NCT05219201

Effectiveness of Cryotherapy on the Fatigue of Patients With Multiple Sclerosis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Fondation Ildys · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2022-09-12
• Primary completion: 2024-06-30
• Completion: 2025-07-11
• First posted: 2022-02-01
• Last updated: 2026-04-17

Locations

1 site across 1 country: France