Performance and Long-term Safety of FlowOx2.0™, Multiple Sclerosis, Spasticity and Pain

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 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. A 4-week double-blind part (NCT05562453) is followed by this 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 of - 40 mmHg).