Sonographic Analysis of Nails in Psoriatic Arthritis and Healthy Controls

NCT ID: NCT04718428

Last Updated: 2021-01-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-14
• Study Completion Date: 2020-08-30

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.

Conditions

Psoriatic Arthritis; Psoriatic Nail

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

psoriatic arthritis

Patients with psoriatic arthritis who met the CASPAR criteria and were 18-70 years old were included. Participants with infection of the nails to be examined, loss of nails, trauma history of the nails, having the habit of nail biting, peripheral neuropathy, peripheral vascular disease, another rheumatological disease, systemic infection, and pregnancy were excluded.

Nail Ultrasonography

Intervention Type: DIAGNOSTIC_TEST

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

healthy controls

A gender- and age-matched healthy controls were included. They were recruited from the healthy relatives of the hospital staff. Participants with infection of the nails to be examined, loss of nails, trauma history of the nails, having the habit of nail biting, peripheral neuropathy, peripheral vascular disease, any rheumatological disease, systemic infection, and pregnancy were excluded.

Nail Ultrasonography

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Nail Ultrasonography

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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mehmet Tuncay Duruöz, Professor

Role: STUDY_DIRECTOR

Marmara University

Locations

Marmara University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 24932889 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26688297 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33901660 (View on PubMed)

Other Identifiers

09.2017.242

Identifier Type: -

Identifier Source: org_study_id