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

  • France
      • Marseille, France, 13354
        • Assistance Publique Hopitaux de Marseille

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
Biological: BLOOD SAMPLES
Device: Radiographs of the sacroiliac joints
Device: Radiographs of heels
Device: SCAN
Experimental: sports subjects
Biological: BLOOD SAMPLES
Device: Radiographs of the sacroiliac joints
Device: Radiographs of heels
Device: SCAN
Other: control subjects
Biological: BLOOD SAMPLES
Device: Radiographs of the sacroiliac joints
Device: Radiographs of heels
Device: SCAN

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.

Sponsor

Assistance Publique Hopitaux De Marseille

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.

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