Treatment of Fibromyalgia Syndrome Using Low-Intensity Neurofeedback with the Flexyx Neurotherapy System: A Randomized Controlled Clinical Trial

Background. Treatment of fibromyalgia syndrome (FMS) remains a clinical challenge. Pain, somatic and cognitive symptoms may be due to neurosensitization involving CNS-activated autonomic and musculoskeletal reactions, associated with EEG abnormalities that may respond to brainwave-based stimulation biofeedback. This study’s objective was to examine the efficacy and safety of a novel EEG neurobiofeedback treatment, the Flexyx Neurotherapy System® (FNS), and electrophysiological responses in persons with fibromyalgia. Methods. A randomized, double-blind, placebo-controlled clinical trial was conducted in two private practices: a free-standing neurobiofeedback center and a rheumatologist’s office at an academic medical center. Sixty-four participants with FMS (American College of Rheumatology criteria; Wolfe et al., 1990) for at least three years and symptoms for at least 48 months with no recent remission were randomized to treatment. A total of 22 treatment sessions were administered over at least 11 weeks of active (n = 33) or sham (n = 31) FNS therapy. Primary efficacy measures were the Clinical Global Impressions improvement scores, Clinician (CGI-I) and Participant (PGI-I) versions. Secondary outcomes included dolorimetry and tender point count, questionnaires (fibromyalgia symptom scales, CNS Dysfunction Questionnaire, Fibromyalgia Impact Questionnaire, Symptom Checklist-90-R), and EEG activity (delta, alpha, total amplitude). Results. More participants treated with active FNS than with sham improved partially or fully on the CGI-I at session 22 (p = .01) and follow-up (p = .04). The active FNS group had a higher