Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00456

2 Trial Registration Date

2015-06-17

i Registration Status

Prospective

3 Secondary IDs

CREC 2014.059-T

4 Source(s) of Funding

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

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

Wing Yin TAM

ii Address

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

iii Phone

25039053

iv Email

wingyintam@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

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

i Name

Professor 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

Effectiveness of dextrose prolotherapy in the treatment of knee osteoarthritis: a randomized controlled trial

10 Public Title

Effectiveness of dextrose prolotherapy in the treatment of knee osteoarthritis: a randomized controlled trial

i Public Title in Chinese 研究名稱

葡萄糖注射治療對退化性膝關節炎的效用

11 Short Title (Optional)

N/A

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?

2014-06-25

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2014.059-T

14 Medical Condition Being Studied

knee osteoarthritis

15 Intervention

i Types of intervention

Other

Please specify

Injection

ii Description/ name of Intervention/article

Intra-articular dextrose injection

iii Dosage form of the intervention

dextrose solution

iv Dosage of the intervention

5 ml 25 % dextrose

v Duration of the intervention

16 weeks

vi Frequency of the intervention

at week 0,4, 8, 16

16 Comparative Treatments

i Description/ name of comparative treatments

Intra-articular normal saline injection

ii Dosage form of the comparative treatments

Normal saline solution

iii Dosage of the comparative treatments

5 ml normal saline

iv Duration of the comparative treatments

16 weeks

v Frequency of the comparative treatments

at week 0, 4, 8, 16

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

-Age ≥ 45 to ≤ 75 years old
-Diagnosis of knee OA based on clinical criteria as defined by the American Rheumatology Association
-Have experienced moderate to severe anterior knee pain for at least 3 months, defined as a score of 3 or more (0-6 ordinal response scale) on the question “What is the average level of your left/right knee pain?”
-Failed 6 months of usual care

ii Exclusion Criteria

-History of corn allergy
-Previous operation either open or arthroscopic, on the referring knee
-Pregnancy
-Body mass index ≥ 35 kg/m2
-Patients on anti-coagulant therapy
-Prior knee prolotherapy
-Any knee injections within 3 months
-Inflammatory or post-infectious knee arthritis
-Significant effusion as defined by a balotteable patella
-Co-morbidity severe enough to prevent participation in the study protocol like attendance at scheduled injection appointments

iii Age Minimum

45

iv Age Maximum

75

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

Placebo

iii Degree of masking

Double-blind

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

2015-10-01

21 Target Sample Size

76

22 Recruitment Status

Complete

23 Primary Outcome

WOMAC score of both intervention and control group from baseline, week 16, week 24 and 52

24 Secondary Outcome

(1)VAS 0-100 mm at week 0,16, 24 and 52.
(3)30 second chair stand performance test at week 0, 16, 24 and 52
(4) timed up and go test at week 0,16, 24 and 52
(5) 40 m fast paced walk test at week 0, 16, 24 and 52
(5) EQ5 at week 0,24 and 52
(6) 7 day recall of analgesic at week 0,16, 24 and 52
(7) treatment satisfaction will be assessed at 24 weeks with the question “Will you recommend the therapy to others with knee OA like yours? (yes/no)”.
(8) Adverse events will be assessed in terms of incidence of knee infection, allergy to medications, nerve or vessel injuries, and any adverse responses as reported by participants.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2017-08-04

27 Primary Registry and Trial Identifying Number

ChiCTR-IPC-15006617

28 Date of Registration in Primary Registry

2015-06-17

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Trial History Detail on 2017-08-04