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Completed

NCT Number: NCT05219201

Effectiveness of Cryotherapy on the Fatigue of Patients With Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Behavioral Symptoms Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Depression Dyssomnias Fatigue Immune System Diseases Mental Disorders Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de Perharidy

Roscoff, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: CRYO00002 ICE X- Cryosauna, local cryotherapy devices DM Class IIb

Primary outcomes

  1. Fatigue syndrome

    Time frame: 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 outcomes

  1. spasticity symptom

    Time frame: 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.

  2. quality of Life evaluation

    Time frame: 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.

  3. pain evaluation

    Time frame: 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.

  4. quality of sleep

    Time frame: 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.

  5. depression symptoms

    Time frame: 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.

  6. physician's global assessment-physical endurance

    Time frame: 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.

  7. habit changes after rehabilitation stay

    Time frame: 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).

  8. physician's global assessment-dynamic balance test

    Time frame: 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.

  9. physician's global assessement-static balance test

    Time frame: 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.

Other outcomes

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

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

    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.

Sponsors and collaborators

Lead sponsor

Fondation Ildys

Other

Collaborators

  • Lille Catholic University

Registry information

Official study title

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

Acronym: CRYOSEP

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Feb 1, 2022
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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