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Completed

NCT Number: NCT00080184

Effectiveness of Brainwave 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Oregon Health & Science University

Portland, Oregon, 97239-3098, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low Energy Neurofeedback System

Procedure

Sponsors and collaborators

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Nih

Registry information

Official study title

Effectiveness of EEG Biofeedback in the Treatment of Fibromyalgia

Important dates

Study start
2003
Study completion
2006
First posted
Mar 25, 2004
Registry last updated
Aug 18, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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