ArticleNeurology and therapy2026
Efficacy and Safety of Intermittent Negative Pressure Treatment on Spasticity and Spasticity-Related Symptoms in Patients with Multiple Sclerosis: A Two-Arm Randomized Trial.
Article in Neurology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05562453 (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), which is not on this map. Not yet cited in PubMed.
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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
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Abstract
introductionTo compare the efficacy of treatment with two different levels of intermittent negative pressure (INP), applied to the lower limb, on self-reported spasticity and pain in patients with multiple sclerosis (MS).
methodsA randomized, two-arm multicenter trial enrolled patients with spasticity in the leg ≥ 4 on the numeric rating scale (NRS). Patients were randomized to treatment with -10 mmHg INP (low-dose group [LDG]) or -40 mmHg INP (high-dose group [HDG]) on the most affected leg, using the FlowOx 2.0 device (Otivio AS, Oslo, Norway). The device applies alternating cycles of 10 s of negative pressure and 7 s of ambient pressure via a sealed pressure chamber around the lower leg, for 1 h daily for 4 weeks.
resultsThere was no difference in the change in NRS spasticity and pain score between the two groups after 4 weeks (estimated treatment effect 0.72; 95% CI [-0.17, 1.61]; p = 0.114, and 1.09; 95% CI [-0.35, 2.53]; p = 0.138, respectively). Both HDG and LDG experienced a statistically significant decrease in NRS spasticity compared with baseline (mean change -1.0; 95% CI [-1.6, -0.4]; p = 0.001, and mean change -1.6; 95% CI [-2.5, -0.6]; p = 0.002, respectively), and both groups had a significant decrease in NRS pain score compared with baseline (mean change -1.5; 95% CI [-2.6, -0.5]; p = 0.007, and mean change -3.0; 95% CI [-5.0, -1.0]; p = 0.006, respectively). No improvements in objective walking tests were observed. Treatment compliance was high, and device-related adverse events were mild to moderate.
conclusionThere was no difference between treatment with a high and a low INP level in spasticity and pain. Both pressure levels led to significant improvements in spasticity and pain compared with baseline. INP treatment appears safe and may represent a useful non-pharmacological treatment option for spasticity in patients with MS.
trial registrationClinicalTrials.gov identifier NCT05562453.
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