A Randomized Controlled Trial to Evaluate the Effectiveness of Electromyography (EMG)-Biofeedback in Patients With Fibromyalgia
- Conditions
- Fibromyalgia
- Interventions
- Other: EMG-Biofeedback and Usual care
- Registration Number
- NCT02186756
- Lead Sponsor
- Ludwig-Maximilians - University of Munich
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EMG-Biofeedback and Usual Care EMG-Biofeedback and Usual care Patients in the intervention group started EMG-biofeedback training within three days after inclusion. In total 14 sessions of EMG-biofeedback training were applied. They started with three sessions of therapy in week 1-3 and had one session per week in week 4-8. Patients were encouraged to do a home exercise program, in which they consciously relaxed the muscle analogously to the biofeedback session for about 15 minutes per day. Additionally, they should try to apply the techniques in stressful situations, for example appointments at the dentist's.
- Primary Outcome Measures
Name Time Method Fibromyalgia Impact Questionnaire (FIQ) 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.
- Secondary Outcome Measures
Name Time Method Tender Point Score Change from baseline to 3 months Tender Point Count Change from baseline to End of treatment (8 weeks after baseline) According to the Tender point manual the examiner applied discrete pressure of 4 kg/cm² to each of the 18 Fibromyalgia typical Tender Points. When the patients expressed pain, the tender point was considered positive.
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 the Symptom Checklist 90 Revised (SCL-90-R) was used for measuring psychological distress. It generates 9 specific scales, one additional unspecific scale and three general scores. The 9 dimensions of the scale are as follows: SCL 1 = somatization; SCL 2 = obsessive-compulsive symptoms; SCL 3 = interpersonal sensitivity; SCL 4 = depression; SCL 5 = anxiety; SCL 6 = hostility; SCL 7 = phobic anxiety; SCL 8 = paranoid ideation; SCL 9 = psychoticism. The Global Severity Index serves as a measure of psychological distress.
Pressure Pain Threshold Change from baseline to End of Treatment (8 weeks after baseline) For measuring the Pressure Pain Threshold, the assessor first searched for an induration with pressure pain in the trapezius muscle pars descendens on each side of the muscle. The palpated part of the muscle was always located above or on a line between the acromioclavicular joint and the spinous process of vertebrae C 7. These two structures also served as coordinates to write down the exact place of the palpated taut band. Second, using a Fischer dolorimeter with a stamp of 1 cm², the examiner applied vertical pressure to the selected point and successively augmented the pressure until the patient signalled pain. In this way, the pressure pain threshold was measured in kg/cm².