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Effectiveness of Brainwave Biofeedback in the Treatment of Fibromyalgia
This study has been completed.
Study NCT00080184   Information provided by National Center for Complementary and Alternative Medicine (NCCAM)
First Received: March 24, 2004   Last Updated: August 16, 2006   History of Changes

March 24, 2004
August 16, 2006
December 2003
 
 
 
Complete list of historical versions of study NCT00080184 on ClinicalTrials.gov Archive Site
 
 
 
Effectiveness of Brainwave Biofeedback in the Treatment of Fibromyalgia
Effectiveness of EEG Biofeedback in the Treatment of Fibromyalgia

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

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.

Phase I, Phase II
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Fibromyalgia
Procedure: Low Energy Neurofeedback System
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
40
May 2006
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00080184
 
R21 AT000930-01A2
National Center for Complementary and Alternative Medicine (NCCAM)
 
 
National Center for Complementary and Alternative Medicine (NCCAM)
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP