Completed

Effectiveness of EEG Biofeedback in the Treatment of Fibromyalgia

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Data Collection

Who is being recruted

Fibromyalgia+4

+ Muscular Diseases

+ Musculoskeletal Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: December 2003
See protocol details

Summary

Principal SponsorNational Center for Complementary and Integrative Health (NCCIH)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2003

Actual date on which the first participant was enrolled.

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.

Official TitleEffectiveness of EEG Biofeedback in the Treatment of Fibromyalgia 
Principal SponsorNational Center for Complementary and Integrative Health (NCCIH)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

FibromyalgiaMuscular DiseasesMusculoskeletal DiseasesMyofascial Pain SyndromesNervous System DiseasesNeuromuscular DiseasesRheumatic Diseases

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Oregon Health & Science University

Portland, United StatesSee the location
CompletedOne Study Center