Multiple SclerosisCRYOSEPNCT05219201
Effectiveness of Cryotherapy on the Fatigue of Patients With Multiple Sclerosis
A study testing partial-body cryotherapy chamber session in people with Multiple Sclerosis, run by Fondation Ildys at 1 site in France.
Trial summary
the aim of the study is to evaluate the effectiveness of partial-body cryotherapy (PBC) on the symptoms of patients with multiple sclerosis during a rehabilitation stay. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- partial-body cryotherapy chamber session
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- 12 Sep 2022to 11 Jul 2025
- 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
- men and woen over 18 years old and under 65 years old
- with multiple sclerosis
- 0-6 points in the expanded disability states scale (EDSS)
- with MS in remission (at least 6 months since the last relapse)
- able to understand and respect the protocol and its requirement
- who signed the consent prior to any other procedure protocol
Who cannot join
- major patients under guardianship/curators/legal protection
- pregnant patients
- patients with contraindication for cryotherapy
- patients unable to complete the entire program
- patients with substantial change in pharmacological treatment the month before the start of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Partial-body Cryotherapy on the Fatigue of Patients With Multiple Sclerosis During Readaptation Stay
the aim of the study is to evaluate the effectiveness of partial-body cryotherapy (PBC) on the symptoms of patients with multiple sclerosis during a rehabilitation stay.
Read the detailed description
Multiple sclerosis (MS) is a chronic heterogeneous disease with an unpredictable clinical course. Symptoms can include paralysis, ataxia, spasticity, incontinence and fatigue syndrome.
Fatigue is considered to be the most prevalent and disabling of the symptoms at all stages of the illness and its occurs in 70-80% of patients. This characteristic of the disease directly impacts the quality of life of patients, affecting their social and physical well being.
Physical rehabilitation is often prescribed in the management of MS, and is recognized to improve modifiable impairments in MS.
However, the benefit of physical activities may be limited by heat stress also named Uhthoff syndrome frequently observed in patients with MS.
Cryotherapy is commonly used as a method to relieve pain and inflammation without marked side effect in respect to contraindication. However well designed studies on PBC in patients with MS are still too sparse.
The investigators propose to evaluate the effectiveness of PBC on the symptoms of MS patients during a rehabilitation stay in out- or inpatients.
- Conditions
- Multiple Sclerosis
- Being tested
- partial-body cryotherapy chamber session
- Keywords
- cryotherapy, fatigue, quality of life, spasticity, quality of sleep, depression symptoms
- Medical subject headings
- Multiple Sclerosis, Fatigue, Muscle Spasticity, Sleep Initiation and Maintenance Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
partial-body cryotherapy chamber sessionDevice
Also called CRYO00002 ICE X- Cryosauna, local cryotherapy devices DM Class IIb
The cryotherapy procedure consisted of a 2-3 min stay in the cryotherapy chamber:
- at -30°C for sham cryotherapy session
- at -120°C for cryotherapy intervention session. For Inpatients, cryotherapy session will be performed daily, late in the afternoon, excluding saturdays and sundays, during 3 weeks. (15 sessions) For outpatient, cryotherapy session will occured late in the afternoon each day care (15 sessions).
| Study group | Role | What they receive |
|---|---|---|
| Sham cryotherapy full time patient (inpatient) | Sham comparator | Patients benefiting from 15 session of "sham" partial-body cryotherapy session (-30°C) during their full-time rehabilitation stay Receives: Device: partial-body cryotherapy chamber session |
| sham cryotherapy part-time hospitalized patient (outpatient) | Sham comparator | Patients benefiting from 15 session of "sham" partial-body cryotherapy session (-30°C) during their part-time rehabilitation stay Receives: Device: partial-body cryotherapy chamber session |
| cryotherapy full-time hospitalized patient (inpatient) | Active comparator | Patients benefiting from 15 session of "sham" partial-body cryotherapy session (-120°C) during their full-time rehabilitation stay Receives: Device: partial-body cryotherapy chamber session |
| cryotherapy part-time hospitalized patient (outpatient) | Active comparator | Patients benefiting from 15 session of "sham" partial-body cryotherapy session (-120°C) during their part-time rehabilitation stay Receives: Device: partial-body cryotherapy chamber session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue syndrome
evaluation of the fatigue syndrome using the fatigue severity scale score (FSS).
The scale ranges in value from 9 to 63 with high scores indicating the worse outcome.
Measured: change from baseline (T0) to discharge between 3 to 5 weeks (T1), and 1 month (T2), 3 months (T3) and 1 year (T4) after hospitalization
Secondary outcomes (9)
spasticity symptom
evaluation of the spasticity syndrome using the Ashworth score The scale ranges in value from 0 to 4 with high scores indicating the worse outcome.
Measured: change from baseline (T0) to discharge between 3 to 5 weeks (T1), and 1 year (T4) after hospitalization
quality of Life evaluation
evaluation of the quality of life using the Medical Outcome Study Short Form 36 health survey (MOS-SF36) score.
The higher score indicating the better outcome.
Measured: change from baseline (T0) to discharge between 3 to 5 weeks(T1), and 1 month (T2), 3 months (T3) and 1 year (T4) after hospitalization
pain evaluation
evaluation of pain syndrome using the visual pain scale The scale ranges in value from 0 to 10 with high scores indicating the worse outcome.
Measured: change from baseline (T0) to discharge between 3 to 5 weeks(T1), and 1 month (T2), 3 months (T3) and 1 year (T4) after hospitalization
quality of sleep
evaluation of sleep quality using the Pittsburgh scale. The scale ranges in value from 0 to 21 with high scores indicating the worse outcome.
Measured: change from baseline (T0) to discharge between 3 to 5 weeks(T1), after 1 month (T2), 3 months (T3) and 1 year (T4)
depression symptoms
evaluation of depression symptoms using the Beck scale. The scale ranges in value from 0 to 39 with high scores indicating the worse outcome.
Measured: change from baseline (T0) to discharge between 3 to 5 weeks(T1), and 1 month (T2), 3 months (T3) and 1 year (T4) after hospitalization
physician's global assessment-physical endurance
Evaluation of the 6MWT (6 minutes walk test). High scores indicating the better outcome.
Measured: change from baseline (T0) to discharge between 3 to 5 weeks (T1), and 1 year (T4) after hospitalization
habit changes after rehabilitation stay
Examining habit changes concerning cold therapy after rehabilitation stay using qualitative questionnaire consisting of a small number of direct and meaningful questions (mode and frequency of use).
Measured: change from baseline (T0) to 1 month (T2), 3 months (T3) and 1 year (T4) after hospitalization
physician's global assessment-dynamic balance test
Evaluation of the TUG (Time up to go) . High scores indicating the worse outcome.
Measured: change from baseline (T0) to discharge between 3 to 5 weeks (T1), and 1 year (T4) after hospitalization
physician's global assessement-static balance test
Evaluation of the OLS (one leg stance) High scores indicating the better outcome.
Measured: change from baseline (T0) to discharge between 3 to 5 weeks (T1), and 1 year (T4) after hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start12 Sep 2022
- Primary completion30 Jun 2024
- Study completion11 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ildys
- Sponsor type
- University, hospital or other
- Collaborators
- Lille Catholic University
- Responsible party
- Sponsor
- Investigators
- Jean-Baptiste Bourseul, MD, Principal investigator, Fondation Ildys
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219201
- Sponsor's protocol ID
- ID-RCB 2021-A02526-35
- Acronym
- CRYOSEP
- Status last verified
- Apr 2026
- First submitted
- 7 Jan 2022
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pawik M, Kowalska J, Rymaszewska J. The effectiveness of whole-body cryotherapy and physical exercises on the psychological well-being of patients with multiple sclerosis: A comparative analysis. Adv Clin Exp Med. 2019 Nov;28(11):1477-1483. doi: 10.17219/acem/104529.
PubMed 30968613Bouzigon R, Grappe F, Ravier G, Dugue B. Whole- and partial-body cryostimulation/cryotherapy: Current technologies and practical applications. J Therm Biol. 2016 Oct;61:67-81. doi: 10.1016/j.jtherbio.2016.08.009. Epub 2016 Aug 27.
PubMed 27712663Radecka A, Knyszynska A, Luczak J, Lubkowska A. Adaptive changes in muscle activity after cryotherapy treatment: Potential mechanism for improvement the functional state in patients with multiple sclerosis. NeuroRehabilitation. 2021;48(1):119-131. doi: 10.3233/NRE-201535.
PubMed 33386821Zielinska-Nowak E, Wlodarczyk L, Kostka J, Miller E. New Strategies for Rehabilitation and Pharmacological Treatment of Fatigue Syndrome in Multiple Sclerosis. J Clin Med. 2020 Nov 7;9(11):3592. doi: 10.3390/jcm9113592.
PubMed 33171768Miller E, Kostka J, Wlodarczyk T, Dugue B. Whole-body cryostimulation (cryotherapy) provides benefits for fatigue and functional status in multiple sclerosis patients. A case-control study. Acta Neurol Scand. 2016 Dec;134(6):420-426. doi: 10.1111/ane.12557. Epub 2016 Jan 18.
PubMed 26778452
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Partial-body Cryotherapy on the Fatigue of Patients With Multiple Sclerosis During Readaptation Stay
- ClinicalTrials.gov ID
- NCT05219201
- Acronym / sponsor ID
- CRYOSEP / ID-RCB 2021-A02526-35
- Conditions
- Multiple Sclerosis
- Keywords
- cryotherapy, fatigue, quality of life, spasticity, quality of sleep, depression symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Fondation IldysUniversity, hospital or other
- Collaborators
- Lille Catholic University
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 11 Jul 2025 (actual)
- First posted
- 1 Feb 2022 (actual)
- 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.
the aim of the study is to evaluate the effectiveness of partial-body cryotherapy (PBC) on the symptoms of patients with multiple sclerosis during a rehabilitation stay.
Detailed description
Multiple sclerosis (MS) is a chronic heterogeneous disease with an unpredictable clinical course. Symptoms can include paralysis, ataxia, spasticity, incontinence and fatigue syndrome.
Fatigue is considered to be the most prevalent and disabling of the symptoms at all stages of the illness and its occurs in 70-80% of patients. This characteristic of the disease directly impacts the quality of life of patients, affecting their social and physical well being.
Physical rehabilitation is often prescribed in the management of MS, and is recognized to improve modifiable impairments in MS.
However, the benefit of physical activities may be limited by heat stress also named Uhthoff syndrome frequently observed in patients with MS.
Cryotherapy is commonly used as a method to relieve pain and inflammation without marked side effect in respect to contraindication. However well designed studies on PBC in patients with MS are still too sparse.
The investigators propose to evaluate the effectiveness of PBC on the symptoms of MS patients during a rehabilitation stay in out- or inpatients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sham cryotherapy full time patient (inpatient) | Sham comparator | Device: partial-body cryotherapy chamber sessionPatients benefiting from 15 session of "sham" partial-body cryotherapy session (-30°C) during their full-time rehabilitation stay |
| sham cryotherapy part-time hospitalized patient (outpatient) | Sham comparator | Device: partial-body cryotherapy chamber sessionPatients benefiting from 15 session of "sham" partial-body cryotherapy session (-30°C) during their part-time rehabilitation stay |
| cryotherapy full-time hospitalized patient (inpatient) | Active comparator | Device: partial-body cryotherapy chamber sessionPatients benefiting from 15 session of "sham" partial-body cryotherapy session (-120°C) during their full-time rehabilitation stay |
| cryotherapy part-time hospitalized patient (outpatient) | Active comparator | Device: partial-body cryotherapy chamber sessionPatients benefiting from 15 session of "sham" partial-body cryotherapy session (-120°C) during their part-time rehabilitation stay |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- men and woen over 18 years old and under 65 years old
- with multiple sclerosis
- 0-6 points in the expanded disability states scale (EDSS)
- with MS in remission (at least 6 months since the last relapse)
- able to understand and respect the protocol and its requirement
Key exclusion criteria (5 listed)
- major patients under guardianship/curators/legal protection
- pregnant patients
- patients with contraindication for cryotherapy
- patients unable to complete the entire program
- patients with substantial change in pharmacological treatment the month before the start of the study
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 |
|---|---|---|
| partial-body cryotherapy chamber sessionAlso: CRYO00002 ICE X- Cryosauna, local cryotherapy devices DM Class IIbThe cryotherapy procedure consisted of a 2-3 min stay in the cryotherapy chamber: * at -30°C for sham cryotherapy session * at -120°C for cryotherapy intervention session. For Inpatients, cryotherapy session will be performed daily, late in the afternoon, excluding saturdays and sundays, during 3 weeks. (15 sessions) For outpatient, cryotherapy session will occured late in the afternoon each day care (15 sessions). | Device | Sham cryotherapy full time patient (inpatient), cryotherapy full-time hospitalized patient (inpatient), cryotherapy part-time hospitalized patient (outpatient), sham cryotherapy part-time hospitalized patient (outpatient) |
Primary outcome
Fatigue syndrome
Time frame: change from baseline (T0) to discharge between 3 to 5 weeks (T1), and 1 month (T2), 3 months (T3) and 1 year (T4) after hospitalization
evaluation of the fatigue syndrome using the fatigue severity scale score (FSS). The scale ranges in value from 9 to 63 with high scores indicating the worse outcome.
9 secondary outcomes
spasticity symptom
Time frame: change from baseline (T0) to discharge between 3 to 5 weeks (T1), and 1 year (T4) after hospitalization
quality of Life evaluation
Time frame: change from baseline (T0) to discharge between 3 to 5 weeks(T1), and 1 month (T2), 3 months (T3) and 1 year (T4) after hospitalization
pain evaluation
Time frame: change from baseline (T0) to discharge between 3 to 5 weeks(T1), and 1 month (T2), 3 months (T3) and 1 year (T4) after hospitalization
quality of sleep
Time frame: change from baseline (T0) to discharge between 3 to 5 weeks(T1), after 1 month (T2), 3 months (T3) and 1 year (T4)
depression symptoms
Time frame: change from baseline (T0) to discharge between 3 to 5 weeks(T1), and 1 month (T2), 3 months (T3) and 1 year (T4) after hospitalization
physician's global assessment-physical endurance
Time frame: change from baseline (T0) to discharge between 3 to 5 weeks (T1), and 1 year (T4) after hospitalization
habit changes after rehabilitation stay
Time frame: change from baseline (T0) to 1 month (T2), 3 months (T3) and 1 year (T4) after hospitalization
physician's global assessment-dynamic balance test
Time frame: change from baseline (T0) to discharge between 3 to 5 weeks (T1), and 1 year (T4) after hospitalization
physician's global assessement-static balance test
Time frame: change from baseline (T0) to discharge between 3 to 5 weeks (T1), and 1 year (T4) after hospitalization
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 17 Apr 2026.
- Background: PubMed 30968613Pawik M, Kowalska J, Rymaszewska J. The effectiveness of whole-body cryotherapy and physical exercises on the psychological well-being of patients with multiple sclerosis: A comparative analysis. Adv Clin Exp Med. 2019 Nov;28(11):1477-1483. doi: 10.17219/acem/104529.
- Background: PubMed 27712663Bouzigon R, Grappe F, Ravier G, Dugue B. Whole- and partial-body cryostimulation/cryotherapy: Current technologies and practical applications. J Therm Biol. 2016 Oct;61:67-81. doi: 10.1016/j.jtherbio.2016.08.009. Epub 2016 Aug 27.
- Background: PubMed 33386821Radecka A, Knyszynska A, Luczak J, Lubkowska A. Adaptive changes in muscle activity after cryotherapy treatment: Potential mechanism for improvement the functional state in patients with multiple sclerosis. NeuroRehabilitation. 2021;48(1):119-131. doi: 10.3233/NRE-201535.
- Background: PubMed 33171768Zielinska-Nowak E, Wlodarczyk L, Kostka J, Miller E. New Strategies for Rehabilitation and Pharmacological Treatment of Fatigue Syndrome in Multiple Sclerosis. J Clin Med. 2020 Nov 7;9(11):3592. doi: 10.3390/jcm9113592.
- Background: PubMed 26778452Miller E, Kostka J, Wlodarczyk T, Dugue B. Whole-body cryostimulation (cryotherapy) provides benefits for fatigue and functional status in multiple sclerosis patients. A case-control study. Acta Neurol Scand. 2016 Dec;134(6):420-426. doi: 10.1111/ane.12557. Epub 2016 Jan 18.
- Individual participant dataSharing planned: No
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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.
Jean-Baptiste Bourseul, MD principal investigator
Fondation Ildys
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing partial-body cryotherapy chamber session in people with Multiple Sclerosis, run by Fondation Ildys 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 6 inclusion and 5 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 17 Apr 2026. 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?
Fatigue syndrome (time frame: change from baseline (T0) to discharge between 3 to 5 weeks (T1), and 1 month (T2), 3 months (T3) and 1 year (T4) after hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05219201, which also lists 5 linked publications.
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 17 Apr 2026.