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

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ClinicalTrials.gov Identifier: NCT01567878
Recruitment Status : Completed
First Posted : March 30, 2012
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
Suellen Narimatsu, University of Sao Paulo

Brief Summary:
  • 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 or disease
Spondylitis, Ankylosing

Study Type : Observational
Actual Enrollment : 80 participants
Official Title: Ultrasound of Enthesis in Patients With Ankylosing Spondylitis: a Comparative Study With Health Subjects
Study Start Date : May 2009
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014


Group/Cohort
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



Primary Outcome Measures :
  1. 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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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)

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

Responsible Party: Suellen Narimatsu, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01567878     History of Changes
Other Study ID Numbers: 1649/09
First Posted: March 30, 2012    Key Record Dates
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