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

NCT02186756 | Completed

• 1 other identifier: PM-FMBFBack
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Complementary Therapies; Biofeedback; Randomized controlled trial; Relaxation Therapy

Outcome Measures

Primary Outcomes (1)

• Fibromyalgia Impact Questionnaire (FIQ)

  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.

  Change from baseline to 3 months

Secondary Outcomes (12)

• Fibromyalgia Impact Questionnaire (FIQ)

  Change from baseline to End of Treatment (8 weeks after baseline)

• Short-Form 36 (SF-36)

  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

  End of Treatment (8 weeks after baseline)

• self-rated Patients' Global Clinical Impression of Change Score

  3 months

Study Arms (2)

EMG-Biofeedback and Usual Care

EXPERIMENTAL

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.

Other: EMG-Biofeedback and Usual care

Usual care

NO INTERVENTION

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.

Interventions

EMG-Biofeedback and Usual care OTHER

Please refer to arm description

Also known as: Schuhfried Biofeedback apparatus

EMG-Biofeedback and Usual Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Martin B Weigl, MD, MPH

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

  PRINCIPAL INVESTIGATOR

• Andreas Winkelmann, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD, MD, MPH (Harvard University)

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 10, 2014
• Study Start: April 1, 2005
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: July 10, 2014

Record last verified: 2014-07