附属北京友谊医院康复医学科 

Primary sponsor's address:

Department of Rehabilitation Medicine, Beijing Friendship Hospital, Capital Medical University, No. 95, Yong An Street, Xi Cheng 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(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京友谊医院

具体地址:

西城区永安路95号

Institution
hospital:

Beijing Friendship Hospital, Capital Medical University

Address:

No. 95, Yong An Street, Xi Cheng District, Beijing

经费或物资来源:

首都医科大学附属北京友谊医院科研启动基金 

Source(s) of funding:

Research Foundation of Beijing Friendship Hospital,Capital Medical University(NO.yyqdkt2020-17) 

研究疾病:

慢性非特异性腰痛 

Target disease:

chronic nonspecific low back pain 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

比较冯氏脊柱关节手法与麦特兰德脊柱关节松动技术的临床疗效:对于疼痛、功能障碍以及活动度的影响,以期为慢性非特异性下腰痛患者的全面康复治疗提供依据。 

Objectives of Study:

this study aims to compare the effects of the FSM and MM on the pain, dysfunction, psychological state and range of motion in patients with CNLBP, in order to provide evidence for the clinical treatment of chronic nonspecific low back pain.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

病例对照研究 

Study design:

Case-Control study 

纳入标准:

①年龄18~68岁; ②符合慢性非特异性腰痛的诊断标准[8]; ③病史>3个月; ④症状在膝关节以上,症状不低于膝关节 ⑤VAS评分≥2 ⑥在临床实践中,接受过FSM或MM ,以及都接受了运动疗法治疗的患者。 

Inclusion criteria

(1)males and females with ages between 18 and 68 years old; (2)suffering from low back pain for more than 12 weeks; (3)with or without leg pain above the knee; (4)pain on numeric pain rating scale (NPRS)≥ 2/10; (5)in chlinical practice,patients recieved FMS or MM,and they all received exercise therapy. 

排除标准:

①MRI显示腰椎滑脱、腰椎间盘脱出; ②神经病变:脊髓及神经根受压刺激、症状在膝关节以下;脊髓及神经根肿瘤、马尾神经损伤等神经系统病变症状期; ③脊柱病变:脊柱肿瘤,脊柱椎体及附件的新鲜骨折,严重骨质疏松、脊柱失稳等; ④心血管疾病:严重高血压、心血管疾病症状期、主动脉瘤等; ⑤代谢性疾病; ⑥较大外科手术恢复期; ⑦急性感染或妊娠期等; 

Exclusion criteria:

Subjects with any previous surgery of the spine, history of spondylosis, spondylolisthesis, spine tumors, cauda equina syndrome, signs of neurological deficit, slipped intervertebral discs, ankylosing spondylitis, spinal infection, or pregnancy 

研究实施时间:

Study execute time:

From2022-07-05To 2023-07-05 

征募观察对象时间:

Recruiting time:

From2022-07-05To 2022-08-05 

干预措施:

Interventions:

组别:

冯氏正骨组

样本量:

43

Group:

Feng’s Spinal Mobilization

Sample size:

干预措施:

冯氏正骨

干预措施代码:

1

Intervention:

Feng’s Spinal Mobilization

Intervention code:

组别:

麦特兰德关节松动组

样本量:

40

Group:

Maitland mobilization

Sample size:

干预措施:

麦特兰德关节松动

干预措施代码:

2

Intervention:

Maitland mobilization

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京友谊医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Friendship Hospital, Capital Medical University  

Level of the institution:

Grade-A Tertiary Hospital 

测量指标:

Outcomes:

指标中文名:

疼痛评分

指标类型:

主要指标 

Outcome:

VAS

Type:

Primary indicator 

测量时间点:

第一次治疗开始前和第三次治疗结束后

测量方法:

填写量表

Measure time point of outcome:

The measurements were taken before the first treatment and after the 3nd treatment

Measure method:

Questionnaire

指标中文名:

改良Oswestry量表

指标类型:

主要指标 

Outcome:

ODI

Type:

Primary indicator 

测量时间点:

第一次治疗开始前和第三次治疗结束后

测量方法:

填写量表

Measure time point of outcome:

The measurements were taken before the first treatment and after the 3nd treatment

Measure method:

Questionnaire

指标中文名:

腰椎前屈延展性测试

指标类型:

主要指标 

Outcome:

modified Schober test

Type:

Primary indicator 

测量时间点:

第一次治疗开始前和第三次治疗结束后

测量方法:

患者双脚分开约8cm站立,暴露腰骶部。治疗师取两侧髂后上棘中点为B点,向上取10 cm为A点,向下取5 cm为C点,测量AC之间的距离为d1;让患者自然站立位保持双腿直立下做无痛范围内的充分向前弯腰,再次测量AC之间的距离为d2,d=d2-d1。

Measure time point of outcome:

The measurements were taken before the first treatment and after the 3nd treatment

Measure method:

Each patient stood with their feet positioned 8 cm apart on a box. A blinded assessor marked 5 cm below and 10 cm above the lumbosacral junction, then each patient was instructed to actively flex forward as far as possible with the limit of painless and the knees extended. The change of dist

指标中文名:

腰椎屈、伸、侧屈活动度测试

指标类型:

主要指标 

Outcome:

Fingertip-to-floor test

Type:

Primary indicator 

测量时间点:

第一次治疗开始前和第三次治疗结束后

测量方法:

患者分别做前屈、后仰以及左右侧屈无痛时的最大范围动作。

Measure time point of outcome:

The measurements were taken before the first treatment and after the 3nd treatment

Measure method:

Firstly a tape measure was used to measure the the fingertips to the floor. Then the patient was asked to bent forward, reaching the fingertips toward the floor and the distance of of the fingertips to the floor is measured again. With the patient standing on the box, it was possible to obta

指标中文名:

抑郁自评量表

指标类型:

次要指标 

Outcome:

patient health questionaire-9

Type:

Secondary indicator 

测量时间点:

第一次治疗开始前和第三次治疗结束后

测量方法:

填写量表

Measure time point of outcome:

The measurements were taken before the first treatment and after the 3nd treatment

Measure method:

Questionnaire

指标中文名:

直腿抬高高度

指标类型:

次要指标 

Outcome:

Straight leg raise

Type:

Secondary indicator 

测量时间点:

第一次治疗开始前和第三次治疗结束后

测量方法:

患者仰卧位,患者无痛范围内直腿抬高高度(外踝离床面距离)。

Measure time point of outcome:

The measurements were taken before the first treatment and after the 3nd treatment

Measure method:

The patient was in supine position. The patient was asked to active raise the lower limb, Then the height of lateral malleolus to the bed was measured by a tape.

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

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

none

盲法:

Blinding:

是否共享原始数据:

IPD sharing

否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):

none

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

none

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:

none

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2022-07-06
返回列表