Clinical trial NCT04533971: 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
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis (ICD10-G35)
Surface Electromyography
Whole-body Cryotherapy
Lead sponsor: Pomeranian Medical University Szczecin
Sponsor class: OTHER
First posted: 2020-09-01
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants were randomly assigned to the two groups, WBC and control.
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Assessment of changes in the level of fatigue
timeFrame: 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).
measure: Assessment of changes in walking speed
timeFrame: 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).
measure: Assessment of changes in hand grip strength
timeFrame: 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).
measure: Assessment of changes in the bioelectrical activity of muscles.
timeFrame: 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).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Functional Diagnostics and Physical Medicine, PUM
name: Aleksandra Radecka
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Functional Diagnostics and Physical Medicine, PUM
name: Anna Lubkowska, Profesor
role: STUDY_DIRECTOR
affiliation: Department of Functional Diagnostics and Physical Medicine, PUM
name: Anna Knyszyńska, PhD
role: STUDY_CHAIR
References: