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| Tracking Information | |
|---|---|
| First Received Date ICMJE | March 24, 2004 |
| Last Updated Date | August 16, 2006 |
| Start Date ICMJE | December 2003 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00080184 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Effectiveness of Brainwave Biofeedback in the Treatment of Fibromyalgia |
| Official Title ICMJE | 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 ICMJE | Interventional |
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
| Condition ICMJE | Fibromyalgia |
| Intervention ICMJE | Procedure: Low Energy Neurofeedback System |
| Study Arms / Comparison Groups | |
| 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. |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 40 |
| Completion Date | May 2006 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00080184 |
| Responsible Party | |
| Study ID Numbers ICMJE | R21 AT000930-01A2 |
| Study Sponsor ICMJE | National Center for Complementary and Alternative Medicine (NCCAM) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Center for Complementary and Alternative Medicine (NCCAM) |
| Verification Date | August 2006 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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