NCT02186756|Completed
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
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Biofeedback in Patients With Fibromyalgia - a Randomized Controlled Trial
Sponsor study identifier
interventional
40
0 countries
N/A
Study Start
April 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2006
Actual (reported)Study Completion
July 2006
Actual (reported)The purpose of this study is to determine whether EMG-Biofeedback is effective in the treatment of Fibromyalgia.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2006
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2005
Date type not reportedThis date has not been verified as actual or estimated.
July 2006
Actual (reported)July 2006
Actual (reported)July 2, 2014
Actual (reported)July 10, 2014
Actual (reported)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
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
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.
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.
Please refer to arm description
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Martin B Weigl, MD, MPH
Department of Orthopedics, Physical Medicine and Rehabilitation, University Hospital Munich, Ludwig Maximilians University Munich
Andreas Winkelmann, MD
Department of Orthopedics, Physical Medicine and Rehabilitation, University Hospital Munich, Ludwig Maximilians University Munich
40 participants (actual enrollment reported by the registry).
First Submitted
July 2, 2014
First Posted
July 10, 2014
Study Start
April 2005
Date type not reportedThis date has not been verified as actual or estimated.
Fibromyalgia Acupuncture Study
Contact the study team to confirm eligibility.
Primary Completion
July 2006
Actual (reported)Study Completion
July 2006
Actual (reported)Last Updated
July 10, 2014
Record last verified: 2014-07
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Source: ClinicalTrials.gov.
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