Ultrasound and Shear Wave Elastography Assessment of Entheses in Psoriatic Arthritis (SWE-PsA)
2026年8月20日 更新者：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.
研究概览
地位
尚未招聘
详细说明
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.
研究类型
观察性的
注册 (估计的)
60
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Zeynep M Kurt, MD
- 电话号码：+905334855911
- 邮箱：kurtzeynepmelis@gmail.com
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
取样方法
非概率样本
研究人群
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.
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Total Madrid Sonography Enthesitis Index (MASEI) Score
大体时间：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
|
|
Shear Wave Elastography Young's Modulus of Bilateral Enthesis Sites
大体时间：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.
|
Baseline
|
|
Shear Wave Elastography Shear Wave Velocity of Bilateral Enthesis Sites
大体时间：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.
|
Baseline
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Health Assessment Questionnaire Disability Index (HAQ-DI) Score
大体时间：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
|
|
Duruöz Hand Index (DHI) Score
大体时间：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.
|
Baseline
|
|
12-Item Short Form Health Survey Physical Component Summary (PCS-12) Score
大体时间：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
|
|
12-Item Short Form Health Survey Mental Component Summary (MCS-12) Score
大体时间：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
|
|
Fibromyalgia Rapid Screening Tool (FiRST) Score
大体时间：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.
|
Baseline
|
|
Serum C-Reactive Protein (CRP) Level
大体时间：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.
|
Baseline
|
|
Erythrocyte Sedimentation Rate (ESR)
大体时间：Baseline
|
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.
|
Baseline
|
|
Disease Activity Index for Psoriatic Arthritis (DAPSA) Score
大体时间：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.
|
Baseline
|
|
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
大体时间：Baseline
|
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.
|
Baseline
|
|
Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS-CRP)
大体时间：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.
|
Baseline
|
|
Minimal Disease Activity (MDA) Status
大体时间：Baseline
|
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.
|
Baseline
|
|
Psoriasis Area and Severity Index (PASI) Score
大体时间：Baseline
|
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.
|
Baseline
|
|
Leeds Enthesitis Index (LEI) Score
大体时间：Baseline
|
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.
|
Baseline
|
|
Patient Pain Visual Analogue Scale (VAS) Score
大体时间：Baseline
|
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.
|
Baseline
|
|
Patient Global Assessment of Disease Activity (PtGA) Score
大体时间：Baseline
|
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.
|
Baseline
|
|
Physician Global Assessment of Disease Activity (PhGA) Score
大体时间：Baseline
|
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.
|
Baseline
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月27日
初级完成 (估计的)
2027年7月27日
研究完成 (估计的)
2027年7月27日
研究注册日期
首次提交
2026年7月26日
首先提交符合 QC 标准的
2026年8月20日
首次发布 (实际的)
2026年8月25日
研究记录更新
最后更新发布 (实际的)
2026年8月25日
上次提交的符合 QC 标准的更新
2026年8月20日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他研究编号
- Marmara FTR ZMK 02
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
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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研究美国 FDA 监管的设备产品
不
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