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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01567878
First Posted: March 30, 2012
Last Update Posted: December 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Suellen Narimatsu, University of Sao Paulo
  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: Ultrasound of Enthesis in Patients With Ankylosing Spondylitis: a Comparative Study With Health Subjects

Resource links provided by NLM:


Further study details as provided by Suellen Narimatsu, University of Sao Paulo:

Primary Outcome Measures:
  • Ultrasound of enthesis in patients with ankylosing spondylitis: a comparative study with healthy subjects [ Time Frame: december ]
    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.


Biospecimen Retention:   Samples With DNA
Blood sample

Enrollment: 80
Study Start Date: May 2009
Study Completion Date: December 2014
Primary Completion Date: December 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01567878


Locations
Brazil
Suellen Narimatsu
Sao Paulo, Brazil, 04021-001
Sponsors and Collaborators
University of Sao Paulo
  More Information

Responsible Party: Suellen Narimatsu, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01567878     History of Changes
Other Study ID Numbers: 1649/09
First Submitted: March 28, 2012
First Posted: March 30, 2012
Last Update Posted: December 2, 2014
Last Verified: December 2014

Keywords provided by Suellen Narimatsu, 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