Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00599

2 Trial Registration Date

2018-04-06

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 and 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

Room09A31, 9/F, Main Block, PWH

iii Phone

54821994

iv Email

koko@cuhk.edu.hk

v Affiliation

The Hong Kong Institute of Integrative Care, CUHK

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

Translation, Cross-cultural Adaptation and Validation of the Traditional Chinese Douleur Neuropathique En 4 (DN4) Questionnaire for Neuropathic Pain

10 Public Title

Translation, Cross-cultural Adaptation and Validation of the Traditional Chinese Douleur Neuropathique En 4 (DN4) Questionnaire for Neuropathic Pain

i Public Title in Chinese 研究名稱

參與中文版DN4調查問卷內容理解分析訪問

11 Short Title (Optional)

Traditional Chinese DN4

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?

2018-02-21

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2018.074

14 Medical Condition Being Studied

Neuropathic Pain

15 Intervention

i Types of intervention

Other

Please specify

the Traditional Chinese Douleur Neuropathique En 4 (DN4) Questionnaire

ii Description/ name of Intervention/article

The Douleur Neuropathique En 4 (DN4) questionnaire is one of the screening tools suggested by the Neuropathic Pain Special Interest Group to identify neuropathic pain with good measurement properties.

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

participants aged 18 or above with the diagnosis of sciatica based on history and physical examination

patients with radiating pain to below knee in the leg that follows a dermatomal pattern and positive straight leg raising test

ii Exclusion Criteria

not Cantonese speaking

had other back problems or widespread pain

an inability or unwillingness to complete the questionnaire

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Observational

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

1

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2018-04-13

21 Target Sample Size

100

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

Psychometric properties

ii The metric or method of measurement used

Construct validity, Face validity, Reliability, Responsiveness,Internal consistency

iii The timepoint(s) of primary interest

NA

Primary Outcome

i The Name of the outcome

ii The metric or method of measurement used

iii The timepoint(s) of primary interest

initial

24 Secondary Outcome

i The Name of the outcome

NA

ii The metric or method of measurement used

NA

iii The timepoint(s) of primary interest

NA

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-03-15

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2018-04-09