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

Primary Purpose

Spondylitis, Ankylosing

Status
Completed
Phase
Locations
Brazil
Study Type
Observational
Intervention
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Spondylitis, Ankylosing focused on measuring ultrasound, MASEI index, clinical and ultrasound correlation, enthesis ultrasound, articular ultrasound, ankylosing spondylitis ultrasound, radiographic and ultrasound correlation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Suellen Narimatsu

Arms of the Study

Arm 1

Arm 2

Arm Type

Arm Label

ankylosing spondylitis

Healthy pelople

Arm Description

It will be held ultrasound exam in enthesis and joints in patients with ankylosing spondylitis and healthy subjects

It will be held ultrasound exam in enthesis and joints of healthy subjects

Outcomes

Primary Outcome Measures

Ultrasound of enthesis in patients with ankylosing spondylitis: a comparative study with healthy subjects
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.

Secondary Outcome Measures

Full Information

First Posted
March 28, 2012
Last Updated
December 1, 2014
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01567878
Brief Title
Ultrasound of Enthesis in Patients With Ankylosing Spondylitis: a Comparative Study With Health Subjects
Official Title
Ultrasound of Enthesis in Patients With Ankylosing Spondylitis: a Comparative Study With Health Subjects
Study Type
Observational

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondylitis, Ankylosing
Keywords
ultrasound, MASEI index, clinical and ultrasound correlation, enthesis ultrasound, articular ultrasound, ankylosing spondylitis ultrasound, radiographic and ultrasound correlation

7. Study Design

Enrollment
80 (Actual)
Biospecimen Retention
Samples With DNA
Biospecimen Description
Blood sample

8. Arms, Groups, and Interventions

Arm Title
ankylosing spondylitis
Arm Description
It will be held ultrasound exam in enthesis and joints in patients with ankylosing spondylitis and healthy subjects
Arm Title
Healthy pelople
Arm Description
It will be held ultrasound exam in enthesis and joints of healthy subjects
Primary Outcome Measure Information:
Title
Ultrasound of enthesis in patients with ankylosing spondylitis: a comparative study with healthy subjects
Description
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.
Time Frame
december

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Study Population Description
Patients with ankylosing spondylitis healthy subjects
Sampling Method
Non-Probability Sample
Facility Information:
Facility Name
Suellen Narimatsu
City
Sao Paulo
ZIP/Postal Code
04021-001
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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