<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/NCT03782181</url>
  </required_header>
  <id_info>
    <org_study_id>IB 2586/15 PI</org_study_id>
    <nct_id>NCT03782181</nct_id>
  </id_info>
  <brief_title>Use of Whole Body Vibration in Patients With Fibromyalgia</brief_title>
  <official_title>Randomized Controlled Trial of a Therapeutic Intervention Consisting of the Use of Whole Body Vibration in Patients With Fibromyalgia.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of the Balearic Islands</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of the Balearic Islands</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the efficacy of a 3-month program consisted of the&#xD;
      use of whole body vibration (WBV) in patients with fibromyalgia in order to determine whether&#xD;
      this intervention would be effective to short and medium-term improvement of symptoms in&#xD;
      these patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a single blind randomized controlled trial. Forty patients of FM group were assigned&#xD;
      randomly to 2 study groups: 20 patients will be part of the experimental group (EG) that will&#xD;
      perform a neuromuscular treatment using the vertical whole body vibration platform and&#xD;
      another 20 will constitute the control group (CG). All these subjects will sign the&#xD;
      corresponding informed consent for their participation in the study, according to the ethical&#xD;
      criteria established in the Helsinki Declaration. The study took place between January and&#xD;
      Juny 2019. Two groups of variables were analyzed in the present study three times: before,&#xD;
      after and follow-up after three months of the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Actual">June 28, 2019</completion_date>
  <primary_completion_date type="Actual">March 25, 2019</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>
    <intervention_model_description>In this clinical,two groups of participants receive different interventions. One group receives a training with a whole body vibration plattform and the other is the control group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>In this clinical trial design strategy, the participants and the investigator do not know which participants have been assigned which interventions so there is a double-blind masking.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pressure Pain Thresholds</measure>
    <time_frame>20 minutes</time_frame>
    <description>Pressure stimuli were applied on two bilateral body locations: epicondyles and index finger. The pressure pain threshold was defined as the pressure value considered as painful by the participant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vibration Thresholds</measure>
    <time_frame>20 minutes</time_frame>
    <description>Vibration thresholds at the great toes and at the index fingers were quantified bilaterally using a Vibratron II (Physitemp, Clifton, USA). Using a two-alternative forced-choice procedure, subjects identified which of two rods was vibrating. Vibration values displayed on the control unit are vibration units (the amplitude of vibration, proportional to the square of applied voltage). Vibration threshold for the index finger in the normal population between 18 and 65 years of age is 0.7 vibration units with a standard deviation of 0.4 vibration units. The vibration threshold for the great toe in a similar population is 1.2 vibration units with a standard deviation of 0.5 vibration units. There is an increase in threshold scores and in variance as a function of age. There is an increase in threshold scores and variance depending on age. When the vibratory threshold is lower, it indicates the patient's greater ability to detect vibratory stimuli.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Berg Scale</measure>
    <time_frame>30 minutes</time_frame>
    <description>This is a functional balance assessment tool, consisting of 14 functional tasks with values ranging from 0 (cannot perform) to 4 (normal performance). The general scores range from 0 (severely impaired balance) to 56 (excellent balance). The Berg scale has been previously used in patients with fibromyalgia to assess balance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Six-minute Walking Test (6MWT)</measure>
    <time_frame>6 minutes</time_frame>
    <description>The 6MWT is a functional test in which the patient walks what he can during 6 minutes, analyzing the total distance walked.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dynamometer</measure>
    <time_frame>5 minutes</time_frame>
    <description>A back muscle dynamometer was used to measure isometric back muscle strength.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Analysis of the Romberg's Balance Test With the CvMob Software</measure>
    <time_frame>1 minute</time_frame>
    <description>The CvMob is an Open Source tool for the movement analysis. The software is capable to analyse the trajectories and to determinate the kinematic variables from a movie, that can be done with a simple camera. The tool includes the Movement Elements Decomposition Method (MED).In the present study, we analyzed the oscillatory body movements during the test performance. These ocillatory movements should be minimal with good balance.The patients were asked to remain in orthostatic position with feet parallel at shoulder height, arms extended along the body and eyes closed for 1 minute. A body marker is placed on the patient's head. A camera placed on the ceiling records the movements. Subsequently, the software analyzes and decomposes the movement that the patient has described in the anteroposterior and mediolateral axis. Higher values represent a worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gait Task</measure>
    <time_frame>5 minutes</time_frame>
    <description>Subjects were instructed to walk on a 4 meters carpet at their normal walking step, with shocks and with flexed arms positioned on the abdomen. Optical markers were attached at the following three body positions: area between the lateral condyle of the femur and the fibular head, great trochanter and lateral malleolus. Subject's motion was digitally recorded with a video camera at 210 frames per second (CasioExilimEX-FS10). The camera was positioned at a distance of 4 meters from the carpet to visualize changes in position, velocity and anatomical points along the x-axis. It was calculated the stride length by an open- source software for computer vision analysis of human movement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fibromyalgia Impact Questionnaire (FIQ)</measure>
    <time_frame>5 minutes</time_frame>
    <description>The Fibromyalgia Impact Questionnaire (FIQ) is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes. It has been designed to measure the components of health status that are believed to be most affected by fibromyalgia. The FIQ is a self administered instrument that takes approximately 5 minutes to complete. The directions are simple and the scoring is self-explanatory. The FIQ is scored in such a way that a higher score indicates a greater impact of the syndrome on the person. Each of the 10 items has a maximum possible score of 10. Thus the maximum possible score is 100. The average FM patient scores about 50, severely afflicted patients are usually 70 plus.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analogue Pain Scale (VAS)</measure>
    <time_frame>5 minutes</time_frame>
    <description>Each participant was asked to indicate their current level of pain using a 20 cm VAS that ranged from 0 (no pain) to 100 (highest level of pain).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Life Index (QLI)</measure>
    <time_frame>10 minutes</time_frame>
    <description>The Quality of Life Index (QLI) is a self-report questionnaire that measures perceived health-related quality of life. We used the total score of QLI. Its scale is scored by simply adding the score on each item. The range of scores is between 15 to 105, with a higher score or number being indicative of a higher quality of life. An average total rating for a healthy person is usually around 90, whereas a low quality of life measures around 15.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Fibromyalgia</condition>
  <arm_group>
    <arm_group_label>Whole body vibration plat</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>An arm type in which a group of patients with fibromyalgia receives an intervention based on the use of a whole body vibration platform, considered to be effective by clinical evidence.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention arm</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Whole body vibration platform</intervention_name>
    <description>A neuromuscular treatment using a rotational whole body vibration platform.</description>
    <arm_group_label>Whole body vibration plat</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with FM were included in the study if they fulfilled the 1990 classification&#xD;
             criteria of the American College of Rheumatology for fibromyalgia.&#xD;
&#xD;
          -  Pain-free volunteers were included if they did not present pain symptoms or some type&#xD;
             of treatment in any part of the body during the previous 12 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants were excluded from the study if they had not signed the informed consent&#xD;
             or if they reported any other musculoskeletal disorder rather than patients with FM,&#xD;
             any neurological disorder or had previous spinal fusion surgery or spinal cord&#xD;
             stimulation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>José A Mingorance, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Balearic Islands University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Balearic Islands</name>
      <address>
        <city>Palma de Mallorca</city>
        <state>Balearic Islands</state>
        <zip>07122</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <results_reference>
    <citation>Adsuar JC, Del Pozo-Cruz B, Parraca JA, Olivares PR, Gusi N. Whole body vibration improves the single-leg stance static balance in women with fibromyalgia: a randomized controlled trial. J Sports Med Phys Fitness. 2012 Feb;52(1):85-91.</citation>
    <PMID>22327091</PMID>
  </results_reference>
  <results_reference>
    <citation>Sanudo B, de Hoyo M, Carrasco L, Rodriguez-Blanco C, Oliva-Pascual-Vaca A, McVeigh JG. Effect of whole-body vibration exercise on balance in women with fibromyalgia syndrome: a randomized controlled trial. J Altern Complement Med. 2012 Feb;18(2):158-64. doi: 10.1089/acm.2010.0881. Epub 2012 Feb 9.</citation>
    <PMID>22321155</PMID>
  </results_reference>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>December 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <results_first_submitted>October 11, 2019</results_first_submitted>
  <results_first_submitted_qc>January 16, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 29, 2020</results_first_posted>
  <last_update_submitted>January 29, 2020</last_update_submitted>
  <last_update_submitted_qc>January 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 28, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT03782181/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Whole Body Vibration Plat</title>
          <description>An arm type in which a group of patients with fibromyalgia receives an intervention based on the use of a whole body vibration platform, considered to be effective by clinical evidence.&#xD;
Whole body vibration platform: A neuromuscular treatment using a rotational whole body vibration platform.</description>
        </group>
        <group group_id="P2">
          <title>Control Group</title>
          <description>No intervention arm</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The analysis population is the same from the assignment in participant flow.</population>
      <group_list>
        <group group_id="B1">
          <title>Patients Perform Whole Body Vibration Plat</title>
          <description>An arm type in which a group of patients with fibromyalgia receives an intervention based on the use of a whole body vibration platform, considered to be effective by clinical evidence.&#xD;
Whole body vibration platform: A neuromuscular treatment using a rotational whole body vibration platform.</description>
        </group>
        <group group_id="B2">
          <title>Control Group</title>
          <description>No intervention arm</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <description>Sex: female or male</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67" spread="7.46"/>
                    <measurement group_id="B2" value="65" spread="5.82"/>
                    <measurement group_id="B3" value="66" spread="6.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pressure Pain Thresholds</title>
        <description>Pressure stimuli were applied on two bilateral body locations: epicondyles and index finger. The pressure pain threshold was defined as the pressure value considered as painful by the participant.</description>
        <time_frame>20 minutes</time_frame>
        <population>Patients diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology (n=40).</population>
        <group_list>
          <group group_id="O1">
            <title>Whole Body Vibration Plat</title>
            <description>An arm type in which a group of patients with fibromyalgia receives an intervention based on the use of a whole body vibration platform, considered to be effective by clinical evidence.&#xD;
Whole body vibration platform: A neuromuscular treatment using a rotational whole body vibration platform, on January 18, 2017</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>No intervention arm</description>
          </group>
        </group_list>
        <measure>
          <title>Pressure Pain Thresholds</title>
          <description>Pressure stimuli were applied on two bilateral body locations: epicondyles and index finger. The pressure pain threshold was defined as the pressure value considered as painful by the participant.</description>
          <population>Patients diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology (n=40).</population>
          <units>Newton/centimeter² (N/cm²)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.8" spread="9.7"/>
                    <measurement group_id="O2" value="22.1" spread="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Vibration Thresholds</title>
        <description>Vibration thresholds at the great toes and at the index fingers were quantified bilaterally using a Vibratron II (Physitemp, Clifton, USA). Using a two-alternative forced-choice procedure, subjects identified which of two rods was vibrating. Vibration values displayed on the control unit are vibration units (the amplitude of vibration, proportional to the square of applied voltage). Vibration threshold for the index finger in the normal population between 18 and 65 years of age is 0.7 vibration units with a standard deviation of 0.4 vibration units. The vibration threshold for the great toe in a similar population is 1.2 vibration units with a standard deviation of 0.5 vibration units. There is an increase in threshold scores and in variance as a function of age. There is an increase in threshold scores and variance depending on age. When the vibratory threshold is lower, it indicates the patient's greater ability to detect vibratory stimuli.</description>
        <time_frame>20 minutes</time_frame>
        <population>Patients diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology (n=40).</population>
        <group_list>
          <group group_id="O1">
            <title>Whole Body Vibration Plat</title>
            <description>An arm type in which a group of patients with fibromyalgia receives an intervention based on the use of a whole body vibration platform, considered to be effective by clinical evidence.&#xD;
Whole body vibration platform: A neuromuscular treatment using a rotational whole body vibration platform.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>No intervention arm</description>
          </group>
        </group_list>
        <measure>
          <title>Vibration Thresholds</title>
          <description>Vibration thresholds at the great toes and at the index fingers were quantified bilaterally using a Vibratron II (Physitemp, Clifton, USA). Using a two-alternative forced-choice procedure, subjects identified which of two rods was vibrating. Vibration values displayed on the control unit are vibration units (the amplitude of vibration, proportional to the square of applied voltage). Vibration threshold for the index finger in the normal population between 18 and 65 years of age is 0.7 vibration units with a standard deviation of 0.4 vibration units. The vibration threshold for the great toe in a similar population is 1.2 vibration units with a standard deviation of 0.5 vibration units. There is an increase in threshold scores and in variance as a function of age. There is an increase in threshold scores and variance depending on age. When the vibratory threshold is lower, it indicates the patient's greater ability to detect vibratory stimuli.</description>
          <population>Patients diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology (n=40).</population>
          <units>Hertz</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" spread="0.7"/>
                    <measurement group_id="O2" value="3.5" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Berg Scale</title>
        <description>This is a functional balance assessment tool, consisting of 14 functional tasks with values ranging from 0 (cannot perform) to 4 (normal performance). The general scores range from 0 (severely impaired balance) to 56 (excellent balance). The Berg scale has been previously used in patients with fibromyalgia to assess balance.</description>
        <time_frame>30 minutes</time_frame>
        <population>Patients diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology (n=40).</population>
        <group_list>
          <group group_id="O1">
            <title>Whole Body Vibration Plat</title>
            <description>An arm type in which a group of patients with fibromyalgia receives an intervention based on the use of a whole body vibration platform, considered to be effective by clinical evidence.&#xD;
Whole body vibration platform: A neuromuscular treatment using a rotational whole body vibration platform, on January 18, 2017</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>No intervention arm</description>
          </group>
        </group_list>
        <measure>
          <title>Berg Scale</title>
          <description>This is a functional balance assessment tool, consisting of 14 functional tasks with values ranging from 0 (cannot perform) to 4 (normal performance). The general scores range from 0 (severely impaired balance) to 56 (excellent balance). The Berg scale has been previously used in patients with fibromyalgia to assess balance.</description>
          <population>Patients diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology (n=40).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.1" spread="4.8"/>
                    <measurement group_id="O2" value="28.4" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Six-minute Walking Test (6MWT)</title>
        <description>The 6MWT is a functional test in which the patient walks what he can during 6 minutes, analyzing the total distance walked.</description>
        <time_frame>6 minutes</time_frame>
        <population>Patients diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology (n=40).</population>
        <group_list>
          <group group_id="O1">
            <title>Whole Body Vibration Plat</title>
            <description>An arm type in which a group of patients with fibromyalgia receives an intervention based on the use of a whole body vibration platform, considered to be effective by clinical evidence.&#xD;
Whole body vibration platform: A neuromuscular treatment using a rotational whole body vibration platform, on January 18, 2017</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>No intervention arm</description>
          </group>
        </group_list>
        <measure>
          <title>Six-minute Walking Test (6MWT)</title>
          <description>The 6MWT is a functional test in which the patient walks what he can during 6 minutes, analyzing the total distance walked.</description>
          <population>Patients diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology (n=40).</population>
          <units>Metres</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="415" spread="26.1"/>
                    <measurement group_id="O2" value="387" spread="42.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Dynamometer</title>
        <description>A back muscle dynamometer was used to measure isometric back muscle strength.</description>
        <time_frame>5 minutes</time_frame>
        <population>Patients diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology (n=40).</population>
        <group_list>
          <group group_id="O1">
            <title>Whole Body Vibration Plat</title>
            <description>An arm type in which a group of patients with fibromyalgia receives an intervention based on the use of a whole body vibration platform, considered to be effective by clinical evidence.&#xD;
Whole body vibration platform: A neuromuscular treatment using a rotational whole body vibration platform, on January 18, 2017</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>No intervention arm</description>
          </group>
        </group_list>
        <measure>
          <title>Dynamometer</title>
          <description>A back muscle dynamometer was used to measure isometric back muscle strength.</description>
          <population>Patients diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology (n=40).</population>
          <units>Newtons.</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.8" spread="5.9"/>
                    <measurement group_id="O2" value="32.8" spread="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Analysis of the Romberg's Balance Test With the CvMob Software</title>
        <description>The CvMob is an Open Source tool for the movement analysis. The software is capable to analyse the trajectories and to determinate the kinematic variables from a movie, that can be done with a simple camera. The tool includes the Movement Elements Decomposition Method (MED).In the present study, we analyzed the oscillatory body movements during the test performance. These ocillatory movements should be minimal with good balance.The patients were asked to remain in orthostatic position with feet parallel at shoulder height, arms extended along the body and eyes closed for 1 minute. A body marker is placed on the patient's head. A camera placed on the ceiling records the movements. Subsequently, the software analyzes and decomposes the movement that the patient has described in the anteroposterior and mediolateral axis. Higher values represent a worse outcome.</description>
        <time_frame>1 minute</time_frame>
        <population>Patients diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology (n=40).</population>
        <group_list>
          <group group_id="O1">
            <title>Whole Body Vibration Plat</title>
            <description>An arm type in which a group of patients with fibromyalgia receives an intervention based on the use of a whole body vibration platform, considered to be effective by clinical evidence.&#xD;
Whole body vibration platform: A neuromuscular treatment using a rotational whole body vibration platform, on January 18, 2017</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>No intervention arm</description>
          </group>
        </group_list>
        <measure>
          <title>Analysis of the Romberg's Balance Test With the CvMob Software</title>
          <description>The CvMob is an Open Source tool for the movement analysis. The software is capable to analyse the trajectories and to determinate the kinematic variables from a movie, that can be done with a simple camera. The tool includes the Movement Elements Decomposition Method (MED).In the present study, we analyzed the oscillatory body movements during the test performance. These ocillatory movements should be minimal with good balance.The patients were asked to remain in orthostatic position with feet parallel at shoulder height, arms extended along the body and eyes closed for 1 minute. A body marker is placed on the patient's head. A camera placed on the ceiling records the movements. Subsequently, the software analyzes and decomposes the movement that the patient has described in the anteroposterior and mediolateral axis. Higher values represent a worse outcome.</description>
          <population>Patients diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology (n=40).</population>
          <units>Centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.004" spread="0.002"/>
                    <measurement group_id="O2" value="0.12" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Gait Task</title>
        <description>Subjects were instructed to walk on a 4 meters carpet at their normal walking step, with shocks and with flexed arms positioned on the abdomen. Optical markers were attached at the following three body positions: area between the lateral condyle of the femur and the fibular head, great trochanter and lateral malleolus. Subject's motion was digitally recorded with a video camera at 210 frames per second (CasioExilimEX-FS10). The camera was positioned at a distance of 4 meters from the carpet to visualize changes in position, velocity and anatomical points along the x-axis. It was calculated the stride length by an open- source software for computer vision analysis of human movement.</description>
        <time_frame>5 minutes</time_frame>
        <population>Patients diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology (n=40).</population>
        <group_list>
          <group group_id="O1">
            <title>Whole Body Vibration Plat</title>
            <description>An arm type in which a group of patients with fibromyalgia receives an intervention based on the use of a whole body vibration platform, considered to be effective by clinical evidence.&#xD;
Whole body vibration platform: A neuromuscular treatment using a rotational whole body vibration platform, on January 18, 2017</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>No intervention arm</description>
          </group>
        </group_list>
        <measure>
          <title>Gait Task</title>
          <description>Subjects were instructed to walk on a 4 meters carpet at their normal walking step, with shocks and with flexed arms positioned on the abdomen. Optical markers were attached at the following three body positions: area between the lateral condyle of the femur and the fibular head, great trochanter and lateral malleolus. Subject's motion was digitally recorded with a video camera at 210 frames per second (CasioExilimEX-FS10). The camera was positioned at a distance of 4 meters from the carpet to visualize changes in position, velocity and anatomical points along the x-axis. It was calculated the stride length by an open- source software for computer vision analysis of human movement.</description>
          <population>Patients diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology (n=40).</population>
          <units>Meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.2"/>
                    <measurement group_id="O2" value="1.1" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Fibromyalgia Impact Questionnaire (FIQ)</title>
        <description>The Fibromyalgia Impact Questionnaire (FIQ) is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes. It has been designed to measure the components of health status that are believed to be most affected by fibromyalgia. The FIQ is a self administered instrument that takes approximately 5 minutes to complete. The directions are simple and the scoring is self-explanatory. The FIQ is scored in such a way that a higher score indicates a greater impact of the syndrome on the person. Each of the 10 items has a maximum possible score of 10. Thus the maximum possible score is 100. The average FM patient scores about 50, severely afflicted patients are usually 70 plus.</description>
        <time_frame>5 minutes</time_frame>
        <population>Patients diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology (n=40).</population>
        <group_list>
          <group group_id="O1">
            <title>Whole Body Vibration Plat</title>
            <description>An arm type in which a group of patients with fibromyalgia receives an intervention based on the use of a whole body vibration platform, considered to be effective by clinical evidence.&#xD;
Whole body vibration platform: A neuromuscular treatment using a rotational whole body vibration platform, on January 18, 2017</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>No intervention arm</description>
          </group>
        </group_list>
        <measure>
          <title>Fibromyalgia Impact Questionnaire (FIQ)</title>
          <description>The Fibromyalgia Impact Questionnaire (FIQ) is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes. It has been designed to measure the components of health status that are believed to be most affected by fibromyalgia. The FIQ is a self administered instrument that takes approximately 5 minutes to complete. The directions are simple and the scoring is self-explanatory. The FIQ is scored in such a way that a higher score indicates a greater impact of the syndrome on the person. Each of the 10 items has a maximum possible score of 10. Thus the maximum possible score is 100. The average FM patient scores about 50, severely afflicted patients are usually 70 plus.</description>
          <population>Patients diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology (n=40).</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.3" spread="15.2"/>
                    <measurement group_id="O2" value="81.7" spread="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Visual Analogue Pain Scale (VAS)</title>
        <description>Each participant was asked to indicate their current level of pain using a 20 cm VAS that ranged from 0 (no pain) to 100 (highest level of pain).</description>
        <time_frame>5 minutes</time_frame>
        <population>Patients diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology (n=40).</population>
        <group_list>
          <group group_id="O1">
            <title>Whole Body Vibration Plat</title>
            <description>An arm type in which a group of patients with fibromyalgia receives an intervention based on the use of a whole body vibration platform, considered to be effective by clinical evidence.&#xD;
Whole body vibration platform: A neuromuscular treatment using a rotational whole body vibration platform, on January 18, 2017</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>No intervention arm</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analogue Pain Scale (VAS)</title>
          <description>Each participant was asked to indicate their current level of pain using a 20 cm VAS that ranged from 0 (no pain) to 100 (highest level of pain).</description>
          <population>Patients diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology (n=40).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.2" spread="7.9"/>
                    <measurement group_id="O2" value="78" spread="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Quality of Life Index (QLI)</title>
        <description>The Quality of Life Index (QLI) is a self-report questionnaire that measures perceived health-related quality of life. We used the total score of QLI. Its scale is scored by simply adding the score on each item. The range of scores is between 15 to 105, with a higher score or number being indicative of a higher quality of life. An average total rating for a healthy person is usually around 90, whereas a low quality of life measures around 15.</description>
        <time_frame>10 minutes</time_frame>
        <population>Patients diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology (n=40).</population>
        <group_list>
          <group group_id="O1">
            <title>Whole Body Vibration Plat</title>
            <description>An arm type in which a group of patients with fibromyalgia receives an intervention based on the use of a whole body vibration platform, considered to be effective by clinical evidence.&#xD;
Whole body vibration platform: A neuromuscular treatment using a rotational whole body vibration platform, on January 18, 2017</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>No intervention arm</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life Index (QLI)</title>
          <description>The Quality of Life Index (QLI) is a self-report questionnaire that measures perceived health-related quality of life. We used the total score of QLI. Its scale is scored by simply adding the score on each item. The range of scores is between 15 to 105, with a higher score or number being indicative of a higher quality of life. An average total rating for a healthy person is usually around 90, whereas a low quality of life measures around 15.</description>
          <population>Patients diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology (n=40).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" spread="0.9"/>
                    <measurement group_id="O2" value="3.8" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Whole Body Vibration Plat</title>
          <description>An arm type in which a group of patients with fibromyalgia receives an intervention based on the use of a whole body vibration platform, considered to be effective by clinical evidence.&#xD;
Whole body vibration platform: A neuromuscular treatment using a rotational whole body vibration platform.</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>No intervention arm</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>José Mingorance</name_or_title>
      <organization>University of Balearic Islands</organization>
      <phone>+34677602465</phone>
      <email>josea.mingorance@uib.es</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03782181
org study id: IB 2586/15 PI
nct id: NCT03782181
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to evaluate the efficacy of a 3-month program consisted of the
      use of whole body vibration (WBV) in patients with fibromyalgia in order to determine whether
      this intervention would be effective to short and medium-term improvement of symptoms in
      these patients.
This was a single blind randomized controlled trial. Forty patients of FM group were assigned
      randomly to 2 study groups: 20 patients will be part of the experimental group (EG) that will
      perform a neuromuscular treatment using the vertical whole body vibration platform and
      another 20 will constitute the control group (CG). All these subjects will sign the
      corresponding informed consent for their participation in the study, according to the ethical
      criteria established in the Helsinki Declaration. The study took place between January and
      Juny 2019. Two groups of variables were analyzed in the present study three times: before,
      after and follow-up after three months of the intervention.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: In this clinical,two groups of participants receive different interventions. One group receives a training with a whole body vibration plattform and the other is the control group.
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: In this clinical trial design strategy, the participants and the investigator do not know which participants have been assigned which interventions so there is a double-blind masking.
measure: Pressure Pain Thresholds
time frame: 20 minutes
description: Pressure stimuli were applied on two bilateral body locations: epicondyles and index finger. The pressure pain threshold was defined as the pressure value considered as painful by the participant.
measure: Vibration Thresholds
time frame: 20 minutes
description: Vibration thresholds at the great toes and at the index fingers were quantified bilaterally using a Vibratron II (Physitemp, Clifton, USA). Using a two-alternative forced-choice procedure, subjects identified which of two rods was vibrating. Vibration values displayed on the control unit are vibration units (the amplitude of vibration, proportional to the square of applied voltage). Vibration threshold for the index finger in the normal population between 18 and 65 years of age is 0.7 vibration units with a standard deviation of 0.4 vibration units. The vibration threshold for the great toe in a similar population is 1.2 vibration units with a standard deviation of 0.5 vibration units. There is an increase in threshold scores and in variance as a function of age. There is an increase in threshold scores and variance depending on age. When the vibratory threshold is lower, it indicates the patient's greater ability to detect vibratory stimuli.
measure: Berg Scale
time frame: 30 minutes
description: This is a functional balance assessment tool, consisting of 14 functional tasks with values ranging from 0 (cannot perform) to 4 (normal performance). The general scores range from 0 (severely impaired balance) to 56 (excellent balance). The Berg scale has been previously used in patients with fibromyalgia to assess balance.
measure: Six-minute Walking Test (6MWT)
time frame: 6 minutes
description: The 6MWT is a functional test in which the patient walks what he can during 6 minutes, analyzing the total distance walked.
measure: Dynamometer
time frame: 5 minutes
description: A back muscle dynamometer was used to measure isometric back muscle strength.
measure: Analysis of the Romberg's Balance Test With the CvMob Software
time frame: 1 minute
description: The CvMob is an Open Source tool for the movement analysis. The software is capable to analyse the trajectories and to determinate the kinematic variables from a movie, that can be done with a simple camera. The tool includes the Movement Elements Decomposition Method (MED).In the present study, we analyzed the oscillatory body movements during the test performance. These ocillatory movements should be minimal with good balance.The patients were asked to remain in orthostatic position with feet parallel at shoulder height, arms extended along the body and eyes closed for 1 minute. A body marker is placed on the patient's head. A camera placed on the ceiling records the movements. Subsequently, the software analyzes and decomposes the movement that the patient has described in the anteroposterior and mediolateral axis. Higher values represent a worse outcome.
measure: Gait Task
time frame: 5 minutes
description: Subjects were instructed to walk on a 4 meters carpet at their normal walking step, with shocks and with flexed arms positioned on the abdomen. Optical markers were attached at the following three body positions: area between the lateral condyle of the femur and the fibular head, great trochanter and lateral malleolus. Subject's motion was digitally recorded with a video camera at 210 frames per second (CasioExilimEX-FS10). The camera was positioned at a distance of 4 meters from the carpet to visualize changes in position, velocity and anatomical points along the x-axis. It was calculated the stride length by an open- source software for computer vision analysis of human movement.
measure: Fibromyalgia Impact Questionnaire (FIQ)
time frame: 5 minutes
description: The Fibromyalgia Impact Questionnaire (FIQ) is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes. It has been designed to measure the components of health status that are believed to be most affected by fibromyalgia. The FIQ is a self administered instrument that takes approximately 5 minutes to complete. The directions are simple and the scoring is self-explanatory. The FIQ is scored in such a way that a higher score indicates a greater impact of the syndrome on the person. Each of the 10 items has a maximum possible score of 10. Thus the maximum possible score is 100. The average FM patient scores about 50, severely afflicted patients are usually 70 plus.
measure: Visual Analogue Pain Scale (VAS)
time frame: 5 minutes
description: Each participant was asked to indicate their current level of pain using a 20 cm VAS that ranged from 0 (no pain) to 100 (highest level of pain).
measure: Quality of Life Index (QLI)
time frame: 10 minutes
description: The Quality of Life Index (QLI) is a self-report questionnaire that measures perceived health-related quality of life. We used the total score of QLI. Its scale is scored by simply adding the score on each item. The range of scores is between 15 to 105, with a higher score or number being indicative of a higher quality of life. An average total rating for a healthy person is usually around 90, whereas a low quality of life measures around 15.
arm group label: Whole body vibration plat
arm group type: Active Comparator
description: An arm type in which a group of patients with fibromyalgia receives an intervention based on the use of a whole body vibration platform, considered to be effective by clinical evidence.
arm group label: Control group
arm group type: No Intervention
description: No intervention arm
intervention type: Device
intervention name: Whole body vibration platform
description: A neuromuscular treatment using a rotational whole body vibration platform.
arm group label: Whole body vibration plat
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: José A Mingorance, PhD
role: Principal Investigator
affiliation: Balearic Islands University
facility: 
country: Spain
citation: Adsuar JC, Del Pozo-Cruz B, Parraca JA, Olivares PR, Gusi N. Whole body vibration improves the single-leg stance static balance in women with fibromyalgia: a randomized controlled trial. J Sports Med Phys Fitness. 2012 Feb;52(1):85-91.
PMID: 22327091
citation: Sanudo B, de Hoyo M, Carrasco L, Rodriguez-Blanco C, Oliva-Pascual-Vaca A, McVeigh JG. Effect of whole-body vibration exercise on balance in women with fibromyalgia syndrome: a randomized controlled trial. J Altern Complement Med. 2012 Feb;18(2):158-64. doi: 10.1089/acm.2010.0881. Epub 2012 Feb 9.
PMID: 22321155
responsible party type: Sponsor
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 