Effectiveness of Cryotherapy on the Fatigue of Patients With Multiple Sclerosis

NCT05219201 | Completed

• 1 other identifier: ID-RCB 2021-A02526-35
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

cryotherapy; fatigue; quality of life; spasticity; quality of sleep; depression symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• spasticity symptom

  change from baseline (T0) to discharge between 3 to 5 weeks (T1), and 1 year (T4) after hospitalization

• 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

• 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

• 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)

• 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

Other Outcomes (1)

• Evaluation of cryotherapy effectiveness on fatigue syndrome in accordance to hospitalisation pattern

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

Study Arms (4)

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

Device: partial-body cryotherapy chamber session

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

Device: partial-body cryotherapy chamber session

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

Device: partial-body cryotherapy chamber session

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

Device: partial-body cryotherapy chamber session

Interventions

partial-body cryotherapy chamber session DEVICE

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).

Also known as: CRYO00002 ICE X- Cryosauna, local cryotherapy devices DM Class IIb

Sham cryotherapy full time patient (inpatient); cryotherapy full-time hospitalized patient (inpatient); cryotherapy part-time hospitalized patient (outpatient); sham cryotherapy part-time hospitalized patient (outpatient)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men and woen over 18 years old and under 65 years old
• with multiple sclerosis
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ildys: lead
• Lille Catholic University: collaborator

Study Sites (1)

Centre de Perharidy

Roscoff, France

Location

Related Publications (5)

• 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.

  PMID: 30968613 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.

  PMID: 27712663 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.

  PMID: 33386821 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.

  PMID: 33171768 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.

  PMID: 26778452 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue; Muscle Spasticity; Sleep Initiation and Maintenance Disorders; Depression

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Jean-Baptiste Bourseul, MD

  Fondation Ildys

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: February 1, 2022
• Study Start: September 12, 2022
• Primary Completion: June 30, 2024
• Study Completion: July 11, 2025
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)