Detection of Subclinical Enthesitis by Ultrasonography

Completed

• Conditions: Enthesitis
• Interventions: Diagnostic Test: Ultrasound

• Registration Number: NCT04209894
• Lead Sponsor: Fatih Sultan Mehmet Training and Research Hospital

Brief Summary

Detection of subclinical enthesitis by ultrasonography

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 Timeline

• Study First Submitted: 2019-12-14
• Study First Submitted QC: 2019-12-23
• Study First Posted: 2019-12-24
• Study Start: 2021-09-15
• Primary Completion: 2023-02-15
• Study Completion: 2023-03-15
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-22
• Last Update Posted: 2023-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Ultrasound	They will also undergo dermatological assessment and a blinded ultrasound (US) evaluation.
Psoriasis	Ultrasound	They will undergo dermatological assessment and a blinded ultrasound (US) evaluation.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of participants with Risk factors of subclinical enthesitis	1 year	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.

Trial Locations

Locations (1)

Fatih Sultan Mehmet Training and Research Hospital; 🇹🇷 Istanbul, Atasehir, Turkey