Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00588

2 Trial Registration Date

2018-03-05

i Registration Status

Prospective

3 Secondary IDs

Not applicable

4 Source(s) of Funding

NIL

5 Primary Sponsor

The Jockey Club School of Public Health & Primary Care

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Ko Shaau Yiu

ii Address

Room 09A31, 9/F, Main Block, PWH

iii Phone

54821994

iv Email

koko@cuhk.edu.hk

v Affiliation

The Hong Kong Institute of Integrative care

vi Country

Hong Kong, China

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

i Name

Regina Wing Shan SIT

ii Address

4/F Public Health Building, Prince of Wales Hospital

iii Phone

25039053

iv Email

reginasit@cuhk.edu.hk

v Affiliation

The Jockey Club School of Public Health & Primary Care

vi Country

Hong Kong, China

9 Official Scientific Title of the Study

Implementation of a low back pain care model in Hong Kong: A pilot prospective feasibility, acceptability and clinical effectiveness study

10 Public Title

Implementation of a low back pain care model in Hong Kong: A pilot prospective feasibility, acceptability and effectiveness study

i Public Title in Chinese 研究名稱

先導計劃 – 研究香港腰痛護理模式的可行性、接受性及臨床有效性”

11 Short Title (Optional)

A Low Back Pain Care model in Hong Kong

12 Countries of Recruitment

Hong Kong, China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2017-12-08

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2017.527

14 Medical Condition Being Studied

Low Back Pain

15 Intervention

i Types of intervention

Other

Please specify

A low back pain care model

ii Description/ name of Intervention/article

A low back pain care model which triage low risk patients to receive early primary care attention.

iii Dosage form of the intervention

Not applicable

iv Dosage of the intervention

Not applicable

v Duration of the intervention

Not applicable

vi Frequency of the intervention

Not applicable

16 Comparative Treatments

i Description/ name of comparative treatments

Not applicable

ii Dosage form of the comparative treatments

Not applicable

iii Dosage of the comparative treatments

Not applicable

iv Duration of the comparative treatments

Not applicable

v Frequency of the comparative treatments

Not applicable

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

(1) Age ≥ 18 years old;

(2) Non-specific low back pain of any episodic duration;

(3) With or without referred leg pain;

(4) STarT Back total score ≤ 3 or subscore ≤ 3

(5)Understand Cantonese to a level where they can read the study leaflet and questionnaires.

ii Exclusion Criteria

(1) Participants in active work compensation claims;

(2) With “red flags” indicative of possible serious spinal pathology such as cauda equina, inflammatory arthritis, malignancy, infection and fracture etc.;

(3) pregnancy related LBP;

(4) Co-morbidity severe enough to prevent participation in the model, like attendance at scheduled appointments

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

2

Please specify

vi Study Objectives (Optional)

The aims of this project are to pilot test the acceptability, feasibility and clinical effectiveness of the LBP co-care model.

20 Anticipated trial start date

2018-03-14

21 Target Sample Size

30

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

Acceptability, Feasibility

ii The metric or method of measurement used

The total number of eligible patients and the number of patients willing to join the model will be documented,The average waiting time for the first consultation and the treatments received by subjects will be recorded.

iii The timepoint(s) of primary interest

0,3,6 months

24 Secondary Outcome

i The Name of the outcome

Ronald Morris Disability Score

ii The metric or method of measurement used

Ronald Morris Disability Questionnaire

iii The timepoint(s) of primary interest

0,3,6 months

Secondary Outcome

i The Name of the outcome

Pain Self-Efficacy questionnaire

ii The metric or method of measurement used

Pain Self-Efficacy questionnaire

iii The timepoint(s) of primary interest

0,3,6 months

Secondary Outcome

i The Name of the outcome

Health-related Quality of Life

ii The metric or method of measurement used

Euro-Quol 5D

iii The timepoint(s) of primary interest

0,3,6 months

Secondary Outcome

i The Name of the outcome

Numeric Pain Rating Scale

ii The metric or method of measurement used

Numeric Pain Rating Scale from 0-10

iii The timepoint(s) of primary interest

0,3,6 months

Secondary Outcome

i The Name of the outcome

Numeric Global Rating of Change Scale

ii The metric or method of measurement used

Numeric Global Rating of Change Scale

iii The timepoint(s) of primary interest

3,6 months

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2018-10-30

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2018-03-12