Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00581

2 Trial Registration Date

2018-02-07

iRegistration Status

Prospective

3 Secondary IDs

CREC 2016.440

4 Source(s) of Funding

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

5 Primary Sponsor

Professor Regina Wing Shan SIT

6 Secondary Sponsor

N/A

Function

Take on all the responsibilities of sponsorship jointly with the primary sponsor

Please specify

7Responsible Contact Person (public contact person for patients interested in participating)

i Name

Wing Man AU-YEUNG

ii Address

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

iii Phone

95403121/25039056

iv Email

auyeungwingman@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

8Research Contact Person (person to contact for scientific inquiries)

i Name

Regina Wing Shan SIT

ii Address

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

iii Phone

25039053

iv Email

reginasit@cuhk.edu.hk

v Affiliation

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

vi Country

Hong Kong

9 Official Scientific Title of the Study

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

10 Public Title

Neuromuscular training exercise for Chronic Musculoskeletal Pain

i Public Title in Chinese 研究名稱

長者慢性肌骼痛症運動治療研究計劃

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong

13Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2017-12-14

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2016.440

14 Medical Condition Being Studied

chronic musculoskeletal pain

15Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

Neuromuscular training

iii Dosage form of the intervention

NA

iv Dosage of the intervention

12 classes

v Duration of the intervention

6 weeks

vi Frequency of the intervention

Twice a week

16Comparative Treatments

i Description/ name of comparative treatments

Waiting list control

ii Dosage form of the comparative treatments

Elderly exercise pamphlets

iii Dosage of the comparative treatments

NA

iv Duration of the comparative treatments

6 weeks

v Frequency of the comparative treatments

NA

17Key Inclusion and Exclusion Criteria

i 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

ii 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.

iii Age Minimum

65

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19Study Design

i Randomization

Randomized

Please specify

1:1 randomization

ii Nature of control

Active

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

2

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2018-02-20

21 Target Sample Size

72

22 Recruitment Status

Recruiting

23Primary Outcome

iThe Name of the outcome

The Brief Pain Inventory

iiThe metric or method of measurement used

self report

iiiThe timepoint(s) of primary interest

week 0,6, 12

24Secondary Outcome

iThe Name of the outcome

Pain Self-Efficacy Questionnaire (PSEQ)

iiThe metric or method of measurement used

self report

iiiThe timepoint(s) of primary interest

week 0,6,12

Secondary Outcome

iThe Name of the outcome

Timed up and go test

iiThe metric or method of measurement used

functional assessment

iiiThe timepoint(s) of primary interest

week 0,6, 12

Secondary Outcome

iThe Name of the outcome

Grip strength

iiThe metric or method of measurement used

functional assessment

iiiThe timepoint(s) of primary interest

week 0, 6,12

Secondary Outcome

iThe Name of the outcome

General Anxiety Disorder (GAD-7)

iiThe metric or method of measurement used

self report

iiiThe timepoint(s) of primary interest

week 0,6, 12

Secondary Outcome

iThe Name of the outcome

Patient Health Questionnaire (PHQ-9)

iiThe metric or method of measurement used

self report

iiiThe timepoint(s) of primary interest

week 0,6, 12

Secondary Outcome

iThe Name of the outcome

Health Survey (SF-12)

iiThe metric or method of measurement used

self report

iiiThe timepoint(s) of primary interest

week 0, 6,12

Secondary Outcome

iThe Name of the outcome

Instrumental Activities of Daily Living Scale (IADL)

iiThe metric or method of measurement used

self report

iiiThe timepoint(s) of primary interest

week 0

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last Update Date

2019-10-22

27 Primary Registry and Trial Identifying Number

ChiCTR1800014890

28 Date of Registration in Primary Registry

2018-02-07

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Trial History Detail on 2018-03-22