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| Descriptive Information Fields | |
| Brief Title † | Effectiveness of Brainwave Biofeedback in the Treatment of Fibromyalgia |
| Official Title † | Effectiveness of EEG Biofeedback in the Treatment of Fibromyalgia |
| 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 Phase | Phase I, Phase II |
| Study Type † | Interventional |
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
| Primary Outcome Measure † | |
| Secondary Outcome Measure † | |
| Condition † | Fibromyalgia |
| Intervention † | Procedure: Low Energy Neurofeedback System |
| MEDLINE PMIDs | 11406805 |
| Links | Information regarding chronic widespread musculoskeletal and myofascial pain with clinical, educational, and research information ![]() |
| Recruitment Information Fields | |
| Recruitment Status † | Completed |
| Enrollment † | 40 |
| Start Date † | December 2003 |
| Completion Date | May 2006 |
| Eligibility Criteria † | Inclusion criteria:
Exclusion criteria:
|
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | United States |
| Administrative Information Fields | |
| NCT ID † | NCT00080184 |
| Organization ID | R21 AT000930-01A2 |
| Secondary IDs †† | |
| Study Sponsor † | National Center for Complementary and Alternative Medicine (NCCAM) |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | National Center for Complementary and Alternative Medicine (NCCAM) |
| Verification Date | August 2006 |
| First Received Date † | March 24, 2004 |
| Last Updated Date | August 16, 2006 |