Assessment of Whole Body Cryotherapy in Treatment of Active Axial Spondylarthritis
Primary Purpose
Spondylarthritis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cryotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Spondylarthritis
Eligibility Criteria
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
Sites / Locations
- Assistance Publique Hopitaux de Marseille
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
cryotherapy
light cryotherapy
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02473315
First Posted
June 10, 2015
Last Updated
November 9, 2022
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02473315
Brief Title
Assessment of Whole Body Cryotherapy in Treatment of Active Axial Spondylarthritis
Official Title
Assessment of Whole Body Cryotherapy in Treatment of Active Axial Spondylarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
September 18, 2018 (Actual)
Study Completion Date
October 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondylarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cryotherapy
Arm Type
Experimental
Arm Title
light cryotherapy
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
cryotherapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
Whole body cryotherpy (WBC) efficacy assesment
Description
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
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ANNA DELLYES, MD
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
Learn more about this trial
Assessment of Whole Body Cryotherapy in Treatment of Active Axial Spondylarthritis
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