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

NCT04533971 | Completed

• 1 other identifier: 2016.01.01
• Study Type: interventional
• Target: 114
• Locations: 0 countries
• Sites: N/A

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)

Outcome Measures

Primary Outcomes (4)

• Assessment of changes in the level of fatigue

  The assessment tool: Fatigue Severity Scale (FSS). The FSS questionnaire is composed of 9 items related to the severity of symptoms commonly present in MS patients. Each question is rated on a scale of 1 to 7 (where 1 - "strongly disagree", 7 - "strongly agree"). Minimum value: 9 points (if you answer "1" to all questions) Maximum value: 63 points (if you answer "7" to all questions) A higher score indicates greater fatigue intensity - i.e. a worse result. A score of ≥ 36 points is considered significantly elevated and indicates significant fatigue intensity.

  On the day preceding the start of a 20 series of WBC ( 4 weeks) ( T0) and between the second and the fourth day, after the end of a series of WBC (T1).

• Assessment of changes in walking speed

  The aassessment tool: 25 Foot Walk (T25-FW) Maximal walking speed, across a clearly marked, linear 25-foot (7.62-m course). The T25-FW score was an average in seconds from the two successive trials

  On the day preceding the start of a 20 series of WBC ( 4 weeks) ( T0) and between the second and the fourth day, after the end of a series of WBC (T1).

• Assessment of changes in hand grip strength

  The aassessment tool: hand grip strength (HGS). Dominant hand. HGS measurements were performed in according to the recommendations of the American Society of Hand Therapists

  On the day preceding the start of a 20 series of WBC ( 4 weeks) ( T0) and between the second and the fourth day, after the end of a series of WBC (T1).

• Assessment of changes in the bioelectrical activity of muscles.

  The aassessment tool: surface electromyography (sEMG) of the dominant hand. The sEMG test was performed for extensor (ECR - Extensor carpi radialis) and a flexor (FCR- Flexor carpi radialis) muscles of the wrist, for the dominant hand. * 30-second electromyographic signal in the resting position * 2 isometric maximal voluntary contractions (MVC) of five seconds against a fixed handle separated by 90 s rest, for FCR and ECR of the dominant side. * voluntary contraction during 10 sec (wrist flexion and next extension against the fixed plates). Recording of VC repeated three times.

  On the day preceding the start of a 20 series of WBC ( 4 weeks) ( T0) and between the second and the fourth day, after the end of a series of WBC (T1).

Study Arms (2)

WBC group

EXPERIMENTAL

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

Other: Whole body cryotherapy

Control Group

NO INTERVENTION

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

Interventions

Whole body cryotherapy 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.

WBC group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Aleksandra Radecka

  Department of Functional Diagnostics and Physical Medicine, PUM

  PRINCIPAL INVESTIGATOR

• Anna Lubkowska, Profesor

  Department of Functional Diagnostics and Physical Medicine, PUM

  STUDY DIRECTOR

• Anna Knyszyńska, PhD

  Department of Functional Diagnostics and Physical Medicine, PUM

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor

Model Details: The participants were randomly assigned to the two groups, WBC and control.

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: September 1, 2020
• Study Start: April 1, 2015
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: June 24, 2025

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share