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Effect of Three Different Physical Therapy Approaches on Function and Disability of The Knee Joint in Patients with Knee Osteoarthritis.
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注册号:

Registration number:

ChiCTR-INR-17014012 

最近更新日期:

Date of Last Refreshed on:

2017-12-18 

注册时间:

Date of Registration:

2017-12-18 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

膝关节骨性关节炎三种不同物理治疗方法对膝关节功能和残疾的影响 

Public title:

Effect of Three Different Physical Therapy Approaches on Function and Disability of The Knee Joint in Patients with Knee Osteoarthritis. 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

膝关节骨性关节炎三种不同物理治疗方法对膝关节功能和残疾的影响 

Scientific title:

Effect of Three Different Physical Therapy Approaches on Function and Disability of The Knee Joint in Patients with Knee Osteoarthritis.  

研究课题代号(代码):

Study subject ID:

Tongji 12- 2017 

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:

艾哈迈德 

研究负责人:

陆敏 

Applicant:

Ahmed Youssef 

Study leader:

Min Lu 

申请注册联系人电话:

Applicant telephone:

+86 13260654401 

研究负责人电话:

Study leader's telephone:

+86 13971268939 

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:

i201622099@hust.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

lumin.tj@aliyun.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:

中国湖北武汉硚口区解放大道1095号 

研究负责人通讯地址:

中国湖北武汉硚口区解放大道1095号 

Applicant address:

1095 Jiefang Avenue, Qiaokou District, Wuhan, Hubei, China. 

Study leader's address:

1095 Jiefang Avenue, Qiaokou District, Wuhan, Hubei, China. 

申请注册联系人邮政编码:

Applicant postcode:

430030 

研究负责人邮政编码:

Study leader's postcode:

430030 

申请人所在单位:

华中科技大学同济医学院 

Applicant's institution:

Tongji Medical College 

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:

TJ-IRB20170703 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

同济医院伦理委员会 

Name of the ethic committee:

ETHICAL Commitee of Tongji Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

同济医院伦理委员会 

Contact Name of the ethic committee:

ETHICAL Commitee of Tongji Hospital 

伦理委员会联系地址:

中国湖北武汉硚口区解放大道1095号 

Contact Address of the ethic committee:

1095 Jiefang rode,Wuhan, 430030, 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:

同济医院 

Primary sponsor:

Tongji Hospital 

研究实施负责(组长)单位地址:

中国湖北武汉硚口区解放大道1095号 

Primary sponsor's address:

1095 Jiefang rode,Wuhan, 430030, 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):

湖北

市(区县):

武汉

Country:

China

Province:

Hubei

City:

wuhan

单位(医院):

同济医院

具体地址:

中国湖北武汉硚口区解放大道1095号

Institution
hospital:

Tongji Medical College

Address:

1095 Jiefang rode,Wuhan, 430030, China

经费或物资来源:

同济医院 

Source(s) of funding:

Tongji Hospital 

研究疾病:

膝关节骨性关节炎 

Target disease:

knee osteoarthritis 

研究疾病代码:

 

Target disease code:

 

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:

研究三种物理治疗方法对膝关节骨性关节炎患者膝关节活动度、疼痛程度、肌力和功能状态的影响。 

Objectives of Study:

study investigated the effect of three physical therapy approaches on knee range of motion (ROM), pain level, muscle strength and functional condition in patients with knee osteoarthritis. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机抽样 

Study design:

Randomly Sampling 

纳入标准:

纳入标准包括基于放射学和临床诊断标准的单侧膝关节骨性关节炎,患者可在不平坦的表面上行走100米以上,膝关节疼痛持续超过6个月,膝关节屈曲度超过15度。 

Inclusion criteria

The inclusion criteria included unilateral knee osteoarthritis based on the radiological and clinical criteria for osteoarthritis diagnosis, the patients can walk for 100m or more on a surface that is uneven, they have knee pain lasting over 6 months and they have a limitation in knee flexion ROM more than 15 degrees  

排除标准:

排除标准:下肢在过去的6个月内有手术史,在关节软骨,类固醇或注射透明质酸糖尿病、交际、认知障碍、先天性畸形、心脏病、神经系统疾病、不稳定型心绞痛,完全或部分的髋关节或膝关节置换术,未控制的高血压、呼吸系统疾病、创伤的情况下,肌肉骨骼系统疾病、慢性肾病、肝病、脑卒中患者。 

Exclusion criteria:

The exclusion criteria included any surgical history in the last 6 months on lower extremities, injection of steroids or hyaluronic acid in the articular cartilage, diabetes mellitus, communicative or cognitive impairments, congenital abnormalities, heart problems, neurological disease, unstable angina, total or partial hip or knee replacement, uncontrolled hypertension, traumatic conditions, respiratory diseases, musculoskeletal diseases, chronic kidney or liver diseases and stroke patients. 

研究实施时间:

Study execute time:

From2017-07-04To 2018-04-04 

干预措施:

Interventions:

组别:

A

样本量:

24

Group:

Group A

Sample size:

干预措施:

physical agents and isometric quadriceps exercises

干预措施代码:

Intervention:

physical agents and isometric quadriceps exercises

Intervention code:

组别:

B

样本量:

24

Group:

Group B

Sample size:

干预措施:

They received the same physical agents as group A in addition to OKC exercises.

干预措施代码:

Intervention:

They received the same physical agents as group A in addition to OKC exercises.

Intervention code:

组别:

C

样本量:

24

Group:

Group C

Sample size:

干预措施:

received the same physical agents as group A performed CKC exercises.

干预措施代码:

Intervention:

received the same physical agents as group A performed CKC exercises.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

同济医院 

单位级别:

三甲医院 

Institution
hospital:

Tongji Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

Knee ROM measurement

指标类型:

主要指标 

Outcome:

Knee ROM measurement

Type:

Primary indicator 

测量时间点:

at 0 days and after 5 weeks.

测量方法:

Measure time point of outcome:

at 0 days and after 5 weeks.

Measure method:

指标中文名:

Knee pain measurement

指标类型:

主要指标 

Outcome:

Knee pain measurement

Type:

Primary indicator 

测量时间点:

at 0 days and after 5 weeks.

测量方法:

Measure time point of outcome:

at 0 days and after 5 weeks.

Measure method:

指标中文名:

Muscle strength

指标类型:

主要指标 

Outcome:

Muscle strength

Type:

Primary indicator 

测量时间点:

at 0 days and after 5 weeks.

测量方法:

Measure time point of outcome:

at 0 days and after 5 weeks.

Measure method:

指标中文名:

Knee functional condition

指标类型:

主要指标 

Outcome:

Knee functional condition

Type:

Primary indicator 

测量时间点:

at 0 days and after 5 weeks.

测量方法:

Measure time point of outcome:

at 0 days and after 5 weeks.

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

knee

Tissue:

knee joint

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:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 40 years
最大 Max age 70 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):

他们随机采用随机置换块完成三组间样本量的平衡。随机化是由一个没有参与这项研究的大学工作人员完成的,结果评估也与小组的类型无关。

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

They were randomized by using randomized permuted blocks to accomplish the balance of the sample sizes among the three groups. The randomization was done by a college’s staff who wasn’t involved in this study, performed the outcome assessments were also blinded to group’s types.

盲法:

Blinding:

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

Not stated

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

Not stated

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:

Patient’s recruitment All patients in this study were chosen from Rehabilitation medicine and physical therapy clinic, Tongji Hospital, HUST University, Wuhan, China. Eighty six patients were initially examined. The inclusion criteria included unilateral knee osteoarthritis based on the radiological and clinical criteria for osteoarthritis diagnosis, the patients can walk for 100m or more on a surface that is uneven, they have knee pain lasting over 6 months and they have a limitation in knee flexion ROM more than 15 degrees (14,18). The exclusion criteria included any surgical history in the last 6 months on lower extremities, injection of steroids or hyaluronic acid in the articular cartilage, diabetes mellitus, communicative or cognitive impairments, congenital abnormalities, heart problems, neurological disease, unstable angina, total or partial hip or knee replacement, uncontrolled hypertension, traumatic conditions, respiratory diseases, musculoskeletal diseases, chronic kidney or liver diseases and stroke patients (19). Fourteen patients were excluded after the initial examination, they included eight patients (10 %) did not meet the inclusion criteria and six patients (7.5%) assessed only at the baseline and didn’t continue the study. The patients that didn’t meet the inclusion criteria were having a total hip replacement (2) uncontrolled hypertension (3) unstable angina. Seventy-two patients who fulfilled all criteria, their age ranged from 40 to 70 years old. They were randomized by using randomized permuted blocks to accomplish the balance of the sample sizes among the three groups. The randomization was done by a college’s staff who wasn’t involved in this study, performed the outcome assessments were also blinded to group’s types. The three groups included group A (n=24) (physical agents and isometric quadriceps muscle exercises) and group B (n=24) (physical agents and OKC) and group C (n=24) (physical agents and CKC). The patients were examined both at the baseline and after 5 weeks of treatment. The physical therapy program for three groups was equal in time (60 min/session, 3seesions/week for 5 weeks)

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

Data analysis Descriptive statistics including mean and standard deviation were conducted to show the distribution of age, BMI, gender, pain history, level of activity, knee ROM, VAS, quadriceps muscle strength and functional condition among the study patients of three groups. ANOVA test was used to test within-group analysis and between group analysis. Shapiro-Wilk's test (P> .05) (27) was used to detect the normal distribution of the data. This supports our used parametric statistical method. Post-hoc analysis based on Tukey HSD was performed to compare the results after the treatment. The significance level was established at less than 0.05. The SPSS (ver. 24, IBM Inc., Armonk, NY, USA) was used for statistical analysis in this study.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2017-12-18
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