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
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Other: EMG-Biofeedback and Usual care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- 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.
- Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: Change from baseline to End of Treatment (8 weeks after baseline) ]
- 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.
- Short-Form 36 (SF-36) [ Time Frame: Change from baseline to 3 months ]
- 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).
- self-rated Patients' Global Clinical Impression of Change Score [ Time Frame: 3 months ]
- 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.
- Beck Depression Inventory (BDI) [ Time Frame: Change from baseline to 3 months ]
- 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.
- 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.
- Tender Point Score [ Time Frame: Change from baseline to 3 months ]
- 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.
- 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.
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
|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|