Sonographic Analysis of Nails in Psoriatic Arthritis and Healthy Controls

NCT04718428 | Completed

• 1 other identifier: 09.2017.242
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriatic Arthritis; Psoriatic Nail

Keywords

nail ultrasonography; psoriatic arthritis

Outcome Measures

Primary Outcomes (5)

• The nail plate impairment score

  The sonographic normal nail plate term indicates a trilaminar band of the nail plate with two hyperechoic layers separated by a hypoechoic one. The "nail plate impairment score" means the number of nails with impaired trilaminar band (plate) among the 12 nails (all hand nails and toenails). The score ranges between 0-12, with 0 indicating no plate impairments (better) and 12 reflecting the maximal prevalence of impairment (worse).

  Baseline (T0)

• The nail plate thickness score

  The plate thickness of each nail was measured (in millimeters) by greyscale USG, then, the sum of 12 nails evaluated (all hand nails and toenails) was calculated as "nail plate thickness score" for a participant (in millimeters). Higher scores were expected to mean worse outcome.

  Baseline (T0)

• The nail bed thickness score

  The sonographic nail bed is the dark area below the nail plate to the cortical bone. The nail bed thickness of each nail was measured (in millimeters) by greyscale USG, then, the sum of 12 nails evaluated (all hand nails and toenails) was calculated as "nail bed thickness score" (in millimeters) for a participant. Higher scores were expected to mean worse outcome.

  Baseline (T0)

• The nail thickness score

  The total nail thickness (including the plate and bed) of each nail was measured (in millimeters) by greyscale USG, then, the sum of 12 nails evaluated (all hand nails and toenails) was calculated as "nail thickness score" (in millimeters) for a participant. Higher scores were expected to mean worse outcome.

  Baseline (T0)

• The Doppler activity score

  Doppler activity of the nail bed and matrix was measured by power Doppler USG. The power Doppler signal for each nail was graded from 0 to 3: 1 point for a signal in less than 25 percent of the nail bed area, 2 points for a signal 25 to 50 percent, 3 points for a confluent signal in more than 50 percent of the nail bed area, and 0 point for no signal. Then, the sum of 12 nails evaluated (all hand nails and toenails) was calculated as "Doppler activity score". The score ranges between 0-36, with 0 indicating no activity (better) and 36 reflecting the maximal activity (worse).

  Baseline (T0)

Secondary Outcomes (2)

• Interobserver reliability of the NUSG scorings

  Baseline (T0)

• Intraobserver reliability of the NUSG scorings

  Two weeks after the baseline (T1)

Other Outcomes (4)

• Minimal Disease Activity

  Baseline (T0)

• Disease Activity index for PSoriatic Arthritis

  Baseline (T0)

• Psoriasis Area and Severity Index

  Baseline (T0)

Study Arms (2)

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.

Diagnostic Test: Nail Ultrasonography

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.

Diagnostic Test: Nail Ultrasonography

Interventions

Nail Ultrasonography 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; psoriatic arthritis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, 34899, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 24932889 BACKGROUND

• 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.

  PMID: 26688297 BACKGROUND

• 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.

  PMID: 33901660 DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Mehmet Tuncay Duruöz, Professor

  Marmara University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 22, 2021
• Study Start: October 14, 2017
• Primary Completion: June 15, 2019
• Study Completion: August 30, 2020
• Last Updated: January 26, 2021

Record last verified: 2021-01

Locations

TU (1)