Shear Wave ElastographyNCT07188688
SWE to Detect Enthesitis in PsA: Relationship With SIRT2 Expression and Disease Activity
An observational study of Shear Wave Elastography, run by Assiut University at 1 site in Egypt.
Trial summary
1. To assess the diagnostic utility of shear-wave elastography (SWE), gray-scale (GS) ultrasound, and Power Doppler (PD) in detecting Patellar and Achilles tendinopathy in psoriatic patients with and without arthritis. 2. Investigate the relation between SWE, GS ultrasound, and PD finding and SIRT2 expression levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shear Wave Elastography
- What is being tested?
- Musculoskeletal Ultrasound Device
- Type of treatment
- Medical device
- How many people
- 57 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2025to Nov 2026
- 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
- Adult, Older adult
Study population: 57 participants: 19 Psoriatic arthritis patients, 19 Psoriasis-only patients and 19 healthy control.
Who may be able to join
- Patients diagnosed as PsO by a dermatologist according to PASI score.
- Patients diagnosed as PsA by rheumatologist according to CASPAR classification criteria for psoriatic arthritis
- Adult patients of both sexes with an average > 18 years
Who cannot join
- Patients with a history of metabolic disease affecting tendons.
- Patients with history of surgery, injury or trauma of patellar and/or Achilles tendon.
- Patients with other rheumatological diseases.
- Patients below 18.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Shear-Wave Elastography to Detect Enthesitis in Psoriatic Arthritis: Relationship With SIRT2 Expression and Disease Activity
- To assess the diagnostic utility of shear-wave elastography (SWE), gray-scale (GS) ultrasound, and Power Doppler (PD) in detecting Patellar and Achilles tendinopathy in psoriatic patients with and without arthritis.
- Investigate the relation between SWE, GS ultrasound, and PD finding and SIRT2 expression levels.
- Evaluate the association of the imaging findings and SIRT2 levels with psoriatic arthritis disease activity score.
Read the detailed description
Psoriatic arthritis is chronic inflammatory arthritis associated with psoriasis which was found in about 20% of patients with psoriatic arthritis. Psoriatic arthritis (PsA) is associated with decreased quality of life. As delayed diagnosis may lead to progressive joint destruction and long-term disability, the key clinical features of PsA should be recognizable to a wide range of clinicians to facilitate early diagnosis. The transition from psoriasis (PsO) to psoriatic arthritis (PsA) and the early diagnosis of PsA is of considerable scientific and clinical interest for the prevention and interception of PsA. Enthesopathy is the cornerstone of the pathophysiology of psoriatic arthritis (PsA). Even in patients without entheses symptoms, enthesitis has been demonstrated by imaging modalities both at the enthesis of load and the so-called "mini-enthesis" (pseudo-enthesis of the fingers). Moreover, inflammatory enthesopathy has been demonstrated in patients with psoriasis (PsO), and it is presumed that this finding could be, to some extent, a predictor of the development of PsA. Psoriatic arthritis is a complex heterogeneous disease manifesting skin disease and several musculoskeletal abnormalities including arthritis, enthesitis, dactylitis and spondylitis. While not all these manifestations are present in every patient, assessment of disease activity should account for these domains. To combining these domains into one composite score has been challenging but several have been developed as Psoriatic Arthritis Disease Activity Score (PASDAS) and Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Composite scorE (GRACE index). Musculoskeletal ultrasound (MSUS) imaging plays a pivotal role in the diagnosis and management of musculoskeletal disorders. Additionally, MSUS is a non-invasive, radiation-free and cost-effective tool, making it accessible for routine use in clinical practice. MSUS is playing an increasingly important role in optimizing clinical assessment of patients with rheumatic ultrasound conditions and substantially improves therapeutic and diagnostic capabilities. Ultrasound (US) is a reliable modality in detecting a wide range of musculoskeletal inflammatory lesions in PsA. MSUS correlates well with MRI findings and was found to be more reliable than physical examination in the assessment of musculoskeletal abnormalities. In addition, it is an affordable and accessible tool that is widely used in rheumatology practice. Recent advances in US technology hold promise to introduce highly mobile devices that could potentially be used in non-rheumatology settings (e.g., dermatology, primary care), increasing access to this technology. This highlights the potential use of the US as a point-of-care tool for optimizing early diagnosis of PsA at early stages of their disease. Shear-wave elastography (SWE) is a new technique that provides information on the elastic properties of tissues. It generates the quantitative data in kilopascals (kPa) by measuring the propagation velocity distribution of shear waves in tissues produced by a focused acoustic push pulse. It also provides qualitative data as colour coded images; these images are superimposed on a GS ultrasound image. Harder tissues appear red or yellow and softer tissues appear blue or green. Strain elastography and shear wave elastography reported as shear wave velocity have the best potential to be used in the identification of tendinopathy. Further high-quality studies with robust longitudinal designs to investigate responsiveness are needed to aid the monitoring of tendon recovery. The purpose of the study is to compare the accuracy of SWE with conventional ultrasound (GS and PD) for diagnosing patellar and Achilles tendinopathy in patients with psoriasis with and without arthritis and correlate the findings with clinical symptoms and disease severity scores in patients with psoriasis and psoriatic arthritis. Psoriatic arthritis (PsA) is characterized by a heterogeneous clinical phenotype that makes diagnosis and treatment challenging, particularly in the early stages where diagnosis remains difficult. Currently, diagnosis relies predominantly on clinical findings, highlighting the need for reliable biomarkers to improve diagnostic precision, refine prognostic evaluations, and guide personalized therapeutic strategies. Since a diagnostic delay of more than six months may contribute to poor functional and radiographic outcomes, it is critical to identify biomarkers that can facilitate the early diagnosis of PsA and help predict therapeutic responses. Sirtuins (SIRTs; silent information regulators) are an evolutionarily conserved group of enzymes involved in the post-translational modification of proteins including deacetylation, polyADP-ribosylation, demalonylation and lipoamidation. They exist in many cells and in a variety of organisms. Their names are derived from the SIRT2 (silent information regulator 2) gene, first identified in cells of the yeast Saccharomyces cerevisiae. SIRTs are involved in the recombination of ribosomal DNA and participate in gene silencing and DNA repair. SIRTs are involved in several cellular pathways related to ageing, inflammation, oxidative stress, epigenetics, tumorigenesis, the cell cycle, DNA repair and cell proliferation, positioning them as an essential component in the pathogenesis of many diseases, including psoriasis.
- Conditions
- Shear Wave Elastography
- Being tested
- Musculoskeletal Ultrasound Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Musculoskeletal Ultrasound DeviceDevice
Musculoskeletal Ultrasound assessment by LOGIQ P10 from General Electric (GE) Healthcare, each patient will be evaluated by grey scale, power doppler MSUS and Shear Wave Elastography (SWE)
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment and comparting the diagnostic utility of shear-wave elastography (SWE) , Gray-scale (GS) ultrasound. and Power Doppler (PD) in detecting tendinopathy in psoriatic patients with and without arthritis.
Musculoskeletal Ultrasound assessment by LOGIQ P10 from General Electric (GE) Healthcare, a division of General Electric Company
Measured: At baseline (single study visit)
Secondary outcomes (1)
Investigate the correlation between SWE, GS ultrasound and PD finding and SIRT2 expression levels and evaluate the correlation of the imaging finding and SIRT2 levels with psoriatic arthritis disease activity score (PASDAS).
Measured: At baseline (single study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study startOct 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Shear Wave ElastographyStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Mahmoud Mostafa Nasr Elshenawy, Assiut University
- Investigators
- Eman Abbas M Alkady, Professor, Principal investigator, Rheumatology, Rehabilitation and Physical Medicine, Assiut University HospitalsDoaa Kamal M. Abdelhafez, Associate Professor, Principal investigator, Rheumatology, Rehabilitation and Physical Medicine, Assiut University HospitalsNesreen Ismail Ibrahim, Lecturer, Principal investigator, Rheumatology, Rehabilitation and Physical Medicine, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188688
- Sponsor's protocol ID
- SWE of tendons in PsA
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Scalcon MRR, Waclawovsky AJ, Schuch FB, Speeckaert MM, Moresco RN. Proteomic biomarkers in psoriatic arthritis. Clin Chim Acta. 2025 May 15;572:120244. doi: 10.1016/j.cca.2025.120244. Epub 2025 Mar 15.
PubMed 40096904Saha D, Prakash M, Sinha A, Singh T, Dogra S, Sharma A. Role of Shear-Wave Elastography in Achilles Tendon in Psoriatic Arthritis and Its Correlation with Disease Severity Score, Psoriasis Area and Severity Index. Indian J Radiol Imaging. 2022 Jul 13;32(2):159-165. doi: 10.1055/s-0042-1743116. eCollection 2022 Jun.
PubMed 35924126Mifsud T, Gatt A, Micallef-Stafrace K, Chockalingam N, Padhiar N. Elastography in the assessment of the Achilles tendon: a systematic review of measurement properties. J Foot Ankle Res. 2023 Apr 27;16(1):23. doi: 10.1186/s13047-023-00623-1.
PubMed 37101290
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shear-Wave Elastography to Detect Enthesitis in Psoriatic Arthritis: Relationship With SIRT2 Expression and Disease Activity
- ClinicalTrials.gov ID
- NCT07188688
- Acronym / sponsor ID
- SWE of tendons in PsA
- Conditions
- Shear Wave Elastography
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 23 Sep 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.
- To assess the diagnostic utility of shear-wave elastography (SWE), gray-scale (GS) ultrasound, and Power Doppler (PD) in detecting Patellar and Achilles tendinopathy in psoriatic patients with and without arthritis.
- Investigate the relation between SWE, GS ultrasound, and PD finding and SIRT2 expression levels.
- Evaluate the association of the imaging findings and SIRT2 levels with psoriatic arthritis disease activity score.
Detailed description
Psoriatic arthritis is chronic inflammatory arthritis associated with psoriasis which was found in about 20% of patients with psoriatic arthritis. Psoriatic arthritis (PsA) is associated with decreased quality of life. As delayed diagnosis may lead to progressive joint destruction and long-term disability, the key clinical features of PsA should be recognizable to a wide range of clinicians to facilitate early diagnosis. The transition from psoriasis (PsO) to psoriatic arthritis (PsA) and the early diagnosis of PsA is of considerable scientific and clinical interest for the prevention and interception of PsA. Enthesopathy is the cornerstone of the pathophysiology of psoriatic arthritis (PsA). Even in patients without entheses symptoms, enthesitis has been demonstrated by imaging modalities both at the enthesis of load and the so-called "mini-enthesis" (pseudo-enthesis of the fingers). Moreover, inflammatory enthesopathy has been demonstrated in patients with psoriasis (PsO), and it is presumed that this finding could be, to some extent, a predictor of the development of PsA. Psoriatic arthritis is a complex heterogeneous disease manifesting skin disease and several musculoskeletal abnormalities including arthritis, enthesitis, dactylitis and spondylitis. While not all these manifestations are present in every patient, assessment of disease activity should account for these domains. To combining these domains into one composite score has been challenging but several have been developed as Psoriatic Arthritis Disease Activity Score (PASDAS) and Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Composite scorE (GRACE index). Musculoskeletal ultrasound (MSUS) imaging plays a pivotal role in the diagnosis and management of musculoskeletal disorders. Additionally, MSUS is a non-invasive, radiation-free and cost-effective tool, making it accessible for routine use in clinical practice. MSUS is playing an increasingly important role in optimizing clinical assessment of patients with rheumatic ultrasound conditions and substantially improves therapeutic and diagnostic capabilities. Ultrasound (US) is a reliable modality in detecting a wide range of musculoskeletal inflammatory lesions in PsA. MSUS correlates well with MRI findings and was found to be more reliable than physical examination in the assessment of musculoskeletal abnormalities. In addition, it is an affordable and accessible tool that is widely used in rheumatology practice. Recent advances in US technology hold promise to introduce highly mobile devices that could potentially be used in non-rheumatology settings (e.g., dermatology, primary care), increasing access to this technology. This highlights the potential use of the US as a point-of-care tool for optimizing early diagnosis of PsA at early stages of their disease. Shear-wave elastography (SWE) is a new technique that provides information on the elastic properties of tissues. It generates the quantitative data in kilopascals (kPa) by measuring the propagation velocity distribution of shear waves in tissues produced by a focused acoustic push pulse. It also provides qualitative data as colour coded images; these images are superimposed on a GS ultrasound image. Harder tissues appear red or yellow and softer tissues appear blue or green. Strain elastography and shear wave elastography reported as shear wave velocity have the best potential to be used in the identification of tendinopathy. Further high-quality studies with robust longitudinal designs to investigate responsiveness are needed to aid the monitoring of tendon recovery. The purpose of the study is to compare the accuracy of SWE with conventional ultrasound (GS and PD) for diagnosing patellar and Achilles tendinopathy in patients with psoriasis with and without arthritis and correlate the findings with clinical symptoms and disease severity scores in patients with psoriasis and psoriatic arthritis. Psoriatic arthritis (PsA) is characterized by a heterogeneous clinical phenotype that makes diagnosis and treatment challenging, particularly in the early stages where diagnosis remains difficult. Currently, diagnosis relies predominantly on clinical findings, highlighting the need for reliable biomarkers to improve diagnostic precision, refine prognostic evaluations, and guide personalized therapeutic strategies. Since a diagnostic delay of more than six months may contribute to poor functional and radiographic outcomes, it is critical to identify biomarkers that can facilitate the early diagnosis of PsA and help predict therapeutic responses. Sirtuins (SIRTs; silent information regulators) are an evolutionarily conserved group of enzymes involved in the post-translational modification of proteins including deacetylation, polyADP-ribosylation, demalonylation and lipoamidation. They exist in many cells and in a variety of organisms. Their names are derived from the SIRT2 (silent information regulator 2) gene, first identified in cells of the yeast Saccharomyces cerevisiae. SIRTs are involved in the recombination of ribosomal DNA and participate in gene silencing and DNA repair. SIRTs are involved in several cellular pathways related to ageing, inflammation, oxidative stress, epigenetics, tumorigenesis, the cell cycle, DNA repair and cell proliferation, positioning them as an essential component in the pathogenesis of many diseases, including psoriasis.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 57 participants: 19 Psoriatic arthritis patients, 19 Psoriasis-only patients and 19 healthy control.
Key inclusion criteria (3 listed)
- Patients diagnosed as PsO by a dermatologist according to PASI score.
- Patients diagnosed as PsA by rheumatologist according to CASPAR classification criteria for psoriatic arthritis
- Adult patients of both sexes with an average > 18 years
Key exclusion criteria (4 listed)
- Patients with a history of metabolic disease affecting tendons.
- Patients with history of surgery, injury or trauma of patellar and/or Achilles tendon.
- Patients with other rheumatological diseases.
- Patients below 18.
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 |
|---|---|---|
| Musculoskeletal Ultrasound DeviceMusculoskeletal Ultrasound assessment by LOGIQ P10 from General Electric (GE) Healthcare, each patient will be evaluated by grey scale, power doppler MSUS and Shear Wave Elastography (SWE) | Device | – |
Primary outcome
Assessment and comparting the diagnostic utility of shear-wave elastography (SWE) , Gray-scale (GS) ultrasound. and Power Doppler (PD) in detecting tendinopathy in psoriatic patients with and without arthritis.
Time frame: At baseline (single study visit)
Musculoskeletal Ultrasound assessment by LOGIQ P10 from General Electric (GE) Healthcare, a division of General Electric Company
1 secondary outcome
Investigate the correlation between SWE, GS ultrasound and PD finding and SIRT2 expression levels and evaluate the correlation of the imaging finding and SIRT2 levels with psoriatic arthritis disease activity score (PASDAS).
Time frame: At baseline (single study visit)
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 23 Sep 2025.
- Background: PubMed 40096904Scalcon MRR, Waclawovsky AJ, Schuch FB, Speeckaert MM, Moresco RN. Proteomic biomarkers in psoriatic arthritis. Clin Chim Acta. 2025 May 15;572:120244. doi: 10.1016/j.cca.2025.120244. Epub 2025 Mar 15.
- Background: PubMed 35924126Saha D, Prakash M, Sinha A, Singh T, Dogra S, Sharma A. Role of Shear-Wave Elastography in Achilles Tendon in Psoriatic Arthritis and Its Correlation with Disease Severity Score, Psoriasis Area and Severity Index. Indian J Radiol Imaging. 2022 Jul 13;32(2):159-165. doi: 10.1055/s-0042-1743116. eCollection 2022 Jun.
- Background: PubMed 37101290Mifsud T, Gatt A, Micallef-Stafrace K, Chockalingam N, Padhiar N. Elastography in the assessment of the Achilles tendon: a systematic review of measurement properties. J Foot Ankle Res. 2023 Apr 27;16(1):23. doi: 10.1186/s13047-023-00623-1.
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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.
Eman Abbas M Alkady, Professor principal investigator
Rheumatology, Rehabilitation and Physical Medicine, Assiut University Hospitals
Doaa Kamal M. Abdelhafez, Associate Professor principal investigator
Rheumatology, Rehabilitation and Physical Medicine, Assiut University Hospitals
Nesreen Ismail Ibrahim, Lecturer principal investigator
Rheumatology, Rehabilitation and Physical Medicine, Assiut University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shear Wave Elastography, run by Assiut University at 1 site in Egypt.
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 3 inclusion and 4 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 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Nada MMN ELSHENAWY, Specialist (+201002973457 ext. +201020417494, nadaaa.mahmoud@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment and comparting the diagnostic utility of shear-wave elastography (SWE) , Gray-scale (GS) ultrasound. and Power Doppler (PD) in detecting tendinopathy in psoriatic patients with and without arthritis. (time frame: At baseline (single study visit)). 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 NCT07188688, which also lists 3 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 23 Sep 2025.