A randomized controlled trial on the use of biofeedback with wireless technology in the therapy of fibromyalgia

Fibromyalgia (FM) is a chronic disease characterized by persistent and widespread musculoskeletal pain with an indefinite etiology, which often occurs in comorbidity with other functional, organic and psychiatric pathologies. The main clinical manifestation of FM is pain, which is predominantly described by affected individuals as a burning sensation, stiffness, contracture and tension. this work his is a pilot study, based on a randomized controlled design, to ascertain thehypothetical sample size useful for verifying the efficacy of biofeedback training treatmenton heart rate variability (HRV-BF) as add on to usual care in patients with fibromyalgia.Methods: 10-weeks Randomized Controlled Trial (RCT). Participants were assigned byrandomization to either an active interventional protocol based on HRV-BF plus usual care(N=16) or to a control intervention based on usual care (N=16). Pain was measuredthrough the Visual Analogical Scale (VAS).Results: The score at the VAS scale improved in both groups; in the HRV-BF group thedifference between the end and the beginning of the trial was statistically significantaccording to the predefined threshold (F[1;20]=4.414; p=0.049, one way-ANOVA), in thecontrol group it didn’t (F[1;18]=0.309; p=0.585). The sample size for a placebo-controlledtrial of HRV-BF would be 60.Conclusions: This pilot study supports the hypothesis that HVR-BF treatment might beeffective in the treatment of pain in fibromyalgia. Future studies should be conducted witha double-blind randomized controlled design in a larger sample.