Comparison of the Frequency of Subclinic Synovitis in the... | NCT04750993

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

NCT04750993

Sponsor

Ufuk University

Status

Completed

Last Update Posted

Feb 11, 2021Actual

Enrollment

56Actual

Phase

Not provided

Conditions

Psoriasis
Synovitis

Interventions

musculoskeletal ultrasonography

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2014Actual

Primary Completion Date

Jun 1, 2015Actual

Completion Date

Jun 1, 2015Actual

First Submitted Date

Feb 10, 2021

First Submission Date that Met QC Criteria

Feb 10, 2021

First Posted Date

Feb 11, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2021

Last Update Posted Date

Feb 11, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Name	Type	Description	Arm Group Labels	Other Names
musculoskeletal ultrasonography	Diagnostic Test	The presence of subclinic synovitis findings in the hand joints was evaluated with musculoskeletal ultrasonography.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

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

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

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Ufuk University		Ankara	Çankaya	06520	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D007592	Joint Diseases