ChiCTR2100043262 版本V1.0 版本创建时间2021/05/28 20:22:12 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2100043262 

最近更新日期：

Date of Last Refreshed on：

 2021-02-09 07:32:34 

注册时间：

Date of Registration：

 2021-02-09 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Effect of Pilates group exercises on transversus abdominis, function and pain in females with chronic low back pain

Public title：

Effect of Pilates group exercises on transversus abdominis, function and pain in females with chronic low back pain

注册题目简写：

English Acronym：

EPGETA

研究课题的正式科学名称：

Effect of Pilates group exercises on transversus abdominis, function and pain in females with chronic low back pain

Scientific title：

Effect of Pilates group exercises on transversus abdominis, function and pain in females with chronic 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：

asaf 

研究负责人：

Youssef Masharawi 

Applicant：

asaf 

Study leader：

Youssef Masharawi 

申请注册联系人电话：

Applicant telephone：

 +97 25 43455468

研究负责人电话：

Study leader's
telephone：

+97 25 07288737

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：

 asafweisman@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 yossefm@tauex.tau.ac.il

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 Tel-Aviv University

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：

35 Klatchkin street, Tel-Aviv, Israel

研究负责人通讯地址：

35 Klatchkin street, Tel-Aviv, Israel

Applicant address：

35 Klatchkin street, Tel-Aviv, Israel

Study leader's address：

35 Klatchkin street, Tel-Aviv, Israel

申请注册联系人邮政编码：

Applicant postcode：

 6997801

研究负责人邮政编码：

Study leader's postcode：

 6997801

申请人所在单位：

以色列特拉维夫大学

Applicant's institution：

Tel-Aviv University

研究负责人所在单位：

以色列特拉维夫大学

Affiliation of the Leader：

Tel-Aviv 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：

 13.1.2013

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：

Tel-Aviv University IRB

Name of the ethic committee：

Tel-Aviv University IRB

伦理委员会批准日期：

Date of approved by ethic committee：

 2013-01-06 00:00:00

伦理委员会联系人：

Einat Berlowitz

Contact Name of the ethic committee：

Einat Berlowitz

伦理委员会联系地址：

以色列特拉维夫大学69978

Contact Address of the ethic committee：

Tel Aviv University campus, 69978, Tel-Aviv University, Israel

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +97 25 07288737

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 ethicsbe@tauex.tau.ac.il

研究实施负责（组长）单位：

No sponsor

Primary sponsor：

No sponsor

研究实施负责（组长）单位地址：

No sponsor

Primary sponsor's address：

No sponsor

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

No external funding was provided for this study

Source(s) of funding：

No external funding was provided for this study

研究疾病：

Chronic low back pain  

Target disease：

Chronic low back pain

研究疾病代码：

M54.5

Target disease code：

M54.5

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

研究设计：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

1) To examine whether Pilates group exercising have an effect on transversus abdominis (TrA) thickness, function and pain levels in females with non-specific chronic low back pain (NSCLBP). 2) to test a novel ultrasound procedure for measuring TrA Thickness.  

Objectives of Study：

1) To examine whether Pilates group exercising have an effect on transversus abdominis (TrA) thickness, function and pain levels in females with non-specific chronic low back pain (NSCLBP). 2) to test a novel ultrasound procedure for measuring TrA Thickness.

药物成份或治疗方案详述：

Following an explanation of the nature of the study, all volunteers signed a consent form and filled out a general health questionnaire aimed at establishing the capability of the subjects to participate in the study. Out of 98 potential females, 49 females were eventually included in the study. Out of the 49 females, 26 met the criteria of the females with NSCLBP whereas 23 healthy females were assigned to an active comparison group (Table 1). Informed consent was received prior to any testing in order to protect the rights of the subjects in accordance with the international good clinical practice rules. All potential participants were screened by a single examiner who reviewed their general health statements and liaised with them only once at the beginning of the study. Consequently, this examiner placed them into two groups: the NSCLBP group and an active healthy group. Following assignment to the groups, participants were then assessed by a different blinded examiner, a physical therapist with 12 years of experience and trained in US imaging. Examiner A collected the outcome measures in two assessments: once prior to the intervention and then once more following the intervention period. Intra and inter rater reliability tests were performed on the first 10 participants by two therapists (A and B), who had been trained in US imaging of the abdominal muscles. The intervention included biweekly sessions of 60 minutes over a period of 5 weeks (a total of 10 sessions). The exercises were selected from the classical Pilates repertoire including working with apparatus such as Cadillac, Reformer and Wunda chair and mattress. The same exercises were performed 10 times at each lesson, in the same order, according to the classic Pilates method. Every session began with 30 minutes of 16 mat exercises followed by 30 minutes of apparatus exercises in the following order (figures 2-3):10 exercises on the Reformer (ca. 15 minutes), 2 exercises on the Cadillac (ca. 5 minutes), 2 exercises on the Wunda Chair, and 2 exercises on the Ladder Barrel (ca. 5 minutes). All group lessons were conducted by two well-trained Pilates instructors, both with 5 years of experience and qualifications from the Pilates method alliance. All of the exercises employed in the study are thoroughly described in the supplementary material. TrA cross sections in three different locations were measured on both sides (right and left) using the “Mindray 6600” B-mode US unit with a convex 6MHz transducer. The participants were examined in a hook lying position. The examiner then placed the transducer between the 12th rib and the anterior aspect of the iliac crest so that the hyperechoic line between the TrA and the thoraco-lumbar fascia was positioned at the right end of the image. Before the examination, the ADIM was described to the patient according to existing protocols.17,18 The protocol was practiced once as recommended. Following a 5-minute break, testing resumed. In order to control the participants’ breathing, the ADIM was executed during exhalation and the image was acquired at the end of the normal exhalation. Three different locations were measured across the muscle from medial to lateral on both sides as follows: Location A at 10 mm from the fascial insertion, location B at 20mm from the fascial insertion and location C at 30 mm from the fascial insertion (Figure 1). TrA muscle thickness values while contracted were normalized based on the resting-thickness values as described previously.19 Accordingly, the TrA percent of change was calculated to assess the relative changes in muscle thickness using the following formula:{(TrA active – TrA rest)/TrA rest × 100.19 In addition, the results of the VAS scale and the Roland-Morris questionnaire (RMDQ) were included in the assessment of the NSCLBP group before and after the Pilates intervention.  

Description for medicine or protocol of treatment in detail：

Following an explanation of the nature of the study, all volunteers signed a consent form and filled out a general health questionnaire aimed at establishing the capability of the subjects to participate in the study. Out of 98 potential females, 49 females were eventually included in the study. Out of the 49 females, 26 met the criteria of the females with NSCLBP whereas 23 healthy females were assigned to an active comparison group (Table 1). Informed consent was received prior to any testing in order to protect the rights of the subjects in accordance with the international good clinical practice rules. All potential participants were screened by a single examiner who reviewed their general health statements and liaised with them only once at the beginning of the study. Consequently, this examiner placed them into two groups: the NSCLBP group and an active healthy group. Following assignment to the groups, participants were then assessed by a different blinded examiner, a physical therapist with 12 years of experience and trained in US imaging. Examiner A collected the outcome measures in two assessments: once prior to the intervention and then once more following the intervention period. Intra and inter rater reliability tests were performed on the first 10 participants by two therapists (A and B), who had been trained in US imaging of the abdominal muscles. The intervention included biweekly sessions of 60 minutes over a period of 5 weeks (a total of 10 sessions). The exercises were selected from the classical Pilates repertoire including working with apparatus such as Cadillac, Reformer and Wunda chair and mattress. The same exercises were performed 10 times at each lesson, in the same order, according to the classic Pilates method. Every session began with 30 minutes of 16 mat exercises followed by 30 minutes of apparatus exercises in the following order (figures 2-3):10 exercises on the Reformer (ca. 15 minutes), 2 exercises on the Cadillac (ca. 5 minutes), 2 exercises on the Wunda Chair, and 2 exercises on the Ladder Barrel (ca. 5 minutes). All group lessons were conducted by two well-trained Pilates instructors, both with 5 years of experience and qualifications from the Pilates method alliance. All of the exercises employed in the study are thoroughly described in the supplementary material. TrA cross sections in three different locations were measured on both sides (right and left) using the Mindray 6600 B-mode US unit with a convex 6MHz transducer. The participants were examined in a hook lying position. The examiner then placed the transducer between the 12th rib and the anterior aspect of the iliac crest so that the hyperechoic line between the TrA and the thoraco-lumbar fascia was positioned at the right end of the image. Before the examination, the ADIM was described to the patient according to existing protocols.17,18 The protocol was practiced once as recommended. Following a 5-minute break, testing resumed. In order to control the participants’ breathing, the ADIM was executed during exhalation and the image was acquired at the end of the normal exhalation. Three different locations were measured across the muscle from medial to lateral on both sides as follows: Location A at 10 mm from the fascial insertion, location B at 20mm from the fascial insertion and location C at 30 mm from the fascial insertion (Figure 1). TrA muscle thickness values while contracted were normalized based on the resting-thickness values as described previously.19 Accordingly, the TrA percent of change was calculated to assess the relative changes in muscle thickness using the following formula:{(TrA active – TrA rest)/TrA rest × 100.19 In addition, the results of the VAS scale and the Roland-Morris questionnaire (RMDQ) were included in the assessment of the NSCLBP group before and after the Pilates intervention.  

纳入标准：

adult females (21-65 years old) who have been suffering from nonspecific central LBP1 for>12 weeks

Inclusion criteria

adult females (21-65 years old) who have been suffering from nonspecific central LBP1 for>12 weeks

排除标准：

pregnancy, BMI >30, spine or abdominal operations, trauma, spondyloarthropathies, neurological symptoms in the limbs, neurological diseases, any ongoing physical exercise program, any previous treatments or medication during the last three months and any experience with the Pilates method.

Exclusion criteria：

pregnancy, BMI >30, spine or abdominal operations, trauma, spondyloarthropathies, neurological symptoms in the limbs, neurological diseases, any ongoing physical exercise program, any previous treatments or medication during the last three months and any experience with the Pilates method.

研究实施时间：

Study execute time：

从 From 2013-03-15 00:00:00至 To 2013-07-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2013-03-01 00:00:00 至 To 2013-03-31 00:00:00

干预措施：

Interventions：

组别：

Two groups

样本量：

 40

Group：

Two groups

Sample size：

干预措施：

Pilates group exercises versus control

干预措施代码：

Intervention：

Pilates group exercises versus control

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 以色列

省(直辖市)：

 Dan Metropolin 

市(区县)：

 特拉维夫 

Country：

Israel

Province：

Dan Metropolin

City：

Tel-Aviv

单位(医院)：

 特拉维夫大学 

单位级别：

 大学 

Institution
hospital：

Tel-Aviv university campus

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Pain levels

指标类型：

主要指标

Outcome：

Pain levels

Type：

Primary indicator

测量时间点：

6 weeks

测量方法：

VAS scale

Measure time point of outcome：

6 weeks

Measure method：

VAS scale

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织：

Sample Name：

Not applicable

Tissue：

not applicable

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：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 23 岁 years
最大 Max age 61. 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

Not Applicable

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

Not Applicable

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Not Applicable

Blinding：

Not applicable

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）：

Data will be shared upon request

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

Data will be shared upon request

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：

The data has already been collected and is kept as either CSV or excel file format.

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

The data has already been collected and is kept as either CSV or excel file format.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2021-02-09 07:32:34