Back to resultsA Randomized Controlled Trial to Evaluate the Effectiveness of Electromyography (EMG)-Biofeedback in Patients With Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EMG-Biofeedback and Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Complementary Therapies, Biofeedback, Randomized controlled trial, Relaxation Therapy
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
EMG-Biofeedback and Usual Care
Usual care
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Fibromyalgia Impact Questionnaire (FIQ)
Short-Form 36 (SF-36)
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)
self-rated Patients' Global Clinical Impression of Change Score
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
Beck Depression Inventory (BDI)
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)
Symptom Checklist 90 Revised (SCL-90-R)
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
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
Tender Point Count
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
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.
Full Information
NCT ID
NCT02186756
First Posted
July 2, 2014
Last Updated
July 8, 2014
Sponsor
Ludwig-Maximilians - University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT02186756
Brief Title
A Randomized Controlled Trial to Evaluate the Effectiveness of Electromyography (EMG)-Biofeedback in Patients With Fibromyalgia
Official Title
Biofeedback in Patients With Fibromyalgia - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ludwig-Maximilians - University of Munich
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Complementary Therapies, Biofeedback, Randomized controlled trial, Relaxation Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EMG-Biofeedback and Usual Care
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
EMG-Biofeedback and Usual care
Other Intervention Name(s)
Schuhfried Biofeedback apparatus
Intervention Description
Please refer to arm description
Primary Outcome Measure Information:
Title
Fibromyalgia Impact Questionnaire (FIQ)
Description
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.
Time Frame
Change from baseline to 3 months
Secondary Outcome Measure Information:
Title
Fibromyalgia Impact Questionnaire (FIQ)
Time Frame
Change from baseline to End of Treatment (8 weeks after baseline)
Title
Short-Form 36 (SF-36)
Description
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.
Time Frame
Change from baseline to End of treatment (8 weeks after baseline)
Title
Short-Form 36 (SF-36)
Time Frame
Change from baseline to 3 months
Title
self-rated Patients' Global Clinical Impression of Change Score
Description
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).
Time Frame
End of Treatment (8 weeks after baseline)
Title
self-rated Patients' Global Clinical Impression of Change Score
Time Frame
3 months
Title
Beck Depression Inventory (BDI)
Description
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.
Time Frame
Change from baseline to End of treatment (8 weeks after baseline)
Title
Beck Depression Inventory (BDI)
Time Frame
Change from baseline to 3 months
Title
Symptom Checklist 90 Revised (SCL-90-R)
Description
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.
Time Frame
Change from baseline to 3 Months
Title
Tender Point Score
Description
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.
Time Frame
Change from baseline to End of treatment (8 weeks after baseline)
Title
Tender Point Score
Time Frame
Change from baseline to 3 months
Title
Tender Point Count
Description
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.
Time Frame
Change from baseline to End of treatment (8 weeks after baseline)
Title
Pressure Pain Threshold
Description
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.
Time Frame
Change from baseline to End of Treatment (8 weeks after baseline)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin B Weigl, MD, MPH
Organizational Affiliation
Department of Orthopedics, Physical Medicine and Rehabilitation, University Hospital Munich, Ludwig Maximilians University Munich
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andreas Winkelmann, MD
Organizational Affiliation
Department of Orthopedics, Physical Medicine and Rehabilitation, University Hospital Munich, Ludwig Maximilians University Munich
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Randomized Controlled Trial to Evaluate the Effectiveness of Electromyography (EMG)-Biofeedback in Patients With Fibromyalgia
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