Sonographic Analysis of Nails in Psoriatic Arthritis and Healthy Controls

Psoriatic Arthritis Clinical Trial

— NUSGI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04718428
• Other study ID #: 09.2017.242
• Status: Completed
• Start date: October 14, 2017
• Est. completion date: August 30, 2020

Study information

• Verified date: January 2021
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 30, 2020
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis
• Psoriatic Nail

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Turkey	Marmara University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Minimal Disease Activity	"Minimal Disease Activity" is used for remission criteria in patients with PsA. It is defined as 5 out of 7 of the following criteria: tender joint count =1, swollen joint count =1, PASI =1, patient pain visual analog score (VAS) =15 mm, patient global disease activity VAS =20 mm, health assessment questionnaire =0.5, and tender entheseal points =1	Baseline (T0)
Other	Disease Activity index for PSoriatic Arthritis	"Disease Activity index for Psoriatic Arthritis" is used for disease activity states and response criteria in patients with PsA. It is simply calculated by summing swollen + tender joint counts + VAS pain + VAS patient global assessments + C reactive protein.	Baseline (T0)
Other	Psoriasis Area and Severity Index	"Psoriasis Area and Severity Index" is used for the measurement of severity of psoriasis. It combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). The body is divided into four sections: head 10 percent, arms 20 percent, trunk 30 percent, legs 40 percent. Each of these areas is scored by itself, and then the four scores are combined into the final score. For each section, the percent of area of skin involved, is estimated and then transformed into a grade from 0 to 6 (0: 0 percent of involved area, 1: < 10 percent of involved area, 2: 10-29 percent of involved area, 3: 30-49 percent of involved area, 4: 50-69 percent of involved area, 5: 70-89 percent of involved area, 6: 90-100 percent of involved area) Within each area, the severity is estimated by three clinical signs: erythema, induration and desquamation.	Baseline (T0)
Other	Nail Psoriasis Severity Index	"Nail Psoriasis Severity Index" is used to measure the severity of inspectional nail psoriasis by area of involvement in the nail unit: Each nail is divided into four quadrants and any nail plate or bed changes found are accounted for, generating a score that varies from 1-80. Higher scores mean a worse outcome.	Baseline (T0)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Interobserver reliability of the NUSG scorings	Patients with PsA were evaluated twice in order to assess interobserver reliability. For this purpose, another investigator experienced in musculoskeletal USG performed the ultrasonographic evaluations with the same device but separately from the one who made the first assessment. Then, the consistency between the observers was calculated for each scoring by intraclass correlation coefficient (range 0-1).	Baseline (T0)
Secondary	Intraobserver reliability of the NUSG scorings	Patients with PsA were evaluated again in order to assess intraobserver reliability. For this purpose, the same rheumatologist experienced in musculoskeletal USG performed the ultrasonographic evaluations again, after 2 weeks. Then, the consistency between the observers was calculated for each scoring by intraclass correlation coefficient (range 0-1).	Two weeks after the baseline (T1)