Ultrasonography Assessment of Peripheral Entheses in Axial Spondyloarthritis and in Healthy Subjects, Athletes or Not

Not Applicable

Completed

• Conditions: Peripheral Entheses
• Interventions: Biological: BLOOD SAMPLES; Device: Radiographs of the sacroiliac joints; Device: Radiographs of heels; Device: SCAN

• Registration Number: NCT02038426
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-01
• Study Start: 2013-11
• Study First Submitted QC: 2014-01-15
• Study First Posted: 2014-01-16
• Primary Completion: 2014-08
• Study Completion: 2015-01
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-10
• Last Update Posted: 2016-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the patients with SpA	SCAN	-
the patients with SpA	BLOOD SAMPLES	-
sports subjects	SCAN	-
the patients with SpA	Radiographs of the sacroiliac joints	-
sports subjects	Radiographs of heels	-
control subjects	Radiographs of the sacroiliac joints	-
the patients with SpA	Radiographs of heels	-
sports subjects	BLOOD SAMPLES	-
sports subjects	Radiographs of the sacroiliac joints	-
control subjects	BLOOD SAMPLES	-
control subjects	Radiographs of heels	-
control subjects	SCAN	-

Primary Outcome Measures

Name	Time	Method
enthesitis detection	12 months	Number of subject having at least an enthesitis in every group of subjects

Secondary Outcome Measures

Name	Time	Method
MASEI scores	12 months

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France