Sonographic Analysis of Nails in Psoriatic Arthritis and Healthy Controls (NUSGI)

January 22, 2021 updated by: Marmara University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34899
        • Marmara University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The nail plate impairment score
Time Frame: Baseline (T0)
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
Time Frame: Baseline (T0)
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
Time Frame: Baseline (T0)
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
Time Frame: Baseline (T0)
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
Time Frame: Baseline (T0)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Interobserver reliability of the NUSG scorings
Time Frame: Baseline (T0)
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)
Intraobserver reliability of the NUSG scorings
Time Frame: Two weeks after the baseline (T1)
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)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Minimal Disease Activity
Time Frame: Baseline (T0)
"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)
Disease Activity index for PSoriatic Arthritis
Time Frame: Baseline (T0)
"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)
Psoriasis Area and Severity Index
Time Frame: Baseline (T0)
"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)
Nail Psoriasis Severity Index
Time Frame: Baseline (T0)
"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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marmara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 14, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 09.2017.242

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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