Ultrasound and Shear Wave Elastography Assessment of Entheses in Psoriatic Arthritis

NCT07785089 | Not Yet Recruiting

• 1 other identifier: Marmara FTR ZMK 02
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Psoriatic Arthritis; Enthesitis

Keywords

Psoriatic Arthritis; CASPAR Criteria; Enthesitis; MASEI; Shear Wave Elastography; Musculoskeletal Ultrasonography; Power Doppler Ultrasonography

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline

Secondary Outcomes (16)

• Health Assessment Questionnaire Disability Index (HAQ-DI) Score

  Baseline

• Duruöz Hand Index (DHI) Score

  Baseline

• 12-Item Short Form Health Survey Physical Component Summary (PCS-12) Score

  Baseline

• 12-Item Short Form Health Survey Mental Component Summary (MCS-12) Score

  Baseline

• Fibromyalgia Rapid Screening Tool (FiRST) Score

  Baseline

Study Arms (2)

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

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

Interventions

Grayscale Ultrasonography, Power Doppler Ultrasonography, and Shear Wave Elastography DIAGNOSTIC_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.

Healthy Controls; Psoriatic Arthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Zeynep M Kurt, MD

CONTACT

+905334855911; kurtzeynepmelis@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: August 25, 2026
• Study Start: July 27, 2026
• Primary Completion (Estimated): July 27, 2027
• Study Completion (Estimated): July 27, 2027
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share