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

Primary Purpose

Multiple Sclerosis (ICD10-G35), Surface Electromyography, Whole-body Cryotherapy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Whole body cryotherapy
Sponsored by
Pomeranian Medical University Szczecin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Multiple Sclerosis (ICD10-G35)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    WBC group

    Control Group

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    Assessment of changes in the level of fatigue
    The assessment tool: Severity Scale (FSS). The FSS questionnaire is composed of 9 items related to the severity of symptoms commonly present in MS patients
    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
    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
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 18, 2020
    Last Updated
    August 26, 2020
    Sponsor
    Pomeranian Medical University Szczecin
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04533971
    Brief Title
    The Effect of a Series of Systemic Cryotherapy Treatments on the Functional State of Patients With Multiple Sclerosis
    Official Title
    The Effect of a Series of Systemic Cryotherapy Treatments on the Bioelectrical Activity of Muscles and the Functional State of Patients With Multiple Sclerosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2015 (undefined)
    Primary Completion Date
    December 20, 2019 (Actual)
    Study Completion Date
    December 20, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Pomeranian Medical University Szczecin

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis (ICD10-G35), Surface Electromyography, Whole-body Cryotherapy

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The participants were randomly assigned to the two groups, WBC and control.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    114 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    WBC group
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Whole body cryotherapy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Assessment of changes in the level of fatigue
    Description
    The assessment tool: Severity Scale (FSS). The FSS questionnaire is composed of 9 items related to the severity of symptoms commonly present in MS patients
    Time Frame
    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).
    Title
    Assessment of changes in walking speed
    Description
    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
    Time Frame
    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).
    Title
    Assessment of changes in hand grip strength
    Description
    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
    Time Frame
    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).
    Title
    Assessment of changes in the bioelectrical activity of muscles.
    Description
    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.
    Time Frame
    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).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Aleksandra Radecka
    Organizational Affiliation
    Department of Functional Diagnostics and Physical Medicine, PUM
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Anna Lubkowska, Profesor
    Organizational Affiliation
    Department of Functional Diagnostics and Physical Medicine, PUM
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Anna Knyszyńska, PhD
    Organizational Affiliation
    Department of Functional Diagnostics and Physical Medicine, PUM
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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