Treatment of fibromyalgia syndrome using low-intensity neuro feedback with the flexyx neurotherapy system: A randomized controlled clinical trial

Abstract

Treatment of fibromyalgia syndrome (FMS) remains a clinical challenge. Pain, somatic and cognitive symptoms may be due to neurosensitization involving CNS-ac-tivated 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 (fibro-myalgia 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 Howard M. Kravitz is affiliated with the Department of Psychiatry and the Department of Preventive Medicine, Rush University Medical Center, Chicago, IL. Mary Lee Esty is affiliated with the Neurotherapy Center of Washington, Chevy Chase, MD. Robert S. Katz is affiliated with the Department of Internal Medicine, Section of Rheumatology, Rush University Medical Center, Chicago, IL. Jan Fawcett is affiliated with the Department of Psychiatry, University of New Mexico School of Medicine, Albuquerque, NM and the Department of Psychiatry, Rush University Medical Center, Chicago, IL. Address correspondence to: Howard M. Kravitz, Rush University Medical Center, Department of Psychiatry, Marshall Field IV Building, 1720 West Polk Street, Chicago, IL 60612 (E-mail: Hkravitz@rush.edu). The authors thank the study staff at each site and all of the patients who participated in this research study. They also appreciate the diligent efforts of Ms. Mary Onofrio in organizing the data and assisting in database preparations. This study was funded by the Delaney Foundation and an anonymous donor.