ChiCTR2200056964 版本V1.0 版本创建时间2022/02/25 06:08:01 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：

 ChiCTR2200056964 

最近更新日期：

Date of Last Refreshed on：

 2022-02-25 06:05:39 

注册时间：

Date of Registration：

 2022-02-25 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

此为补注册，需在www.medresman.org上建立项目、审核原始数据并公示后才能补注册

Public title：

The effect of thoracic manipulation on spinal kinematics during functional tasks and thoracic stiffness in patients with Chronic Neck Pain

注册题目简写：

English Acronym：

研究课题的正式科学名称：

The effect of thoracic manipulation on spinal kinematics during functional tasks and thoracic stiffness in patients with Chronic Neck Pain

Scientific title：

The effect of thoracic manipulation on spinal kinematics during functional tasks and thoracic stiffness in patients with Chronic Neck 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：

Ng Shiu Hong 

研究负责人：

Tsang Man Ha 

Applicant：

Ng Shiu Hong 

Study leader：

Tsang Man Ha 

申请注册联系人电话：

Applicant telephone：

 +852 51128492

研究负责人电话：

Study leader's
telephone：

+852 27664332

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：

 19029317g@connect.polyu.hk

研究负责人电子邮件：

Study leader's E-mail：

 sharon.tsang@polyu.edu.hk

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：

ST535, the Hong Kong Polytechnic University, 11 Yuk Choi Rd, Hung Hom, Hong Kong, China

研究负责人通讯地址：

ST535, the Hong Kong Polytechnic University, 11 Yuk Choi Rd, Hung Hom, Hong Kong, China

Applicant address：

ST535, the Hong Kong Polytechnic University, 11 Yuk Choi Rd, Hung Hom, Hong Kong, China

Study leader's address：

ST535, the Hong Kong Polytechnic University, 11 Yuk Choi Rd, Hung Hom, Hong Kong, China

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：

香港理工大學

Applicant's institution：

The Hong Kong Polytechnic University

研究负责人所在单位：

香港理工大學

Affiliation of the Leader：

The Hong Kong Polytechnic 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：

 HSEARS20201029002

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：

Departmental Research Committee

Name of the ethic committee：

Departmental Research Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2020-12-10 00:00:00

伦理委员会联系人：

Yee Kay Yan Benjamin

Contact Name of the ethic committee：

Yee Kay Yan Benjamin

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：

 benjamin.yee@polyu.edu.hk

研究实施负责（组长）单位：

Nil

Primary sponsor：

Nil

研究实施负责（组长）单位地址：

Nil

Primary sponsor's address：

Nil

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

香港理工大學

Source(s) of funding：

The Hong Kong Polytechnic University

研究疾病：

Chronic neck pain  

Target disease：

Chronic neck pain

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：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

To investigate the 1) Test-retest reliability of the spinal segmental stiffness measurement device, and 2) the effect of Thoracic manipulation on thoracic segmental stiffness, thoracic spine mobility and pain intensity during neck pain-related functional tasks in participants with CNP.  

Objectives of Study：

To investigate the 1) Test-retest reliability of the spinal segmental stiffness measurement device, and 2) the effect of Thoracic manipulation on thoracic segmental stiffness, thoracic spine mobility and pain intensity during neck pain-related functional tasks in participants with CNP.

药物成份或治疗方案详述：

Intervention The experimental group received thoracic manipulation directed to the one hypomobile segment in both upper (T1-4) and mid (T5-8) thoracic spine. The spinal levels of segmental hypomobility in upper and mid thoracic region were determined by the baseline result of spinal stiffness. For upper and mid thoracic spine manipulation, the participant was positioned supine with both hand clasp across the neck or to the opposite shoulder, respectively. The clinician would place the stabilising hand caudal to the hypomobile segment of upper or mid thoracic region with a pistol grip. A high-velocity, low-amplitude thrust was performed through the elbow to the upper thoracic spine on mid thoracic spine in anterior-posterior direction during participants exhalation (18, 22). The control group received sham thoracic manipulation with the same participants positioning as in the intervention group. The clinician would put an open hand under the hypomobile segments of the thoracic spine and maintain minimal pressure onto the participant’s arms to avoid unintended mobilisation to thoracic joints. No high-velocity thrust would be performed, regarding studies by Fisher et al. (31) and Cleland et al. (18). In both manipulation procedures, if no cracking sound was heard from the first attempt of manipulation, the clinician would reposition the participant and carried out the same procedure again. A maximum of two attempts for each manipulation would be performed on each participant (22, 32). All participants were instructed to inform the on-site clinician or other investigators if they encountered any side effect on-site or the next day, respectively. 

Description for medicine or protocol of treatment in detail：

Intervention The experimental group received thoracic manipulation directed to the one hypomobile segment in both upper (T1-4) and mid (T5-8) thoracic spine. The spinal levels of segmental hypomobility in upper and mid thoracic region were determined by the baseline result of spinal stiffness. For upper and mid thoracic spine manipulation, the participant was positioned supine with both hand clasp across the neck or to the opposite shoulder, respectively. The clinician would place the stabilising hand caudal to the hypomobile segment of upper or mid thoracic region with a pistol grip. A high-velocity, low-amplitude thrust was performed through the elbow to the upper thoracic spine on mid thoracic spine in anterior-posterior direction during participants exhalation (18, 22). The control group received sham thoracic manipulation with the same participants positioning as in the intervention group. The clinician would put an open hand under the hypomobile segments of the thoracic spine and maintain minimal pressure onto the participants arms to avoid unintended mobilisation to thoracic joints. No high-velocity thrust would be performed, regarding studies by Fisher et al. (31) and Cleland et al. (18). In both manipulation procedures, if no cracking sound was heard from the first attempt of manipulation, the clinician would reposition the participant and carried out the same procedure again. A maximum of two attempts for each manipulation would be performed on each participant (22, 32). All participants were instructed to inform the on-site clinician or other investigators if they encountered any side effect on-site or the next day, respectively. 

纳入标准：

Participants with a condition of ongoing CNP over three months, aged 18 to 60, were recruited in this study

Inclusion criteria

Participants with a condition of ongoing CNP over three months, aged 18 to 60, were recruited in this study

排除标准：

Participants with the following condition were excluded from the study: constant neck pain, concurrent shoulder pain, precaution and contraindication to thoracic manipulation, history of whiplash-associated disorder, serious orthopaedic conditions, cancer, systemic disease, with knowledge of manipulation technique, or having back tattoos.

Exclusion criteria：

Participants with the following condition were excluded from the study: constant neck pain, concurrent shoulder pain, precaution and contraindication to thoracic manipulation, history of whiplash-associated disorder, serious orthopaedic conditions, cancer, systemic disease, with knowledge of manipulation technique, or having back tattoos.

研究实施时间：

Study execute time：

从 From 2020-11-05 00:00:00至 To 2022-04-27 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2020-11-05 00:00:00 至 To 2021-01-01 00:00:00

干预措施：

Interventions：

组别：

Intervention

样本量：

 17

Group：

Intervention

Sample size：

干预措施：

Thoracic manipulation

干预措施代码：

Intervention：

Thoracic manipulation

Intervention code：

组别：

Control

样本量：

 17

Group：

Control

Sample size：

干预措施：

Sham Thoracic manipulation

干预措施代码：

Intervention：

Sham Thoracic manipulation

Intervention code：

组别：

Asymptomatic group

样本量：

 17

Group：

Asymptomatic group

Sample size：

干预措施：

Nil

干预措施代码：

Intervention：

Nil

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 香港理工大學 

单位级别：

 三级医院 

Institution
hospital：

The Hong Kong Polytechnic University

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

Thoracic segmental stiffness

指标类型：

主要指标

Outcome：

Thoracic segmental stiffness

Type：

Primary indicator

测量时间点：

Before intervention and immediately after intervention

测量方法：

VerteTrack

Measure time point of outcome：

Before intervention and immediately after intervention

Measure method：

VerteTrack

指标中文名：

Spinal Kinematic during functional tasks

指标类型：

次要指标

Outcome：

Spinal Kinematic during functional tasks

Type：

Secondary indicator

测量时间点：

Before intervention and immediately after intervention

测量方法：

DIERS

Measure time point of outcome：

Before intervention and immediately after intervention

Measure method：

DIERS

指标中文名：

Pain Intensity during functional tasks

指标类型：

次要指标

Outcome：

Pain Intensity during functional tasks

Type：

Secondary indicator

测量时间点：

Before intervention and immediately after intervention

测量方法：

Numeric Pain Rating Scale

Measure time point of outcome：

Before intervention and immediately after intervention

Measure method：

Numeric Pain Rating Scale

指标中文名：

Neck Disability Index (NDI)

指标类型：

附加指标

Outcome：

Neck Disability Index (NDI)

Type：

Additional indicator

测量时间点：

Baseline measurement

测量方法：

Self-rated Questionnaire

Measure time point of outcome：

Baseline measurement

Measure method：

Self-rated Questionnaire

指标中文名：

Patient Specific Functional Scale (PSFS)

指标类型：

附加指标

Outcome：

Patient Specific Functional Scale (PSFS)

Type：

Additional indicator

测量时间点：

Baseline measurement

测量方法：

Self-rated Questionnaire

Measure time point of outcome：

Baseline measurement

Measure method：

Self-rated Questionnaire

指标中文名：

Fear-Avoidance Beliefs Questionnaire (FABQ)

指标类型：

附加指标

Outcome：

Fear-Avoidance Beliefs Questionnaire (FABQ)

Type：

Additional indicator

测量时间点：

Baseline measurement

测量方法：

Self-rated Questionnaire

Measure time point of outcome：

Baseline measurement

Measure method：

Self-rated Questionnaire

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 18 岁 years
最大 Max age 60 岁 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）：

An author coded each subject with a computer-generated random number.

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

An author coded each subject with a computer-generated random number.

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：

Subjects were blinded on their group allocation by sham thoracic manipulation.

Blinding：

Subjects were blinded on their group allocation by sham thoracic manipulation.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

NA

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

NA

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：

NA

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

NA

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2022-02-25 06:05:39