Ultrasound and Shear Wave Elastography Assessment of Entheses in Psoriatic Arthritis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMarmara University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Grayscale Ultrasonography, Power Doppler Ultrasonography, and Shear Wave Elastography
Diagnostic testParticipants 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Psoriatic Arthritis1 intervention
Group B: Healthy Controls1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline2
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.
Time frame
Baseline3
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.
Time frame
BaselineSecondary outcomes
1
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.
Time frame
Baseline2
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.
Time frame
Baseline3
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.
Time frame
Baseline4
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.
Time frame
BaselineLocations
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Source ClinicalTrials.gov
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