Effectiveness of Brainwave Biofeedback in the Treatment of Fibromyalgia

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00080184
First received: March 24, 2004
Last updated: August 16, 2006
Last verified: August 2006
  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 1
Phase 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
  More Information

Additional Information:
Publications:
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 September 16, 2014