Comparation of Ultrasonic Imaging of Enthesopathy in Patients With Psoriatic Arthritis and Psoriasis

November 9, 2016 updated by: Jian Zhu, Chinese PLA General Hospital
Psoriatic arthritis(PsA) and psoriasis(Ps) are two systemic inflammatory diseases linked with rash of psoriasis, but there's still great controversy regarding the exact relationship between them. Our study is to investigate the characteristics and differences of the ultrasonic imaging of enthesopathy in the lower extremity in patients with PsA and Ps, to explore the risk factors of Ps developing into PsA in the long term course.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

As one of the most common chronic inflammatory skin diseases, psoriasis(Ps) can be intimately associated to psoriatic arthritis (PsA), affecting approximately 1% to 2% of the world's population. About 30% of them will develop into PsA with serious impact on their health-related quality of life.

PsA, characterised by different subsets with varying degree of severity, is a chronic, complicated inflammatory disease.Enthesitis is the prevalent and distinctive feature of PsA.

Musculoskeletal Ultrasound (MSUS) is a valid noninvasive modality, essential to evaluate entheses thickness, enthesophytes, bursitis and bone erosions as well as to disclose vascularisation on tendons through power doppler (PD) assessment. In recent years, more and more attention has been paid to the diagnosis and management of Ps and PsA, owing to its discrimination of identifying subclinical entheses and joint changes.

Study Type

Observational

Enrollment (Anticipated)

187

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100000
        • Recruiting
        • Chinese PLA General hospital
        • Contact:

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

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

A series of 44 patients with PsA, 44 age- and sex-matched patients of Ps and 44 HCs consecutively admitted from the outpatients clinic and ward from January 2016 to September 2016.

Description

Inclusion Criteria:

  • Clinical diagnosis of plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, rheumatoid arthritis or osteoarthritis.
  • Body Mass Index (BMI)<30 kg/m2.
  • Absence of local glucocorticoid or other drugs injection or surgical treatment for entheses scanned in the previous 6 weeks prior to clinical and musculoskeletal ultrasound (MSUS) evaluation.

Exclusion Criteria:

  • Other systemic rheumatic diseases or malignant neoplasms.
  • Peripheral neuropathy of lower extremity.

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: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Psoriatic Arthritis
Musculoskeletal ultrasound (MSUS) of the lower limbs' entheses were performed
Device: Musculoskeletal Ultrasound
Musculoskeletal ultrasound (MSUS) of the lower limbs' entheses were performed
Psoriasis
Musculoskeletal ultrasound (MSUS) of the lower limbs' entheses were performed
Device: Musculoskeletal Ultrasound
Musculoskeletal ultrasound (MSUS) of the lower limbs' entheses were performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The rate of enthesopathy comparison between psoriatic arthritis(PsA) and psoriasis(Ps) as assessed by SPSS v17.0
Time Frame: up to 10 months
up to 10 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The potential risk factors of Ps for PsA as assessed by SPSS v17.0
Time Frame: up to 10 months
up to 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Investigators

  • Principal Investigator: Jian Zhu, Department of Rheumatology,PLA General Hospital

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

January 1, 2016

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

November 3, 2016

First Submitted That Met QC Criteria

November 9, 2016

First Posted (Estimate)

November 11, 2016

Study Record Updates

Last Update Posted (Estimate)

November 11, 2016

Last Update Submitted That Met QC Criteria

November 9, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChinaPLAGH-PsA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All individual participant data (IPD) are to be shared with other researchers, whenever it will be available, and it may be obtained by requesting from the principal investigator

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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