A randomized placebo-controlled cross-over study using a low frequency magnetic field in the treatment of fatigue in multiple sclerosis

Background: Fatigue is one of the most common disabling symptoms in multiple sclerosis (MS). There is growing evidence in the literature for beneficial effects of magnetic fields on different MS symptoms and this has been reported to be beneficial in patients with MS, especially those with fatigue. Objectives: The aim of the study was to assess the effects on primary fatigue with a pulsed systemic low frequency magnetic field by means of clinical scales in a population of MS subjects. Methods: Randomized double-blind cross-over trial with 50 MS subjects with primary fatigue who were recruited among those followed as outpatients at the AISM Rehabilitation Centre, Genova, Italy. Subjects were randomized into two groups: magnetic field group and sham therapy group and evaluated with the Modified Fatigue Impact Scale (MFIS), the Fatigue Severity Scale (FSS), VAS and Time Walking Test 10 meter (TWT10m.) at the time points of the study. Each group received both sham therapy and magnetic field therapy with a wash-out period of 5 months. Subjects were treated for 24 min per session, three times per week, for 8 weeks. Statistical analysis was performed using multivariate analysis. Results: Results showed a statistically significant improvement in MFIS Physical Score for T0 - T1 (p<0.05) for TIME but not for TREATMENT and TIME*TREATMENT factors. No statistically significant differences were found for all other parameters considered in the study. Conclusions: Exposure to a low frequency magnetic field, within the parameters of this treatment protocol, has no advantage over sham exposure in reducing the impact of fatigue.