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

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ClinicalTrials.gov Identifier: NCT02962271
Recruitment Status : Unknown
Verified November 2016 by Jian Zhu, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : November 11, 2016
Last Update Posted : November 11, 2016
Sponsor:
Information provided by (Responsible Party):
Jian Zhu, Chinese PLA General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Enthesopathy Device: Musculoskeletal Ultrasound

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.


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Study Type : Observational
Estimated Enrollment : 187 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Comparation of Ultrasonic Imaging of Enthesopathy in Patients With Psoriatic Arthritis and Psoriasis
Study Start Date : January 2016
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : December 2016


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




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

Secondary Outcome Measures :
  1. The potential risk factors of Ps for PsA as assessed by SPSS v17.0 [ Time Frame: up to 10 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02962271


Contacts
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Contact: Fei Sun 86-01-55499314 sunfeighy8911@163.com

Locations
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China
Chinese PLA General Hospital Recruiting
Beijing, China, 100000
Contact: Feng Huang    8610-55499114    frankfhuang@126.com   
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Principal Investigator: Jian Zhu Department of Rheumatology,PLA General Hospital

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Responsible Party: Jian Zhu, Clinical Professor, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02962271     History of Changes
Other Study ID Numbers: ChinaPLAGH-PsA
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: November 11, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Keywords provided by Jian Zhu, Chinese PLA General Hospital:
Musculoskeletal Ultrasound
Psoriatic Arthritis
Enthesopathy
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Enthesopathy
Psoriasis
Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Tendinopathy
Muscular Diseases
Tendon Injuries
Wounds and Injuries