SpondylarthritisNCT02473315
Assessment of Whole Body Cryotherapy in Treatment of Active Axial Spondylarthritis
A study testing cryotherapy in people with Spondylarthritis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spondylarthritis
- What is being tested?
- cryotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2016to 28 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- contra indication to cooling,
- previous WBC treatment,
- no social security cover
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Spondylarthritis
- Being tested
- cryotherapy
- Medical subject headings
- Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryotherapyOther
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).
| Study group | Role | What they receive |
|---|---|---|
| cryotherapy | Experimental | Not described Receives: Other: cryotherapy |
| light cryotherapy | Placebo comparator | Not described Receives: Other: cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2015 (estimated)
- Study start1 Jul 2016
- Primary completion18 Sep 2018
- Study completion28 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondylarthritisStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ANNA DELLYES, MD, Principal investigator, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02473315
- Sponsor's protocol ID
- 2015- A00337-42
- Status last verified
- Nov 2022
- First submitted
- 10 Jun 2015
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Whole Body Cryotherapy in Treatment of Active Axial Spondylarthritis
- ClinicalTrials.gov ID
- NCT02473315
- Acronym / sponsor ID
- 2015- A00337-42
- Conditions
- Spondylarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 18 Sep 2018 (actual)
- Study completion
- 28 Oct 2022 (actual)
- First posted
- 16 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cryotherapy | Experimental | Other: cryotherapy |
| light cryotherapy | Placebo comparator | Other: cryotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- contra indication to cooling,
- previous WBC treatment,
- no social security cover
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cryotherapyThe 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). | Other | cryotherapy, light cryotherapy |
Primary outcome
Whole body cryotherpy (WBC) efficacy assesment
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
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Treatment Effectiveness in People With axSpA or PsA Starting Treatment With Bimekizumab, Risankizumab, Guselkumab, Upadacitinib, or a TNF Inhibitor
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ANNA DELLYES, MD principal investigator
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryotherapy in people with Spondylarthritis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole body cryotherpy (WBC) efficacy assesment (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022; AzTrials last refreshed its copy on 8 Nov 2026.