Effectiveness of Brainwave Biofeedback in the Treatment of Fibromyalgia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2006-05-31

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.

Conditions

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Fibromyalgia

Keywords

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Fibromyalgia Electroencephalograph (EEG) biofeedback Electromagnetic stimulation Neurofeedback Neurotherapy Complementary and Alternative Medicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Low Energy Neurofeedback System

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status

Countries

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United States

References

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Mueller HH, Donaldson CC, Nelson DV, Layman M. Treatment of fibromyalgia incorporating EEG-Driven stimulation: a clinical outcomes study. J Clin Psychol. 2001 Jul;57(7):933-52. doi: 10.1002/jclp.1060.

Reference Type BACKGROUND

PMID: 11406805 (View on PubMed)

Other Identifiers

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R21AT000930-01A2

Identifier Type: NIH

Identifier Source: org_study_id

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