Effectiveness of Cryotherapy on the Fatigue of Patients With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— CRYOSEP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05219201
• Other study ID #: ID-RCB 2021-A02526-35
• Status: Recruiting
• Phase: N/A
• Start date: September 12, 2022
• Est. completion date: June 2027

Study information

• Verified date: September 2022
• Source: Fondation Ildys
• Contact: Matthieu Pichelin
• Phone: 02.98.02.85.00
• Email: matthieu.pichelin[@]ildys.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2027
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis
• Sclerosis

Intervention

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).

Locations

Country	Name	City	State
France	Centre de Perharidy	Roscoff

Sponsors (2)

Lead Sponsor	Collaborator
Fondation Ildys	Lille Catholic University

Country where clinical trial is conducted

France, 

References & Publications (5)

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. Review. — View Citation

Miller E, Kostka J, Wlodarczyk T, Dugué 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. — View Citation

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. — View Citation

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. — View Citation

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). pii: E3592. doi: 10.3390/jcm9113592. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	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	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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