Effectiveness of Cryotherapy on the Fatigue of Patients With Multiple Sclerosis

Study Overview
=================
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.

Official Title
-----------------
Effectiveness of Partial-body Cryotherapy on the Fatigue of Patients With Multiple Sclerosis During Readaptation Stay

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Device: partial-body cryotherapy chamber session


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham cryotherapy full time patient (inpatient)<br>Patients benefiting from 15 session of sham partial-body cryotherapy session (-30°C) during their full-time rehabilitation stay | Device: partial-body cryotherapy chamber session<br>* 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).<br>* Other names: local cryotherapy devices DM Class IIb;|
| Sham Comparator: sham cryotherapy part-time hospitalized patient (outpatient)<br>Patients benefiting from 15 session of sham partial-body cryotherapy session (-30°C) during their part-time rehabilitation stay | Device: partial-body cryotherapy chamber session<br>* 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).<br>* Other names: local cryotherapy devices DM Class IIb;|
| Active Comparator: cryotherapy full-time hospitalized patient (inpatient)<br>Patients benefiting from 15 session of sham partial-body cryotherapy session (-120°C) during their full-time rehabilitation stay | Device: partial-body cryotherapy chamber session<br>* 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).<br>* Other names: local cryotherapy devices DM Class IIb;|
| Active Comparator: cryotherapy part-time hospitalized patient (outpatient)<br>Patients benefiting from 15 session of sham partial-body cryotherapy session (-120°C) during their part-time rehabilitation stay | Device: partial-body cryotherapy chamber session<br>* 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).<br>* Other names: local cryotherapy devices DM Class IIb;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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. | change from baseline (T0) to discharge between 3 to 5 weeks (T1), and 1 year (T4) after hospitalization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spasticity, cryotherapy, fatigue, quality of life, quality of sleep, depression symptoms