The Effect of a Series of Systemic Cryotherapy Treatments on the Functional State of Patients With Multiple Sclerosis

NCT04533971 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2025-06-24

No results posted yet for this study

Summary

Multiple sclerosis (Latin: Sclerosis multiplex; MS) is a chronic, inflammatory and degenerative disease of the central nervous system (CNS) characterised by a varied course and symptomatology. The chronic nature of the disease and gradual loss of tissue within the CNS result in increasing neurological deficits and motor failure over time. Due to the characteristics of the symptoms and the chronic course of MS, patients with MS use various forms of physiotherapeutic procedures throughout most of their lives, including especially often whole-body cryotherapy (WBC) treatments. The aim of this study was to assess potential changes in bioelectrical muscle activity during rest and contraction after exposure on 20 series of Whole body cryotherapy (WBC) in patients with multiple sclerosis (MS). Assessment potential relationships between the sEMG parameters and functional state in patients with multiple sclerosis pre and post 20 series of WBC.

Finally, 114 patients with MS participated in the planned procedures of research. The participants were randomly assigned to the two groups, WBC and control. The sample size was 60 in WBC, and 54 in control groups. Testing before and after series of WBC consisted of: clinical assessment of fatigue was performed by the Fatigue Severity Scale (FSS), gait speed using Timed 25 Foot Walk (T25-FW), Hand grip strength (HGS), and surface electromyography (sEMG) of the dominant hand.

Conditions

  • Multiple Sclerosis (ICD10-G35)

Interventions

OTHER

Whole body cryotherapy

The WBC procedure consisted of 2-3 min walk in the cryogenic chamber at -110℃. Immediately before the WBC procedures, the patients were provided with a special treatment suit, they were instructed as to how to protect the parts of the body that are particularly vulnerable to frostbite, on the proper way of moving and breathing during the treatment. Excluding Saturdays and Sundays, the WBC treatments were performed daily for the next four weeks. Each time after the WBC the subjects participated in 15-minute kinesitherapy exercises conducted in groups of 5-6 people. The exercises were of general improvement nature and took into account the mobility of the subjects.

Sponsors & Collaborators

  • Pomeranian Medical University Szczecin

    lead OTHER

Principal Investigators

  • Aleksandra Radecka · Department of Functional Diagnostics and Physical Medicine, PUM

  • Anna Lubkowska, Profesor · Department of Functional Diagnostics and Physical Medicine, PUM

  • Anna Knyszyńska, PhD · Department of Functional Diagnostics and Physical Medicine, PUM

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-01
Primary Completion
2019-12-20
Completion
2019-12-20

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04533971 on ClinicalTrials.gov