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Clinical and Radiographic Correlation of Ultrasound MASEI Index in Patients With Ankylosing Spondylitis

This study is currently recruiting participants.
Verified April 2012 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Suellen Narimatsu, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01567878
First received: March 28, 2012
Last updated: April 25, 2012
Last verified: April 2012
History of Changes
  Purpose
  • Evaluate the correlation of ultrasound MASEI index with clinical, functional, radiographic and laboratorial variables in patients with ankylosing spondylitis.
  • Evaluate correlation between articular (shoulders, hips, knees and ankles) ultrasound (synovitis, erosions, power doppler) with same variables.
  • Evaluate correlation between articular and enthesis ultrasound exam in this study.
  • Compare patients and healthy individuals data, to calculate the ROC curve to estimate predictor value of disease.

Condition
Spondylitis, Ankylosing

Study Type: Observational
Official Title: Clinical and Radiographic Correlation of Ultrasound MASEI Index in Patients With Ankylosing Spondylitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Biospecimen Retention:   Samples With DNA

Blood sample


Estimated Enrollment: 80
Study Start Date: May 2009
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
ankylosing spondylitis
It will be held ultrasound exam in enthesis and joints in patients with ankylosing spondylitis and healthy subjects
Healthy pelople
It will be held ultrasound exam in enthesis and joints of healthy subjects

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with ankylosing spondylitis healthy subjects

Criteria

Inclusion Criteria:

  • Ankylosing spondylitis by the Modified New York Criteria (1984)or ASAS classification (2009)
  • Healthy people with no history of joint pain, inflammatory lumbar pain inflammatory disease,
  • 18 - 65 years old

Exclusion Criteria:

  • Fibromyalgia
  • Corticosteroid injection in the last 3 months
  • Previous surgery in joint or enthesis of study
  • Peripheric neuropathy
  • Diabetes mellitus
  • Hypothyroidism
  • Peripheric venous insufficiency (with edema or ocre dermatitis)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01567878

Contacts
Contact: Suellen Narimatsu 55 11 84153927 su_narimatsu@yahoo.com
Contact: Jamil Natour 55 11 55492198 jnatour@unifesp.br

Locations
Brazil
Suellen Narimatsu Recruiting
Sao Paulo, Brazil, 04021-001
Contact: Unifesp     55 11 55764000     jnatour@unifesp.br    
Principal Investigator: Suellen Narimatsu            
Sponsors and Collaborators
University of Sao Paulo
  More Information

No publications provided

Responsible Party: Suellen Narimatsu, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01567878     History of Changes
Other Study ID Numbers: 1649/09
Study First Received: March 28, 2012
Last Updated: April 25, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
ultrasound
MASEI index
clinical and ultrasound correlation
enthesis ultrasound
 articular ultrasound
ankylosing spondylitis ultrasound
radiographic and ultrasound correlation

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
 Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on May 16, 2013