Multiple Sclerosis
Conditions
Keywords
cryotherapy, fatigue, quality of life, spasticity, quality of sleep, depression symptoms
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.
Interventions
DEVICEpartial-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).
Sponsors
Fondation Ildys
Lille Catholic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue syndrome | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| spasticity symptom | change from baseline (T0) to discharge between 3 to 5 weeks (T1), and 1 year (T4) after hospitalization | 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. |
| quality of Life evaluation | 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 quality of life using the Medical Outcome Study Short Form 36 health survey (MOS-SF36) score. The higher score indicating the better outcome. |
| pain evaluation | 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 pain syndrome using the visual pain scale The scale ranges in value from 0 to 10 with high scores indicating the worse outcome. |
| quality of sleep | change from baseline (T0) to discharge between 3 to 5 weeks(T1), after 1 month (T2), 3 months (T3) and 1 year (T4) | evaluation of sleep quality using the Pittsburgh scale. The scale ranges in value from 0 to 21 with high scores indicating the worse outcome. |
| depression symptoms | 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 depression symptoms using the Beck scale. The scale ranges in value from 0 to 39 with high scores indicating the worse outcome. |
| physician's global assessment-physical endurance | change from baseline (T0) to discharge between 3 to 5 weeks (T1), and 1 year (T4) after hospitalization | Evaluation of the 6MWT (6 minutes walk test). High scores indicating the better outcome. |
| habit changes after rehabilitation stay | change from baseline (T0) to 1 month (T2), 3 months (T3) and 1 year (T4) after hospitalization | 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). |
| physician's global assessment-dynamic balance test | change from baseline (T0) to discharge between 3 to 5 weeks (T1), and 1 year (T4) after hospitalization | Evaluation of the TUG (Time up to go) . High scores indicating the worse outcome. |
| physician's global assessement-static balance test | change from baseline (T0) to discharge between 3 to 5 weeks (T1), and 1 year (T4) after hospitalization | Evaluation of the OLS (one leg stance) High scores indicating the better outcome. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORJean-Baptiste Bourseul, MD
Fondation Ildys
Outcome results
None listed