Assessment of Whole Body Cryotherapy in Treatment of Active Axial Spondylarthritis

Spondylarthritis Clinical Trial

Official title:

Assessment of Whole Body Cryotherapy in Treatment of Active Axial Spondylarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02473315
• Other study ID #: 2015- A00337-42
• Status: Completed
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: October 28, 2022

Study information

• Verified date: November 2022
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 28, 2022
• Est. primary completion date: September 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Spondylarthritis
• Spondylitis

Intervention

Other:
• cryotherapy
The treatment arm :Whole body cryotherpy (WBC) (20 sessions of 3 minutes at a temperature of -110 degrees Celsius, on the basis of two sessions a day, spread over two weeks). The control arm : Whole body cryotherpy (WBC) (20 sessions of 1 minute at a temperature of -60 degrees Celsius, on the basis of two sessions a day, spread over two weeks).

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whole body cryotherpy (WBC) efficacy assesment	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	15 days