NCT04750993

Brief Summary

In this cross-sectional study, it was planned to compare the frequency of subclinical synovitis in the distal interphalangeal joints of the hands in psoriasis patients. 28 patients followed up by the Dermatology Department with a diagnosis of psoriasis and referred to us and 28 healthy volunteers were included in the study. Participants' age, gender, body mass index (BMI), year of psoriasis diagnosis, treatments they received, and comorbid diseases were recorded as demographic information. Psoriasis Area and Severity Index (PASI) and Nail Psoriasis Severity Index (NAPSI) were calculated by a dermatologist. Tenderness in the distal interphalangeal joints of both hands was evaluated by palpation. Subsequently, the presence of ultrasonographic synovitis findings of the participants was examined by a physician who was experienced in musculoskeletal ultrasonography and was blind to clinical evaluations. Scoring was done with the EULAR GS / PD joint scoring system and EULAR-OMERACT composite scoring system. The scores of the most affected joint were used in statistical analysis. Comparisons were made between psoriasis and control groups in terms of scores. Relationships between variables in the psoriasis group were examined.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2021

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

8 months

First QC Date

February 10, 2021

Last Update Submit

February 10, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • GS/PD score

    Intaarticular fluid (0 = absent, 1 = present), synovial hypertrophy (0 = absent, 1 = mild, 2 = moderate, 3 = severe), bone erosion (0 = absent, 1 = 2 erosion, 2 = More than 2 erosion), surrounding soft tissue swelling (0 = absent, 1 = mild, 2 = moderate) with gray scale; the presence of blood flow in the area with synovial proliferation with power Doppler (0 = no signal, 1 = less signal in one vessel, 2 = moderate signal at vascular intersections, 3 = intense signal on more than half of the joint surface) are evaluated and scored. GS and PD scores of the joint with the greatest involvement are used in statistical analysis.

    8 month

Interventions

The presence of subclinic synovitis findings in the hand joints was evaluated with musculoskeletal ultrasonography.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

30 psoriasis patients and 30 healthy volunteers were included in the study.

You may qualify if:

  • For patient group
  • Being over the age of 18
  • Being followed up by the Dermatology Department with a diagnosis of psoriasis and receiving topical or systemic treatment for this
  • Absence of clinically detected signs of arthritis
  • Absence of serious trauma, surgical intervention or injection in the joint areas to be evaluated.
  • Absence of any known inflammatory rheumatic disease For control group
  • \> 18 years old 2. Absence of clinically detected signs of arthritis 3.Lack of clinical signs suggestive of psoriasis

You may not qualify if:

  • For patient group
  • To be \<18 years old
  • Clinically detected evidence of arthritis
  • History of serious trauma, surgical intervention or injection in the joint areas to be evaluated
  • Having a known inflammatory rheumatic disease For control group
  • \. To be \<18 years old 2. Having clinical signs suggestive of psoriasis 3. Having clinically detectable signs of arthritis 4. History of known inflammatory disease, severe trauma in the joint areas to be evaluated, surgical intervention, injection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ufuk University

Ankara, Çankaya, 06520, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PsoriasisSynovitis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesJoint DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Doctor

Study Record Dates

First Submitted

February 10, 2021

First Posted

February 11, 2021

Study Start

October 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

February 11, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations