Psoriatic ArthritisNUSGINCT04718428
Sonographic Analysis of Nails in Psoriatic Arthritis and Healthy Controls
An observational study of Psoriatic Arthritis and Psoriatic Nail, run by Marmara University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriatic Arthritis, Psoriatic Nail
- What is being tested?
- Nail Ultrasonography
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Oct 2017to 30 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Clinical diagnosis of Psoriatic arthritis
- Healthy controls without any musculoskeletal disease
- Must be at the age of 18-70 years
Who cannot join
- 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
Show all 9Show fewer
- Any rheumatological disease, except psoriatic arthritis
- Systemic infection
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Nail Ultrasonography
- Keywords
- nail ultrasonography, psoriatic arthritis
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nail UltrasonographyDiagnostic test
The MyLab 60 (Esaote Biomedica Genoa, Italy) device and linear probe were used. Nails were examined in B-mode grayscale and power Doppler.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Nail Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline (T0)
Secondary outcomes (2)
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).
Measured: Baseline (T0)
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).
Measured: Two weeks after the baseline (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start14 Oct 2017
- Primary completion15 Jun 2019
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehmet Tuncay Duruöz, Professor, Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718428
- Sponsor's protocol ID
- 09.2017.242
- Acronym
- NUSGI
- Status last verified
- Jan 2021
- First submitted
- 30 Dec 2020
- Last updated
- 26 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24932889Arbault 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.
PubMed 26688297Acer 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.
PubMed 33901660
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardized Sonographic Analysis of Nails in Psoriatic Arthritis and Healthy Controls: Feasibility, Reliability, Discriminative Performance, and Demographic and Clinical Associations
- ClinicalTrials.gov ID
- NCT04718428
- Acronym / sponsor ID
- NUSGI / 09.2017.242
- Conditions
- Psoriatic Arthritis, Psoriatic Nail
- Keywords
- nail ultrasonography, psoriatic arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 14 Oct 2017 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| psoriatic arthritis | – | Diagnostic Test: Nail UltrasonographyPatients 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. |
| healthy controls | – | Diagnostic Test: Nail UltrasonographyA 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Clinical diagnosis of Psoriatic arthritis
- Healthy controls without any musculoskeletal disease
- Must be at the age of 18-70 years
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nail UltrasonographyThe MyLab 60 (Esaote Biomedica Genoa, Italy) device and linear probe were used. Nails were examined in B-mode grayscale and power Doppler. | Diagnostic test | healthy controls, psoriatic arthritis |
Primary outcome
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).
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.
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.
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.
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).
2 secondary outcomes
Interobserver reliability of the NUSG scorings
Time frame: Baseline (T0)
Intraobserver reliability of the NUSG scorings
Time frame: Two weeks after the baseline (T1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Background: PubMed 24932889Sandre 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.
- Background: PubMed 26688297Arbault 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.
- Derived from this study: PubMed 33901660Acer 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet Tuncay Duruöz, Professor study director
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriatic Arthritis and Psoriatic Nail, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The nail plate impairment score (time frame: Baseline (T0)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04718428, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.