Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00653

2 Trial Registration Date

2019-01-15

i Registration Status

Prospective

3 Secondary IDs

CREC Ref. No.: 2018.572

4 Source(s) of Funding

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

5 Primary Sponsor

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

6 Secondary Sponsor

NA

Function

Not Applicable

Please specify

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

i Name

Annie Leong

ii Address

Room 124007, 10/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, N.T., Hong Kong

iii Phone

35053535

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 124007, 10/F, Lui Che Woo Clinical Sciences Building, Prince 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

Clinical and ultrasound evaluation of shoulders in people with diabetes mellitus

10 Public Title

Clinical and ultrasound evaluation of shoulders in people with diabetes mellitus

i Public Title in Chinese 研究名稱

糖尿病與肩膊功能、肌肉力量、柔韌度及超聲波的評估

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?

2019-01-10

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CREC Ref. No.: 2018.572

14 Medical Condition Being Studied

Diabetes mellitus

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Ultrasound measurement of supraspinatus tendon thickness and subacromial space, shoulder internal and external rotation range of motion measurement, shoulder rotational strength and scapular muscles strength tests, and shoulder pain and function questionnaires.

iii Dosage form of the intervention

NA

iv Dosage of the intervention

NA

v Duration of the intervention

NA

vi Frequency of the intervention

NA

16 Comparative Treatments

i Description/ name of comparative treatments

NA

ii Dosage form of the comparative treatments

NA

iii Dosage of the comparative treatments

NA

iv Duration of the comparative treatments

NA

v Frequency of the comparative treatments

NA

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

aged 50 or above

medically diagnosed with Type 2 diabetes

able to sit, stand and walk independently, will be recruited

ii Exclusion Criteria

History of central nervous dysfunction or comorbidities within 6 months (e.g. Heart attack, myocardial infarction, angina, peripheral artery disease, uncontrolled arrhythmias, uncontrolled hypertension, uncontrolled diabetes mellitus, asthmatic exacerbation, COPD exacerbation, active cancer on chemotherapy/radiotherapy, tuberculosis on medication, infectious disease, or any other conditions as declared unfit by a medical officer.)

Significant musculoskeletal deformity or acute orthopaedics conditions (e.g. Recent fall/repeated falls, recent prolapsed intervertebral disc, severe spinal stenosis, recent joint replacement, severe OA knee(s)/hip(s), obvious limb deformity, presence of arthritis with pain limiting mobility, severe scoliosis, or any other conditions as declared unfit by a medical officer.)

Neurological conditions (e.g. Stroke, frequent epilepsy, Parkinsonism, gait disturbance, recent head injury, cognitive impairment or any other conditions as declared unfit by a medical officer.)

History or evidence of vestibular dysfunction

Total blindness/severe visual impairment

iii Age Minimum

50

iv Age Maximum

100

v Gender

Both Male and Female

18 Study Type

Observational

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

0

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2019-01-28

21 Target Sample Size

100

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

supraspinatus tendon thickness and subacromial space

ii The metric or method of measurement used

Ultrasound

iii The timepoint(s) of primary interest

Baseline, 1 year and 3 year

Primary Outcome

i The Name of the outcome

Shoulder internal and external rotation range of motion

ii The metric or method of measurement used

Passive range of motion of shoulder internal/ external rotation will be measured by Goniometer

iii The timepoint(s) of primary interest

Baseline, 1 year and 3 year

Primary Outcome

i The Name of the outcome

Shoulder rotational strength and scapular muscles strength

ii The metric or method of measurement used

Handheld dynamometer to measure isometric force of shoulder internal/ external rotation and scapular muscles of the upper trapezius, middle trapezius, lower trapezius and serratus anterior

iii The timepoint(s) of primary interest

Baseline, 1 year and 3 year

24 Secondary Outcome

i The Name of the outcome

Shoulder Pain and Disability Score

ii The metric or method of measurement used

The Chinese Version of the Shoulder Pain and Disability Index (SPADI) questionnaire

iii The timepoint(s) of primary interest

Baseline, 1 year and 3 year

Secondary Outcome

i The Name of the outcome

Shoulder funcional score

ii The metric or method of measurement used

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

iii The timepoint(s) of primary interest

Baseline, 1 year and 3 year

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-06-28

27 Primary Registry and Trial Identifying Number

ChiCTR1900021050

28 Date of Registration in Primary Registry

2019-01-15

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Trial History Detail on 2019-01-29