Clinical trial NCT04209894: Detection of Subclinical Enthesitis by Ultrasonography
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Enthesitis
Keywords: subclinical enthesitis
psoriasis
ultrasound
psoriatic arthritis
Lead sponsor: Fatih Sultan Mehmet Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-12-24
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Both patients with psoriasis and healthy controls.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Detection of Subclinical Enthesitis by Ultrasonography in Psoriasis Patients with Psoriasis and Controls: by Ultrasonography; Incidence of Psoriatic Arthritis During Within One 1 Year
timeFrame: 1 year.
Secondary outcomes:
measure: Number of participants with Risk factors of subclinical enthesitis
timeFrame: 1 year
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Fatih Sultan Mehmet Training and Research Hospital
state: Atasehir
Study officials:
affiliation: Fatih Sultan Mehmet Training and Research Hospital
name: Duygu Silte Karamanlioglu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fatih Sultan Mehmet Training and Research Hospital
name: Feyza Unlu Ozkan, Prof.
role: STUDY_CHAIR
affiliation: Fatih Sultan Mehmet Training and Research Hospital
name: Eylem Ceren Arikan, MD
role: STUDY_CHAIR
affiliation: Istanbul Sultangazi District Health Directorate
name: Betül Zehra Pirdal, MD
role: STUDY_CHAIR
affiliation: Fatih Sultan Mehmet Training and Research Hospital
name: Gulcan Ozturk, MD
role: STUDY_CHAIR
affiliation: Fatih Sultan Mehmet Training and Research Hospital
name: Ilknur Aktas, Prof
role: STUDY_DIRECTOR
References: