A Randomized Controlled Trial to Evaluate the Effectiveness of Electromyography (EMG)-Biofeedback in Patients With Fibromyalgia

Biofeedback in Patients With Fibromyalgia - a Randomized Controlled Trial

The purpose of this study is to determine whether EMG-Biofeedback is effective in the treatment of Fibromyalgia.

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• gravity