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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
43
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).
Centre de Perharidy
Roscoff, France
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.
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
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.
Time frame: 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.
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
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.
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
evaluation of sleep quality using the Pittsburgh scale. The scale ranges in value from 0 to 21 with high scores indicating the worse outcome.
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
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evaluation of depression symptoms using the Beck scale. The scale ranges in value from 0 to 39 with high scores indicating the worse outcome.
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
Evaluation of the 6MWT (6 minutes walk test). High scores indicating the better outcome.
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
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).
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
Evaluation of the TUG (Time up to go) . High scores indicating the worse outcome.
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
Evaluation of the OLS (one leg stance) High scores indicating the better outcome.
Time frame: change from baseline (T0) to discharge between 3 to 5 weeks (T1), and 1 year (T4) after hospitalization