Ultrasound Evaluation of Hands in Patients With Systemic Lupus Erythematosus
|ClinicalTrials.gov Identifier: NCT01471301|
Recruitment Status : Unknown
Verified November 2011 by Ana Leticia Pirozzi Buosi, Federal University of São Paulo.
Recruitment status was: Recruiting
First Posted : November 15, 2011
Last Update Posted : November 15, 2011
|Condition or disease|
|Lupus Erythematosus, Systemic Arthritis, Rheumatoid|
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%.
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Observational Model:||Case Control|
|Official Title:||Ultrasound Evaluation of Hands in Patients With Systemic Lupus Erythematosus|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||November 2011|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01471301
|Contact: Ana Leticia Pirozzi Buosifirstname.lastname@example.org|
|Sao Paulo, Brazil|
|Contact: Ana Leticia Piirozzi Buosi 551181352131|
|Principal Investigator:||Ana Letícia Pirozzi Buosi||Outros|