search
Back to results

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
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spondylarthritis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 10, 2015
Last Updated
November 9, 2022
Sponsor
Assistance Publique Hopitaux De Marseille
search

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

We'll reach out to this number within 24 hrs