Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00457

2 Trial Registration Date

2015-06-17

i Registration Status

Prospective

3 Secondary IDs

CREC 2014.379-T

4 Source(s) of Funding

Hong Kong College of Family Physicians

5 Primary Sponsor

Professor Regina Wing Shan SIT

6 Secondary Sponsor

N/A

Function

Not Applicable

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 patella mobilization therapy versus usual care in knee osteoarthritis: a pragmatic, randomized clinical trial

10 Public Title

Effectiveness of patella mobilization therapy versus usual care in knee osteoarthritis: a pragmatic, randomized clinical trial

i Public Title in Chinese 研究名稱

膝關節手法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?

2014-08-04

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2014-379T

14 Medical Condition Being Studied

knee osteoarthritis

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Patella mobilization therapy

iii Dosage form of the intervention

N/A

iv Dosage of the intervention

N/A

v Duration of the intervention

16 weeks

vi Frequency of the intervention

Every 8 weeks at week 0, 8, 16

16 Comparative Treatments

i Description/ name of comparative treatments

Usual care

ii Dosage form of the comparative treatments

N.A

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

N/A

v Frequency of the comparative treatments

N/A

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1) Age ≥ 45 to ≤ 75 years old
2) Diagnosis of knee OA based on clinical criteria as defined by the American Rheumatology Association
3) Have experienced moderate to severe 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?”
4) Involvement of anterior knee compartment and exhibit 2 of the following criteria on initial assessment: pain on direct compression of the patella against the femoral condyles with the knee in full extension, tenderness on palpation of the posterior surface of the patella, pain on resisted knee extension, and pain with isometric quadriceps contraction against suprapatellar resistance with the knee in slight flexion

ii Exclusion Criteria

1) Previous operation either open or arthroscopic, on the referring knee
2) Body mass index ≥ 35 kg/m2
3) Any knee injections within 1 month
4) Inflammatory or post-infectious knee arthritis
5) Daily use of opioid medication
6) Co-morbidity severe enough to prevent participation in the study protocol like attendance at scheduled appointments
7) Fixed flexion deformity >5 degree and varus and valgus deformity > 15 degree made manual mobilization of the patella impossible.

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

Active

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

2015-06-30

21 Target Sample Size

208

22 Recruitment Status

Recruiting

23 Primary Outcome

The composite Western Ontario McMaster University Osteoarthritis Index (WOMAC)assessed at week 0 and week 24.

24 Secondary Outcome

1) A visual analogue score (0-100mm) to assess knee pain of each symptomatic knee at week 0 and 24.
2) Knee flexion range at week 0 and week 24
3) 30 second chair stand performance test at week 0 and 24
4) timed up and go test at week 0 and 24.
5) 40 m fast-paced walk test at week 0 and 24
6) Compliance of the home based medial thigh exercise will be assessed by a 7 day recall on the number of days in the exercise participations at week 8,16 and 24.
7) Type and frequency of analgesics use will be assessed by pill counting in the past 7 days. It will be done at week 0,8,16 and 24 weeks for both groups
8)EuroQuol-5 at week 0 and 24 weeks
9) Standford Expectancy questionnaire (SAQ) at week 0
10) International Physical Activity Questionnaire (IPAQ) at week 0

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2017-07-31

27 Primary Registry and Trial Identifying Number

ChiCTR-IPC-15006618

28 Date of Registration in Primary Registry

2015-06-17

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Trial History Detail on 2016-08-17