Disease: Multiple Sclerosis
Type of study: Interventional trial
Coordinating investigator &Study director: Kjell-Morten Myhr
Information for patients: on this page (in Norwegian only.) (Inclusion is closed)
Background: The treatment of pain and spasticity in multiple sclerosis (MS) is often challenging due to suboptimal effects, and reasonable goals are often to alleviate and not eliminate the symptoms. This may lead to despairing patients, often trying alternative treatment strategies. In this context, several MS-patients have tried a new treatment method shown to reduce lower extremity pain by improved blood circulation in the lower extremities. A pressure chamber (FlowOx) sealed around the patient’s legs just below the knee, applies a negative pressure and atmospheric pressure cycles. The treatment is currently approved and used for selected patients with arterial insufficiency caused by intermittent claudication or diabetes-related leg
ulcers. A recent pilot study showed significant relief of pain and spasticity with consequent improvement in functional levels in 10 MS patients.
The objective is to evaluate the clinical effects of treatment with – 40 mm Hg intermittent negative pressure applied by FlowOx2.0 on spasticity caused by multiple sclerosis (MS).
Design: This is a randomized double-blinded study where 60 patients with spasticity due to MS will receive 40 Hg intermittent negative pressure applied by FlowOx2.0 (n=30 active treatment) or 10 Hg intermittent negative pressure applied by FlowOx2.0 (n=30 placebo treatment) for four weeks, followed by an open label extension period of a total of 6 months.
The primary endpoint is the change in self-reported spasticity using Numeric Rating Scale (NRS) after 4 weeks.
Participating Centres
- Haukeland University Hospital, Bergen
- NeuroCentrum, Stockholm, Sweden
- Department of Neurology, Motala Hospital, Motala, Sweden
- Department of Clinical Medicine - The Department of Neurology, Aarhus University Hospital, Denmark
Funding
- Haukeland University Hospital
- The University of Bergen
- Otivio AS, Oslo