Multiple SclerosisFO-NP002NCT05562453
Performance and Long-term Safety of FlowOx2.0™ in Patients With Multiple Sclerosis - Impact on Spasticity and Pain
A study testing FlowOx 2.0 in people with Multiple Sclerosis and Spasticity, Muscle, run by Otivio AS at 1 site in Sweden.
Trial summary
The study is a 4-week double-blind, randomized, controlled, parallel design investigation to investigate the impact of intermittent negative pressure on spasticity and pain in people with multiple sclerosis (pwMS). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis, Spasticity, Muscle, Pain, Chronic
- What is being tested?
- FlowOx 2.0
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteSweden
- Study dates
- 4 Oct 2022to 2 Jan 2024
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects must meet all the following criteria to be eligible to participate in the clinical investigation:
- Diagnosed MS according to revised McDonald criteria.
- Give written informed consent.
- Age 18-70 years.
- Stable MS disease without attack within the last three months.
- Ability to perform the walk tests:
Show all 14Show fewer
- 2-minute walk test, and
- 25-Foot walk.
- Self-reported spasticity in the most affected leg that would be subject to treatment at baseline with a score of ≥ 4, scored using the numeric rating scale (NRS) during the last 24 hours.
- Pain and/or discomfort related to the spasticity described in inclusion criteria 6., over the last 7 days using the numeric rating scale (NRS).
- Stable and unchanged treatment of spasticity and pain over the last month, as judged by the Investigator.
- Stable and unchanged disease-modulating treatment for MS last 6 months, as judged by the Investigator.
- Can self-manage study equipment.
- Willingness and ability to comply with study procedures, visit schedules, and requirements.
Who cannot join
- Subjects meeting any of the following criteria will not be permitted to participate in the clinical investigation:
- Have spasticity due to a disease other than MS.
- Pregnancy or planned pregnancy within the upcoming study period, up to 7 months (includes the optional extension part).
- Have an ongoing infection that subjectively affects their MS state, as judged by the Investigator.
- Have received botulinum toxin injection for spasticity within the last 4 months.
- Have symptoms or illness that make it difficult to participate in the study, as judged by the Investigator.
- Having planned surgery or other treatment within the coming study period of up to 7 months making it difficult to participate in the study, as judged by the Investigator.
- Subjects with uncontrolled wound infections or infections in the skin of the treated leg.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
NeuroCentrum (Centrum för Neurologi)
Stockholm, Stockholm County, 113 65
About this study
Official title: A Double-blind, Randomized, Controlled, Parallel Design 4-week Investigation, Followed by an Open 6-month Investigation, to Evaluate the Performance and Long-term Safety of FlowOx2.0™ in Patients With Multiple Sclerosis
The study is a 4-week double-blind, randomized, controlled, parallel design investigation to investigate the impact of intermittent negative pressure on spasticity and pain in people with multiple sclerosis (pwMS). The investigational device (FlowOx2.0™) is composed of a Pressure Chamber and a Control Unit (and disposable parts). All subjects will receive the same pressure chamber but be randomized to either a Control Unit that generates intermittent negative pressure (INP) of - (minus) 40 mmHg or a Control Unit that generates INP of - 10 mmHg. FlowOx2.0™ generating -40 mmHg is the investigational device, and FlowOx2.0™ generating -10 mmHg, is the comparator device. After the initial 4-week double-blind period, all participants will be offered the -40mmHg control unit to be used during a 6-months optional extension part.
Read the detailed description
FlowOx2.0™ is a commercially available device for home treatment of peripheral arterial disease. It is designed to be used at home by patients and has been shown to cause rapid changes in blood flow velocity in the treated leg. Recently, individuals with multiple sclerosis have reported a positive impact on their self-perceived spasticity and pain levels. The purpose of this study is to control for potential placebo effects using a comparator device.
The study will recruit patients from Norway, Sweden, and Denmark. All subjects will be instructed to treat the most affected leg for 60 minutes per day, preferentially in the evening. The same leg should be treated throughout the study period. The 4-week double-blind part is immediately followed by an optional extension part. This part is an open investigation in which all randomized subjects that have completed the main part are offered to continue for an additional 6 months using the active device (INP pulses of - 40 mmHg).
- Conditions
- Multiple Sclerosis, Spasticity, Muscle, Pain, Chronic
- Being tested
- FlowOx 2.0, FlowOx2.0 (Sham)
- Medical subject headings
- Multiple Sclerosis, Muscle Spasticity, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlowOx 2.0Device
Also called Intermittent negative pressure (Active)
Subjects randomized to tretament with the investigational device will receive treatment with -40 mmHg intermittent negative pressure for 60 minutes per day.
FlowOx2.0 (Sham)Device
Also called Intermittent negative pressure (Sham)
Subjects randomized to treatment with the comparator will receive treatment with -10 mmHg intermittent negative pressure for 60 minutes per day.
| Study group | Role | What they receive |
|---|---|---|
| Investigational device | Experimental | The investigational device (FlowOx2.0) is composed of a Pressure Chamber and a Control Unit (and disposable parts). All subjects will receive the commercial Pressure Chamber (and disposable parts). Subjects randomized to the investigational device arm will receive a Control Unit that generates intermittent negative pressure (INP) of - (minus) 40 mmHg. Receives: Device: FlowOx 2.0 |
| Comparator | Sham comparator | The investigational device (FlowOx2.0) is composed of a Pressure Chamber and a Control Unit (and disposable parts). All subjects will receive the commercial Pressure Chamber (and disposable parts). Subjects randomized to the comparator arm will receive a Control Unit that generates INP pulses of only - (minus) 10 mmHg. Receives: Device: FlowOx2.0 (Sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported spasticity using Numeric Rating Scale (NRS)
Numerical Rating Scale The minimum and maximum values: 0, 10 Higher scores mean a worse outcome the last 24 hours. The scale scores spasticity from 0-10, where 0 is no spasticity, and 10 is worst imaginable spasticity. The scoring should be done at roughly the same time of day and not during or immediately after treatment.
Measured: 4 weeks
Secondary outcomes (7)
Change in self-reported pain using NRS for subjects with a baseline NRS ≥4.
Pain is scored using the NRS which describes the average score of pain over the last 24 hours. The scale scores pain from 0-10, where 0 is no pain, and 10 is worst imaginable pain. The scoring is done each day of the study. The scoring should be done roughly at the same time and not during or immediately after treatment.
Measured: 4 weeks
Frequency of adverse events
All incidences of adverse events (AEs) and device deficiencies (DDs) will be documented and reported during the clinical investigation. At visits and phone calls, study staff will ask whether the subject has experienced any AEs/DDs since the last call/visit. Staff will also follow-up any previous AEs during visits and calls, i.e., are AEs resolved or still ongoing. The subjects will also be encouraged to call and report between visits and calls.
Measured: 4 weeks
Change in timed 25-foot walk (T25-FW)
The Timed 25-Foot Walk (T25-FW). The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-Foot Walk. The subject is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the subject has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. The "score" is the average of these two walks. Subjects may use assistive devices when doing this task. Staff record the average T25-FW score in seconds.
Measured: 4 weeks
Change in 2-minute walking tests
The 2-min walk test, should be tested in a hallway free of obstacles. Subject instruction will be: "Cover as much ground as possible over 2 minutes. Walk continuously, if possible, but do not be concerned if you need to slow down or stop to rest. The goal is to feel at the end of the test that more ground could not have been covered in the 2 minutes."
Measured: 4 weeks
Change in health-related quality of life measured by Multiple sclerosis impact scale (MSIS-29)
The MSIS-29 is a measure of the physical and psychological impact of multiple sclerosis (MS) from the patients' perspective. Twenty-nine (29) questions are responded by the subject by circling the number that best describes the subject's situation (graded 1-5, where 1 is "not at all" and 5 is extremely). It captures the subject's views about the impact of MS on his/her day-to-day life during the past two weeks.
Measured: 4 weeks
Change in health-related quality of life measured by EQ-5D-5L
The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
Measured: 4 weeks
Change in Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) is a 14-item measure designed to assess anxiety and depression symptoms in medical patients, with emphasis on reducing the impact of physical illness on the total score. Items are rated on a 4-point severity scale. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start4 Oct 2022
- Primary completion2 Jan 2024
- Study completion2 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, parallel design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otivio AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kjell-Morten Myhr, MD, PhD, Principal investigator, Dept. of Neurology Haukeland Univ. Hospital & Dept. of Clin. Med., Univ. of Bergen, Bergen, NorwaySara Haghighi Mobarhan Smith, MD, PhD, Principal investigator, Department of Neurology, Motala Hospital, Motala, SwedenPeter Vestergaard Rasmussen, MD, PhD, Principal investigator, Department of Clinical Medicine - The Department of Neurology, Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562453
- Sponsor's protocol ID
- CIV-22-04-039306
- Acronym
- FO-NP002
- Status last verified
- Jun 2023
- First submitted
- 23 Sep 2022
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Norregaard J, Hoel H, Mathiesen I, Haghighi S, Kierkegaard M, Piehl F, Blinkenberg M, Myhr KM. Efficacy and Safety of Intermittent Negative Pressure Treatment on Spasticity and Spasticity-Related Symptoms in Patients with Multiple Sclerosis: A Two-Arm Randomized Trial. Neurol Ther. 2026 Jul 15. doi: 10.1007/s40120-026-00985-1. Online ahead of print.
PubMed 42455218
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Controlled, Parallel Design 4-week Investigation, Followed by an Open 6-month Investigation, to Evaluate the Performance and Long-term Safety of FlowOx2.0™ in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05562453
- Acronym / sponsor ID
- FO-NP002 / CIV-22-04-039306
- Conditions
- Multiple Sclerosis, Spasticity, Muscle, Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Otivio ASIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- 2 Jan 2024 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 30 Sep 2022 (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.
The study is a 4-week double-blind, randomized, controlled, parallel design investigation to investigate the impact of intermittent negative pressure on spasticity and pain in people with multiple sclerosis (pwMS). The investigational device (FlowOx2.0™) is composed of a Pressure Chamber and a Control Unit (and disposable parts). All subjects will receive the same pressure chamber but be randomized to either a Control Unit that generates intermittent negative pressure (INP) of - (minus) 40 mmHg or a Control Unit that generates INP of - 10 mmHg. FlowOx2.0™ generating -40 mmHg is the investigational device, and FlowOx2.0™ generating -10 mmHg, is the comparator device. After the initial 4-week double-blind period, all participants will be offered the -40mmHg control unit to be used during a 6-months optional extension part.
Detailed description
FlowOx2.0™ is a commercially available device for home treatment of peripheral arterial disease. It is designed to be used at home by patients and has been shown to cause rapid changes in blood flow velocity in the treated leg. Recently, individuals with multiple sclerosis have reported a positive impact on their self-perceived spasticity and pain levels. The purpose of this study is to control for potential placebo effects using a comparator device.
The study will recruit patients from Norway, Sweden, and Denmark. All subjects will be instructed to treat the most affected leg for 60 minutes per day, preferentially in the evening. The same leg should be treated throughout the study period. The 4-week double-blind part is immediately followed by an optional extension part. This part is an open investigation in which all randomized subjects that have completed the main part are offered to continue for an additional 6 months using the active device (INP pulses of - 40 mmHg).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, controlled, parallel design
| Arm | Type | Receives |
|---|---|---|
| Investigational device | Experimental | Device: FlowOx 2.0The investigational device (FlowOx2.0) is composed of a Pressure Chamber and a Control Unit (and disposable parts). All subjects will receive the commercial Pressure Chamber (and disposable parts). Subjects randomized to the investigational device arm will receive a Control Unit that generates intermittent negative pressure (INP) of - (minus) 40 mmHg. |
| Comparator | Sham comparator | Device: FlowOx2.0 (Sham)The investigational device (FlowOx2.0) is composed of a Pressure Chamber and a Control Unit (and disposable parts). All subjects will receive the commercial Pressure Chamber (and disposable parts). Subjects randomized to the comparator arm will receive a Control Unit that generates INP pulses of only - (minus) 10 mmHg. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- The subjects must meet all the following criteria to be eligible to participate in the clinical investigation:
- Diagnosed MS according to revised McDonald criteria.
- Give written informed consent.
- Age 18-70 years.
- Stable MS disease without attack within the last three months.
Key exclusion criteria (8 listed)
- Subjects meeting any of the following criteria will not be permitted to participate in the clinical investigation:
- Have spasticity due to a disease other than MS.
- Pregnancy or planned pregnancy within the upcoming study period, up to 7 months (includes the optional extension part).
- Have an ongoing infection that subjectively affects their MS state, as judged by the Investigator.
- Have received botulinum toxin injection for spasticity within the last 4 months.
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 |
|---|---|---|
| FlowOx 2.0Also: Intermittent negative pressure (Active)Subjects randomized to tretament with the investigational device will receive treatment with -40 mmHg intermittent negative pressure for 60 minutes per day. | Device | Investigational device |
| FlowOx2.0 (Sham)Also: Intermittent negative pressure (Sham)Subjects randomized to treatment with the comparator will receive treatment with -10 mmHg intermittent negative pressure for 60 minutes per day. | Device | Comparator |
Primary outcome
Change in self-reported spasticity using Numeric Rating Scale (NRS)
Time frame: 4 weeks
Numerical Rating Scale The minimum and maximum values: 0, 10 Higher scores mean a worse outcome the last 24 hours. The scale scores spasticity from 0-10, where 0 is no spasticity, and 10 is worst imaginable spasticity. The scoring should be done at roughly the same time of day and not during or immediately after treatment.
7 secondary outcomes
Change in self-reported pain using NRS for subjects with a baseline NRS ≥4.
Time frame: 4 weeks
Frequency of adverse events
Time frame: 4 weeks
Change in timed 25-foot walk (T25-FW)
Time frame: 4 weeks
Change in 2-minute walking tests
Time frame: 4 weeks
Change in health-related quality of life measured by Multiple sclerosis impact scale (MSIS-29)
Time frame: 4 weeks
Change in health-related quality of life measured by EQ-5D-5L
Time frame: 4 weeks
Change in Hospital Anxiety and Depression Scale (HADS)
Time frame: 4 weeks
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 19 Oct 2026.
- Derived from this study: PubMed 42455218Norregaard J, Hoel H, Mathiesen I, Haghighi S, Kierkegaard M, Piehl F, Blinkenberg M, Myhr KM. Efficacy and Safety of Intermittent Negative Pressure Treatment on Spasticity and Spasticity-Related Symptoms in Patients with Multiple Sclerosis: A Two-Arm Randomized Trial. Neurol Ther. 2026 Jul 15. doi: 10.1007/s40120-026-00985-1. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Kjell-Morten Myhr, MD, PhD principal investigator
Dept. of Neurology Haukeland Univ. Hospital & Dept. of Clin. Med., Univ. of Bergen, Bergen, Norway
Sara Haghighi Mobarhan Smith, MD, PhD principal investigator
Department of Neurology, Motala Hospital, Motala, Sweden
Peter Vestergaard Rasmussen, MD, PhD principal investigator
Department of Clinical Medicine - The Department of Neurology, Aarhus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FlowOx 2.0 in people with Multiple Sclerosis and Spasticity, Muscle, run by Otivio AS at 1 site in Sweden.
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 14 inclusion and 8 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 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Change in self-reported spasticity using Numeric Rating Scale (NRS) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05562453, which also lists 1 linked publication.
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 19 Oct 2026.