Fibromyalgia
Conditions
Keywords
Fibromyalgia, Electroencephalograph (EEG) biofeedback, Electromagnetic stimulation, Neurofeedback, Neurotherapy, Complementary and Alternative Medicine
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.
Interventions
PROCEDURELow Energy Neurofeedback System
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Countries
United States
Outcome results
None listed