Ultrasound and Shear Wave Elastography Assessment of Entheses in Psoriatic Arthritis (SWE-PsA)

August 20, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Psoriatic arthritis group:

    1. Adults aged 18 years or older.
    2. Diagnosis of psoriatic arthritis according to the Classification Criteria for Psoriatic Arthritis (CASPAR).
    3. Ability to provide written informed consent.
    4. Willingness to undergo clinical assessment, laboratory evaluation, grayscale ultrasonography, Power Doppler ultrasonography, and shear wave elastography.

  • Healthy control group:

    1. Adults aged 18 years or older.
    2. No history or diagnosis of inflammatory rheumatic disease.
    3. Age- and sex-matched to the psoriatic arthritis group.
    4. Ability to provide written informed consent.
    5. Willingness to undergo grayscale ultrasonography, Power Doppler ultrasonography, and shear wave elastography.

Exclusion Criteria:

  • Psoriatic arthritis group:

    1. Age younger than 18 years.
    2. Refusal to participate in the study or inability/unwillingness to provide written informed consent.
    3. Inability to complete the clinical or ultrasonographic assessments.
    4. History of surgery, fracture, major trauma, or tendon rupture involving the enthesis sites to be evaluated.
    5. 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.
    6. Presence of acute traumatic tendinopathy, active soft tissue infection, open wound, or ulcer at the enthesis sites to be evaluated.
    7. Diagnosis of another inflammatory rheumatic disease or connective tissue disease other than psoriatic arthritis.
    8. Active infection, active malignancy, or severe systemic disease that may interfere with study assessments.

  • Healthy control group:

    1. Age younger than 18 years.
    2. Refusal to participate in the study or inability/unwillingness to provide written informed consent.
    3. Inability to complete the clinical or ultrasonographic assessments.
    4. History or diagnosis of psoriasis, psoriatic arthritis, or any other inflammatory rheumatic disease.
    5. History of surgery, fracture, major trauma, or tendon rupture involving the enthesis sites to be evaluated.
    6. 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.
    7. Presence of acute traumatic tendinopathy, active soft tissue infection, open wound, or ulcer at the enthesis sites to be evaluated.
    8. Active infection, active malignancy, or severe systemic disease that may interfere with study assessments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Diagnostic test: Grayscale Ultrasonography, Power Doppler Ultrasonography, and Shear Wave Elastography
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.
Diagnostic test: Grayscale Ultrasonography, Power Doppler Ultrasonography, and Shear Wave Elastography
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline
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.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Health Assessment Questionnaire Disability Index (HAQ-DI) Score
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 27, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 27, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 27, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Marmara FTR ZMK 02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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