<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02186756</url>
  </required_header>
  <id_info>
    <org_study_id>PM-FMBFBack</org_study_id>
    <nct_id>NCT02186756</nct_id>
  </id_info>
  <brief_title>A Randomized Controlled Trial to Evaluate the Effectiveness of Electromyography (EMG)-Biofeedback in Patients With Fibromyalgia</brief_title>
  <official_title>Biofeedback in Patients With Fibromyalgia - a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ludwig-Maximilians - University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ludwig-Maximilians - University of Munich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether EMG-Biofeedback is effective in the&#xD;
      treatment of Fibromyalgia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this randomized controlled trial is to evaluate the effectiveness of&#xD;
      EMG-biofeedback in patients with Fibromyalgia. The assessors are blinded to the group&#xD;
      assignment. There are three time points of assessment: before intervention, at the end of&#xD;
      treatment (T1) and 3-months follow-up (T2). Patients are recruited from the waiting list of&#xD;
      the Fibromyalgia day hospital program at the University Hospital Munich fulfilling the&#xD;
      inclusion criteria. The intervention group is treated with 14 sessions of EMG-biofeedback&#xD;
      during eight weeks in addition to usual care. The control group receives usual care only. The&#xD;
      main specific aim is to assess the change in fibromyalgia specific health status.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2005</start_date>
  <completion_date type="Actual">July 2006</completion_date>
  <primary_completion_date type="Actual">July 2006</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fibromyalgia Impact Questionnaire (FIQ)</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fibromyalgia Impact Questionnaire (FIQ)</measure>
    <time_frame>Change from baseline to End of Treatment (8 weeks after baseline)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short-Form 36 (SF-36)</measure>
    <time_frame>Change from baseline to End of treatment (8 weeks after baseline)</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short-Form 36 (SF-36)</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>self-rated Patients' Global Clinical Impression of Change Score</measure>
    <time_frame>End of Treatment (8 weeks after baseline)</time_frame>
    <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 &quot;very much worse&quot; (score 1) to &quot;very much better&quot; (score 6).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>self-rated Patients' Global Clinical Impression of Change Score</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory (BDI)</measure>
    <time_frame>Change from baseline to End of treatment (8 weeks after baseline)</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory (BDI)</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom Checklist 90 Revised (SCL-90-R)</measure>
    <time_frame>Change from baseline to 3 Months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tender Point Score</measure>
    <time_frame>Change from baseline to End of treatment (8 weeks after baseline)</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tender Point Score</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tender Point Count</measure>
    <time_frame>Change from baseline to End of treatment (8 weeks after baseline)</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pressure Pain Threshold</measure>
    <time_frame>Change from baseline to End of Treatment (8 weeks after baseline)</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Fibromyalgia</condition>
  <arm_group>
    <arm_group_label>EMG-Biofeedback and Usual Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EMG-Biofeedback and Usual care</intervention_name>
    <description>Please refer to arm description</description>
    <arm_group_label>EMG-Biofeedback and Usual Care</arm_group_label>
    <other_name>Schuhfried Biofeedback apparatus</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  fibromyalgia according to the American Congress of Rheumatology (ACR)-criteria and the&#xD;
             criteria.&#xD;
&#xD;
          -  female gender&#xD;
&#xD;
          -  age between 18 and 65&#xD;
&#xD;
          -  cognitive ability and sufficient German language skills to fill in health status&#xD;
             questionnaires&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  major medical disorders, i.e. cancer, chronic heart failure New York Heart Association&#xD;
             (NYHA) IV or asthma requiring cortisone medication&#xD;
&#xD;
          -  suffering from psychosis or major affective disorders&#xD;
&#xD;
          -  substance abuse&#xD;
&#xD;
          -  co-medication with opiates or benzodiazepine&#xD;
&#xD;
          -  transmeridian flight in the last weeks&#xD;
&#xD;
          -  shift-work&#xD;
&#xD;
          -  gravity&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin B Weigl, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Orthopedics, Physical Medicine and Rehabilitation, University Hospital Munich, Ludwig Maximilians University Munich</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Andreas Winkelmann, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Orthopedics, Physical Medicine and Rehabilitation, University Hospital Munich, Ludwig Maximilians University Munich</affiliation>
  </overall_official>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>July 8, 2014</last_update_submitted>
  <last_update_submitted_qc>July 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ludwig-Maximilians - University of Munich</investigator_affiliation>
    <investigator_full_name>PD Dr. Martin Weigl, MPH</investigator_full_name>
    <investigator_title>PD, MD, MPH (Harvard University)</investigator_title>
  </responsible_party>
  <keyword>Fibromyalgia</keyword>
  <keyword>Complementary Therapies</keyword>
  <keyword>Biofeedback</keyword>
  <keyword>Randomized controlled trial</keyword>
  <keyword>Relaxation Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02186756
org study id: PM-FMBFBack
nct id: NCT02186756
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether EMG-Biofeedback is effective in the
      treatment of Fibromyalgia.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Fibromyalgia Impact Questionnaire (FIQ)
time frame: Change from baseline to 3 months
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.
measure: Fibromyalgia Impact Questionnaire (FIQ)
time frame: Change from baseline to End of Treatment (8 weeks after baseline)
measure: Short-Form 36 (SF-36)
time frame: Change from baseline to End of treatment (8 weeks after baseline)
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.
measure: Short-Form 36 (SF-36)
time frame: Change from baseline to 3 months
measure: self-rated Patients' Global Clinical Impression of Change Score
time frame: End of Treatment (8 weeks after baseline)
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).
measure: self-rated Patients' Global Clinical Impression of Change Score
time frame: 3 months
measure: Beck Depression Inventory (BDI)
time frame: Change from baseline to End of treatment (8 weeks after baseline)
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.
measure: Beck Depression Inventory (BDI)
time frame: Change from baseline to 3 months
measure: Symptom Checklist 90 Revised (SCL-90-R)
time frame: Change from baseline to 3 Months
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.
measure: Tender Point Score
time frame: Change from baseline to End of treatment (8 weeks after baseline)
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.
measure: Tender Point Score
time frame: Change from baseline to 3 months
measure: Tender Point Count
time frame: Change from baseline to End of treatment (8 weeks after baseline)
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.
measure: Pressure Pain Threshold
time frame: Change from baseline to End of Treatment (8 weeks after baseline)
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.
arm group label: EMG-Biofeedback and Usual Care
arm group type: Experimental
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 group label: Usual care
arm group type: No Intervention
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: EMG-Biofeedback and Usual care
description: Please refer to arm description
arm group label: EMG-Biofeedback and Usual Care
other name: Schuhfried Biofeedback apparatus
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Martin B Weigl, MD, MPH
role: Principal Investigator
affiliation: Department of Orthopedics, Physical Medicine and Rehabilitation, University Hospital Munich, Ludwig Maximilians University Munich
last name: Andreas Winkelmann, MD
role: Principal Investigator
affiliation: Department of Orthopedics, Physical Medicine and Rehabilitation, University Hospital Munich, Ludwig Maximilians University Munich
responsible party type: Principal Investigator
investigator affiliation: Ludwig-Maximilians - University of Munich
investigator full name: PD Dr. Martin Weigl, MPH
investigator title: PD, MD, MPH (Harvard University)
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes