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Trial History Detail on 2016-01-21

CUHK_CCT00456

2015-06-17

Prospective

CREC 2014.059-T

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

Professor Regina Wing Shan SIT

N/A

Take on all the responsibilities of sponsorship jointly with the primary sponsor

Wing Yin TAM

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

25039053

wingyintam@cuhk.edu.hk

The Chinese University of Hong Kong

Hong Kong

Professor Regina Wing Shan SIT

Room 17A, 4/F, Lek Yuen Health Centre, 9 Lek Yuen Street, Shatin, N.T., Hong Kong

25039053

reginasit@cuhk.edu.hk

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

Hong Kong

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

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

葡萄糖注射治療對退化性膝關節炎的效用

N/A

Hong Kong

Yes

2014-06-25

Joint CUHK-NTEC Clinical Research Ethics Committee

2014.059-T

knee osteoarthritis

Other

Injection

Intra-articular dextrose injection

dextrose solution

5 ml 25 % dextrose

16 weeks

at week 0,4, 8, 16

Intra-articular normal saline injection

Normal saline solution

5 ml normal saline

16 weeks

at week 0, 4, 8, 16

-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

-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

45

75

Both Male and Female

Interventional

Randomized

1:1 randomization

Placebo

Double-blind

Parallel

4

2015-10-01

76

Recruiting

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

(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.

No

2017-08-04

ChiCTR-IPC-15006617

2015-06-17

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