Riassunto dello studio

Twenty patients diagnosed with fibromyalgia were randomized to receive 6 weeks of high-frequency neuro-navigated repetitive transcranial magnetic stimulation (rTMS) treatment (n=10) or sham treatment (n=10) for the improvement of pain. The primary outcome of interest was pain severity measured using a Visual Analogue Scale (VAS). Secondary outcomes of interest included stiffness measured on VAS, the Fibromyalgia Impact Questionnaire (FIQ) for quality of life, the Fatigue Severity Scale (FSS), the Hospital Anxiety and Depression Scale (HADS), and the Addenbrooke Cognitive Examination Revised (ACE-R) total score and associated sub-scores (mini-mental state examination; attention and orientation; memory; verbal fluency; language; visual-spatial abilities). Outcomes were assessed at 2 weeks and 6 weeks follow-up for VAS pain, VAS stiffness, FIQ scores, and FSS scores. Furthermore, HADS and ACE-R total scores and sub-scores were assessed at 6 weeks follow-up only. Also, VAS stiffness scores and FIQ scores were statistically significantly improved from baseline in the rTMS group at 2 weeks follow up (p<0.05 for both). Also, HADS depression scores in the sham group and ACE-R memory scores in the rTMS group were statistically significantly improved from baseline at 6 weeks follow up (p<0.05 for both). Whilst 6 week ACE-R total and attention and orientation scores were statistically significantly in favour of the sham group, no statistically significant differences in the improvement from baseline in all outcomes, at all timepoints, were observed between the two groups.