Comparison of the Frequency of Subclinic Synovitis in the Distal Interphalangeal Joints of the Hand in Psoriasis Patients

February 10, 2021 updated by: Elzem Bolkan Günaydın, Ufuk University

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.

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.

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.
56

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
    • Çankaya
      • Ankara, Çankaya, Turkey, 06520
        • Ufuk 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

For patient group

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

1.> 18 years old 2. Absence of clinically detected signs of arthritis 3.Lack of clinical signs suggestive of psoriasis

Exclusion Criteria:

For patient group

  1. To be <18 years old
  2. Clinically detected evidence of arthritis
  3. History of serious trauma, surgical intervention or injection in the joint areas to be evaluated
  4. Having a known inflammatory rheumatic disease For control group

1. 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

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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

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

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
GS/PD score
Time Frame: 8 month
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

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.
Ufuk University

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 1, 2014

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 1, 2015

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.
June 1, 2015

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).
February 10, 2021

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.
February 10, 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.
February 11, 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.
February 11, 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.
February 10, 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.
February 1, 2021

More Information

Terms related to this study

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.
  • 465/Gazi University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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