Effectiveness of Brainwave Biofeedback in the Treatment of Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Effectiveness of EEG Biofeedback in the Treatment of Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00080184
• Other study ID #: R21AT000930-01A2
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 24, 2004
• Last updated: August 16, 2006
• Start date: December 2003
• Est. completion date: May 2006

Study information

• Verified date: August 2006
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Procedure:
• Low Energy Neurofeedback System

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

External Links

•   Information regarding chronic widespread musculoskeletal and myofascial pain with clinical, educational, and research information