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

NCT ID: NCT02186756

Last Updated: 2014-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2006-07-31

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

EMG-Biofeedback and Usual care

Intervention Type: OTHER

Please refer to arm description

Usual care

The patients in the control group had only two encounters with the therapist in the eight week interval. At these encounters pain was assessed by a visual analogue scale and their trapezius muscle activity was measured during 5 minutes analogously to the intervention group. However, afterwards they did not continue with muscle straining and relaxation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

EMG-Biofeedback and Usual care

Please refer to arm description

Intervention Type: OTHER

Other Intervention Names

Schuhfried Biofeedback apparatus

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role: lead

Responsible Party

PD Dr. Martin Weigl, MPH

PD, MD, MPH (Harvard University)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin B Weigl, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopedics, Physical Medicine and Rehabilitation, University Hospital Munich, Ludwig Maximilians University Munich

Andreas Winkelmann, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopedics, Physical Medicine and Rehabilitation, University Hospital Munich, Ludwig Maximilians University Munich

Other Identifiers

PM-FMBFBack

Identifier Type: -

Identifier Source: org_study_id