Clinical trial NCT04718428: Sonographic Analysis of Nails in Psoriatic Arthritis and Healthy Controls
Official title: Standardized Sonographic Analysis of Nails in Psoriatic Arthritis and Healthy Controls: Feasibility, Reliability, Discriminative Performance, and Demographic and Clinical Associations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriatic Arthritis
Psoriatic Nail
Keywords: nail ultrasonography
psoriatic arthritis
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients met the CASPAR criteria and healthy controls had no inflammatory or mechanical musculoskeletal disease. Participants in the age range of 18-70 were included.

The control group was recruited from the healthy relatives of the hospital staff.

The PsA group was recruited from Marmara University Physical Medicine and Rehabilitation/Rheumatology clinic.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Psoriatic arthritis
* Healthy controls without any musculoskeletal disease
* Must be at the age of 18-70 years

Exclusion Criteria:

* Infection of the nails to be examined
* Loss of nails to be examined
* Trauma history of the nails to be examined
* Having the habit of nail-biting
* Peripheral neuropathy
* Peripheral vascular disease
* Any rheumatological disease, except psoriatic arthritis
* Systemic infection
* Pregnancy

Primary outcomes:
measure: The nail plate impairment score
timeFrame: Baseline (T0)
measure: The nail plate thickness score
timeFrame: Baseline (T0)
measure: The nail bed thickness score
timeFrame: Baseline (T0)
measure: The nail thickness score
timeFrame: Baseline (T0)
measure: The Doppler activity score
timeFrame: Baseline (T0)
Secondary outcomes:
measure: Interobserver reliability of the NUSG scorings
timeFrame: Baseline (T0)
measure: Intraobserver reliability of the NUSG scorings
timeFrame: Two weeks after the baseline (T1)
Other outcomes:
measure: Minimal Disease Activity
timeFrame: Baseline (T0)
measure: Disease Activity index for PSoriatic Arthritis
timeFrame: Baseline (T0)
measure: Psoriasis Area and Severity Index
timeFrame: Baseline (T0)
measure: Nail Psoriasis Severity Index
timeFrame: Baseline (T0)
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
affiliation: Marmara University
name: Mehmet Tuncay Duruöz, Professor
role: STUDY_DIRECTOR
References:
citation: Sandre MK, Rohekar S. Psoriatic arthritis and nail changes: exploring the relationship. Semin Arthritis Rheum. 2014 Oct;44(2):162-9. doi: 10.1016/j.semarthrit.2014.05.002. Epub 2014 May 6.
citation: Arbault A, Devilliers H, Laroche D, Cayot A, Vabres P, Maillefert JF, Ornetti P. Reliability, validity and feasibility of nail ultrasonography in psoriatic arthritis. Joint Bone Spine. 2016 Oct;83(5):539-44. doi: 10.1016/j.jbspin.2015.11.004. Epub 2015 Dec 10.
citation: Acer Kasman S, Gezer HH, Baklacioglu HS, Erdem Gursoy D, Duruoz MT. A standardized sonographic analysis of nails in psoriatic arthritis and healthy controls: Feasibility, reliability, diagnostic performance, and demographic and clinical associations. Joint Bone Spine. 2021 Oct;88(5):105197. doi: 10.1016/j.jbspin.2021.105197. Epub 2021 Apr 24.