Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00561

2 Trial Registration Date

2017-09-04

i Registration Status

Prospective

3 Secondary IDs

2017.075-T

4 Source(s) of Funding

NA

5 Primary Sponsor

NA

6 Secondary Sponsor

NA

Function

Not Applicable

Please specify

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

i Name

Leong Hio Teng

ii Address

Room 74029, 5/F
Lui Che Woo Clinical Sciences Building
Price of Wales Hospital
Shatin, N.T., Hong Kong

iii Phone

65791767

iv Email

annieleonght@cuhk.edu.hk

v Affiliation

Department of Orthopaedics & Traumatology, The Chinese University of Hong Kong

vi Country

Hong Kong

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

i Name

Hio Teng Leong

ii Address

Room 74029, 5/F
Lui Che Woo Clinical Sciences Building
Price of Wales Hospital
Shatin, N.T., Hong Kong

iii Phone

65791767

iv Email

annieleonght@cuhk.edu.hk

v Affiliation

Department of Orthopaedics & Traumatology, The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

The effect of scapular-focused programme on pain, function, life quality, subacromial space, scapular kinematics and muscle performance in patients with rotator cuff tendinopathy and scapular dyskinesis

10 Public Title

The effect of scapular-focused programme for patients with rotator cuff tendinopathy and scapular dyskinesis

i Public Title in Chinese 研究名稱

肩胛骨訓練計劃對患有肩部肌腱炎的病人之效能

11 Short Title (Optional)

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?

2017-06-07

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2017.075-T

14 Medical Condition Being Studied

Rotator cuff tendinopathy

15 Intervention

i Types of intervention

Other

Please specify

Physiotherapy

ii Description/ name of Intervention/article

Scapular taping, Scapular consciousness exercise, and scapular muscle strengthening exercises

iii Dosage form of the intervention

Exercise

iv Dosage of the intervention

3 sets of 15 repetitions per exercise

v Duration of the intervention

6 weeks

vi Frequency of the intervention

3 sessions per week

16 Comparative Treatments

i Description/ name of comparative treatments

Conventional physiotherapy treatment: combination of range of motion, rotator cuff exercises, therapeutic ultrasound

ii Dosage form of the comparative treatments

conventional physiotherapy

iii Dosage of the comparative treatments

3 sets of 15 repetitions per exercise

iv Duration of the comparative treatments

6 weeks

v Frequency of the comparative treatments

3 sessions per week

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Presence of shoulder pain for more than 3 months

3 out of 5 positive tests (painful arc, resisted external rotation, Neer test, Kennedy-Hawkins test and Jobe test). The intensity of pain being provoked should be ≥ 3/10 on a visual analogue scale (VAS) from 0 to 10, with 0 indicating no pain, and 10 indicating the worst pain

Obvious scapular dyskinesis while the participant’s performing 5 repetition of weighted shoulder flexion according to their body weight (3lb for weight <150lb; 5lb for those > 150lb) (Clarsen et al. 2014)

Ultrasound image showed pathological changes of the supraspinatus tendon (Leong et al. 2016b), and the severity of pathological changes will be graded (Tsui et al. 2017)

ii Exclusion Criteria

Full-thickness tear of the rotator cuff tendon

Shoulder dislocation or instability

Labral tears

Frozen shoulders

Symptoms referred from or related to the spine

History of shoulder fractures

Previous shoulder surgery a shoulder injury

Previous clinical treatment for a shoulder injury within the last 12 months

iii Age Minimum

18

iv Age Maximum

60

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Randomized controlled trial

ii Nature of control

Active

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

1

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2017-09-08

21 Target Sample Size

62

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Subacromial space

ii The metric or method of measurement used

Ultrasound imaging

iii The timepoint(s) of primary interest

Baseline, 6-weeks, 3-months, and 1-year post intervention

Primary Outcome

i The Name of the outcome

Pain score

ii The metric or method of measurement used

Visual analogue scale

iii The timepoint(s) of primary interest

Baseline, 6-weeks, 3-months, and 1-year post intervention

Primary Outcome

i The Name of the outcome

Functional score

ii The metric or method of measurement used

Chinese Version of the Disability of the Arm, Shoulder and Hand (DASH-HKPWH) questionnaire

iii The timepoint(s) of primary interest

Baseline, 6-weeks, 3-months, and 1-year post intervention

Primary Outcome

i The Name of the outcome

Quality of life

ii The metric or method of measurement used

The Chinese (HK) SF-36 Health Survey

iii The timepoint(s) of primary interest

Baseline, 6-weeks, 3-months, and 1-year post intervention

24 Secondary Outcome

i The Name of the outcome

Scapular muscle strenght

ii The metric or method of measurement used

handheld dynamometer

iii The timepoint(s) of primary interest

Baseline, 6-weeks, 3-months, and 1-year post intervention

Secondary Outcome

i The Name of the outcome

Shoulder rotational muscle strength

ii The metric or method of measurement used

Isokinetic dynamometer

iii The timepoint(s) of primary interest

Baseline, 6-weeks, 3-months, and 1-year post intervention

Secondary Outcome

i The Name of the outcome

Biomechanical assessment of scapular motion and neuromuscular performance

ii The metric or method of measurement used

Vicon and EMG

iii The timepoint(s) of primary interest

Baseline, 6-weeks, 3-months, and 1-year post intervention

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2020-01-13

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2017-09-04