Ultrasound Evaluation of Hands in Patients With Systemic Lupus Erythematosus

Arthritis, Rheumatoid Clinical Trial

Official title:

Ultrasound Evaluation of Hands in Patients With Systemic Lupus Erythematosus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01471301
• Other study ID #: ABuosi
• Status: Recruiting
• Phase: N/A
• First received: November 10, 2011
• Last updated: November 14, 2011
• Start date: June 2011

Study information

• Verified date: November 2011
• Source: Federal University of São Paulo
• Contact: Ana Leticia Pirozzi Buosi
• Phone: 551181352131
• Email: ana_buosi[@]yahoo.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: Ministry of HealthBrazil: National Committee of Ethics in ResearchBrazil: National Health Surveillance Agency
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate ultrasound hands in patients with systemic lupus erythematosus.

Description:

Introduction: The systemic lupus erythematosus (SLE) is a disease with a common articular involvement. Approximately 1-2% of patients with SLE have joint inflammation similar to rheumatoid arthritis (RA). There are no well-designed studies of lupus arthropathy.

Primary objectives: To evaluate the ultrasonographic examination of the hands in patients with systemic lupus erythematosus and make its correlation with examination of patients with rheumatoid arthritis (RA) established and with clinical, serological, radiological and functional.

Material and methods: a transversal study will be carried out on patients diagnosed with with SLE and RA.

Clinical Instruments: count of swollen and tender joints, visual analogue scale (VAS) for pain (0-10 cm), edema and for disease activity; disease activity (DAS 28 and SLEDAI), hand grip strength and pinch (Jamar dynamometer and Preston Pinch Gauge); functional questionnaires (HAQ and DASH). It will be observed the presence of "puffy hands", Raynaud's phenomenon and presence of autoantibodies.

Radiographic instruments: evaluation of radiographs of hands and wrists according to the Sharp score modified by van der Heijde. Ultrasonographic Instruments (quantitative and semi-quantitative measures): synovial hyperplasia, synovial blood flow (Power Doppler), bone erosions and cartilage. The joints that will be evaluated: radiocarpal, distal radioulnar, first to fifth metacarpophalangeal and proximal interphalangeal. Ultrasonographic interobserver reproducibility will be carried out in 10% of the patients. All the examinators will be blind for each other findings. Rheumatoid factor and anti-CCP will be investigated in RA patients. Statistical significance will be set at 5%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• age between 18 and 60 years;

• female and male;

• patients with SLE, according to the revised classification criteria of the ACR (Arthritis Rheum, 1997) with current or previous joint activity (arthritis or arthralgia;

• patients with established RA according to ACR classification criteria (Arthritis Rheum, 1988)

Exclusion Criteria:

• changing the dose or drug-based immunosuppression in the last 3 months.

• corticosteroid pulse therapy in the last 30 days;

• infiltration with corticosteroids at hand in the last 3 months;

• previous surgery in the joints studied;

• irreducible deformity of the joints studied;

• overlap with other joint diseases or collagen;

• chiropractic diabetic;

• hypothyroidism

Study Design

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

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Lupus Erythematosus, Systemic

Locations

Country	Name	City	State
Brazil	Unifesp	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil,