Effectiveness of Cryotherapy on the Fatigue of Patients With Multiple Sclerosis (CRYOSEP)

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Device: partial-body cryotherapy chamber session

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Roscoff, France
    • Centre de Perharidy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham cryotherapy full time patient (inpatient); 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; 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).; Other Names: CRYO00002 ICE X- Cryosauna; local cryotherapy devices DM Class IIb
Sham Comparator: sham cryotherapy part-time hospitalized patient (outpatient); 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; 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).; Other Names: CRYO00002 ICE X- Cryosauna; local cryotherapy devices DM Class IIb
Active Comparator: cryotherapy full-time hospitalized patient (inpatient); 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; 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).; Other Names: CRYO00002 ICE X- Cryosauna; local cryotherapy devices DM Class IIb
Active Comparator: cryotherapy part-time hospitalized patient (outpatient); 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; 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).; Other Names: CRYO00002 ICE X- Cryosauna; 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

Other Outcome Measures

Outcome Measure	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.	change from baseline (T0) to discharge between 3 to 5 weeks (T1)

Collaborators and Investigators

• Sponsor: Fondation Ildys
• Collaborators: Lille Catholic University
• Investigators: Principal Investigator: Jean-Baptiste Bourseul, MD, Fondation Ildys

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2022
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): July 11, 2025

Study Registration Dates

• First Submitted: January 7, 2022
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: fatigue; quality of life; cryotherapy; spasticity; quality of sleep; depression symptoms
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Mental Disorders; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Muscle Spasticity; Multiple Sclerosis; Depression; Fatigue; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: ID-RCB 2021-A02526-35

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No