Supraspinatus InjuryNCT06803303
Added Value of Sonoelastography in Assessment of Traumatic and Non Traumatic Supraspinatus Tendinopathy and Tear Compared with Magnetic Resonance Imaging
An observational study of Supraspinatus Injury, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Supraspinatus Injury
- What is being tested?
- sonoelastography
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients with shoulder pain either due to traumatic or non traumatic causes
- Age > 18 year
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Hossam El-din Galal M Elmalah, Assisstant Professor contact
About this study
Primary Aims:
To assess the value of sonoelastography in the evaluation of supraspinatus tendon abnormalities.
Secondary Aims:
- To assess the association between SWE and grades of tendon abnormalities on MRI (the standard imaging in the evaluation of rotator cuff abnormalities).
- To help in reaching shear wave elastography cutoff value to determine tendinopathy and tear.
Read the 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.
- Conditions
- Supraspinatus Injury
- Being tested
- sonoelastography
- Keywords
- Supraspinatus sonoelastography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sonoelastographyDevice
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 oblique T1 and T2 weighted fast spin-echo, coronal oblique proton density fat suppressed, oblique sagittal T2-weighted spin-echo and axial T1-weighted spin-echo Image evaluation will be conducted by experienced musculoskeletal radiologist, Then we correlate results of sonoelastography to that of MRI .
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the value of sonoelastography in the evaluation of supraspinatus tendon abnormalities
Assess the value of sonoelastography in evaluation of supraspinatus tendinopathy and tear in comparison with Magnetic Resonance Imaging
Measured: 2 year
Secondary outcomes (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).
Measured: 2 year
2. To help in reaching shear wave elastography cutoff value to determine tendinopathy and tear
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Supraspinatus InjuryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Hassan Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803303
- Sponsor's protocol ID
- supraspinatus sonoelastography
- Status last verified
- Jan 2025
- First submitted
- 26 Jan 2025
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 17289860Jacobson JA. Shoulder US: anatomy, technique, and scanning pitfalls. Radiology. 2011 Jul;260(1):6-16. doi: 10.1148/radiol.11101082.
PubMed 21697306Amr 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.
PubMed 27928468Manzoor 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.
PubMed 29844938Seo 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.
PubMed 26191102Vlychou 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.
PubMed 19052931Shin KM. Partial-thickness rotator cuff tears. Korean J Pain. 2011 Jun;24(2):69-73. doi: 10.3344/kjp.2011.24.2.69. Epub 2011 Jun 3.
PubMed 21716613Bendale S, Vedpathak S (2019) Sonographic Evaluation of rotator cuff pathologies causing restricted movements of shoulder. Int J Contemp Med Surg Radiol 4(3):C276-C280
Tawfik AM, El-Morsy A, Badran MA. Rotator cuff disorders: How to write a surgically relevant magnetic resonance imaging report? World J Radiol. 2014 Jun 28;6(6):274-83. doi: 10.4329/wjr.v6.i6.274.
PubMed 24976930
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Added Value of Sonoelastography in Assessment of Traumatic and Non Traumatic Supraspinatus Tendinopathy and Tear Compared with Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT06803303
- Acronym / sponsor ID
- supraspinatus sonoelastography
- Conditions
- Supraspinatus Injury
- Keywords
- Supraspinatus sonoelastography
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Aims:
To assess the value of sonoelastography in the evaluation of supraspinatus tendon abnormalities.
Secondary Aims:
- To assess the association between SWE and grades of tendon abnormalities on MRI (the standard imaging in the evaluation of rotator cuff abnormalities).
- 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients with shoulder pain either due to traumatic or non traumatic causes
- Age > 18 year
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sonoelastographySonoelastography 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 oblique T1 and T2 weighted fast spin-echo, coronal oblique proton density fat suppressed, oblique sagittal T2-weighted spin-echo and axial T1-weighted spin-echo Image evaluation will be conducted by experienced musculoskeletal radiologist, Then we correlate results of sonoelastography to that of MRI . | Device | – |
Primary outcome
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 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Background: PubMed 17289860Sein 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.
- Background: PubMed 21697306Jacobson JA. Shoulder US: anatomy, technique, and scanning pitfalls. Radiology. 2011 Jul;260(1):6-16. doi: 10.1148/radiol.11101082.
- BackgroundAmr 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
- BackgroundReem 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
- Background: PubMed 27928468Winn 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.
- Background: PubMed 29844938Manzoor 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.
- Background: PubMed 26191102Seo 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.
- Background: PubMed 19052931Vlychou 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.
- Background: PubMed 21716613Shin KM. Partial-thickness rotator cuff tears. Korean J Pain. 2011 Jun;24(2):69-73. doi: 10.3344/kjp.2011.24.2.69. Epub 2011 Jun 3.
- BackgroundBendale S, Vedpathak S (2019) Sonographic Evaluation of rotator cuff pathologies causing restricted movements of shoulder. Int J Contemp Med Surg Radiol 4(3):C276-C280
- Background: PubMed 24976930Tawfik AM, El-Morsy A, Badran MA. Rotator cuff disorders: How to write a surgically relevant magnetic resonance imaging report? World J Radiol. 2014 Jun 28;6(6):274-83. doi: 10.4329/wjr.v6.i6.274.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hossam El-din Galal M Elmalah, Assisstant Professor contact
Questions about this trial
What is this clinical trial studying?
An observational study of Supraspinatus Injury, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hossam Hassan Sayed Hammad, Resident doctor (01008933979, hh6173303@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the value of sonoelastography in the evaluation of supraspinatus tendon abnormalities (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06803303, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.