Clinical trial NCT05769712: A Multicenter Cross-sectional Study of Shear Wave Ultrasound Imaging in Evaluating Supraspinatus Tendon Elasticity
Official title: A Multicenter Cross-sectional Study of Shear Wave Ultrasound Imaging in Evaluating Supraspinatus Tendon Elasticity.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus, Type 2
Keywords: supraspinatus tendon
Shear wave elastic imaging
ultrasound
Lead sponsor: Guangdong Second Provincial General Hospital
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Guangxi University of Chinese Medicine
name: The People's Hospital of Chongzuo
name: Dongguan People's Hospital
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
name: Dongguan Tungwah Hospital
name: Yangjiang People's Hospital
name: Affiliated Hospital of Guangdong Medical University
First posted: 2023-03-15
Enrollment: 361
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: diabetic 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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Elasticity of the supraspinatus tendon
timeFrame: 10 mins
Secondary outcomes:
measure: Thickness of the supraspinatus tendon
timeFrame: 2 mins
Other outcomes:
measure: Blood flow within the supraspinatus tendon
timeFrame: 3 mins
Locations:
city: Guangzhou
country: China
facility: Guangdong second provincial general hospital
state: Guangdong
Study officials:
References:
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.
citation: 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.
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.
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.
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.
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.