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| Name | Class |
|---|---|
| Lille Catholic University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham cryotherapy full time patient (inpatient) | Sham Comparator | Patients benefiting from 15 session of "sham" partial-body cryotherapy session (-30°C) during their full-time rehabilitation stay |
|
| sham cryotherapy part-time hospitalized patient (outpatient) | Sham Comparator | 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) | Active Comparator | Patients benefiting from 15 session of "sham" partial-body cryotherapy session (-120°C) during their full-time rehabilitation stay |
|
| cryotherapy part-time hospitalized patient (outpatient) | Active Comparator | Patients benefiting from 15 session of "sham" partial-body cryotherapy session (-120°C) during their part-time rehabilitation stay |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| partial-body cryotherapy chamber session | Device | The cryotherapy procedure consisted of a 2-3 min stay in the cryotherapy chamber:
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of cryotherapy effectiveness on fatigue syndrome in accordance to hospitalisation pattern | Primary outcome will be analyzed separately in outpatient versus inpatient in order to determine whether hospitalisation pattern may impact the effectiveness of cryotherapy on fatigue. 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Baptiste Bourseul, MD | Fondation Ildys | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Perharidy | Roscoff | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30968613 | Background | 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. | |
| 27712663 | Background | 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. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D005221 | Fatigue |
| D009128 | Muscle Spasticity |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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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 |
| change from baseline (T0) to discharge between 3 to 5 weeks (T1) |
| 33386821 | Background | 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. |
| 33171768 | Background | 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. |
| 26778452 | Background | 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. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |