Assessment of Whole Body Cryotherapy in Treatment of Active Axial Spondylarthritis

Not Applicable

Completed

• Conditions: Spondylarthritis
• Interventions: Other: cryotherapy

• Registration Number: NCT02473315
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

Whole body cryotherpy (WBC) is a well-tolerated procedure that implies patients' exposition at a temperature of approximately -110 degrees.

A considerable increase in the popularity of WBC has occurred in rheumatologic patients, despite a lack of evidences of its efficiency.

Because of its interesting anti-inflammatory properties, the investigators think that WBC could be an alternative treatment to classical NSAIDs (Non Steroidal Anti Inflammatory Drugs) and corticosteroids, in patients suffering from axial spondyloarthritis.

This is a proof of concept study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-10
• Study First Submitted QC: 2015-06-12
• Study First Posted: 2015-06-16
• Study Start: 2016-07-01
• Primary Completion: 2018-09-18
• Study Completion: 2022-10-28
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-09
• Last Update Posted: 2022-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• patients suffering from axial spondyloarthritis diagnosed according to ASAS criteria, with sacroiliitis on X-rays or MRI, with active disease (BASDAI > 4/10) despite a stable treatment will be included.

Exclusion Criteria

• contra indication to cooling,
• previous WBC treatment,
• no social security cover

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
light cryotherapy	cryotherapy	-
cryotherapy	cryotherapy	-

Primary Outcome Measures

Name	Time	Method
Whole body cryotherpy (WBC) efficacy assesment	15 days	assess WBC efficacy on disease activity with Bath Ankylosing Spondylitis Activity Index improvement between baseline and week 2 in patients with active axial spondyloarthritis. a difference of 20 points on BASDAI scale is expected between the experimental arm and the placebo is expected

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France