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

i Registration 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

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

i Name

Lyan Chow Lai yan

ii Address

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

iii Phone

95403121

iv Email

chowlyan@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

8 Research 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

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2016-12-14

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

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

Neuromuscular training exercise

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

16 Comparative 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

12 weeks

v Frequency of the comparative treatments

NA

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

(i) community-dwelling older adults (age ≥65 years)

(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) Musculoskeletal 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

(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

99

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study 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

Complete

23 Primary Outcome

i The Name of the outcome

The Brief Pain Inventory

ii The metric or method of measurement used

self-report

iii The timepoint(s) of primary interest

week 0, 6, 12

24 Secondary Outcome

i The Name of the outcome

Pain Self-Efficacy Questionnaire (PSEQ)

ii The metric or method of measurement used

self-report

iii The timepoint(s) of primary interest

week 0, 6, 12

Secondary Outcome

i The Name of the outcome

Timed up and go test

ii The metric or method of measurement used

functional assessment

iii The timepoint(s) of primary interest

week 0, 6, 12

Secondary Outcome

i The Name of the outcome

Grip strength

ii The metric or method of measurement used

functional assessment

iii The timepoint(s) of primary interest

week 0, 6, 12

Secondary Outcome

i The Name of the outcome

General Anxiety Disorder (GAD-7)

ii The metric or method of measurement used

self report

iii The timepoint(s) of primary interest

week 0, 6, 12

Secondary Outcome

i The Name of the outcome

Patient Health Questionnaire (PHQ-9)

ii The metric or method of measurement used

self-report

iii The timepoint(s) of primary interest

week 0, 6, 12

Secondary Outcome

i The Name of the outcome

Health Survey (SF-12)

ii The metric or method of measurement used

self-report

iii The timepoint(s) of primary interest

week 0, 6,12

Secondary Outcome

i The Name of the outcome

Instrumental Activities of Daily Living Scale (IADL)

ii The metric or method of measurement used

self report

iii The timepoint(s) of primary interest

week 0

Secondary Outcome

i The Name of the outcome

Frailty Scale

ii The metric or method of measurement used

self-report

iii The timepoint(s) of primary interest

week 0

Secondary Outcome

i The Name of the outcome

Sarcopenia Assessment

ii The metric or method of measurement used

self-report

iii The timepoint(s) of primary interest

week 0

Secondary Outcome

i The Name of the outcome

Physical Activity Scale for the Elderly (PASE)

ii The metric or method of measurement used

self-report

iii The timepoint(s) of primary interest

week 0

Secondary Outcome

i The Name of the outcome

Stanford Expectations of Treatment Scale (SETS)

ii The metric or method of measurement used

self-report

iii The timepoint(s) of primary interest

week 0

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last 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 2019-03-15