Added Value of Sonoelastography in Assessment of Traumatic and Non Traumatic Supraspinatus Tendinopathy and Tear Compared with Magnetic Resonance Imaging

January 26, 2025 updated by: Hossam Hassan Sayed, Assiut University

Primary Aims:

To assess the value of sonoelastography in the evaluation of supraspinatus tendon abnormalities.

Secondary Aims:

  1. To assess the association between SWE and grades of tendon abnormalities on MRI (the standard imaging in the evaluation of rotator cuff abnormalities).
  2. To help in reaching shear wave elastography cutoff value to determine tendinopathy and tear.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Shoulder pain is a common condition that can be caused by a variety of factors, including injury, overuse, poor posture, and age-related degeneration. The shoulder is a highly mobile joint, which makes it prone to certain injuries and conditions. The pain can arise from structures in or around the shoulder joint, including the muscles, tendons, ligaments, and the bones of the shoulder itself.

Rotator cuff abnormalities one of the important causes that can cause chronic shoulder pain , discomfort and lead to a lack of stability of the shoulder joint[1].The supraspinatus tendon is one of rotator cuff muscle that commonly affected as it anatomically traverses between two bones (the acromion process and humeral head),its pathology including tendinopathy and tearing whether its partial or complete.

Clinical examination and imaging modalities as ultrasound and MRI are needed for proper diagnosis of supraspinatus pathology .

Ultrasonography used as primary modality compared to MRI which considered gold standard of non invasive investigations as ultrasound is an cheap, available, noninvasive, repeatable and reliable modality for rotator cuff assessment with accuracy reaching 100% in the diagnosis of full-thickness tears and 91% for partial-thickness tears, on ultrasound, tendinopathy appears as thickening of the tendon showing a heterogeneous hypoechoic pattern. Tendon tear appears as a hypoechoic defect within the tendon, not involving the tendon's full thickness in PTT and involving the full tendon thickness in FTT , however, diagnosis of tendinopathy may be challenging with the conventional US as the echogenicity of the affected tendon may appear similar to that of the healthy one, especially in early stages of tendinopathy.

Sonoelastography (SE) is a new US imaging technique that allows non invasive estimation of tissue stiffness and elasticity. It is based on the fact that tissue compression produces displacement within the tissue, which is less in hard than in soft tissue [8], In addition possibility of using share wave elastography which allow to assess tissue stiffness by measuring the propagation speed of shear waves in the body. It is primarily used to evaluate the stiffness of tissues such as muscles, liver, and tendons, aiding in differentiation between the diseased and normal tissue, as tendon softening in cases of tendinopathy, resulting in a reduction in the velocity of propagation of shear waves compared to the healthy tendons that are stiff, so elastography may be helpful in the early detection of tendinopathy before alteration in tendon echogenicity or thickness appear on the conventional US. And provides qualitative as well as quantitative assessment of tendon quality through alteration in the tissue composition.

Study Type

Observational

Enrollment (Estimated)

43

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

  • Name: Hossam Hassan Sayed Hammad, Resident doctor
  • Phone Number: 01008933979
  • Email: hh6173303@gmail.com

Study Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with shoulder pain either due to traumatic or non traumatic causes referred to our radiology department for assessment of rotator cuff muscles.

Description

Inclusion Criteria:

  • Patients with shoulder pain either due to traumatic or non traumatic causes
  • Age > 18 year

Exclusion Criteria:

  • History of operative intervention for rotator cuff tendons,
  • Signs of calcific tendinopathy on MRI or ultrasound (as calcification causes artifact on obtaining SWE results and the measured velocities were exceeding the velocity scale on our device),
  • Patients with general contraindications to MRI as patients with pacemakers

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the value of sonoelastography in the evaluation of supraspinatus tendon abnormalities
Time Frame: 2 year
Assess the value of sonoelastography in evaluation of supraspinatus tendinopathy and tear in comparison with Magnetic Resonance Imaging
2 year

Secondary Outcome Measures

Outcome Measure
Time Frame
1. To assess the association between share wave elastography and grades of tendon abnormalities on MRI (the standard imaging in the evaluation of rotator cuff abnormalities).
Time Frame: 2 year
2 year
2. To help in reaching shear wave elastography cutoff value to determine tendinopathy and tear
Time Frame: 2 year
2 year

Collaborators and Investigators

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

Sponsor

Assiut University

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 (Estimated)

March 1, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

January 26, 2025

First Submitted That Met QC Criteria

January 26, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 26, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • supraspinatus sonoelastography

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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