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

March 3, 2023 updated by: Tong Wang, Guangdong Second Provincial General Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

361

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510317
        • Recruiting
        • Guangdong Second Provincial General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Elasticity of the supraspinatus tendon
Time Frame: 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.
10 mins

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood flow within the supraspinatus tendon
Time Frame: 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.
3 mins

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Second Provincial General Hospital

Collaborators

Guangdong Provincial Hospital of Traditional Chinese Medicine
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Dongguan People's Hospital
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
The First Affiliated Hospital of Guangxi University of Chinese Medicine
Affiliated Hospital of Guangdong Medical University
The People's Hospital of Chongzuo
Dongguan Tungwah Hospital
The People's Hospital of Yangjiang

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Anticipated)

November 5, 2023

Study Completion (Anticipated)

November 5, 2023

Study Registration Dates

First Submitted

March 3, 2023

First Submitted That Met QC Criteria

March 3, 2023

First Posted (Actual)

March 15, 2023

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

March 3, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Guangdong2ndcsk

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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