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
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
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
NCT ID
NCT01567878
First Posted
March 28, 2012
Last Updated
December 1, 2014
Sponsor
University of Sao Paulo
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
We'll reach out to this number within 24 hrs