Detection of Subclinical Enthesitis by Ultrasonography

Detection of Subclinical Enthesitis by Ultrasonography in Psoriasis Patients With Psoriasis and Controls: by Ultrasonography; Incidence of Psoriatic Arthritis During Within One 1 Year

Detection of subclinical enthesitis by ultrasonography

Study Overview

• Status: Completed
• Conditions: Enthesitis
• Intervention / Treatment: Diagnostic test: Ultrasound

Detailed Description

A total of 30 patients with psoriasis and 30 age-matched healthy controls, all without musculoskeletal diseases, will be recruited. They will undergo dermatological assessment and a blinded ultrasound (US) evaluation. Clinical assessment included demographics, severity of psoriasis and musculoskeletal clinical examination. Evaluation consisted of the detection of grey scale (GS) enthesitis and Power Doppler signal in enthesis areas. The Madrid Sonography Enthesitis Index (MASEI) scoring system was used to quantify the extent of sonographic entheseal abnormalities.

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• Turkey
  • Atasehir
    • Istanbul, Atasehir, Turkey, 34758
      • Fatih Sultan Mehmet Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Both patients with psoriasis and healthy controls.

Description

Inclusion Criteria:

• Age≥18years
• Patients with psoriasis without musculoskeletal symptoms
• Healthy controls
• No joint involvement and no clinical symptoms and signs of enthesitis and synovitis

Exclusion Criteria:

• Have history of gout or arthritis or peripheral neurological disease of lower extremity.
• Have history of trauma and intensive sport activity in last 2 weeks.
• Have received any systemic therapy (i.e. DMARD, NSAIDs, corticosteroids, immunosuppressants, retinoids or biological agents) in 3 months
• Pregnant or breast-feeding

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Psoriasis; They will undergo dermatological assessment and a blinded ultrasound (US) evaluation.	Diagnostic test: Ultrasound; Evaluation consisted of the detection of grey scale (GS) enthesitis and Power Doppler signal in enthesis areas of participants. The Madrid Sonography Enthesitis Index (MASEI) scoring system was used to quantify the extent of sonographic entheseal abnormalities
Control; They will also undergo dermatological assessment and a blinded ultrasound (US) evaluation.	Diagnostic test: Ultrasound; Evaluation consisted of the detection of grey scale (GS) enthesitis and Power Doppler signal in enthesis areas of participants. The Madrid Sonography Enthesitis Index (MASEI) scoring system was used to quantify the extent of sonographic entheseal abnormalities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of Subclinical Enthesitis by Ultrasonography in Psoriasis Patients with Psoriasis and Controls: by Ultrasonography; Incidence of Psoriatic Arthritis During Within One 1 Year	Incidence of subclinical enthesitis,To investigate the incidence of subclinical enthesitis in patients with psoriasis	1 year.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Risk factors of subclinical enthesitis	To find out predictor factors of subclinical enthesitis in patients with psoriasis. To assess increase in enthesis area and PsA incidence, and show a possible relationship with baseline findings in a prospective 1-year follow-up of patients with PsO.	1 year

Collaborators and Investigators

• Sponsor: Fatih Sultan Mehmet Training and Research Hospital
• Investigators: Study Chair: Eylem Ceren Arikan, MD, Fatih Sultan Mehmet Training and Research Hospital; Principal Investigator: Duygu Silte Karamanlioglu, MD, Fatih Sultan Mehmet Training and Research Hospital; Study Chair: Feyza Unlu Ozkan, Prof., Fatih Sultan Mehmet Training and Research Hospital; Study Chair: Betül Zehra Pirdal, MD, Istanbul Sultangazi District Health Directorate; Study Chair: Gulcan Ozturk, MD, Fatih Sultan Mehmet Training and Research Hospital; Study Director: Ilknur Aktas, Prof, Fatih Sultan Mehmet Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2021
• Primary Completion (Actual): February 15, 2023
• Study Completion (Actual): March 15, 2023

Study Registration Dates

• First Submitted: December 14, 2019
• First Submitted That Met QC Criteria: December 23, 2019
• First Posted (Actual): December 24, 2019

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 22, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: ultrasound; psoriatic arthritis; psoriasis; subclinical enthesitis
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Enthesopathy
• Other Study ID Numbers: karamanlioglu.duygu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No