Effectiveness of Brainwave Biofeedback in the Treatment of Fibromyalgia

This study has been completed.

First Received on March 24, 2004. Last Updated on August 16, 2006 History of Changes

Sponsor:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00080184

Purpose

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

Condition	Intervention	Phase
Fibromyalgia	Procedure: Low Energy Neurofeedback System	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Effectiveness of EEG Biofeedback in the Treatment of Fibromyalgia

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment:	40
Study Start Date:	December 2003
Estimated Study Completion Date:	May 2006

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00080184

Locations

United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239-3098

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

More Information

Additional Information:

Information regarding chronic widespread musculoskeletal and myofascial pain with clinical, educational, and research information This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

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.

ClinicalTrials.gov Identifier:	NCT00080184 History of Changes
Other Study ID Numbers:	R21 AT000930-01A2
Study First Received:	March 24, 2004
Last Updated:	August 16, 2006
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Fibromyalgia
Electroencephalograph (EEG) biofeedback
Electromagnetic stimulation

Neurofeedback
Neurotherapy
Complementary and Alternative Medicine

Additional relevant MeSH terms:

Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases

Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on February 09, 2012