Today is 2019-12-08

Neuromuscular training exercise for Chronic Musculoskeletal Pain
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注册号:

Registration number:

ChiCTR1800014890 

最近更新日期:

Date of Last Refreshed on:

2019-10-22 

注册时间:

Date of Registration:

2018-02-07 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

長者慢性肌骼痛症運動治療研究計劃 

Public title:

Neuromuscular training exercise for Chronic Musculoskeletal Pain 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

長者慢性肌骼痛症運動治療研究計劃 

Scientific title:

Clinical effectiveness of a neuromuscular training exercise based pain management program for community-dwelling elders with chronic musculoskeletal pain: a pragmatic randomized trial 

研究课题代号(代码):

Study subject ID:

CREC 2016.440 

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:

CUHK_CCRB00581 

申请注册联系人:

Lyan Chow Lai yan 

研究负责人:

Regina Wing Shan SIT 

Applicant:

Lyan Chow Lai yan 

Study leader:

Regina Wing Shan SIT 

申请注册联系人电话:

Applicant telephone:

+852 95403121 

研究负责人电话:

Study leader's telephone:

+852 25039053 

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:

chowlyan@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):

https://www2.ccrb.cuhk.edu.hk/registry/public/470 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

https://www2.ccrb.cuhk.edu.hk/registry/public/470 

申请注册联系人通讯地址:

Room 04, 4/F, Lek Yuen Health Centre, 9 Lek Yuen Street, Shatin, N.T., Hong Kong, China 

研究负责人通讯地址:

Room 17A, 4/F, Lek Yuen Health Centre, 9 Lek Yuen Street, Shatin, N.T., Hong Kong, China 

Applicant address:

Room 04, 4/F, Lek Yuen Health Centre, 9 Lek Yuen Street, Shatin, N.T., Hong Kong, China 

Study leader's address:

Room 17A, 4/F, Lek Yuen Health Centre, 9 Lek Yuen Street, Shatin, N.T., 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:

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

Applicant's institution:

Division of Family Medicine and Primary Health Care, The Jockey Club School of Public Health and Primary Care, 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:

CREC 2016.440 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

Joint CUHK-NTEC Clinical Research Ethics Committee 

Name of the ethic committee:

Joint CUHK-NTEC Clinical Research Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-12-14 

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 Chinese University Of Hong Kong 

Primary sponsor:

The Chinese University of Hong Kong 

研究实施负责(组长)单位地址:

The Chinese University of Hong Kong 

Primary sponsor's address:

The Chinese University of Hong Kong 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

Health Care and Promotion Scheme, Food and Health Bureau, The Government of SAR 

Source(s) of funding:

Health Care and Promotion Scheme, Food and Health Bureau, The Government of SAR 

研究疾病:

慢性肌骼痛症 

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:

其它 

Study phase:

N/A 

研究目的:

長者慢性肌骼痛症運動治療研究計劃 

Objectives of Study:

Clinical effectiveness of a neuromuscular training exercise based pain management program for community-dwelling elders with chronic musculoskeletal pain 

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:

(i) community-dwelling older adults (age ≥65 years); and (ii) mobile over 10m with or without a walking aid; (iii) present of chronic musculoskeletal pain over the past month and for at least 3 month of the previous year; (iv) pain intensity score ≥ 3 on a numerical rating scale of 10; (v) stable baseline activity; (vi) able to understand written and verbal Chinese. 

Inclusion criteria

(i) community-dwelling older adults (age ≥65 years); and (ii) mobile over 10?m with or without a walking aid; (iii) present of chronic musculoskeletal pain over the past month and for at least 3 month of the previous year; (iv) pain intensity score ≥ 3 on a numerical rating scale of 10; (v) stable baseline activity; (vi) able to understand written and verbal Chinese. 

排除标准:

(i) dementia or mild cognitive impairment (including those showing any signs of cognitive impairment as advised by the scheme manager/medical records); (ii) MSK pain due to uncontrolled rheumatic disease ; (iii) a recent self-reported history of stroke or major surgery (in the past 6 months); (iv) terminally ill; (v) has a serious mental illness; (vi) comorbid conditions which might interfere with the participant's active participation in the study; (vii) severe or uncontrolled heart disease; (viii) participants with major joint replacement or spinal surgery; and (ix) participants who fulfil the diagnostic criteria of Chronic Fatigue Syndrome (CFS) by the Center of Disease Control, which is a debilitating and complex disorder characterized by intense fatigue, which worsens with physical and mental exertion, with widespread pain as one of its presentations. 

Exclusion criteria:

(i) dementia or mild cognitive impairment (including those showing any signs of cognitive impairment as advised by the scheme manager/medical records); (ii) MSK pain due to uncontrolled rheumatic disease ; (iii) a recent self-reported history of stroke or major surgery (in the past 6 months); (iv) terminally ill; (v) has a serious mental illness; (vi) comorbid conditions which might interfere with the participant's active participation in the study; (vii) severe or uncontrolled heart disease; (viii) participants with major joint replacement or spinal surgery; and (ix) participants who fulfil the diagnostic criteria of Chronic Fatigue Syndrome (CFS) by the Center of Disease Control, which is a debilitating and complex disorder characterized by intense fatigue, which worsens with physical and mental exertion, with widespread pain as one of its presentations. 

研究实施时间:

Study execute time:

FromTo  

干预措施:

Interventions:

组别:

Two groups

样本量:

72

Group:

Two groups

Sample size:

干预措施:

Neuromuscular training, 12 classes, 6 weeks, twice a week versus Waiting list control, Elderly exercise pamphlets

干预措施代码:

Intervention:

Neuromuscular training, 12 classes, 6 weeks, twice a week versus Waiting list control, Elderly exercise pamphlets

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):

香港中文大學 

单位级别:

香港中文大學 

Institution
hospital:

Chinese University of Hong Kong  

Level of the institution:

Chinese University of Hong Kong 

测量指标:

Outcomes:

指标中文名:

The Brief Pain Inventory

指标类型:

主要指标 

Outcome:

The Brief Pain Inventory

Type:

Primary indicator 

测量时间点:

week 0, 6, 12

测量方法:

self report

Measure time point of outcome:

week 0, 6, 12

Measure method:

self report

指标中文名:

Pain Self-Efficacy Questionnaire (PSEQ)

指标类型:

次要指标 

Outcome:

Pain Self-Efficacy Questionnaire (PSEQ)

Type:

Secondary indicator 

测量时间点:

week 0, 6, 12

测量方法:

self report

Measure time point of outcome:

week 0, 6, 12

Measure method:

self report

指标中文名:

Timed up and go test

指标类型:

次要指标 

Outcome:

Timed up and go test

Type:

Secondary indicator 

测量时间点:

week 0, 6, 12

测量方法:

functional assessment

Measure time point of outcome:

week 0, 6, 12

Measure method:

functional assessment

指标中文名:

Grip strength

指标类型:

次要指标 

Outcome:

Grip strength

Type:

Secondary indicator 

测量时间点:

week 0, 6, 12

测量方法:

functional assessment

Measure time point of outcome:

week 0, 6, 12

Measure method:

functional assessment

指标中文名:

General Anxiety Disorder (GAD-7)

指标类型:

次要指标 

Outcome:

General Anxiety Disorder (GAD-7)

Type:

Secondary indicator 

测量时间点:

week 0, 6, 12

测量方法:

Self report

Measure time point of outcome:

week 0, 6, 12

Measure method:

Self report

指标中文名:

Patient Health Questionnaire (PHQ-9)

指标类型:

次要指标 

Outcome:

Patient Health Questionnaire (PHQ-9)

Type:

Secondary indicator 

测量时间点:

week 0, 6, 12

测量方法:

Self report

Measure time point of outcome:

week 0, 6, 12

Measure method:

Self report

指标中文名:

Health Survey (SF-12)

指标类型:

次要指标 

Outcome:

Health Survey (SF-12)

Type:

Secondary indicator 

测量时间点:

week 0, 6, 12

测量方法:

Self report

Measure time point of outcome:

week 0, 6, 12

Measure method:

Self report

指标中文名:

Instrumental Activities of Daily Living Scale (IADL)

指标类型:

次要指标 

Outcome:

Instrumental Activities of Daily Living Scale (IADL)

Type:

Secondary indicator 

测量时间点:

week 0

测量方法:

self report

Measure time point of outcome:

week 0

Measure method:

self report

指标中文名:

Frailty Scale

指标类型:

次要指标 

Outcome:

Frailty Scale

Type:

Secondary indicator 

测量时间点:

week 0

测量方法:

self-report

Measure time point of outcome:

week 0

Measure method:

self-report

指标中文名:

Sarcopenia Assessment

指标类型:

次要指标 

Outcome:

Sarcopenia Assessment

Type:

Secondary indicator 

测量时间点:

week 0

测量方法:

self-report

Measure time point of outcome:

week 0

Measure method:

self-report

指标中文名:

Physical Activity Scale for the Elderly (PASE)

指标类型:

次要指标 

Outcome:

Physical Activity Scale for the Elderly (PASE)

Type:

Secondary indicator 

测量时间点:

week 0

测量方法:

self-report

Measure time point of outcome:

week 0

Measure method:

self-report

指标中文名:

Stanford Expectations of Treatment Scale (SETS)

指标类型:

次要指标 

Outcome:

Stanford Expectations of Treatment Scale (SETS)

Type:

Secondary indicator 

测量时间点:

week 0

测量方法:

self-report

Measure time point of outcome:

week 0

Measure method:

self-report

采集人体标本:

Collecting sample(s)
from participants:

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 65 years
最大 Max age 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):

1:1 randomization

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

1:1 randomization

盲法:

Open label

Blinding:

Open label

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

Not stated

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

Not stated

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:

Not stated

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

Not stated

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-02-07
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