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Efficacy and Safety of Intermittent Negative Pressure Treatment on Spasticity and Spasticity-Related Symptoms in
Jesper Nørregaard1, Henrik Hoel2, Iacob Mathiesen2
1Danish Multiple Sclerosis Center, Department of Neurology, Glostrup Hospital, Copenhagen, Denmark. Jesper.noerregaard@regionh.dk.
Introduction:
To 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).
Methods:
A 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.
Results:
There 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.
Conclusion:
There 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 Registration:
ClinicalTrials.gov identifier NCT05562453.
