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Ultrasound of Enthesis in Patients With Ankylosing Spondylitis: a Comparative Study With Health Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Suellen Narimatsu, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01567878
First received: March 28, 2012
Last updated: December 1, 2014
Last verified: December 2014

March 28, 2012
December 1, 2014
May 2009
December 2014   (final data collection date for primary outcome measure)
Ultrasound of enthesis in patients with ankylosing spondylitis: a comparative study with healthy subjects [ Time Frame: december ] [ Designated as safety issue: Yes ]
a comparative study of enthesis by ultrasound revealed statistical differences among patients with ankylosing spondylitis and healthy volunteers in analysis of calcaneal enthesis, plantar fascia and quadriceps.
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Complete list of historical versions of study NCT01567878 on ClinicalTrials.gov Archive Site
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Ultrasound of Enthesis in Patients With Ankylosing Spondylitis: a Comparative Study With Health Subjects
Ultrasound of Enthesis in Patients With Ankylosing Spondylitis: a Comparative Study With Health Subjects
  • 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.
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Observational
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Retention:   Samples With DNA
Description:
Blood sample
Non-Probability Sample
Patients with ankylosing spondylitis healthy subjects
Spondylitis, Ankylosing
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  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
December 2014
December 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01567878
1649/09
No
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Suellen Narimatsu, University of Sao Paulo
University of Sao Paulo
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University of Sao Paulo
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP