Effectiveness of EEG Biofeedback in the Treatment of Fibromyalgia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to determine whether a new form of brainwave biofeedback is effective in the treatment of fibromyalgia.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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);
排除标准
- •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