Diabetes Mellitus, Type 2 Clinical Trial
— SWEOfficial title:
A Multicenter Cross-sectional Study of Shear Wave Ultrasound Imaging in Evaluating Supraspinatus Tendon Elasticity.
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.
Status | Recruiting |
Enrollment | 361 |
Est. completion date | November 5, 2023 |
Est. primary completion date | November 5, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: ? Age range (above 18 years old); ? Non-professional athletes; ? No medical history of shoulder and neck pain; ? Ultrasound examination (-). Exclusion criteria: ? pregnant women or postpartum 1 year; ? Shoulder pain with active or passive cervical motion; ? 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; ? Systemic autoimmune diseases, metabolic diseases, endocrine diseases, psoriasis; ? unable to complete the relevant movements and positions; ? Those who are reluctant to continue the experiment and ask to quit. |
Country | Name | City | State |
---|---|---|---|
China | Guangdong second provincial general hospital | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Guangdong Second Provincial General Hospital | Affiliated Hospital of Guangdong Medical University, Dongguan People's Hospital, Dongguan Tungwah Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The First Affiliated Hospital of Guangxi University of Chinese Medicine, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, The People's Hospital of Chongzuo, The People's Hospital of Yangjiang |
China,
Abate M, Schiavone C, Salini V. Sonographic evaluation of the shoulder in asymptomatic elderly subjects with diabetes. BMC Musculoskelet Disord. 2010 Dec 7;11:278. doi: 10.1186/1471-2474-11-278. — View Citation
Breda SJ, van der Vlist A, de Vos RJ, Krestin GP, Oei EHG. The association between patellar tendon stiffness measured with shear-wave elastography and patellar tendinopathy-a case-control study. Eur Radiol. 2020 Nov;30(11):5942-5951. doi: 10.1007/s00330-020-06952-0. Epub 2020 Jun 4. — View Citation
Evranos B, Idilman I, Ipek A, Polat SB, Cakir B, Ersoy R. Real-time sonoelastography and ultrasound evaluation of the Achilles tendon in patients with diabetes with or without foot ulcers: a cross sectional study. J Diabetes Complications. 2015 Nov-Dec;29(8):1124-9. doi: 10.1016/j.jdiacomp.2015.08.012. Epub 2015 Aug 20. — View Citation
Guney A, Vatansever F, Karaman I, Kafadar IH, Oner M, Turk CY. Biomechanical properties of Achilles tendon in diabetic vs. non-diabetic patients. Exp Clin Endocrinol Diabetes. 2015 Jul;123(7):428-32. doi: 10.1055/s-0035-1549889. Epub 2015 Apr 28. — View Citation
Lin DJ, Burke CJ, Abiri B, Babb JS, Adler RS. Supraspinatus muscle shear wave elastography (SWE): detection of biomechanical differences with varying tendon quality prior to gray-scale morphologic changes. Skeletal Radiol. 2020 May;49(5):731-738. doi: 10.1007/s00256-019-03334-6. Epub 2019 Dec 6. — View Citation
Rosskopf AB, Ehrmann C, Buck FM, Gerber C, Fluck M, Pfirrmann CW. Quantitative Shear-Wave US Elastography of the Supraspinatus Muscle: Reliability of the Method and Relation to Tendon Integrity and Muscle Quality. Radiology. 2016 Feb;278(2):465-74. doi: 10.1148/radiol.2015150908. Epub 2015 Nov 5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Blood flow within the supraspinatus tendon | After activating the blood flow mode, the blood flow signal grading in the supraspinatus tendon was evaluated after the blood flow filled and stabilized. | 3 mins | |
Primary | 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 | 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 |
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