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

NCT ID: NCT04533971

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-01
• Study Completion Date: 2019-12-20

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

WBC group

Criteria

• documented diagnosis of MS,
• functional status classified according to the Expanded Disability Status Scale (EDSS) to a level lower or equal to 0-3
• no contraindications for WBC treatments found in the medical examination
• no other serious chronic diseases identified that may affect the results of the tests carried out
• readiness to participate in daily WBC
• a written statement of volunteers about not using WBC treatments in the last 2 years, and not using other forms of physiotherapeutic and complementary therapies (other than planned in the procedures) for the period of this study

Group Type: EXPERIMENTAL

Whole body cryotherapy

Intervention Type: OTHER

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.

Control Group

Criteria

• documented diagnosis of MS,
• functional status classified according to the Expanded Disability Status Scale (EDSS) to a level lower or equal to 0-3
• no contraindications for WBC treatments found in the medical examination
• no other serious chronic diseases identified that may affect the results of the tests carried out
• readiness to participate in daily WBC
• a written statement of volunteers about not using WBC treatments in the last 2 years, and not using other forms of physiotherapeutic and complementary therapies (other than planned in the procedures) for the period of this study

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• documented diagnosis of MS,
• functional status classified according to the Expanded Disability Status Scale (EDSS) to a level lower or equal to 0-3
• no contraindications for WBC treatments found in the medical examination
• no other serious chronic diseases identified that may affect the results of the tests carried out
• readiness to participate in daily WBC
• a written statement of volunteers about not using WBC treatments in the last 2 years, and not using other forms of physiotherapeutic and complementary therapies (other than planned in the procedures) for the period of this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pomeranian Medical University Szczecin

OTHER

Sponsor Role: lead

Responsible Party

Anna Lubkowska

Profesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aleksandra Radecka

Role: PRINCIPAL_INVESTIGATOR

Department of Functional Diagnostics and Physical Medicine, PUM

Anna Lubkowska, Profesor

Role: STUDY_DIRECTOR

Department of Functional Diagnostics and Physical Medicine, PUM

Anna Knyszyńska, PhD

Role: STUDY_CHAIR

Department of Functional Diagnostics and Physical Medicine, PUM

Other Identifiers

2016.01.01

Identifier Type: -

Identifier Source: org_study_id