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

Sponsor
Guangdong Second Provincial General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05769712
Collaborator
The First Affiliated Hospital of Guangxi University of Chinese Medicine (Other), The People's Hospital of Chongzuo (Other), Dongguan People's Hospital (Other), Guangdong Provincial Hospital of Traditional Chinese Medicine (Other), Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine (Other), Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other), The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine (Other), Dongguan Tungwah Hospital (Other), The People's Hospital of Yangjiang (Other), Affiliated Hospital of Guangdong Medical University (Other)
361
1
32.2
11.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Shear wave ultrasonic imaging

Study Design

Study Type:
Observational
Anticipated Enrollment :
361 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
A Multicenter Cross-sectional Study of Shear Wave Ultrasound Imaging in Evaluating Supraspinatus Tendon Elasticity.
Actual Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
Nov 5, 2023
Anticipated Study Completion Date :
Nov 5, 2023

Arms and Interventions

Arm Intervention/Treatment
healthy people

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
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.

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.

Diagnostic Test: Shear wave ultrasonic imaging
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.

Outcome Measures

Primary Outcome Measures

  1. Elasticity of the supraspinatus tendon [10 mins]

    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.

Secondary Outcome Measures

  1. Thickness of the supraspinatus tendon [2 mins]

    The thickness of the supraspinatus tendon was measured at a tangent line perpendicular to the surface of the humerus 15mm from insertion.

Other Outcome Measures

  1. Blood flow within the supraspinatus tendon [3 mins]

    After activating the blood flow mode, the blood flow signal grading in the supraspinatus tendon was evaluated after the blood flow filled and stabilized.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Guangdong second provincial general hospital Guangzhou Guangdong China 510317

Sponsors and Collaborators

  • Guangdong Second Provincial General Hospital
  • The First Affiliated Hospital of Guangxi University of Chinese Medicine
  • The People's Hospital of Chongzuo
  • Dongguan People's 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, Guangzhou University of Traditional Chinese Medicine
  • Dongguan Tungwah Hospital
  • The People's Hospital of Yangjiang
  • Affiliated Hospital of Guangdong Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Tong Wang, physician, Guangdong Second Provincial General Hospital
ClinicalTrials.gov Identifier:
NCT05769712
Other Study ID Numbers:
  • Guangdong2ndcsk
First Posted:
Mar 15, 2023
Last Update Posted:
Mar 15, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tong Wang, physician, Guangdong Second Provincial General Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 15, 2023