NCT05562453Completed
Performance and Long-term Safety of FlowOx2.0™ in Patients With Multiple Sclerosis - Impact on Spasticity and Pain
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
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 56 (actual)
- First submitted
- 23 Sept 2022
- Start date
- 4 Oct 2022
- Primary completion date
- 2 Jan 2024
- Lead sponsor
- Otivio AS
- Diseases
- Multiple sclerosis
- NCT number
- NCT05562453
What you commit to
- Study type: Interventional
- Participants enrolled: 56
- From 4 Oct 2022 to the primary completion date, 2 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have received botulinum toxin injection for spasticity within the last 4 months.
- 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.
Other illness
- Have spasticity due to a disease other than MS.
- Have an ongoing infection that subjectively affects their MS state, as judged by the Investigator.
- Have symptoms or illness that make 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.
Other
- Subjects meeting any of the following criteria will not be permitted to participate in the clinical investigation:
- Pregnancy or planned pregnancy within the upcoming study period, up to 7 months (includes the optional extension part).
Who the study is looking for
- 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:
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NeuroCentrum (Centrum för Neurologi) Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.