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

Overview

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.

Interventions

• Device sonoelastography
  Sonoelastography examination\[10,11\] will be performed using (GE logiqs8,) device system with a high-frequency (a 5-12 MHz linearMHz) linear probe. The procedure will be carried out by a radiologist , who is blinded to the MRI results. Magnetic resonance imaging (MRI) \[12\] will be performed on the patients in our radiology department using a Philips Achieva 1.5 Tesla superconducting magnet (The Netherlands), shoulder joint MRI protocol included several imaging sequences, included coronal obl

Primary outcome measures

• To assess the value of sonoelastography in the evaluation of supraspinatus tendon abnormalities [Time frame: 2 year]

Secondary outcome measures (2)

• 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. To help in reaching shear wave elastography cutoff value to determine tendinopathy and tear [Time frame: 2 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Sein ML, Walton J, Linklater J, Harris C, Dugal T, Appleyard R, Kirkbride B, Kuah D, Murrell GA. Reliability of MRI assessment of supraspinatus tendinopathy. Br J Sports Med. 2007 Aug;41(8):e9. doi: 10.1136/bjsm.2006.034421. Epub 2007 Feb 8. PMID 17289860
• Jacobson JA. Shoulder US: anatomy, technique, and scanning pitfalls. Radiology. 2011 Jul;260(1):6-16. doi: 10.1148/radiol.11101082. PMID 21697306
• Amr A. Elfattah Hassan Gadalla, Gehad Ramadan Hassanein, Hatem Mohammed Saeed El Azizy, Walid Reda Mohammed & Neiven Ezzat Mohammed Elliethy ,Egyptian Journal of Radiology and Nuclear Medicine volume 54, Article number: 37 (2023) Cite this articl
• Reem A. Frere a, Ibrahim Libda a, Fathy Tantawy a, Hossam M. Sakr b, Ali T. El-Alfy, Sonoelastography, conventional ultrasound and magnetic resonance imaging in detection of rotator cuff lesions in patients with chronic shoulder pain, The Egyptian Rheumatologist,Volume 43, Issue 1, January 2021, Pages 17-21
• Winn N, Lalam R, Cassar-Pullicino V. Sonoelastography in the musculoskeletal system: Current role and future directions. World J Radiol. 2016 Nov 28;8(11):868-879. doi: 10.4329/wjr.v8.i11.868. PMID 27928468
• Manzoor I, Bacha R, Gilani SA. Diagnostic accuracy of sonoelastography in different diseases. J Ultrason. 2018 Mar;18(72):29-36. doi: 10.15557/JoU.2018.0005. Epub 2018 Mar 30. PMID 29844938
• Seo JB, Yoo JS, Ryu JW. Sonoelastography findings of supraspinatus tendon in rotator cuff tendinopathy without tear: comparison with magnetic resonance images and conventional ultrasonography. J Ultrasound. 2014 Dec 7;18(2):143-9. doi: 10.1007/s40477-014-0148-8. eCollection 2015 Jun. PMID 26191102
• Vlychou M, Dailiana Z, Fotiadou A, Papanagiotou M, Fezoulidis IV, Malizos K. Symptomatic partial rotator cuff tears: diagnostic performance of ultrasound and magnetic resonance imaging with surgical correlation. Acta Radiol. 2009 Jan;50(1):101-5. doi: 10.1080/02841850802600764. PMID 19052931

Identifiers

NCT: NCT06803303 · supraspinatus sonoelastography

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗