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Two methods of treatment for knee osteoarthritis
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注册号:

Registration number:

ChiCTR-IIR-16009240 

最近更新日期:

Date of Last Refreshed on:

2016-09-21 

注册时间:

Date of Registration:

2016-09-21 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

Two methods of treatment for knee osteoarthritis 

Public title:

Two methods of treatment for knee osteoarthritis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

Manual Therapy combined with Cryotherapy versus Kinesiotherapy combined with Cryotherapy for knee osteoarthritis treatment: a randomized trial 

Scientific title:

Manual Therapy combined with Cryotherapy versus Kinesiotherapy combined with Cryotherapy for knee osteoarthritis treatment: a randomized trial 

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:

Pawel Lizis 

研究负责人:

Pawel Lizis 

Applicant:

Pawel Lizis 

Study leader:

Pawel Lizs 

申请注册联系人电话:

Applicant telephone:

+48 6 63793834 

研究负责人电话:

Study leader's telephone:

+48 6 63793834 

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:

pawel_lizis@poczta.onet.pl 

研究负责人电子邮件:

Study leader's E-mail:

pawel_lizis@poczta.onet.pl 

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:

51, Mielczarskiego Str., Kielce, Poland 

研究负责人通讯地址:

51, Mielczarskiego Str., Kielce, Poland 

Applicant address:

51, Mielczarskiego Str., Kielce, Poland 

Study leader's address:

51, Mielczarskiego Str., Kielce, Poland 

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:

Holy Cross College 

Applicant's institution:

Holy Cross 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:

03/072016KB 

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:

The Holy Cross College Ethics Committee 

Name of the ethic committee:

The Holy Cross College Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

The Holy Cross College 

Primary sponsor:

The Holy Cross College 

研究实施负责(组长)单位地址:

51, Mielczarskiego Str., Kielce, Poland 

Primary sponsor's address:

51, Mielczarskiego Str., Kielce, Poland 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

Poland

省(直辖市):

Sliesia

市(区县):

Country:

Poland

Province:

Sliesia

City:

Bielsko-Biala

单位(医院):

Bielski College named after Tyszkiewicz

具体地址:

12, Nadbrzena Str., Bielsko-Biala

Institution
hospital:

Bielski College named after Tyszkiewicz

Address:

12, Nadbrzena Str., Bielsko-Biala

经费或物资来源:

The Holy Cross College 

Source(s) of funding:

The Holy Cross College 

研究疾病:

knee osteoarthritis 

Target disease:

knee osteoarthritis 

研究疾病代码:

knee OA 

Target disease code:

knee OA 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

I期临床试验 

Study phase:

研究目的:

Comparison of the effects of Manual Therapy combined with Cryotherapy versus Kinesiotherapy combined with Cryotherapy on severity of knee pain evaluated by the Visual Analogue Scale, on perceived health evaluated by the Western Ontario and McMaster Universities Questionnaire (WOMAC) Osteoarthritis Index, on range of motion (ROM) of the knees evaluated by a goniometer and also on functional exercise capacity evaluated by the Six-Minute Walk Test (6-MWT). 

Objectives of Study:

Comparison of the effects of Manual Therapy combined with Cryotherapy versus Kinesiotherapy combined with Cryotherapy on severity of knee pain evaluated by the Visual Analogue Scale, on perceived health evaluated by the Western Ontario and McMaster Universities Questionnaire (WOMAC) Osteoarthritis Index, on range of motion (ROM) of the knees evaluated by a goniometer and also on functional exercise capacity evaluated by the Six-Minute Walk Test (6-MWT). 

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:

minimum age of 40, ability to perform physical exercises, not currently receiving any physical therapy treatments for the knee OA condition, medication compliance (all patients will be taking glucocorticoids at the time of the study), and the diagnosis of knee OA according to the American College of Rheumatology criteria 

Inclusion criteria

minimum age of 40, ability to perform physical exercises, not currently receiving any physical therapy treatments for the knee OA condition, medication compliance (all patients will be taking glucocorticoids at the time of the study), and the diagnosis of knee OA according to the American College of Rheumatology criteria 

排除标准:

bilateral knee OA; previous knee joint surgery; any surgical procedure of the lower limbs for the prior 6 months; initiation of opioid analgesia or cortico-steroid or analgesic injection intervention for knee pain within prior 30 days; rheumatoid arthritis of the knee; physical impairments preventing safe participation in exercise, manual therapy, walking or stationary cycling such as: uncontrolled hypertension or cardiovascular, pulmonary or endocrinology disease; vision problems that affect mobility, neurogenic disorder, primary or debilitating back pain, advanced osteoporosis, body mass >155kg, unable to 10m walking without an assistive device; insufficient communication ability to comprehend or comply with assessment interventions; stated inability to complete the proposed course of intervention and follow-up.  

Exclusion criteria:

bilateral knee OA; previous knee joint surgery; any surgical procedure of the lower limbs for the prior 6 months; initiation of opioid analgesia or cortico-steroid or analgesic injection intervention for knee pain within prior 30 days; rheumatoid arthritis of the knee; physical impairments preventing safe participation in exercise, manual therapy, walking or stationary cycling such as: uncontrolled hypertension or cardiovascular, pulmonary or endocrinology disease; vision problems that affect mobility, neurogenic disorder, primary or debilitating back pain, advanced osteoporosis, body mass >155kg, unable to 10m walking without an assistive device; insufficient communication ability to comprehend or comply with assessment interventions; stated inability to complete the proposed course of intervention and follow-up.  

研究实施时间:

Study execute time:

From2016-08-10To 2016-11-10 

征募观察对象时间:

Recruiting time:

From2016-08-10To 2016-08-24 

干预措施:

Interventions:

组别:

experimental group

样本量:

64

Group:

experimental group

Sample size:

干预措施:

Manual Therapy combined with Cryotherapy

干预措施代码:

Intervention:

Manual Therapy combined with Cryotherapy

Intervention code:

组别:

control group

样本量:

64

Group:

control group

Sample size:

干预措施:

Kinesiotherapy combined with Cryotherapy

干预措施代码:

Intervention:

Kinesiotherapy combined with Cryotherapy

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

Poland 

省(直辖市):

Swietokrzyskie 

市(区县):

 

Country:

Poland 

Province:

Swietokrzyskie 

City:

Sandomierz 

单位(医院):

Physiotherapy 

单位级别:

Regional Hospital, Sandomierz 

Institution
hospital:

Physiotherapy  

Level of the institution:

Regional Hospital, Sandomierz 

测量指标:

Outcomes:

指标中文名:

knee pain

指标类型:

主要指标 

Outcome:

knee pain

Type:

Primary indicator 

测量时间点:

baseline, post-intervention (5 weeks)

测量方法:

VAS

Measure time point of outcome:

baseline, post-intervention (5 weeks)

Measure method:

VAS

指标中文名:

perceived health

指标类型:

次要指标 

Outcome:

perceived health

Type:

Secondary indicator 

测量时间点:

baseline, post-intervention (5 weeks)

测量方法:

WOMAC

Measure time point of outcome:

baseline, post-intervention (5 weeks)

Measure method:

WOMAC

指标中文名:

range of motion of the knee

指标类型:

次要指标 

Outcome:

range of motion of the knee

Type:

Secondary indicator 

测量时间点:

baseline, post-intervention (5 weeks)

测量方法:

goniometer

Measure time point of outcome:

baseline, post-intervention (5 weeks)

Measure method:

goniometer

指标中文名:

functional exercise capacity

指标类型:

次要指标 

Outcome:

functional exercise capacity

Type:

Secondary indicator 

测量时间点:

baseline, post-intervention (5 weeks)

测量方法:

Six-Minute Walk Test (6-MWT)

Measure time point of outcome:

baseline, post-intervention (5 weeks)

Measure method:

Six-Minute Walk Test (6-MWT)

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

bedsheets

组织:

Sample Name:

bedsheets

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:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 40 years
最大 Max age 80 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):

Individuals who consent to take part in the study and fulfill all inclusion and exclusion criteria will be assigned on 1:1 ratio using a simple random number table into two treatment groups: a MT-C group and a KIN-C one.

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

Individuals who consent to take part in the study and fulfill all inclusion and exclusion criteria will be assigned on 1:1 ratio using a simple random number table into two treatment groups: a MT-C group and a KIN-C one.

盲法:

Blinding:

the people assessing the outcomes, and the people analyzing the results/data.

试验完成后的统计结果(上传文件):

点击下载

Calculated Results ater
the Study Completed(upload file):

download

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):

After data acquisition and data entry (expected in November 10th), the way: you can apply to view the original data.

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

After data acquisition and data entry (expected in November 10th), the way: you can apply to view the original data.

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:

Save:Excel; Entry: EpiData.The original file into the office.

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

Save:Excel; Entry: EpiData.The original file into the office.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-09-21
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