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CompletedNCT04750993Updated Feb 11, 2021

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

An observational study in Psoriasis and Synovitis, sponsored by Ufuk University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-11.

Sponsored by Ufuk University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
56
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Psoriasis
  • Synovitis
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

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

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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04

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
56 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testmusculoskeletal ultrasonography

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

05

What researchers measure

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.

    Time frame: 8 month

06

Study locations

1 site
  • Ufuk University
    Ankara, Çankaya 06520, Turkey
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04750993
Lead sponsor
Ufuk University
Responsible party
Elzem Bolkan Günaydın (Lecturer Doctor, Ufuk University) — Principal investigator
First posted
Feb 11, 2021
Start date
Oct 1, 2014
Primary completion
Jun 1, 2015
Completion
Jun 1, 2015
Last update
Feb 11, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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