Clinical trial NCT00080184: Effectiveness of Brainwave Biofeedback in the Treatment of Fibromyalgia
Official title: Effectiveness of EEG Biofeedback in the Treatment of Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Electroencephalograph (EEG) biofeedback
Electromagnetic stimulation
Neurofeedback
Neurotherapy
Complementary and Alternative Medicine
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2004-03-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
References:
citation: 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. doi: 10.1002/jclp.1060.