Clinical trial NCT02186756: A Randomized Controlled Trial to Evaluate the Effectiveness of Electromyography (EMG)-Biofeedback in Patients With Fibromyalgia
Official title: Biofeedback in Patients With Fibromyalgia - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Complementary Therapies
Biofeedback
Randomized controlled trial
Relaxation Therapy
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2014-07-10
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: Change from baseline to 3 months
Secondary outcomes:
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: Change from baseline to End of Treatment (8 weeks after baseline)
measure: Short-Form 36 (SF-36)
timeFrame: Change from baseline to End of treatment (8 weeks after baseline)
measure: Short-Form 36 (SF-36)
timeFrame: Change from baseline to 3 months
measure: self-rated Patients' Global Clinical Impression of Change Score
timeFrame: End of Treatment (8 weeks after baseline)
measure: self-rated Patients' Global Clinical Impression of Change Score
timeFrame: 3 months
measure: Beck Depression Inventory (BDI)
timeFrame: Change from baseline to End of treatment (8 weeks after baseline)
measure: Beck Depression Inventory (BDI)
timeFrame: Change from baseline to 3 months
measure: Symptom Checklist 90 Revised (SCL-90-R)
timeFrame: Change from baseline to 3 Months
measure: Tender Point Score
timeFrame: Change from baseline to End of treatment (8 weeks after baseline)
measure: Tender Point Score
timeFrame: Change from baseline to 3 months
measure: Tender Point Count
timeFrame: Change from baseline to End of treatment (8 weeks after baseline)
measure: Pressure Pain Threshold
timeFrame: Change from baseline to End of Treatment (8 weeks after baseline)
Other outcomes:
Locations:
Study officials:
affiliation: Department of Orthopedics, Physical Medicine and Rehabilitation, University Hospital Munich, Ludwig Maximilians University Munich
name: Martin B Weigl, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Orthopedics, Physical Medicine and Rehabilitation, University Hospital Munich, Ludwig Maximilians University Munich
name: Andreas Winkelmann, MD
role: PRINCIPAL_INVESTIGATOR
References: