Detection of Subclinical Enthesitis by Ultrasonography

Enthesitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04209894
• Other study ID #: karamanlioglu.duygu
• Status: Completed
• Start date: September 15, 2021
• Est. completion date: March 15, 2023

Study information

• Verified date: June 2023
• Source: Fatih Sultan Mehmet Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Detection of subclinical enthesitis by ultrasonography

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: March 15, 2023
• Est. primary completion date: February 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enthesitis
• Enthesopathy

Intervention

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

Locations

Country	Name	City	State
Turkey	Fatih Sultan Mehmet Training and Research Hospital	Istanbul	Atasehir

Sponsors (1)

Lead Sponsor	Collaborator
Fatih Sultan Mehmet Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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