Effectiveness of Cryotherapy on the Fatigue of Patients With Multiple Sclerosis
NCT ID: NCT05219201
Last Updated: 2022-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2022-09-12
2027-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Sham cryotherapy full time patient (inpatient)
Patients benefiting from 15 session of "sham" partial-body cryotherapy session (-30°C) during their full-time rehabilitation stay
partial-body cryotherapy chamber session
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).
sham cryotherapy part-time hospitalized patient (outpatient)
Patients benefiting from 15 session of "sham" partial-body cryotherapy session (-30°C) during their part-time rehabilitation stay
partial-body cryotherapy chamber session
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).
cryotherapy full-time hospitalized patient (inpatient)
Patients benefiting from 15 session of "sham" partial-body cryotherapy session (-120°C) during their full-time rehabilitation stay
partial-body cryotherapy chamber session
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).
cryotherapy part-time hospitalized patient (outpatient)
Patients benefiting from 15 session of "sham" partial-body cryotherapy session (-120°C) during their part-time rehabilitation stay
partial-body cryotherapy chamber session
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).
Interventions
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partial-body cryotherapy chamber session
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Lille Catholic University
OTHER
Fondation Ildys
OTHER
Responsible Party
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Principal Investigators
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Jean-Baptiste Bourseul, MD
Role: PRINCIPAL_INVESTIGATOR
Fondation Ildys
Locations
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Centre de Perharidy
Roscoff, , France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Bouzigon 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.
Radecka 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.
Zielinska-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.
Miller 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.
Other Identifiers
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ID-RCB 2021-A02526-35
Identifier Type: -
Identifier Source: org_study_id
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