Biofeedback |
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Clinical Trial: Effectiveness of Brainwave Biofeedback in the Treatment of Fibromyalgia
This study is currently recruiting patients.
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Purpose
The purpose of this study is to determine whether a new form of brainwave biofeedback is effective in the treatment of fibromyalgia.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Fibromyalgia | Procedure: Low Energy Neurofeedback System | Phase I Phase II |
MedlinePlus related topics: Fibromyalgia
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Effectiveness of EEG Biofeedback in the Treatment of Fibromyalgia
Expected Total Enrollment: 40
Study start: December 2003; Expected completion: May 2005
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
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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
Location and Contact Information
David Nelson 503-494-7808 nelsonda@ohsu.edu
Oregon
Oregon Health & Science University, Portland, Oregon, 97239-3098, United States; Recruiting
Robert M. Bennett, MD, Sub-Investigator
Andre Barkhuizen, MD, Sub-Investigator
More Information
Information regarding chronic widespread musculoskeletal and myofascial pain with clinical, educational, and research information
Publications
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.
Record last reviewed: March 2005
Last Updated: March 24, 2005
Record first received: March 24, 2004
ClinicalTrials.gov Identifier: NCT00080184
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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