Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080184
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2004-03-24
Brief Title:
Effectiveness of Brainwave Biofeedback in the Treatment of Fibromyalgia
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Effectiveness of EEG Biofeedback in the Treatment of Fibromyalgia
Status:
COMPLETED
Status Verified Date:
2006-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None