Effectiveness of Brainwave Biofeedback in the Treatment of Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00080184
Recruitment Status : Completed
First Posted : March 25, 2004
Last Update Posted : August 18, 2006
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

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

Condition or disease Intervention/treatment Phase
Fibromyalgia Procedure: Low Energy Neurofeedback System Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effectiveness of EEG Biofeedback in the Treatment of Fibromyalgia
Study Start Date : December 2003
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00080184

United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239-3098
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)

Additional Information:
Publications: Identifier: NCT00080184     History of Changes
Other Study ID Numbers: R21AT000930-01A2 ( U.S. NIH Grant/Contract )
First Posted: March 25, 2004    Key Record Dates
Last Update Posted: August 18, 2006
Last Verified: August 2006

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Electroencephalograph (EEG) biofeedback
Electromagnetic stimulation
Complementary and Alternative Medicine

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases