Ultrasonography Assessment of Peripheral Entheses in Axial Spondyloarthritis and in Healthy Subjects, Athletes or Not
June 10, 2016 updated by: Assistance Publique Hopitaux De Marseille
Ultrasonography Assessment of Peripheral Entheses in Axial Spondyloarthritis and in Healthy Subjects, Athletes or Not.
Purpose:
- Assessment of ultrasound MASEI index in axial spondyloarthritis and in healthy subjects, athletes or not
- Comparison of the ultrasound semiology of enthesitis in the 3 populations
- Comparison of the MASEI scores in the 3 populations
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
90
Phase
- Not Applicable
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
-
-
-
Marseille, France, 13354
- Assistance Publique Hôpitaux de Marseille
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-
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 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- - Axial spondyloarthritis according to the ASAS classification criteria
- 18-45 years old
- Athletes are defined by sport activities greater than or equal to 6 hours per week
- Non athletes are defined by sport activities lesser than or equal to 1 hour per week
Exclusion Criteria:
- - History of heel or ankle surgery
- Recent corticosteroid infiltration of the heel or the ankle
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?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: the patients with SpA
|
|
|
Experimental: sports subjects
|
|
|
Other: control subjects
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
enthesitis detection
Time Frame: 12 months
|
Number of subject having at least an enthesitis in every group of subjects
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
MASEI scores
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
November 1, 2013
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
August 1, 2013
First Submitted That Met QC Criteria
January 15, 2014
First Posted (Estimate)
January 16, 2014
Study Record Updates
Last Update Posted (Estimate)
June 13, 2016
Last Update Submitted That Met QC Criteria
June 10, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-A00759-36
- 2013-27 (AP HM)
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.