Clinical Trials Directory

Trials / Completed

CompletedNCT04718428

Sonographic Analysis of Nails in Psoriatic Arthritis and Healthy Controls

Standardized Sonographic Analysis of Nails in Psoriatic Arthritis and Healthy Controls: Feasibility, Reliability, Discriminative Performance, and Demographic and Clinical Associations

Status
Completed
Phase
Study type
Observational
Enrollment
90 (actual)
Sponsor
Marmara University · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Accepted

Summary

This study aims to identify the nail ultrasonography (NUSG) properties in patients with psoriatic arthritis (PsA) and healthy controls by a participant-based evaluation; to assess feasibility, reliability, and discriminative performances; to explore final scorings; and to determine associations between the NUSG scores and participant characteristics, including demographics and disease-related factors.

Detailed description

NUSG is a visualization method suitable for evaluating the subunits of the nail. The main purpose of this study is to identify NUSG properties in patients with PsA and healthy controls. The investigators recruited patients with PsA according to the CASPAR criteria and sex- and age-matched healthy controls into the study. NUSG parameters were examined by grayscale and power Doppler techniques for all of the fingernails and first toenails (12 nails); and five scorings including nail plate impairment score (NPIs), nail plate thickness score (NPTs), nail bed thickness score (NBTs), nail thickness score (NTs), and the Doppler activity score (DAs) were calculated. The investigators compared the PsA and control groups in terms of the NUSG scorings and also documented the discriminative performances (with receiver operating characteristic curve analysis) of the scorings. Then, the feasibility and reliability analysis of the NUSG scorings were performed. Finally, the association between the NUSG scores and participant characteristics, including sex, age, body weight, height, labor market participation, smoking, hemoglobin, disease duration, history of dactylitis, current enthesitis, radiographic sacroiliitis, C reactive protein, minimal disease activity, Disease Activity Index for Psoriatic Arthritis, Nail Psoriasis Severity Index, and Psoriasis Area Severity Index were explored.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTNail UltrasonographyThe MyLab 60 (Esaote Biomedica Genoa, Italy) device and linear probe were used. Nails were examined in B-mode grayscale and power Doppler.

Timeline

Start date
2017-10-14
Primary completion
2019-06-15
Completion
2020-08-30
First posted
2021-01-22
Last updated
2021-01-26

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT04718428. Inclusion in this directory is not an endorsement.