Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00485

2 Trial Registration Date

2015-11-04

iRegistration Status

Prospective

3 Secondary IDs

2014.696T

4 Source(s) of Funding

CUHK

5 Primary Sponsor

CUHK Research Commitee Direct Grants

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Hung Sheung Sheung

ii Address

4L, 4/F, Day Treatment Block,
Prince of Wales Hospital,
Shatin

iii Phone

2873 3500

iv Email

zevarihung@cuhk.edu.hk

v Affiliation

Institute of Integrative Medicine

vi Country

Hong Kong

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

i Name

Regina Wing Shan SIT

ii Address

4L, 4/F, Day Treatment Block,
Prince of Wales Hospital,
Shatin

iii Phone

25039053

iv Email

reginasit@cuhk.edu.hk

v Affiliation

The Jockey Club School of Public Health & Primary Care

vi Country

Hong Kong

9 Official Scientific Title of the Study

Integrated Western and Chinese Medicine compared with Usual care for Work Injury related Subacute Low Back Pain: a comparative prospective effectiveness study

10 Public Title

Integrated Western and Chinese Medicine compared with Usual care for Work Injury related Subacute Low Back Pain: a comparative prospective effectiveness study

i Public Title in Chinese 研究名稱

評核中西醫結合綜合治療模式在治療工傷腰痛的臨床成效

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?

2015-08-31

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2014.696T

14 Medical Condition Being Studied

Low Back Pain

15Intervention

i Types of intervention

Other

Please specify

Integrative treatment with Western and Chinese Medicine

ii Description/ name of Intervention/article

An integrative treatment approach with Western based physiotherapy and Chinese Medicine Theory based acupuncture in the treatment of subacute work related low back pain. Routine care e.g. pharmacological intervention, physiotherapy and orthopedic consultations will continue in this group of patients.

iii Dosage form of the intervention

Acupuncture treatment and Physiotherapy manipulation

iv Dosage of the intervention

10 sessions

v Duration of the intervention

5 weeks

vi Frequency of the intervention

Twice per week

16Comparative Treatments

i Description/ name of comparative treatments

Routine Care e.g. Pharmacological intervention, physiotherapy and orthopedic consultations

ii Dosage form of the comparative treatments

Routine Care

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

N/A

v Frequency of the comparative treatments

N/A

17Key Inclusion and Exclusion Criteria

i Inclusion Criteria

- Age ≥ 18 to ≤ 70 years old

- Suffered from LBP as defined by Pain or discomfort between the costal margins and the gluteal fold

- Reported LBP after Injury at work

- LBP duration ≤12 weeks

- Pain score above ≥ 6 on 0-10 Numerical Rating Scale (NRS)

ii Exclusion Criteria

- Pain above lower back

- History of back surgery

- Progressive or severe neurological symptoms

- Known spondylolisthesis, scoliosis, or ankylosing spondylitis

- Known cancer patients

- Pregnancy (suspected or known)

- Unexplained weight loss or recent unexplained fever

- Severe or disabling co-existing problem

- Unavailable for appointments within the study period

- Unable to understand Chinese

- Unavailable for appointments within the study period

iii Age Minimum

18

iv Age Maximum

70

v Gender

Both Male and Female

18 Study Type

Interventional

19Study 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

Parallel

v Study Phase

2

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2015-11-16

21 Target Sample Size

80

22 Recruitment Status

Suspended

23Primary Outcome

iThe Name of the outcome

Back Pain and Functional disability

iiThe metric or method of measurement used

Roland Morris Disability Questionnaire (RMDQ)

iiiThe timepoint(s) of primary interest

Baseline, 12 week and 26 week

Primary Outcome

iThe Name of the outcome

Back Pain Intensity

iiThe metric or method of measurement used

Numerical Pain Rating Scale

iiiThe timepoint(s) of primary interest

Baseline, 12 week and 26 week

24Secondary Outcome

iThe Name of the outcome

Quality of Life measurement

iiThe metric or method of measurement used

The Chinese Short Form-12 version 2 (SF-12v2) Health Survey

iiiThe timepoint(s) of primary interest

Baseline and 26-week

Secondary Outcome

iThe Name of the outcome

Out of Work due to back pain situation

iiThe metric or method of measurement used

Sick Leave count

iiiThe timepoint(s) of primary interest

baseline, 26-week

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last Update Date

2017-02-28

27 Primary Registry and Trial Identifying Number

ChiCTR-OPC-15007336

28 Date of Registration in Primary Registry

2015-11-04

Back History

Trial Detail