NCT06803303

Brief Summary

Primary Aims: To assess the value of sonoelastography in the evaluation of supraspinatus tendon abnormalities. Secondary Aims:

  1. 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. 2.To help in reaching shear wave elastography cutoff value to determine tendinopathy and tear.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
11mo left

Started Mar 2025

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Mar 2025Apr 2027

First Submitted

Initial submission to the registry

January 26, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 31, 2025

Completed
29 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

January 31, 2025

Status Verified

January 1, 2025

Enrollment Period

2 years

First QC Date

January 26, 2025

Last Update Submit

January 26, 2025

Conditions

Keywords

Supraspinatus sonoelastography

Outcome Measures

Primary Outcomes (1)

  • 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

    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).

    2 year

  • 2. To help in reaching shear wave elastography cutoff value to determine tendinopathy and tear

    2 year

Interventions

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 .

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • 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: 17289860BACKGROUND
  • Jacobson JA. Shoulder US: anatomy, technique, and scanning pitfalls. Radiology. 2011 Jul;260(1):6-16. doi: 10.1148/radiol.11101082.

    PMID: 21697306BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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: 27928468BACKGROUND
  • 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: 29844938BACKGROUND
  • 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: 26191102BACKGROUND
  • 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: 19052931BACKGROUND
  • Shin 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.

    PMID: 21716613BACKGROUND
  • Bendale 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
  • 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.

    PMID: 24976930BACKGROUND

MeSH Terms

Interventions

Elasticity Imaging Techniques

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Hossam Hassan Sayed Hammad, Resident doctor

CONTACT

Hossam El-din Galal M Elmalah, Assisstant Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

January 26, 2025

First Posted

January 31, 2025

Study Start

March 1, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

January 31, 2025

Record last verified: 2025-01