Effectiveness of Brainwave Biofeedback in the Treatment of Fibromyalgia

National Institutes of Health (NIH)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Fibromyalgia

Treatments

Procedure: Low Energy Neurofeedback System

Study type

Interventional

Funder types

NIH

Identifiers

NCT00080184

R21AT000930-01A2

Details and patient eligibility

About

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

Full description

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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