Clinical trial NCT05219201: Effectiveness of Cryotherapy on the Fatigue of Patients With Multiple Sclerosis
Official title: Effectiveness of Partial-body Cryotherapy on the Fatigue of Patients With Multiple Sclerosis During Readaptation Stay
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: cryotherapy
fatigue
quality of life
spasticity
quality of sleep
depression symptoms
Lead sponsor: Fondation Ildys
Sponsor class: OTHER
Collaborators: name: Lille Catholic University
First posted: 2022-02-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Fatigue syndrome
timeFrame: 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:
measure: spasticity symptom
timeFrame: change from baseline (T0) to discharge between 3 to 5 weeks (T1), and 1 year (T4) after hospitalization
measure: quality of Life evaluation
timeFrame: 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
measure: pain evaluation
timeFrame: 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
measure: quality of sleep
timeFrame: change from baseline (T0) to discharge between 3 to 5 weeks(T1), after 1 month (T2), 3 months (T3) and 1 year (T4)
measure: depression symptoms
timeFrame: 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
measure: physician's global assessment-physical endurance
timeFrame: change from baseline (T0) to discharge between 3 to 5 weeks (T1), and 1 year (T4) after hospitalization
measure: habit changes after rehabilitation stay
timeFrame: change from baseline (T0) to 1 month (T2), 3 months (T3) and 1 year (T4) after hospitalization
measure: physician's global assessment-dynamic balance test
timeFrame: change from baseline (T0) to discharge between 3 to 5 weeks (T1), and 1 year (T4) after hospitalization
measure: physician's global assessement-static balance test
timeFrame: change from baseline (T0) to discharge between 3 to 5 weeks (T1), and 1 year (T4) after hospitalization
Other outcomes:
measure: Evaluation of cryotherapy effectiveness on fatigue syndrome in accordance to hospitalisation pattern
timeFrame: change from baseline (T0) to discharge between 3 to 5 weeks (T1)
Locations:
city: Roscoff
country: France
facility: Centre de Perharidy
Study officials:
affiliation: Fondation Ildys
name: Jean-Baptiste Bourseul, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.