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注册号： Registration number：	ChiCTR1900028580
最近更新日期： Date of Last Refreshed on：	2019-12-28 15:12:49
注册时间： Date of Registration：	2019-12-28 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	The manifestation level of motoric skills in patients with pain in different parts of the body
Public title：	The manifestation level of motoric skills in patients with pain in different parts of the body
注册题目简写：
English Acronym：
研究课题的正式科学名称：	Osteopathic Manual Treatment vs. Kaltenborn-Evjenth Orthopedic Manual Therapy for chronic low back pain: A pilot randomized controlled trial
Scientific title：	Osteopathic Manual Treatment vs. Kaltenborn-Evjenth Orthopedic Manual Therapy for chronic low back pain: A pilot randomized controlled 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：	Joanna Bukowska
Applicant：	Pawel Lizis	Study leader：	Joanna Bukowska
申请注册联系人电话： Applicant telephone：	+48 663793834	研究负责人电话： Study leader's telephone：	+48 89 523 3419
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：	joanna.bukowska@uwm.edu.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：	1 Grottgera Street, Olsztyn, Warmian-Masurian Voivodeship, Poland	研究负责人通讯地址：	5 Oczapowskiego Street, Olsztyn, Warmian-Masurian Voivodeship, Poland
Applicant address：	1 Grottgera Street, Olsztyn, Warmian-Masurian Voivodeship, Poland	Study leader's address：	5 Oczapowskiego Street, Olsztyn, Warmian-Masurian Voivodeship, Poland
申请注册联系人邮政编码： Applicant postcode：	30-035 Cracow	研究负责人邮政编码： Study leader's postcode：	10-719 Olsztyn
申请人所在单位：	波兰克拉科夫健康促进学院
Applicant's institution：	Cracow College of Health Promotion
研究负责人所在单位：	波兰克拉科夫健康促进学院
Affiliation of the Leader：	Cracow College of Health Promotion

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：	9/2018	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 Scientific Research Ethics Committee
Name of the ethic committee：	The Scientific Research Ethics Committee
伦理委员会批准日期： Date of approved by ethic committee：	2019-12-17 00:00:00
伦理委员会联系人：	University of Warmia and Mazury
Contact Name of the ethic committee：	University of Warmia and Mazury
伦理委员会联系地址：	2 Oczapowskiego Street, 10-719 Olsztyn, Warmian-Masurian Voivodeship, Poland
Contact Address of the ethic committee：	2 Oczapowskiego Street, 10-719 Olsztyn, Warmian-Masurian Voivodeship, Poland
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：

波兰瓦米亚和马祖里大学

Primary sponsor：

University of Warmia and Mazury

研究实施负责（组长）单位地址：

5 Oczapowskiego Street, 10-719 Olsztyn, Warmian-Masurian Voivodeship, Poland

Primary sponsor's address：

5 Oczapowskiego Street, 10-719 Olsztyn, Warmian-Masurian Voivodeship, Poland

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	波兰	省(直辖市)：	Malopolska	市(区县)：	Krzeszowice
Country：	Poland	Province：	Malopolska	City：	Krzeszowice
单位(医院)：	Physiotherapy Center of the Motion System	具体地址：	1 Daszyńskiego Street, 32-065
Institution hospital：	Physiotherapy Center of the Motion System	Address：	1 Daszyńskiego Street, 32-065

经费或物资来源：

Physiotherapy Center of the Motion System

Source(s) of funding：

Physiotherapy Center of the Motion System

研究疾病：

patients with pain in different parts of the body

Target disease：

patients with pain in different parts of the body

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：

I期临床试验

Study phase：

1

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

To compare the effectiveness of OMT vs. KEOMT on pain and disability in people suffering from chronic LBP.

Objectives of Study：

To compare the effectiveness of OMT vs. KEOMT on pain and disability in people suffering from chronic LBP.

药物成份或治疗方案详述：

The OMT protocol will be limited to the to the following OMT techniques: direct techniques ? high-velocity/low-amplitude (HVLA); muscle energy (ME), indirect techniques strain and counterstrain techniques (SCS), combined techniques ? myofascial release treatment (MFR); visceral manipulative treatment (VIS). The KEOMT will be included lumbar segmental traction, and lumbar segmental mobilization (ie, flexion, extension, and gliding therapy grade 3).

Description for medicine or protocol of treatment in detail：

The OMT protocol will be limited to the to the following OMT techniques: direct techniques ? high-velocity/low-amplitude (HVLA); muscle energy (ME), indirect techniques strain and counterstrain techniques (SCS), combined techniques ? myofascial release treatment (MFR); visceral manipulative treatment (VIS). The KEOMT will be included lumbar segmental traction, and lumbar segmental mobilization (ie, flexion, extension, and gliding therapy grade 3).

纳入标准：

Inclusion criteria

排除标准：

The patients will be excluded if they report histories of any of the following ones: recent low back surgery, receipt of workers compensation benefits or ongoing litigation involving back problems, medical conditions that might impede OMT or KEOMT protocol implementation, corticosteroid use in the past month, use of manual therapy in the past three months or more than three times in the past year.

Exclusion criteria：

The patients will be excluded if they report histories of any of the following ones: recent low back surgery, receipt of workers compensation benefits or ongoing litigation involving back problems, medical conditions that might impede OMT or KEOMT protocol implementation, corticosteroid use in the past month, use of manual therapy in the past three months or more than three times in the past year.

研究实施时间：

Study execute time：

从 From 2020-02-15 00:00:00至 To 1990-01-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2020-01-07 00:00:00 至 To 1990-01-01 00:00:00

干预措施：

Interventions：

组别：	Two treatment groups	样本量：	34
Group：	Two treatment groups	Sample size：	34
干预措施：	OMT vs. KEOMT	干预措施代码：
Intervention：	OMT vs. KEOMT	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	波兰	省(直辖市)：	Malopolska	市(区县)：	Krzeszowice
Country：	Poland	Province：	Malopolska	City：	Krzeszowice
单位(医院)：	Physiotherapy Center of the Motion System	单位级别：	Regional Hospital
Institution hospital：	Physiotherapy Center of the Motion System	Level of the institution：	Regional Hospital

测量指标：

Outcomes：

指标中文名：	Numeric Pain Rating Scale	指标类型：	主要指标
Outcome：	Numeric Pain Rating Scale	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	Oswestry Disability Index	指标类型：	附加指标
Outcome：	Oswestry Disability Index	Type：	Additional 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：	无	组织：
Sample Name：	No	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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：

最小 Min age	40	岁 years
最大 Max age	60	岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

A simple randomization scheme generated with 1:1 ratio. Independent assessor.

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

A simple randomization scheme generated with 1:1 ratio. Independent assessor.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：
Blinding：	Assessor blinded.
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	After data acquisition and data entry (expected in April 2010), 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 April 2010), 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：	有/Yes
注册人： Name of Registration：	2019-12-28 15:12:49