Ultrasound Evaluation of Hands in Patients With Systemic Lupus Erythematosus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Federal University of São Paulo.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Ana Leticia Pirozzi Buosi, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01471301
First received: November 10, 2011
Last updated: November 14, 2011
Last verified: November 2011
  Purpose

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


Condition
Lupus Erythematosus, Systemic
Arthritis, Rheumatoid

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Ultrasound Evaluation of Hands in Patients With Systemic Lupus Erythematosus

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Biospecimen Retention:   Samples With DNA

serum


Estimated Enrollment: 120
Study Start Date: June 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Detailed 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%.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

ambulatory rheumatology

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01471301

Contacts
Contact: Ana Leticia Pirozzi Buosi 551181352131 ana_buosi@yahoo.com.br

Locations
Brazil
Unifesp Recruiting
Sao Paulo, Brazil
Contact: Ana Leticia Piirozzi Buosi    551181352131      
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Ana Letícia Pirozzi Buosi Outros
  More Information

No publications provided

Responsible Party: Ana Leticia Pirozzi Buosi, Ultrasound evaluation of hands in patients with Systemic Lupus Erythematosus, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01471301     History of Changes
Other Study ID Numbers: ABuosi
Study First Received: November 10, 2011
Last Updated: November 14, 2011
Health Authority: Brazil: Ethics Committee
Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency

Keywords provided by Federal University of São Paulo:
systemic lupus erythematosus
rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Lupus Erythematosus, Systemic
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 20, 2014