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

Fondation Ildys

Status: Enrolling

Conditions: Multiple Sclerosis

Treatments: Device: partial-body cryotherapy chamber session

Study type: Interventional

Funder types: Other

Identifiers

NCT05219201

ID-RCB 2021-A02526-35

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 4 patient groups

Sham cryotherapy full time patient (inpatient)

Sham Comparator group

Description:

Patients benefiting from 15 session of "sham" partial-body cryotherapy session (-30°C) during their full-time rehabilitation stay

Treatment:

Device: partial-body cryotherapy chamber session

sham cryotherapy part-time hospitalized patient (outpatient)

Sham Comparator group

Description:

Patients benefiting from 15 session of "sham" partial-body cryotherapy session (-30°C) during their part-time rehabilitation stay

Treatment:

Device: partial-body cryotherapy chamber session

cryotherapy full-time hospitalized patient (inpatient)

Active Comparator group

Description:

Patients benefiting from 15 session of "sham" partial-body cryotherapy session (-120°C) during their full-time rehabilitation stay

Treatment:

Device: partial-body cryotherapy chamber session

cryotherapy part-time hospitalized patient (outpatient)

Active Comparator group

Description:

Patients benefiting from 15 session of "sham" partial-body cryotherapy session (-120°C) during their part-time rehabilitation stay

Treatment:

Device: partial-body cryotherapy chamber session