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

Not Applicable

Completed

• Conditions: Whole-body Cryotherapy; Multiple Sclerosis (ICD10-G35); Surface Electromyography
• Interventions: Other: Whole body cryotherapy

• Registration Number: NCT04533971
• Lead Sponsor: Pomeranian Medical University Szczecin

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-01
• Primary Completion: 2019-12-20
• Study Completion: 2019-12-20
• Status Verified: 2020-08
• Study First Submitted: 2020-08-18
• Study First Submitted QC: 2020-08-26
• Last Update Submitted: 2020-08-26
• Study First Posted: 2020-09-01
• Last Update Posted: 2020-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WBC group	Whole body cryotherapy	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 Outcome Measures

Name	Time	Method
Assessment of changes in the level of fatigue	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).	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	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).	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	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).	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.	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).	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.