Biofeedback in Patients With Fibromyalgia - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Fibromyalgia Impact Questionnaire (FIQ)
研究概览
简要总结
The purpose of this study is to determine whether EMG-Biofeedback is effective in the treatment of Fibromyalgia.
详细描述
The objective of this randomized controlled trial is to evaluate the effectiveness of EMG-biofeedback in patients with Fibromyalgia. The assessors are blinded to the group assignment. There are three time points of assessment: before intervention, at the end of treatment (T1) and 3-months follow-up (T2). Patients are recruited from the waiting list of the Fibromyalgia day hospital program at the University Hospital Munich fulfilling the inclusion criteria. The intervention group is treated with 14 sessions of EMG-biofeedback during eight weeks in addition to usual care. The control group receives usual care only. The main specific aim is to assess the change in fibromyalgia specific health status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •fibromyalgia according to the American Congress of Rheumatology (ACR)-criteria and the criteria.
- •female gender
- •age between 18 and 65
- •cognitive ability and sufficient German language skills to fill in health status questionnaires
- •signed informed consent
排除标准
- •major medical disorders, i.e. cancer, chronic heart failure New York Heart Association (NYHA) IV or asthma requiring cortisone medication
- •suffering from psychosis or major affective disorders
- •substance abuse
- •co-medication with opiates or benzodiazepine
- •transmeridian flight in the last weeks
- •shift-work
结局指标
主要结局
Fibromyalgia Impact Questionnaire (FIQ)
时间窗: Change from baseline to 3 months
The primary outcome measure was the Fibromyalgia Impact Questionnaire (FIQ). The FIQ is a disease specific multidimensional self-administered instrument that covers the dimensions physical functioning (11 items), well-being (1 item), work situation (2 items), pain (1 item), fatigue /sleep (2 items), stiffness (2 items) and psychological symptoms (2 items). Scoring ranges from 0 to 80 with the latter number being the worst case. The FIQ Total Score gives a summary of patients' impairment and is recommended as a highly sensitive measure of change in Fibromyalgia treatment programs and clinical studies. In this study the validated German version was used.
次要结局
- Tender Point Score(Change from baseline to 3 months)
- Tender Point Count(Change from baseline to End of treatment (8 weeks after baseline))
- Fibromyalgia Impact Questionnaire (FIQ)(Change from baseline to End of Treatment (8 weeks after baseline))
- Short-Form 36 (SF-36)(Change from baseline to 3 months)
- self-rated Patients' Global Clinical Impression of Change Score(3 months)
- Beck Depression Inventory (BDI)(Change from baseline to 3 months)
- Symptom Checklist 90 Revised (SCL-90-R)(Change from baseline to 3 Months)
- Pressure Pain Threshold(Change from baseline to End of Treatment (8 weeks after baseline))
研究者
PD Dr. Martin Weigl, MPH
PD, MD, MPH (Harvard University)
Ludwig-Maximilians - University of Munich