Multiple Sclerosis (ICD10-G35)NCT04533971
The Effect of a Series of Systemic Cryotherapy Treatments on the Functional State of Patients With Multiple Sclerosis
A study testing Whole body cryotherapy in people with Multiple Sclerosis (ICD10-G35), run by Pomeranian Medical University Szczecin.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis (ICD10-G35)
- What is being tested?
- Whole body cryotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2015to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
About this study
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
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)
- Being tested
- Whole body cryotherapy
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body cryotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start1 Apr 2015
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis (ICD10-G35)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants were randomly assigned to the two groups, WBC and control.
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Lubkowska, Pomeranian Medical University Szczecin
- Investigators
- Aleksandra Radecka, Principal investigator, Department of Functional Diagnostics and Physical Medicine, PUMAnna Lubkowska, Profesor, Study director, Department of Functional Diagnostics and Physical Medicine, PUMAnna Knyszyńska, PhD, Study chair, Department of Functional Diagnostics and Physical Medicine, PUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533971
- Sponsor's protocol ID
- 2016.01.01
- Status last verified
- Aug 2020
- First submitted
- 18 Aug 2020
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04533971
- Acronym / sponsor ID
- 2016.01.01
- Conditions
- Multiple Sclerosis (ICD10-G35)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 1 Apr 2015
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 1 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participants were randomly assigned to the two groups, WBC and control.
| Arm | Type | Receives |
|---|---|---|
| WBC group | Experimental | Other: Whole body cryotherapyCriteria * 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 |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole body cryotherapyThe 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. | Other | WBC group |
Primary outcome
Assessment of changes in the level of fatigue
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).
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.
Assessment of changes in walking speed
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).
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
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).
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.
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleksandra Radecka principal investigator
Department of Functional Diagnostics and Physical Medicine, PUM
Anna Lubkowska, Profesor study director
Department of Functional Diagnostics and Physical Medicine, PUM
Anna Knyszyńska, PhD study chair
Department of Functional Diagnostics and Physical Medicine, PUM
Questions about this trial
What is this clinical trial studying?
A study testing Whole body cryotherapy in people with Multiple Sclerosis (ICD10-G35), run by Pomeranian Medical University Szczecin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of changes in the level of fatigue (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).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.