Effectiveness of Cryotherapy on the Fatigue of Patients With Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Interventions
- Device: partial-body cryotherapy chamber session
- Registration Number
- NCT05219201
- Lead Sponsor
- Fondation Ildys
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham cryotherapy full time patient (inpatient) partial-body cryotherapy chamber session Patients benefiting from 15 session of "sham" partial-body cryotherapy session (-30°C) during their full-time rehabilitation stay cryotherapy part-time hospitalized patient (outpatient) partial-body cryotherapy chamber session Patients benefiting from 15 session of "sham" partial-body cryotherapy session (-120°C) during their part-time rehabilitation stay sham cryotherapy part-time hospitalized patient (outpatient) partial-body cryotherapy chamber session Patients benefiting from 15 session of "sham" partial-body cryotherapy session (-30°C) during their part-time rehabilitation stay cryotherapy full-time hospitalized patient (inpatient) partial-body cryotherapy chamber session Patients benefiting from 15 session of "sham" partial-body cryotherapy session (-120°C) during their full-time rehabilitation stay
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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.
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.
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 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.
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.
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).
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.
Trial Locations
- Locations (1)
Centre de Perharidy
🇫🇷Roscoff, France