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

Enthesopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02962271
• Other study ID #: ChinaPLAGH-PsA
• Status: Recruiting
• Phase: N/A
• First received: November 3, 2016
• Last updated: November 9, 2016
• Start date: January 2016
• Est. completion date: December 2016

Study information

• Verified date: November 2016
• Source: Chinese PLA General Hospital
• Contact: Fei Sun
• Phone: 86-01-55499314
• Email: sunfeighy8911[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 187
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Enthesopathy
• Psoriasis
• Rheumatic Diseases

Intervention

Device:
• Musculoskeletal Ultrasound
Musculoskeletal ultrasound (MSUS) of the lower limbs' entheses were performed

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of enthesopathy comparison between psoriatic arthritis(PsA) and psoriasis(Ps) as assessed by SPSS v17.0		up to 10 months	No
Secondary	The potential risk factors of Ps for PsA as assessed by SPSS v17.0		up to 10 months	No