<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/NCT03227952</url>
  </required_header>
  <id_info>
    <org_study_id>MOT6932</org_study_id>
    <nct_id>NCT03227952</nct_id>
  </id_info>
  <brief_title>Sensory Stimulation in Fibromyalgia</brief_title>
  <official_title>Study of the Effectiveness of Vibrotactile Sensory Stimulation in Fibromyalgia Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jesus Pujol</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Neurovoxel SLP</source>
  <oversight_info>
    <has_dmc>No</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 purpose of this study is to investigate the effectiveness of low-intensity and prolonged&#xD;
      vibrotactile sensory stimulation on symptom relieve in fibromyalgia patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The trial will last up to 8 weeks for each subject and includes:&#xD;
&#xD;
      Three weeks treatment 1 (sham or actual) Two week washout Three weeks treatment 2 (sham or&#xD;
      actual) Vibrotactile sensory stimulation will consist on whole-body stimulation with&#xD;
      mechanical stimuli of pallesthetic type at high rate, low intensity and long daily duration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 4, 2017</start_date>
  <completion_date type="Actual">May 31, 2018</completion_date>
  <primary_completion_date type="Actual">May 31, 2018</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Parallel Assignment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>a sham device identical to the active device</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>101-point verbal rating scale (VRS)</measure>
    <time_frame>3 weeks</time_frame>
    <description>Change on fibromyalgia key symptoms rated using 101-point verbal rating scale (combining pain, fatigue and subjective cognitive problems).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Associated symptom improvement</measure>
    <time_frame>3 weeks</time_frame>
    <description>Change on fibromyalgia secondary symptoms (including sleep disturbance, anxiety, mood, activity limitation, treatment reduction and general health rating).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">77</enrollment>
  <condition>Fibromyalgia</condition>
  <arm_group>
    <arm_group_label>Active treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Vibrotactile sensory stimulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Identical device. No vibration</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vibrotactile stimulation</intervention_name>
    <description>Vibrotactile sensory stimulation will consist on whole-body stimulation with mechanical stimuli of pallesthetic type at high rate (20-90 Hz), low intensity and long daily duration (3h).</description>
    <arm_group_label>Active treatment</arm_group_label>
    <arm_group_label>Sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A diagnosis of fibromyalgia according to the American College of Rheumatology (ACR)&#xD;
             (Arthritis Rheum, 1990;33:160-172)&#xD;
&#xD;
          -  Clinical symptoms are not a consequence of other medical disorder (although the&#xD;
             presence of other disorders is not an exclusion criterion)&#xD;
&#xD;
          -  Diagnoses established by an expert on fibromyalgia.&#xD;
&#xD;
          -  Stable treatment of chronic use.&#xD;
&#xD;
          -  Subject demonstrates an understanding of the study and a willingness to participate as&#xD;
             evidenced by voluntary written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Generalized inflammatory articular or rheumatic disease.&#xD;
&#xD;
          -  Heavily exercise for 12 hours prior to fMRI assessment&#xD;
&#xD;
          -  Severe, non-stable medical, endocrinological or neurological disorder.&#xD;
&#xD;
          -  Psychotic disorder or drug abuse.&#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>Jesus Pujol, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital del Mar</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital del Mar</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>July 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>October 16, 2018</last_update_submitted>
  <last_update_submitted_qc>October 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Neurovoxel SLP</investigator_affiliation>
    <investigator_full_name>Jesus Pujol</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </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>
  <!-- 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/NCT03227952
org study id: MOT6932
nct id: NCT03227952
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate the effectiveness of low-intensity and prolonged
      vibrotactile sensory stimulation on symptom relieve in fibromyalgia patients.
The trial will last up to 8 weeks for each subject and includes:

      Three weeks treatment 1 (sham or actual) Two week washout Three weeks treatment 2 (sham or
      actual) Vibrotactile sensory stimulation will consist on whole-body stimulation with
      mechanical stimuli of pallesthetic type at high rate, low intensity and long daily duration.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: a sham device identical to the active device
measure: 101-point verbal rating scale (VRS)
time frame: 3 weeks
description: Change on fibromyalgia key symptoms rated using 101-point verbal rating scale (combining pain, fatigue and subjective cognitive problems).
measure: Associated symptom improvement
time frame: 3 weeks
description: Change on fibromyalgia secondary symptoms (including sleep disturbance, anxiety, mood, activity limitation, treatment reduction and general health rating).
arm group label: Active treatment
arm group type: Active Comparator
description: Vibrotactile sensory stimulation
arm group label: Sham
arm group type: Sham Comparator
description: Identical device. No vibration
intervention type: Device
intervention name: Vibrotactile stimulation
description: Vibrotactile sensory stimulation will consist on whole-body stimulation with mechanical stimuli of pallesthetic type at high rate (20-90 Hz), low intensity and long daily duration (3h).
arm group label: Active treatment
arm group label: Sham
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jesus Pujol, MD
role: Principal Investigator
affiliation: Hospital del Mar
facility: 
country: Spain
responsible party type: Sponsor-Investigator
investigator affiliation: Neurovoxel SLP
investigator full name: Jesus Pujol
investigator title: Principal Investigator
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
sharing ipd: No