Effectiveness of Brainwave Biofeedback in the Treatment of Fibromyalgia

Study Overview
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Brief Summary
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The purpose of this study is to determine whether a new form of brainwave biofeedback is effective in the treatment of fibromyalgia.

Detailed Description
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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.

Official Title
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Effectiveness of EEG Biofeedback in the Treatment of Fibromyalgia

Conditions
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Fibromyalgia

Intervention / Treatment
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* Procedure: Low Energy Neurofeedback System


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Diagnosis of fibromyalgia with symptoms for at least 1 year Self-report of having attention/concentration, memory, multi-tasking or other thinking difficulties Able to read and understand English Able to attend treatment sessions weekly and return for planned follow-ups Appropriate balance of average delta (<4 Hertz) EEG waveband and alpha (approximately 4-8 Hertz) EEG waveband amplitude on LENS screening (to be determined by study personnel); Exclusion criteria: Other chronic pain condition of major significance Current chronic viral infection Current other unstable medical condition History of spinal, including neck, surgery Psychological screening indicates psychotic, suicidal, homicidal, and/or substance abusing Use of long-acting opioid medication taken on a continuous 24-hour dosing schedule Current involved in litigation regarding pain condition or seeking disability History of electroconvulsive therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Low Energy Neurofeedback System|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia, Electroencephalograph (EEG) biofeedback, Electromagnetic stimulation, Neurofeedback, Neurotherapy, Complementary and Alternative Medicine