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
  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 University of Sao Paulo:

Primary Outcome Measures:
  • 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.


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

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
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: NCT01567878

Locations
Brazil
Suellen Narimatsu
Sao Paulo, Brazil, 04021-001
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: December 1, 2014
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
Ankylosis
Arthritis
Bone Diseases
Bone Diseases, Infectious
Infection
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthritis
Spondylarthropathies

ClinicalTrials.gov processed this record on August 30, 2015