Spondylarthritis
Conditions
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.
Interventions
OTHERcryotherapy
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).
Sponsors
Assistance Publique Hopitaux De Marseille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed