Fibromyalgia Clinical Trial
Official title:
Effectiveness of EEG Biofeedback in the Treatment of Fibromyalgia
The purpose of this study is to determine whether a new form of brainwave biofeedback is effective in the treatment of fibromyalgia.
Fibromyalgia (FM) is a chronic disorder that involves chronic widespread musculoskeletal
pain typically accompanied by fatigue, disordered sleep, cognitive complaints, psychological
distress, and impairments in functioning. Treatments to date have been only partially
effective and typically of modest benefit. Many persons with FM remain persistently
dysfunctional and often disabled. This has given greater impetus for patients to seek
complementary and alternative medicine (CAM) therapies. In this study, a variant of
electroencephalograph (EEG) biofeedback known as Low Energy Neurofeedback System (LENS) will
be used to reduce FM symptoms.
Participants in this study will be randomly assigned to receive either LENS or placebo for
several sessions. The Fibromyalgia Impact Questionnaire will be used to assess participants
at the end of the study and at the 3- and 6- month follow-up visits.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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