A Multicenter Cross-sectional Study of Shear Wave Ultrasound Imaging in Evaluating Supraspinatus Tendon Elasticity

Study Overview
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Brief Summary
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The goal of this multi-center, cross-sectional, observational study is to test and compare the difference of the supraspinatus tendon's elasticity between diabetics and healthy people. The main questions it aims to answer are: Ultrasonic characteristics of supraspinatus tendon in diabetic patients Influencing factors of elastic value and thickness of supraspinatus tendon Participants will be asked to: Perform ultrasound examination of the shoulder join. Fill in a survey with certain questions on their basic information.

Official Title
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A Multicenter Cross-sectional Study of Shear Wave Ultrasound Imaging in Evaluating Supraspinatus Tendon Elasticity.

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Diagnostic Test: Shear wave ultrasonic imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ① Age range (above 18 years old); ② Non-professional athletes; ③ No medical history of shoulder and neck pain; ④ Ultrasound examination (-). Exclusion criteria: ① pregnant women or postpartum 1 year; ② Shoulder pain with active or passive cervical motion; ③ History of upper extremity trauma; (4) Shoulder surgery or treatment history, intra-articular injection history, use history of glucocorticoids, estrogens, quinolones and cholesterol drugs; (5) Shoulder joint fear test (shoulder joint abduction 90°, slowly increasing external rotation, the subject had a positive expression of fear); (6) Evidence of adhesive shoulder joint bursitis, such as the passive range of motion of the 2 motion planes of the shoulder joint is obviously limited; ⑦ Systemic autoimmune diseases, metabolic diseases, endocrine diseases, psoriasis; ⑧ unable to complete the relevant movements and positions; ⑨ Those who are reluctant to continue the experiment and ask to quit.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| healthy people<br>Inclusion criteria：① Age range (above 18 years old); ② Non-professional athletes; ③ No medical history of shoulder and neck pain; ④ Ultrasound examination (-). Exclusion criteria: ① pregnant women or postpartum 1 year; ② Shoulder pain with active or passive cervical motion; ③ History of upper extremity trauma; (4) Shoulder surgery or treatment history, intra-articular injection history, use history of glucocorticoids, estrogens, quinolones and cholesterol drugs; (5) Shoulder joint fear test (shoulder joint abduction 90°, slowly increasing external rotation, the subject had a positive expression of fear); (6) Evidence of adhesive shoulder joint bursitis, such as the passive range of motion of the 2 motion planes of the shoulder joint is obviously limited; ⑦ Systemic autoimmune diseases, metabolic diseases, endocrine diseases, psoriasis; ⑧ unable to complete the relevant movements and positions; ⑨ Those who are reluctant to continue the experiment and ask to quit. | Diagnostic Test: Shear wave ultrasonic imaging<br>* Shear wave ultrasonic imaging technique was used to measure the superficial and deep shear wave velocity of supraspinatus tendon at 10mm (distal end) and 15mm (proximal end) from the attachment end of the greater tubercle of the humerus on the long axis section of supraspinatus tendon.<br>|
| diabetic<br>Inclusion criteria：① Age range (above 18 years old); ② Non-professional athletes; (3) Patients who meet the clinical guidelines for diabetes diagnosis and treatment and are diagnosed with diabetes (ADA guidelines 2020: patients with typical diabetes symptoms and random blood glucose ≥11.1 mmol/L or fasting blood glucose ≥7.0 mmol/L or 2h blood glucose ≥11.1 mmol/L after glucose loading without typical diabetes symptoms); ④ Medical history ≥2 years. Exclusion criteria: as above. | Diagnostic Test: Shear wave ultrasonic imaging<br>* Shear wave ultrasonic imaging technique was used to measure the superficial and deep shear wave velocity of supraspinatus tendon at 10mm (distal end) and 15mm (proximal end) from the attachment end of the greater tubercle of the humerus on the long axis section of supraspinatus tendon.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elasticity of the supraspinatus tendon | After activating the SWE mode, the elastic image was generated in the two-amplitude mode. After the image quality mode was qualified (the color curve in the figure was smooth), Shear wave velocity in the superficial and deep layers of the supraspinatus tendon were measured at the distal and proximal ends of the tendon perpendicular to the surface of the humerus, respectively. | 10 mins | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thickness of the supraspinatus tendon | The thickness of the supraspinatus tendon was measured at a tangent line perpendicular to the surface of the humerus 15mm from insertion. | 2 mins | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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supraspinatus tendon, Shear wave elastic imaging, ultrasound