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

December 1, 2014 updated by: Suellen Narimatsu, University of Sao Paulo
  • 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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 04021-001
        • Suellen Narimatsu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with ankylosing spondylitis healthy subjects

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
december

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

March 28, 2012

First Submitted That Met QC Criteria

March 28, 2012

First Posted (Estimate)

March 30, 2012

Study Record Updates

Last Update Posted (Estimate)

December 2, 2014

Last Update Submitted That Met QC Criteria

December 1, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1649/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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