Effectiveness of Brainwave Biofeedback in the Treatment of Fibromyalgia

Phase 1

Completed

• Conditions: Fibromyalgia

• Registration Number: NCT00080184
• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)

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.

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2004-03-24
• Study First Submitted QC: 2004-03-24
• Study First Posted: 2004-03-25
• Study Completion: 2006-05
• Status Verified: 2006-08
• Last Update Submitted: 2006-08-16
• Last Update Posted: 2006-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States