ChiCTR2200067014 版本V1.2 版本创建时间2023/05/11 10:17:08 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：

 ChiCTR2200067014 

最近更新日期：

Date of Last Refreshed on：

 2023-05-07 21:28:38 

注册时间：

Date of Registration：

 2022-12-23 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

The Clinical Effectiveness of Virtual-Reality (VR) assisted Tai Chi in Chronic Musculoskeletal Pain: A Randomized Clinical Trial

Public title：

The Clinical Effectiveness of Virtual-Reality (VR) assisted Tai Chi in Chronic Musculoskeletal Pain: A Randomized Clinical Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

The Clinical Effectiveness of Virtual-Reality (VR) assisted Tai Chi in Chronic Musculoskeletal Pain: A Randomized Clinical Trial

Scientific title：

The Clinical Effectiveness of Virtual-Reality (VR) assisted Tai Chi in Chronic Musculoskeletal Pain: A Randomized Clinical Trial

研究课题代号(代码)：

Study subject ID：

 2022.306

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：

Wang bo 

研究负责人：

Prof. Regina Wing Shan SIT 

Applicant：

Wang bo 

Study leader：

Prof. Regina Wing Shan SIT 

申请注册联系人电话：

Applicant telephone：

 +852 2609 5050

研究负责人电话：

Study leader's
telephone：

+852 2609 5388

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：

 bowang@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 reginasit@cuhk.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：

Rm 209, School of Public Health, Prince of Wales Hospital, N.T. Hong Kong

研究负责人通讯地址：

4/F, School of Public Health, Prince of Wales Hospital, N.T. Hong Kong

Applicant address：

Rm 209, School of Public Health, Prince of Wales Hospital, N.T. Hong Kong

Study leader's address：

4/F, School of Public Health, Prince of Wales Hospital, N.T. Hong Kong

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：

香港中文大學

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學

Affiliation of the Leader：

The Chinese University of Hong Kong

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：

 2022.306

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：

Joint Chinese University of Hong Kong- New Territories East Cluster Clinical Research Ethics Committee

Name of the ethic committee：

Joint Chinese University of Hong Kong- New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-02-27 00:00:00

伦理委员会联系人：

Envy Lee

Contact Name of the ethic committee：

Envy Lee

伦理委员会联系地址：

中國香港特別行政區新界沙田銀城街威爾斯親王醫院呂志和臨床醫學大樓8樓

Contact Address of the ethic committee：

8/F，Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3505 3935

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 crec@cuhk.edu.hk

研究实施负责（组长）单位：

The Chinese University of Hong Kong

Primary sponsor：

Investigator Sponsored Trial

研究实施负责（组长）单位地址：

中國香港特別行政區新界沙田威爾斯親王醫院公共衛生與基層醫療學院4樓

Primary sponsor's address：

4/F, School of Public Health, Prince of Wales Hospital, N.T. Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

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)：

The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong

具体地址：

The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong

Institution
hospital：

The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong

Address：

The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong

经费或物资来源：

There was no funding support for this study

Source(s) of funding：

There was no funding support for this study

研究疾病：

Chronic Musculoskeletal Pain  

Target disease：

Chronic Musculoskeletal 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：

 II期临床试验 

Study phase：

2

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

Primary Aim: To assess the clinical effectiveness of VR assisted Tai Chi versus non-VR Tai Chi in adults with chronic MSK pain. Secondary aim: To assess the improvement in self-management of chronic pain, associated anxiety and depressive symptoms, and health-related quality of life.  

Objectives of Study：

Primary Aim: To assess the clinical effectiveness of VR assisted Tai Chi versus non-VR Tai Chi in adults with chronic MSK pain. Secondary aim: To assess the improvement in self-management of chronic pain, associated anxiety and depressive symptoms, and health-related quality of life.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Participants aged 18 years or above with chronic musculoskeletal pain, defined as pain that lasted for more than 3 months persistently or intermittently, including regional pain (joints, limbs, back, and/or neck), a degenerative joint condition, such as osteoarthritis, and/or musculoskeletal complaints that fall under the “chronic primary pain” classification of the International Classification of Disease-11, pain intensity score ≥ 3 on a numerical rating scale of 10; stable baseline physical activity; and ability to understand written and verbal Chinese.

Inclusion criteria

Participants aged 18 years or above with chronic musculoskeletal pain, defined as pain that lasted for more than 3 months persistently or intermittently, including regional pain (joints, limbs, back, and/or neck), a degenerative joint condition, such as osteoarthritis, and/or musculoskeletal complaints that fall under the chronic primary pain classification of the International Classification of Disease-11, pain intensity score ≥ 3 on a numerical rating scale of 10; stable baseline physical activity; and ability to understand written and verbal Chinese.

排除标准：

Participants with cancer-related pain, inflammatory rheumatic disease; a recent history of stroke or major surgery in the past 6 months; terminal illness; serious mental illness; severe or uncontrolled heart disease; major joint replacement or spinal surgery; comorbid conditions that might impede active participation in the study.

Exclusion criteria：

Participants with cancer-related pain, inflammatory rheumatic disease; a recent history of stroke or major surgery in the past 6 months; terminal illness; serious mental illness; severe or uncontrolled heart disease; major joint replacement or spinal surgery; comorbid conditions that might impede active participation in the study.

研究实施时间：

Study execute time：

从 From 2022-12-26 00:00:00至 To 2024-07-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-12-26 00:00:00 至 To 2023-08-15 00:00:00

干预措施：

Interventions：

组别：

Group 1

样本量：

 40

Group：

Group 1

Sample size：

干预措施：

Virtual Reality Tai Chi Intervention

干预措施代码：

Intervention：

Virtual Reality Tai Chi Intervention

Intervention code：

组别：

Group 2

样本量：

 40

Group：

Group 2

Sample size：

干预措施：

Non Virtual Reality Tai Chi Intervention

干预措施代码：

Intervention：

Non Virtual Reality Tai Chi Intervention

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)：

 Unit 1612-13, 16/F, Delta House, 3 On Yiu Street, Shek Mun, Hong Kong N.T. 

单位级别：

 - 

Institution
hospital：

Unit 1612-13, 16/F, Delta House, 3 On Yiu Street, Shek Mun, Hong Kong N.T.

Level of the institution：

-

测量指标：

Outcomes：

指标中文名：

簡易疼痛量表 - 疼痛程度

指标类型：

主要指标

Outcome：

Brief Pain Inventory- severity

Type：

Primary indicator

测量时间点：

第0，8，12 週

测量方法：

Measure time point of outcome：

Week 0，8，12

Measure method：

指标中文名：

健康問卷

指标类型：

次要指标

Outcome：

EuroQoul-5 dimensions questionnaire

Type：

Secondary indicator

测量时间点：

第0，8，12 週

测量方法：

Measure time point of outcome：

Week 0，8，12

Measure method：

指标中文名：

疼痛自我效能問卷

指标类型：

次要指标

Outcome：

Pain Self Efficacy Questionnaire HK

Type：

Secondary indicator

测量时间点：

第0，8，12 週

测量方法：

Measure time point of outcome：

Week 0，8，12

Measure method：

指标中文名：

焦慮自我評估量表

指标类型：

次要指标

Outcome：

Generalized Anxiety Disorder 7

Type：

Secondary indicator

测量时间点：

第0，8，12 週

测量方法：

Measure time point of outcome：

Week 0，8，12

Measure method：

指标中文名：

病人健康狀況量表

指标类型：

次要指标

Outcome：

Patient Health Questionnaire 9

Type：

Secondary indicator

测量时间点：

第0，8，12 週

测量方法：

Measure time point of outcome：

Week 0，8，12

Measure method：

指标中文名：

簡易疼痛量表- 日常生活干擾

指标类型：

次要指标

Outcome：

Brief pain inventory - interference

Type：

Secondary indicator

测量时间点：

第0，8，12 週

测量方法：

Measure time point of outcome：

Week 0，8，12

Measure method：

指标中文名：

Sociodemographic data

指标类型：

次要指标

Outcome：

Sociodemographic data

Type：

Secondary indicator

测量时间点：

第 0 週

测量方法：

Measure time point of outcome：

Week 0

Measure method：

指标中文名：

國際身體活動問卷 - 短版

指标类型：

主要指标

Outcome：

International Physical Activity Questionnaire -Short Form

Type：

Primary indicator

测量时间点：

第0，8，12 週

测量方法：

Measure time point of outcome：

Week 0，8，12

Measure method：

指标中文名：

虛擬情境暈眩量表

指标类型：

主要指标

Outcome：

Simulator Sickness Questionnaire

Type：

Primary indicator

测量时间点：

第0，8，12 週

测量方法：

Measure time point of outcome：

Week 0，8，12

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

-

组织：

Sample Name：

-

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 18 岁 years
最大 Max age 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）：

Randomization will be done in a 1:1 ratio using the Random Allocation Software by a statistician

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

Randomization will be done in a 1:1 ratio using the Random Allocation Software by a statistician

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：

In this open-label study, blinding of participants will not be possible. However, research assistants and statisticians involved in data collection and analysis, respectively, were blinded to the allocation status.

Blinding：

In this open-label study, blinding of participants will not be possible. However, research assistants and statisticians involved in data collection and analysis, respectively, were blinded to the allocation status.

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

是Yes

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）：

sharing upon request

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

sharing 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 will be stored in the CUHK database (cloudstation) and password encrypted;only authorized persons, i.e. participating investigators and the appointed research assistant will have access to the data.

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

The data will be stored in the CUHK database (cloudstation) and password encrypted;only authorized persons, i.e. participating investigators and the appointed research assistant will have access to the data.

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：

  2022-12-23 15:57:13