- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00080184
Effectiveness of Brainwave Biofeedback in the Treatment of Fibromyalgia
Effectiveness of EEG Biofeedback in the Treatment of Fibromyalgia
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Oregon
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Portland, Oregon, United States, 97239-3098
- Oregon Health & Science University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21AT000930-01A2 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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