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Neurotherapy of fibromyalgia?
David V. Nelson, PhD1, Robert M. Bennett, MD2, Andre Barkhuizen, MD2, Gary J. Sexton, PhD3, Kim D. Jones, PhD4, Len Ochs, PhD5, and Mary Lee Esty, PhD6. (1) Department of Psychology & Philosophy, Sam Houston State University, SHSU Box 2447, Huntsville, TX 77341, (2) Department of Medicine, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, (3) Department of Public Health & Preventive Medicine, Oregon Health & Science University, 3181 SW Sam Jackson Park Road CB 669, Portland, OR 97239, (4) School of Nursing, Oregon Health & Science University, 3455 SW US Veterans Road SN ORD, Portland, OR 97239, (5) OchsLabs, 8151 Elphick Lane, Sebastopol, CA 95472, (6) Neurotherapy Center of Washington, 5480 Wisconsin Avenue #221, Chevy Chase, MD 20815
The objective of this study was to evaluate the efficacy of a novel variant of electroencephalograph biofeedback for the amelioration of fibromyalgia (FM) symptoms. This technique, known as the Low Energy Neurofeedback System (LENS), utilizes minute pulses of electromagnetic stimulation to change brainwave activity. The intervention was a randomized, double-blind, placebo-controlled clinical trial in patients diagnosed with FM according to 1990 ACR classification criteria. Participants were randomly assigned for the same number of treatment sessions to either the active or sham intervention. The primary outcome measure, the Fibromyalgia Impact Questionnaire total score, as well as secondary measures of number of tender points (TPs) and pressure required to elicit TPs on physical exam, quantitative sensory testing heat pain threshold, and self-reported cognitive dysfunction, fatigue, sleep problems, global psychological distress, and depression were obtained at baseline, immediate post-treatment, and three- and six-month follow-up time points. Each group included 17 participants who completed assessments through the immediate post-treatment and 16 each through the follow-ups. Repeated measures ANOVAs indicated that at the six-month follow-up participants who had received either the active or sham intervention improved (p's<.05) on the primary and a variety of secondary outcome measures, without statistically significant between group differences in evidence at post-treatment or three- or six-month follow-up. However, individual session self-reported ratings of specific symptoms (cognitive dysfunction, fatigue, pain, and sleep, and overall activity level) over the course of the 22 intervention sessions indicated significant linear trends for improvement for the active intervention condition only (p's<.05). Based on this study, LENS cannot be recommended as a single modality treatment for FM. However, further study is warranted to investigate the potential of LENS to interact synergistically with other pharmacologic and non-pharmacologic therapies for improving symptoms in FM. (Supported by NIH/NCCAM 1R21 AT000930-01-A2 and NIH M01 RR000334.)