Ultrasound and Shear Wave Elastography Assessment of Entheses in Psoriatic Arthritis (SWE-PsA)
20 de agosto de 2026 actualizado por: Marmara University
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Estimado)
60
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Zeynep M Kurt, MD
- Número de teléfono: +905334855911
- Correo electrónico: kurtzeynepmelis@gmail.com
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
Inclusion Criteria:
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:
- 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.
Exclusion Criteria:
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.
- 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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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.
|
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.
|
|
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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Total Madrid Sonography Enthesitis Index (MASEI) Score
Periodo de tiempo: 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.
|
Baseline
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Shear Wave Elastography Young's Modulus of Bilateral Enthesis Sites
Periodo de tiempo: 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.
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Baseline
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Shear Wave Elastography Shear Wave Velocity of Bilateral Enthesis Sites
Periodo de tiempo: 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.
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Baseline
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Health Assessment Questionnaire Disability Index (HAQ-DI) Score
Periodo de tiempo: Baseline
|
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.
|
Baseline
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Duruöz Hand Index (DHI) Score
Periodo de tiempo: Baseline
|
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.
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Baseline
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12-Item Short Form Health Survey Physical Component Summary (PCS-12) Score
Periodo de tiempo: Baseline
|
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.
|
Baseline
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12-Item Short Form Health Survey Mental Component Summary (MCS-12) Score
Periodo de tiempo: Baseline
|
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.
|
Baseline
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Fibromyalgia Rapid Screening Tool (FiRST) Score
Periodo de tiempo: Baseline
|
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.
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Baseline
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Serum C-Reactive Protein (CRP) Level
Periodo de tiempo: Baseline
|
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.
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Baseline
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Erythrocyte Sedimentation Rate (ESR)
Periodo de tiempo: Baseline
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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.
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Baseline
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Disease Activity Index for Psoriatic Arthritis (DAPSA) Score
Periodo de tiempo: Baseline
|
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.
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Baseline
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Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
Periodo de tiempo: Baseline
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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.
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Baseline
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Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS-CRP)
Periodo de tiempo: Baseline
|
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.
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Baseline
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Minimal Disease Activity (MDA) Status
Periodo de tiempo: Baseline
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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.
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Baseline
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Psoriasis Area and Severity Index (PASI) Score
Periodo de tiempo: Baseline
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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.
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Baseline
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Leeds Enthesitis Index (LEI) Score
Periodo de tiempo: Baseline
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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.
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Baseline
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Patient Pain Visual Analogue Scale (VAS) Score
Periodo de tiempo: Baseline
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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.
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Baseline
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Patient Global Assessment of Disease Activity (PtGA) Score
Periodo de tiempo: Baseline
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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.
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Baseline
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Physician Global Assessment of Disease Activity (PhGA) Score
Periodo de tiempo: Baseline
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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.
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Baseline
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
27 de julio de 2026
Finalización primaria (Estimado)
27 de julio de 2027
Finalización del estudio (Estimado)
27 de julio de 2027
Fechas de registro del estudio
Enviado por primera vez
26 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
20 de agosto de 2026
Publicado por primera vez (Actual)
25 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
20 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades óseas
- Enfermedades musculoesqueléticas
- Artritis
- Enfermedades Articulares
- Enfermedades de la columna
- Espondiloartropatías
- Enfermedades De La Piel Papuloescamosa
- Enfermedades de la piel
- Espondiloartritis
- Espondilitis
- Soriasis
- Enfermedades de la piel y del tejido conectivo
- Artritis, Psoriásica
Otros números de identificación del estudio
- Marmara FTR ZMK 02
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .