Detection of Subclinical Enthesitis by Ultrasonography

NCT ID: NCT04209894

Last Updated: 2023-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-15

Study Completion Date

2023-03-15

Brief Summary

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Detection of subclinical enthesitis by ultrasonography

Detailed Description

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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.

Conditions

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Enthesitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Psoriasis

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

Ultrasound

Intervention Type 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

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

Ultrasound

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fatih Sultan Mehmet Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Duygu Karamanlıoğlu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Duygu Silte Karamanlioglu, MD

Role: PRINCIPAL_INVESTIGATOR

Fatih Sultan Mehmet Training and Research Hospital

Feyza Unlu Ozkan, Prof.

Role: STUDY_CHAIR

Fatih Sultan Mehmet Training and Research Hospital

Eylem Ceren Arikan, MD

Role: STUDY_CHAIR

Fatih Sultan Mehmet Training and Research Hospital

Betül Zehra Pirdal, MD

Role: STUDY_CHAIR

Istanbul Sultangazi District Health Directorate

Gulcan Ozturk, MD

Role: STUDY_CHAIR

Fatih Sultan Mehmet Training and Research Hospital

Ilknur Aktas, Prof

Role: STUDY_DIRECTOR

Fatih Sultan Mehmet Training and Research Hospital

Locations

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Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Atasehir, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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karamanlioglu.duygu

Identifier Type: -

Identifier Source: org_study_id

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