Detection of Subclinical Enthesitis by Ultrasonography

NCT04209894 | Completed DMC

• 1 other identifier: karamanlioglu.duygu
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Detection of subclinical enthesitis by ultrasonography

Conditions

Enthesitis

Keywords

subclinical enthesitis; psoriasis; ultrasound; psoriatic arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of participants with Risk factors of subclinical enthesitis

  1 year

Study Arms (2)

Psoriasis

They will undergo dermatological assessment and a blinded ultrasound (US) evaluation.

Diagnostic Test: Ultrasound

Control

They will also undergo dermatological assessment and a blinded ultrasound (US) evaluation.

Diagnostic Test: Ultrasound

Interventions

Ultrasound DIAGNOSTIC_TEST

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; Psoriasis

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

Both patients with psoriasis and healthy controls.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Atasehir, 34758, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Psoriasis; Arthritis, Psoriatic

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Duygu Silte Karamanlioglu, MD

  Fatih Sultan Mehmet Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Feyza Unlu Ozkan, Prof.

  Fatih Sultan Mehmet Training and Research Hospital

  STUDY CHAIR

• Eylem Ceren Arikan, MD

  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 CHAIR

• Ilknur Aktas, Prof

  Fatih Sultan Mehmet Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 14, 2019
• First Posted: December 24, 2019
• Study Start: September 15, 2021
• Primary Completion: February 15, 2023
• Study Completion: March 15, 2023
• Last Updated: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)