Clinical Trial on Biofeedback as a Treatment for Fibromyalgia

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Fibromyalgia (FM) is a chronic disorder that involves chronic widespread musculoskeletal pain and additional accompanying problems, such as fatigue, disordered sleep, cognitive dysfunction, irritable bowel syndrome, psychological distress, and other functioning impairments.

To date, treatments for Fibromyalgia have been only partially effective and usually of little benefit. Despite treatment, many of those diagnosed with Fibromyalgia remain persistently dysfunctional and are often functionally disabled.

The National Center for Complementary and Alternative Medicine (NCCAM) is currently recruiting Fibromyalgia patients for a clinical trial on the Effectiveness of Brainwave Biofeedback in the Treatment of Fibromyalgia. In order to qualify for the study, which is expected to be completed in May 2005, a patient must be 18 years of age or older and have been diagnosed with Fibromyalgia for over a year.

The NCCAM study involves Flexyx Neurotherapy System (FNS), a variant of electroencephalograph (EEG) biofeedback, which will be used to attempt to reduce Fibromyalgia symptoms. According to information available at the ClinicalTrials.gov site, participants in this study will be randomly assigned to receive either FNS or a placebo for several sessions. A Fibromyalgia Impact Questionnaire will then be used to assess participants at the end of the study and at the 3- and 6- month follow-up visits. Additional information:

ClinicalTrials.gov site for “Effectiveness of BrainwaveBiofeedback in the Treatment of Fibromyalgia” clinical trial, with contact phone number and e-mail address

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