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Home > "E" Clinical Trials Conditions > Effectiveness of Brainwave Biofeedback in the Treatment of Fibromyalgia  Effectiveness of Brainwave Biofeedback in the Treatment of Fibromyalgia
Effectiveness of Brainwave Biofeedback in the Treatment of Fibromyalgia
For Condition: Fibromyalgia
Status: Recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) ,
Synopsis: The purpose of this study is to determine whether a new form of brainwave biofeedback is effective in the treatment of fibromyalgia.
Details: 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 Flexyx Neurotherapy System (FNS) will be used to reduce FM symptoms. Participants in this study will be randomly assigned to receive either FNS 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 - Taking anxiolytic-sedative-hypnotic, muscle-relaxant, or opioid medications - Current involved in litigation regarding pain condition or seeking disability - History of electroconvulsive therapy
Total Enrollment: 40
Location and Contact Information:
Oregon Health & Science University *Recruiting*
Portland, Oregon, 97239-3098
United States
Recruiting David Nelson
Additional Information:
Study ID Numbers: 1-R21-AT000930-01A2;
Study Start Date: December 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080184
Other Fibromyalgia Studies:
1. Support, Health, and Fibromyalgia
2. Fibromyalgia: A Randomized Controlled Trial of a Mind/Body Intervention
3. Glucocorticoid Effects on Cellular Cytokine Release
4. Behavioral Insomnia Therapy for Fibromyalgia
5. Tailored Treatments of Fibromyalgia
Related Studies:
Other Fibromyalgia Clinical Trials
Other Oregon Clinical Trials
Other Portland Clinical Trials
Effectiveness of Brainwave Biofeedback in the Treatment of Fibromyalgia
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