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

Not yet recruiting

• Conditions: Supraspinatus Injury

• Registration Number: NCT06803303
• Lead Sponsor: Assiut University

Brief Summary

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.

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 Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-26
• Study First Submitted QC: 2025-01-26
• Last Update Submitted: 2025-01-26
• Study First Posted: 2025-01-31
• Last Update Posted: 2025-01-31
• Study Start: 2025-03-01
• Primary Completion: 2027-03-01
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the value of sonoelastography in the evaluation of supraspinatus tendon abnormalities	2 year	Assess the value of sonoelastography in evaluation of supraspinatus tendinopathy and tear in comparison with Magnetic Resonance Imaging

Secondary Outcome Measures

Name	Time	Method
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).	2 year
2. To help in reaching shear wave elastography cutoff value to determine tendinopathy and tear	2 year