Psoriatic ArthritisSWE-PsANCT07785089
Ultrasound and Shear Wave Elastography Assessment of Entheses in Psoriatic Arthritis
An observational study of Psoriatic Arthritis and Enthesitis, run by Marmara University.
Trial summary
Psoriatic arthritis (PsA) is a chronic inflammatory disease that frequently involves the entheses, where tendons, ligaments, and fascia insert into bone. Early detection of enthesitis is important for disease assessment and management. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriatic Arthritis, Enthesitis
- What is being tested?
- Grayscale Ultrasonography, Power Doppler Ultrasonography, and Shear Wave Elastography
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 27 Jul 2026to 27 Jul 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of adult patients (≥18 years) diagnosed with psoriatic arthritis according to the Classification Criteria for Psoriatic Arthritis (CASPAR) who are followed at the Rheumatology outpatient clinic of Marmara University Pendik Education and Research Hospital, and age- and sex-matched healthy volunteers without inflammatory rheumatic disease. Patients with psoriatic arthritis will undergo clinical evaluation, laboratory assessment, grayscale ultrasonography, Power Doppler ultrasonography, and shear wave elastography of bilateral enthesis sites included in the Madrid Sonography Enthesitis Index (MASEI). Demographic data will be collected from healthy volunteers, who will undergo the same ultrasonographic and shear wave elastography assessments.
Who may be able to join
- Psoriatic arthritis group:
- Adults aged 18 years or older.
- Diagnosis of psoriatic arthritis according to the Classification Criteria for Psoriatic Arthritis (CASPAR).
- Ability to provide written informed consent.
- Willingness to undergo clinical assessment, laboratory evaluation, grayscale ultrasonography, Power Doppler ultrasonography, and shear wave elastography.
- Healthy control group:
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- Adults aged 18 years or older.
- No history or diagnosis of inflammatory rheumatic disease.
- Age- and sex-matched to the psoriatic arthritis group.
- Ability to provide written informed consent.
- Willingness to undergo grayscale ultrasonography, Power Doppler ultrasonography, and shear wave elastography.
Who cannot join
- Psoriatic arthritis group:
- Age younger than 18 years.
- Refusal to participate in the study or inability/unwillingness to provide written informed consent.
- Inability to complete the clinical or ultrasonographic assessments.
- History of surgery, fracture, major trauma, or tendon rupture involving the enthesis sites to be evaluated.
- Local corticosteroid injection, platelet-rich plasma (PRP), prolotherapy, or other local interventional treatment at the enthesis sites to be evaluated within the previous 3 months.
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- Presence of acute traumatic tendinopathy, active soft tissue infection, open wound, or ulcer at the enthesis sites to be evaluated.
- Diagnosis of another inflammatory rheumatic disease or connective tissue disease other than psoriatic arthritis.
- Active infection, active malignancy, or severe systemic disease that may interfere with study assessments.
- Healthy control group:
- Age younger than 18 years.
- Refusal to participate in the study or inability/unwillingness to provide written informed consent.
- Inability to complete the clinical or ultrasonographic assessments.
- History or diagnosis of psoriasis, psoriatic arthritis, or any other inflammatory rheumatic disease.
- History of surgery, fracture, major trauma, or tendon rupture involving the enthesis sites to be evaluated.
- Local corticosteroid injection, platelet-rich plasma (PRP), prolotherapy, or other local interventional treatment at the enthesis sites to be evaluated within the previous 3 months.
- Presence of acute traumatic tendinopathy, active soft tissue infection, open wound, or ulcer at the enthesis sites to be evaluated.
- Active infection, active malignancy, or severe systemic disease that may interfere with study assessments.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Ultrasonography and Shear Wave Elastography Assessment of Enthesis Sites in Patients With Psoriatic Arthritis and Their Relationship With Disease Characteristics
Psoriatic arthritis (PsA) is a chronic inflammatory disease that frequently involves the entheses, where tendons, ligaments, and fascia insert into bone. Early detection of enthesitis is important for disease assessment and management. Conventional musculoskeletal ultrasonography, including grayscale and Power Doppler ultrasonography, can identify structural and inflammatory changes, while shear wave elastography (SWE) provides quantitative information about tissue stiffness. This observational cross-sectional study aims to evaluate bilateral enthesis sites using grayscale ultrasonography, Power Doppler ultrasonography, and SWE in patients with PsA and age- and sex-matched healthy controls. The study will investigate the relationship between imaging findings and clinical disease characteristics, disease activity, functional status, and laboratory parameters. The findings may improve understanding of enthesis involvement in PsA and clarify the potential role of multimodal ultrasound assessment, including SWE, in disease evaluation.
Read the detailed description
Psoriatic arthritis (PsA) is a chronic inflammatory musculoskeletal disease associated with psoriasis and characterized by peripheral arthritis, axial involvement, dactylitis, and enthesitis. Enthesitis, defined as inflammation at the insertion sites of tendons, ligaments, fascia, or joint capsules into bone, is considered one of the hallmark manifestations of PsA and may contribute substantially to pain, functional impairment, and structural damage. Early and accurate assessment of enthesitis is essential for disease evaluation and management. However, clinical examination alone has limited sensitivity for detecting subclinical or early entheseal inflammation.
Musculoskeletal ultrasonography has become an important imaging modality for the evaluation of enthesitis. Grayscale ultrasonography allows assessment of structural abnormalities such as tendon thickening, hypoechogenicity, calcifications, enthesophytes, erosions, and bursitis, while Power Doppler ultrasonography enables the detection of active vascularization associated with ongoing inflammation. In addition, shear wave elastography (SWE) is an ultrasound-based technique that quantitatively measures tissue stiffness and may identify biomechanical changes that are not detectable with conventional ultrasonography. Combining grayscale ultrasonography, Power Doppler ultrasonography, and SWE may provide a more comprehensive evaluation of entheseal involvement in PsA.
This is a single-center, observational, cross-sectional study conducted at Marmara University Pendik Education and Research Hospital. The study will include patients with psoriatic arthritis fulfilling the CASPAR classification criteria and age- and sex-matched healthy controls. Bilateral enthesis sites included in the Madrid Sonography Enthesitis Index (MASEI) will be evaluated using grayscale ultrasonography, Power Doppler ultrasonography, and shear wave elastography. Clinical assessments will include disease activity indices, patient-reported outcome measures, functional assessments, and laboratory inflammatory markers.
The primary objective of the study is to compare ultrasonographic and elastographic findings between patients with PsA and healthy controls. Secondary objectives are to investigate the relationships between imaging findings and disease activity, disease duration, clinical characteristics, functional status, and laboratory parameters. The study aims to determine the potential contribution of shear wave elastography, in combination with conventional ultrasonography and Power Doppler imaging, to the assessment of enthesitis in patients with psoriatic arthritis.
- Conditions
- Psoriatic Arthritis, Enthesitis
- Being tested
- Grayscale Ultrasonography, Power Doppler Ultrasonography, and Shear Wave Elastography
- Keywords
- Psoriatic Arthritis, CASPAR Criteria, Enthesitis, MASEI, Shear Wave Elastography, Musculoskeletal Ultrasonography, Power Doppler Ultrasonography
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grayscale Ultrasonography, Power Doppler Ultrasonography, and Shear Wave ElastographyDiagnostic test
Participants will undergo standardized musculoskeletal ultrasound evaluation of bilateral enthesis sites, including grayscale ultrasonography, Power Doppler ultrasonography, and shear wave elastography. The imaging protocol will be identical for both the psoriatic arthritis and healthy control groups. No therapeutic intervention will be administered as part of the study.
| Study group | Role | What they receive |
|---|---|---|
| Psoriatic Arthritis | Patients aged 18 years or older with psoriatic arthritis fulfilling the CASPAR classification criteria. Participants will undergo clinical assessment, laboratory evaluation, grayscale ultrasonography, Power Doppler ultrasonography, and shear wave elastography of bilateral enthesis sites. Receives: Diagnostic Test: Grayscale Ultrasonography, Power Doppler Ultrasonography, and Shear Wave Elastography | |
| Healthy Controls | Age- and sex-matched healthy volunteers without inflammatory rheumatic disease. Participants will undergo grayscale ultrasonography, Power Doppler ultrasonography, and shear wave elastography of bilateral enthesis sites using the same imaging protocol as the psoriatic arthritis group. Receives: Diagnostic Test: Grayscale Ultrasonography, Power Doppler Ultrasonography, and Shear Wave Elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Madrid Sonography Enthesitis Index (MASEI) Score
Comparison of the total Madrid Sonography Enthesitis Index (MASEI) score between patients with psoriatic arthritis and healthy controls. The total MASEI score is calculated by combining the predefined grayscale ultrasonography and Power Doppler findings assessed at six bilateral enthesis sites: the plantar fascia, Achilles tendon, proximal and distal patellar tendon, quadriceps tendon, and triceps tendon insertions. The total score ranges from 0 to 136 points, with higher scores indicating greater entheseal involvement.
Measured: Baseline
Shear Wave Elastography Young's Modulus of Bilateral Enthesis Sites
Comparison of shear wave elastography measurements between patients with psoriatic arthritis and healthy controls. Young's modulus will be measured in kilopascals (kPa) at the bilateral plantar fascia, Achilles tendon, proximal and distal patellar tendon, quadriceps tendon, and triceps tendon insertions. Three separate SWE images will be acquired at each enthesis site, with two 1-mm circular regions of interest placed on each image, resulting in a total of six measurements per enthesis. The arithmetic mean of the six measurements will be used as the SWE value for that enthesis. Results will be evaluated separately for each enthesis site.
Measured: Baseline
Shear Wave Elastography Shear Wave Velocity of Bilateral Enthesis Sites
Comparison of shear wave velocity measurements between patients with psoriatic arthritis and healthy controls. Shear wave velocity will be measured in meters per second (m/s) at the bilateral plantar fascia, Achilles tendon, proximal and distal patellar tendon, quadriceps tendon, and triceps tendon insertions. Three separate SWE images will be acquired at each enthesis site, with two 1-mm circular regions of interest placed on each image, resulting in a total of six measurements per enthesis. The arithmetic mean of the six measurements will be used as the shear wave velocity value for that enthesis. Results will be evaluated separately for each enthesis site.
Measured: Baseline
Secondary outcomes (16)
Health Assessment Questionnaire Disability Index (HAQ-DI) Score
Physical function in patients with psoriatic arthritis will be assessed using the Health Assessment Questionnaire Disability Index (HAQ-DI), which consists of 20 items covering eight domains of daily functioning. Each domain is scored from 0 to 3, and the overall HAQ-DI score ranges from 0 to 3 points. Higher scores indicate greater functional disability.
Measured: Baseline
Duruöz Hand Index (DHI) Score
Hand-related functional disability in patients with psoriatic arthritis will be assessed using the Duruöz Hand Index (DHI), which consists of 18 items evaluating activities of daily living. Each item is scored from 0 to 5, resulting in a total score ranging from 0 to 90 points. Higher scores indicate greater hand-related functional disability.
Measured: Baseline
12-Item Short Form Health Survey Physical Component Summary (PCS-12) Score
Physical health-related quality of life in patients with psoriatic arthritis will be assessed using the Physical Component Summary of the 12-Item Short Form Health Survey (PCS-12). The score ranges from 0 to 100 points, with higher scores indicating better physical health-related quality of life.
Measured: Baseline
12-Item Short Form Health Survey Mental Component Summary (MCS-12) Score
Mental health-related quality of life in patients with psoriatic arthritis will be assessed using the Mental Component Summary of the 12-Item Short Form Health Survey (MCS-12). The score ranges from 0 to 100 points, with higher scores indicating better mental health-related quality of life.
Measured: Baseline
Fibromyalgia Rapid Screening Tool (FiRST) Score
Fibromyalgia-related symptoms in patients with psoriatic arthritis will be assessed using the Fibromyalgia Rapid Screening Tool (FiRST). The questionnaire consists of six yes-or-no items. Each affirmative response is scored as 1 point, resulting in a total score ranging from 0 to 6 points. Higher scores indicate a greater likelihood of fibromyalgia, and a score of 5 or 6 is considered a positive screening result.
Measured: Baseline
Serum C-Reactive Protein (CRP) Level
Systemic inflammation in patients with psoriatic arthritis will be assessed by measuring the serum C-reactive protein (CRP) level. CRP will be reported in milligrams per liter (mg/L), with higher values indicating greater systemic inflammation.
Measured: Baseline
Erythrocyte Sedimentation Rate (ESR)
Systemic inflammation in patients with psoriatic arthritis will be assessed using the erythrocyte sedimentation rate (ESR). ESR will be reported in millimeters per hour (mm/hour), with higher values indicating greater systemic inflammation.
Measured: Baseline
Disease Activity Index for Psoriatic Arthritis (DAPSA) Score
Peripheral joint disease activity in patients with psoriatic arthritis will be assessed using the Disease Activity Index for Psoriatic Arthritis (DAPSA). The score is calculated as the sum of the 68-joint tender joint count, 66-joint swollen joint count, patient global assessment measured on a 0-to-10 scale, patient pain assessment measured on a 0-to-10 scale, and C-reactive protein level expressed in mg/dL. The minimum possible score is 0, and there is no fixed maximum because C-reactive protein is included as a continuous variable. Higher scores indicate greater disease activity. Scores of 4 or lower indicate remission; scores above 4 and up to 14 indicate low disease activity; scores above 14 and up to 28 indicate moderate disease activity; and scores above 28 indicate high disease activity.
Measured: Baseline
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
Axial and related disease activity in patients with psoriatic arthritis will be assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The index consists of six questions evaluating fatigue, spinal pain, peripheral joint pain or swelling, enthesitis, morning stiffness severity, and morning stiffness duration. Each question is scored from 0 to 10. The mean of the two morning stiffness item scores is calculated. This mean and the scores of the remaining four items are summed and divided by five, resulting in an overall score ranging from 0 to 10 points. Higher scores indicate greater disease activity.
Measured: Baseline
Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS-CRP)
Axial disease activity in patients with psoriatic arthritis will be assessed using the Ankylosing Spondylitis Disease Activity Score using C-reactive protein (ASDAS-CRP). The score combines back pain, duration of morning stiffness, patient global assessment, and peripheral joint pain or swelling, each assessed on a 0-to-10 scale, with the C-reactive protein level expressed in mg/L. The minimum possible score is 0, and there is no fixed maximum because C-reactive protein is included as a continuous variable. Higher scores indicate greater disease activity. Scores below 1.3 indicate inactive disease, scores from 1.3 to below 2.1 indicate low disease activity, scores from 2.1 to 3.5 indicate high disease activity, and scores above 3.5 indicate very high disease activity.
Measured: Baseline
Minimal Disease Activity (MDA) Status
Minimal disease activity in patients with psoriatic arthritis will be assessed using the established MDA criteria. A patient will be classified as achieving MDA when at least five of the following seven criteria are met: tender joint count of 1 or lower; swollen joint count of 1 or lower; Psoriasis Area and Severity Index score of 1 or lower or affected body surface area of 3% or lower; patient pain visual analogue scale score of 15 mm or lower; patient global disease activity visual analogue scale score of 20 mm or lower; Health Assessment Questionnaire Disability Index score of 0.5 or lower; and tender entheseal point count of 1 or lower. MDA status will be recorded as a binary categorical outcome: achieved or not achieved.
Measured: Baseline
Psoriasis Area and Severity Index (PASI) Score
Psoriasis severity in patients with psoriatic arthritis will be assessed using the Psoriasis Area and Severity Index (PASI). The index combines the extent of affected body surface area with the severity of erythema, induration, and scaling across four body regions: the head, upper extremities, trunk, and lower extremities. The total score ranges from 0 to 72 points, with higher scores indicating more severe psoriasis.
Measured: Baseline
Leeds Enthesitis Index (LEI) Score
Clinical enthesitis in patients with psoriatic arthritis will be assessed using the Leeds Enthesitis Index (LEI). Tenderness will be evaluated at six entheseal sites: the bilateral lateral epicondyles, bilateral medial femoral condyles, and bilateral Achilles tendon insertions. Each tender site is scored as 1 point and each non-tender site as 0 points, resulting in a total score ranging from 0 to 6 points. Higher scores indicate a greater burden of clinical enthesitis.
Measured: Baseline
Patient Pain Visual Analogue Scale (VAS) Score
Pain severity in patients with psoriatic arthritis will be assessed using a 10-cm visual analogue scale (VAS). The score ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain severity.
Measured: Baseline
Patient Global Assessment of Disease Activity (PtGA) Score
Overall disease activity from the patient's perspective will be assessed using a 10-cm visual analogue scale. The score ranges from 0 to 10, where 0 indicates no disease activity and 10 indicates the highest possible disease activity. Higher scores indicate greater patient-perceived disease activity.
Measured: Baseline
Physician Global Assessment of Disease Activity (PhGA) Score
Overall disease activity from the physician's perspective will be assessed using a 10-cm visual analogue scale. The score ranges from 0 to 10, where 0 indicates no disease activity and 10 indicates the highest possible disease activity. Higher scores indicate greater physician-assessed disease activity.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start27 Jul 2026 (estimated)
- Primary completion27 Jul 2027 (estimated)
- Study completion27 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785089
- Sponsor's protocol ID
- Marmara FTR ZMK 02
- Acronym
- SWE-PsA
- Status last verified
- Aug 2026
- First submitted
- 26 Jul 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because this is a single-center observational study conducted as part of an academic thesis. Data will be used only for the purposes described in the study protocol and managed in accordance with institutional ethics committee requirements and applicable data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonography and Shear Wave Elastography Assessment of Enthesis Sites in Patients With Psoriatic Arthritis and Their Relationship With Disease Characteristics
- ClinicalTrials.gov ID
- NCT07785089
- Acronym / sponsor ID
- SWE-PsA / Marmara FTR ZMK 02
- Conditions
- Psoriatic Arthritis, Enthesitis
- Keywords
- Psoriatic Arthritis, CASPAR Criteria, Enthesitis, MASEI, Shear Wave Elastography, Musculoskeletal Ultrasonography, Power Doppler Ultrasonography
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 27 Jul 2026 (estimated)
- Primary completion
- 27 Jul 2027 (estimated)
- Study completion
- 27 Jul 2027 (estimated)
- First posted
- 25 Aug 2026 (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.
Psoriatic arthritis (PsA) is a chronic inflammatory disease that frequently involves the entheses, where tendons, ligaments, and fascia insert into bone. Early detection of enthesitis is important for disease assessment and management. Conventional musculoskeletal ultrasonography, including grayscale and Power Doppler ultrasonography, can identify structural and inflammatory changes, while shear wave elastography (SWE) provides quantitative information about tissue stiffness. This observational cross-sectional study aims to evaluate bilateral enthesis sites using grayscale ultrasonography, Power Doppler ultrasonography, and SWE in patients with PsA and age- and sex-matched healthy controls. The study will investigate the relationship between imaging findings and clinical disease characteristics, disease activity, functional status, and laboratory parameters. The findings may improve understanding of enthesis involvement in PsA and clarify the potential role of multimodal ultrasound assessment, including SWE, in disease evaluation.
Detailed description
Psoriatic arthritis (PsA) is a chronic inflammatory musculoskeletal disease associated with psoriasis and characterized by peripheral arthritis, axial involvement, dactylitis, and enthesitis. Enthesitis, defined as inflammation at the insertion sites of tendons, ligaments, fascia, or joint capsules into bone, is considered one of the hallmark manifestations of PsA and may contribute substantially to pain, functional impairment, and structural damage. Early and accurate assessment of enthesitis is essential for disease evaluation and management. However, clinical examination alone has limited sensitivity for detecting subclinical or early entheseal inflammation.
Musculoskeletal ultrasonography has become an important imaging modality for the evaluation of enthesitis. Grayscale ultrasonography allows assessment of structural abnormalities such as tendon thickening, hypoechogenicity, calcifications, enthesophytes, erosions, and bursitis, while Power Doppler ultrasonography enables the detection of active vascularization associated with ongoing inflammation. In addition, shear wave elastography (SWE) is an ultrasound-based technique that quantitatively measures tissue stiffness and may identify biomechanical changes that are not detectable with conventional ultrasonography. Combining grayscale ultrasonography, Power Doppler ultrasonography, and SWE may provide a more comprehensive evaluation of entheseal involvement in PsA.
This is a single-center, observational, cross-sectional study conducted at Marmara University Pendik Education and Research Hospital. The study will include patients with psoriatic arthritis fulfilling the CASPAR classification criteria and age- and sex-matched healthy controls. Bilateral enthesis sites included in the Madrid Sonography Enthesitis Index (MASEI) will be evaluated using grayscale ultrasonography, Power Doppler ultrasonography, and shear wave elastography. Clinical assessments will include disease activity indices, patient-reported outcome measures, functional assessments, and laboratory inflammatory markers.
The primary objective of the study is to compare ultrasonographic and elastographic findings between patients with PsA and healthy controls. Secondary objectives are to investigate the relationships between imaging findings and disease activity, disease duration, clinical characteristics, functional status, and laboratory parameters. The study aims to determine the potential contribution of shear wave elastography, in combination with conventional ultrasonography and Power Doppler imaging, to the assessment of enthesitis in patients with psoriatic arthritis.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psoriatic Arthritis | – | Diagnostic Test: Grayscale Ultrasonography, Power Doppler Ultrasonography, and Shear Wave ElastographyPatients aged 18 years or older with psoriatic arthritis fulfilling the CASPAR classification criteria. Participants will undergo clinical assessment, laboratory evaluation, grayscale ultrasonography, Power Doppler ultrasonography, and shear wave elastography of bilateral enthesis sites. |
| Healthy Controls | – | Diagnostic Test: Grayscale Ultrasonography, Power Doppler Ultrasonography, and Shear Wave ElastographyAge- and sex-matched healthy volunteers without inflammatory rheumatic disease. Participants will undergo grayscale ultrasonography, Power Doppler ultrasonography, and shear wave elastography of bilateral enthesis sites using the same imaging protocol as the psoriatic arthritis group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients (≥18 years) diagnosed with psoriatic arthritis according to the Classification Criteria for Psoriatic Arthritis (CASPAR) who are followed at the Rheumatology outpatient clinic of Marmara University Pendik Education and Research Hospital, and age- and sex-matched healthy volunteers without inflammatory rheumatic disease. Patients with psoriatic arthritis will undergo clinical evaluation, laboratory assessment, grayscale ultrasonography, Power Doppler ultrasonography, and shear wave elastography of bilateral enthesis sites included in the Madrid Sonography Enthesitis Index (MASEI). Demographic data will be collected from healthy volunteers, who will undergo the same ultrasonographic and shear wave elastography assessments.
Key inclusion criteria (11 listed)
- Psoriatic arthritis group:
- Healthy control group:
Key exclusion criteria (18 listed)
- Psoriatic arthritis group:
- Healthy control group:
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 |
|---|---|---|
| Grayscale Ultrasonography, Power Doppler Ultrasonography, and Shear Wave ElastographyParticipants will undergo standardized musculoskeletal ultrasound evaluation of bilateral enthesis sites, including grayscale ultrasonography, Power Doppler ultrasonography, and shear wave elastography. The imaging protocol will be identical for both the psoriatic arthritis and healthy control groups. No therapeutic intervention will be administered as part of the study. | Diagnostic test | Healthy Controls, Psoriatic Arthritis |
Primary outcome
Total Madrid Sonography Enthesitis Index (MASEI) Score
Time frame: Baseline
Comparison of the total Madrid Sonography Enthesitis Index (MASEI) score between patients with psoriatic arthritis and healthy controls. The total MASEI score is calculated by combining the predefined grayscale ultrasonography and Power Doppler findings assessed at six bilateral enthesis sites: the plantar fascia, Achilles tendon, proximal and distal patellar tendon, quadriceps tendon, and triceps tendon insertions. The total score ranges from 0 to 136 points, with higher scores indicating greater entheseal involvement.
Shear Wave Elastography Young's Modulus of Bilateral Enthesis Sites
Time frame: Baseline
Comparison of shear wave elastography measurements between patients with psoriatic arthritis and healthy controls. Young's modulus will be measured in kilopascals (kPa) at the bilateral plantar fascia, Achilles tendon, proximal and distal patellar tendon, quadriceps tendon, and triceps tendon insertions. Three separate SWE images will be acquired at each enthesis site, with two 1-mm circular regions of interest placed on each image, resulting in a total of six measurements per enthesis. The arithmetic mean of the six measurements will be used as the SWE value for that enthesis. Results will be evaluated separately for each enthesis site.
Shear Wave Elastography Shear Wave Velocity of Bilateral Enthesis Sites
Time frame: Baseline
Comparison of shear wave velocity measurements between patients with psoriatic arthritis and healthy controls. Shear wave velocity will be measured in meters per second (m/s) at the bilateral plantar fascia, Achilles tendon, proximal and distal patellar tendon, quadriceps tendon, and triceps tendon insertions. Three separate SWE images will be acquired at each enthesis site, with two 1-mm circular regions of interest placed on each image, resulting in a total of six measurements per enthesis. The arithmetic mean of the six measurements will be used as the shear wave velocity value for that enthesis. Results will be evaluated separately for each enthesis site.
16 secondary outcomes
Health Assessment Questionnaire Disability Index (HAQ-DI) Score
Time frame: Baseline
Duruöz Hand Index (DHI) Score
Time frame: Baseline
12-Item Short Form Health Survey Physical Component Summary (PCS-12) Score
Time frame: Baseline
12-Item Short Form Health Survey Mental Component Summary (MCS-12) Score
Time frame: Baseline
Fibromyalgia Rapid Screening Tool (FiRST) Score
Time frame: Baseline
Serum C-Reactive Protein (CRP) Level
Time frame: Baseline
Erythrocyte Sedimentation Rate (ESR)
Time frame: Baseline
Disease Activity Index for Psoriatic Arthritis (DAPSA) Score
Time frame: Baseline
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
Time frame: Baseline
Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS-CRP)
Time frame: Baseline
Minimal Disease Activity (MDA) Status
Time frame: Baseline
Psoriasis Area and Severity Index (PASI) Score
Time frame: Baseline
Leeds Enthesitis Index (LEI) Score
Time frame: Baseline
Patient Pain Visual Analogue Scale (VAS) Score
Time frame: Baseline
Patient Global Assessment of Disease Activity (PtGA) Score
Time frame: Baseline
Physician Global Assessment of Disease Activity (PhGA) Score
Time frame: Baseline
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 25 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because this is a single-center observational study conducted as part of an academic thesis. Data will be used only for the purposes described in the study protocol and managed in accordance with institutional ethics committee requirements and applicable data protection regulations.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriatic Arthritis and Enthesitis, run by Marmara 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 11 inclusion and 18 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 25 Aug 2026. 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 Zeynep M Kurt, MD (+905334855911, kurtzeynepmelis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Madrid Sonography Enthesitis Index (MASEI) Score (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Aug 2026.