A Clinical Study of Subclinical Enthesitis and Synovitis in Patients With Vulgaris Psoriasis

• Conditions: Vulgaris Psoriasis
• Interventions: Other: PDUS examination

• Registration Number: NCT02339636
• Lead Sponsor: The 306 Hospital of People's Liberation Army

Brief Summary

A clinical study of subclinical enthesitis and synovitis in patients with vulgaris psoriasis

Detailed Description

A total of 100 patients with vulgaris psoriasis and 100 age-matched controls with other skin diseases, all without musculoskeletal diseases, will be recruited. They will undergo dermatological assessment and a blinded PDUS evaluation. Clinical assessment included demographics, severity of psoriasis, musculoskeletal clinical examination and sport activities. PDUS evaluation consisted of the detection of grey scale (GS) synovitis and synovial PD signal in joints of extremities, GS enthesopathy and entheseal PD signal in entheses of lower limbs.

Study Timeline

• Status Verified: 2013-08
• Study First Submitted: 2015-01-13
• Study First Submitted QC: 2015-01-14
• Last Update Submitted: 2015-01-14
• Study First Posted: 2015-01-15
• Last Update Posted: 2015-01-15
• Study Start: 2015-03
• Primary Completion: 2016-09
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• age≥18years
• patients with vulgaris psoriasis(dur
• patients with other skin diseases without musculoskeletal disorders
• no joint involvement and no clinical symptoms and signs of enthesitis and synovitis

Exclusion Criteria

• BMI≥24
• have history of gout or arthritis or peripheral neurological disease of lower extremity or trauma
• have received any systemic therapy(i.e.NSAIDs, corticosteroids, immunosuppressants, retinoids or biological agents) in 3 months
• pregnant or breast-feeding

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
case group	PDUS examination	100 patients with vulgaris psoriasi without arthritis
control group	PDUS examination	100 age-matched patients with other skin diseases without arthritis

Primary Outcome Measures

Name	Time	Method
Incidence of subclinical enthesitis and synovitis	one and a half year	To investigate the incidence of subclinical enthesitis and synovitis in patients with vulgaris

Secondary Outcome Measures

Name	Time	Method
Number of participants with Risk factors of subclinical enthesitis and synovitis	one and a half year	To find out predictor factors of subclinical enthesitis and synovitis in patients with vulgaris psoriasis

Trial Locations

Locations (1)

306 Hospital of PLA; 🇨🇳 Beijing, China