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

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ClinicalTrials.gov Identifier: NCT02186756
Recruitment Status : Completed
First Posted : July 10, 2014
Last Update Posted : July 10, 2014
Sponsor:
Information provided by (Responsible Party):
PD Dr. Martin Weigl, MPH, 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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Other: EMG-Biofeedback and Usual care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Biofeedback in Patients With Fibromyalgia - a Randomized Controlled Trial
Study Start Date : April 2005
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: 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.

Other: EMG-Biofeedback and Usual care
Please refer to arm description
Other Name: Schuhfried Biofeedback apparatus

No Intervention: 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.



Primary Outcome Measures :
  1. Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: 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 :
  1. Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: Change from baseline to End of Treatment (8 weeks after baseline) ]
  2. Short-Form 36 (SF-36) [ Time Frame: Change from baseline to End of treatment (8 weeks after baseline) ]
    The SF-36 is a widely used measure of health-related quality of life with 36 items. It yields an eight-scale profile of scores which are Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health.

  3. Short-Form 36 (SF-36) [ Time Frame: Change from baseline to 3 months ]
  4. self-rated Patients' Global Clinical Impression of Change Score [ Time Frame: End of Treatment (8 weeks after baseline) ]
    Change of health was directly measured by the self-rated Patients' Global Clinical Impression of Change Score, which is a validated measure of overall change compared with study onset, including six possible scores from "very much worse" (score 1) to "very much better" (score 6).

  5. self-rated Patients' Global Clinical Impression of Change Score [ Time Frame: 3 months ]
  6. Beck Depression Inventory (BDI) [ Time Frame: Change from baseline to End of treatment (8 weeks after baseline) ]
    This questionnaire was developed and validated for patients with depression and has been applied in clinical trials of patients with Fibromyalgia as well. It contains 21 items that assess the cognitive, affective and neurovegetative factors associated with depression.

  7. Beck Depression Inventory (BDI) [ Time Frame: Change from baseline to 3 months ]
  8. Symptom Checklist 90 Revised (SCL-90-R) [ Time Frame: 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.

  9. Tender Point Score [ Time Frame: Change from baseline to End of treatment (8 weeks after baseline) ]
    It consists of a body diagram, where patients can rate the pain intensity at 24 locations of the front and the back side of the body. It allows calculating a total score for the whole body, as well as specific local scores.

  10. Tender Point Score [ Time Frame: Change from baseline to 3 months ]
  11. Tender Point Count [ Time Frame: 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.

  12. Pressure Pain Threshold [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02186756


Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
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Principal Investigator: 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

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Responsible Party: PD Dr. Martin Weigl, MPH, PD, MD, MPH (Harvard University), Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT02186756     History of Changes
Other Study ID Numbers: PM-FMBFBack
First Posted: July 10, 2014    Key Record Dates
Last Update Posted: July 10, 2014
Last Verified: July 2014

Keywords provided by PD Dr. Martin Weigl, MPH, Ludwig-Maximilians - University of Munich:
Fibromyalgia
Complementary Therapies
Biofeedback
Randomized controlled trial
Relaxation Therapy

Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases