<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/NCT04415866</url>
  </required_header>
  <id_info>
    <org_study_id>IRB202000992</org_study_id>
    <nct_id>NCT04415866</nct_id>
  </id_info>
  <brief_title>Generalized Hypersensitivity in Patients With Fibromyalgia Syndrome</brief_title>
  <official_title>Generalized Hypersensitivity in Patients With Fibromyalgia Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</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>
      Fibromyalgia (FM) is a chronic musculoskeletal pain disorder with unknown causes. Our&#xD;
      previous studies showed abnormal sensations of second pain (wind-up), indicating central&#xD;
      hypersensitivity as an important mechanism of FM. Triggering events have been implicated as&#xD;
      the cause of central hypersensitivity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Increasing evidence has shown that the hypersensitivity of FM is not limited to painful&#xD;
      stimuli but seems to extend to non-painful stimuli as well. These stimuli include smell,&#xD;
      taste, touch, light, and sound. This study will provide detailed QST examinations of FM&#xD;
      subjects and controls' responses to light using visually evoked potentials (VEP). In&#xD;
      addition, careful characterization of experimental pain responding across multiple sensory&#xD;
      modalities will be examined.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 28, 2020</start_date>
  <completion_date type="Anticipated">July 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Participants sensitivity to pressure, heat, and light will be modulated by an attention task.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Verbal Pain Ratings of Painful Heat and Pressure Stimuli using a Numerical Pain Scale from 0 - 100</measure>
    <time_frame>1 hour</time_frame>
    <description>FM and control subjects will provide verbal ratings of experimental pain stimuli. For this purpose a numerical ratings scale (0-100) will be used ranging from &quot;no sensation&quot; to the &quot;most intense sensation possible&quot;. All measures will be obtained in triplicates and the averages will be used for statistical comparisons.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Evoked Potentials (VEP) During Flicker</measure>
    <time_frame>1 hour</time_frame>
    <description>FM and control subject will focus on a light source while VEPs are obtained. EEG tracings will be evaluated by special software to detect VEP. For intensity ratings of the flicker stimulus a numerical ratings scale (0-100) will be used ranging from &quot;no sensation&quot; to the &quot;most intense sensation possible&quot;. All measures will be obtained in triplicates and the averages will be used for statistical comparisons.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response to 2011 Fibromyalgia Criteria Questionnaire</measure>
    <time_frame>0.5 hours</time_frame>
    <description>FM and control subjects will complete the 2011 FM Questionnaire. The answers of this questionnaire will be added to obtain the wide-spread pain index and the somatic symptom score. The scores will be combined to obtain the final score. Scores of &gt;12 fulfill the Criteria for Fibromyalgia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response to the Center for Epidemiological Studies (CES-D) Depression Questionnaire</measure>
    <time_frame>0.5 hours</time_frame>
    <description>FM and control subjects will complete the CES-D. The answers of this questionnaire will be combined to obtain a final score. Total scores of &gt;15 are consistent with the diagnosis of major depression.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Fibromyalgia</condition>
  <arm_group>
    <arm_group_label>Effects of PASAT on Sensory Testing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After baseline evaluation of light and pain sensitivity FM subjects and controls will undergo the PASAT task. This task consists of responding to a rapid presentation of numbers by ear phones. Subjects are asked to add each 2 consecutive numbers and provide a response each time the sum is equal to 13. This test will last several minutes and delivered at increasing speed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Paced Auditory Serial Addition task (PASAT)</intervention_name>
    <description>Single and double digits are presented at intervals between 2 and 3 seconds and the participant must add each new digit to the one immediately prior to it. The participants will be asked to indicate by electronic button press whether the sum of the addition is 13 or not. The duration of the PASAT will be two 12-min tasks.</description>
    <arm_group_label>Effects of PASAT on Sensory Testing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals diagnosed with FM will have pain of &gt; 3 months and meet the 1990 and 2011&#xD;
             Diagnostic Criteria for FM (ACR)&#xD;
&#xD;
          -  Healthy, pain-free age and sex matched controls without chronic pain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of chronic disease (e.g. cancer, cardiovascular disease, liver disease,&#xD;
             kidney disease, diabetes, etc.).&#xD;
&#xD;
          -  FM patients must be willing to discontinue or hold their FM related medications for a&#xD;
             minimum of one day prior to the visit.&#xD;
&#xD;
          -  Significant vision loss not corrected by eye wear&#xD;
&#xD;
          -  Family history of photosensitive epilepsy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roland Staud, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Melyssa Godfrey, BS</last_name>
    <phone>352-265-8901</phone>
    <email>painresearch@medicine.ufl.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Melyssa Godfrey</last_name>
      <phone>352-265-8901</phone>
      <email>Melyssa.Godfrey@medicine.ufl.edu</email>
    </contact>
    <investigator>
      <last_name>Roland Staud, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Geisser ME, Strader Donnell C, Petzke F, Gracely RH, Clauw DJ, Williams DA. Comorbid somatic symptoms and functional status in patients with fibromyalgia and chronic fatigue syndrome: sensory amplification as a common mechanism. Psychosomatics. 2008 May-Jun;49(3):235-42. doi: 10.1176/appi.psy.49.3.235.</citation>
    <PMID>18448779</PMID>
  </reference>
  <reference>
    <citation>Geisser ME, Glass JM, Rajcevska LD, Clauw DJ, Williams DA, Kileny PR, Gracely RH. A psychophysical study of auditory and pressure sensitivity in patients with fibromyalgia and healthy controls. J Pain. 2008 May;9(5):417-22. doi: 10.1016/j.jpain.2007.12.006. Epub 2008 Feb 15.</citation>
    <PMID>18280211</PMID>
  </reference>
  <reference>
    <citation>Frank MG, Fonken LK, Watkins LR, Maier SF. Microglia: Neuroimmune-sensors of stress. Semin Cell Dev Biol. 2019 Oct;94:176-185. doi: 10.1016/j.semcdb.2019.01.001. Epub 2019 Jan 9.</citation>
    <PMID>30638704</PMID>
  </reference>
  <reference>
    <citation>Geisser ME, Casey KL, Brucksch CB, Ribbens CM, Appleton BB, Crofford LJ. Perception of noxious and innocuous heat stimulation among healthy women and women with fibromyalgia: association with mood, somatic focus, and catastrophizing. Pain. 2003 Apr;102(3):243-250. doi: 10.1016/S0304-3959(02)00417-7.</citation>
    <PMID>12670665</PMID>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>February 17, 2023</last_update_submitted>
  <last_update_submitted_qc>February 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>central sensitization</keyword>
  <keyword>peripheral sensitization</keyword>
  <keyword>visual evoke potentials (VEP)</keyword>
  <keyword>quantitative sensory testing</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>
    <mesh_term>Hypersensitivity</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/NCT04415866
org study id: IRB202000992
nct id: NCT04415866
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Fibromyalgia (FM) is a chronic musculoskeletal pain disorder with unknown causes. Our
      previous studies showed abnormal sensations of second pain (wind-up), indicating central
      hypersensitivity as an important mechanism of FM. Triggering events have been implicated as
      the cause of central hypersensitivity.
Increasing evidence has shown that the hypersensitivity of FM is not limited to painful
      stimuli but seems to extend to non-painful stimuli as well. These stimuli include smell,
      taste, touch, light, and sound. This study will provide detailed QST examinations of FM
      subjects and controls' responses to light using visually evoked potentials (VEP). In
      addition, careful characterization of experimental pain responding across multiple sensory
      modalities will be examined.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Participants sensitivity to pressure, heat, and light will be modulated by an attention task.
primary purpose: Other
masking: None (Open Label)
measure: Verbal Pain Ratings of Painful Heat and Pressure Stimuli using a Numerical Pain Scale from 0 - 100
time frame: 1 hour
description: FM and control subjects will provide verbal ratings of experimental pain stimuli. For this purpose a numerical ratings scale (0-100) will be used ranging from "no sensation" to the "most intense sensation possible". All measures will be obtained in triplicates and the averages will be used for statistical comparisons.
measure: Visual Evoked Potentials (VEP) During Flicker
time frame: 1 hour
description: FM and control subject will focus on a light source while VEPs are obtained. EEG tracings will be evaluated by special software to detect VEP. For intensity ratings of the flicker stimulus a numerical ratings scale (0-100) will be used ranging from "no sensation" to the "most intense sensation possible". All measures will be obtained in triplicates and the averages will be used for statistical comparisons.
measure: Response to 2011 Fibromyalgia Criteria Questionnaire
time frame: 0.5 hours
description: FM and control subjects will complete the 2011 FM Questionnaire. The answers of this questionnaire will be added to obtain the wide-spread pain index and the somatic symptom score. The scores will be combined to obtain the final score. Scores of >12 fulfill the Criteria for Fibromyalgia
measure: Response to the Center for Epidemiological Studies (CES-D) Depression Questionnaire
time frame: 0.5 hours
description: FM and control subjects will complete the CES-D. The answers of this questionnaire will be combined to obtain a final score. Total scores of >15 are consistent with the diagnosis of major depression.
arm group label: Effects of PASAT on Sensory Testing
arm group type: Experimental
description: After baseline evaluation of light and pain sensitivity FM subjects and controls will undergo the PASAT task. This task consists of responding to a rapid presentation of numbers by ear phones. Subjects are asked to add each 2 consecutive numbers and provide a response each time the sum is equal to 13. This test will last several minutes and delivered at increasing speed.
intervention type: Behavioral
intervention name: Paced Auditory Serial Addition task (PASAT)
description: Single and double digits are presented at intervals between 2 and 3 seconds and the participant must add each new digit to the one immediately prior to it. The participants will be asked to indicate by electronic button press whether the sum of the addition is 13 or not. The duration of the PASAT will be two 12-min tasks.
arm group label: Effects of PASAT on Sensory Testing
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Roland Staud, MD
role: Principal Investigator
affiliation: University of Florida
last name: Melyssa Godfrey, BS
phone: 352-265-8901
email: painresearch@medicine.ufl.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
citation: Geisser ME, Strader Donnell C, Petzke F, Gracely RH, Clauw DJ, Williams DA. Comorbid somatic symptoms and functional status in patients with fibromyalgia and chronic fatigue syndrome: sensory amplification as a common mechanism. Psychosomatics. 2008 May-Jun;49(3):235-42. doi: 10.1176/appi.psy.49.3.235.
PMID: 18448779
citation: Geisser ME, Glass JM, Rajcevska LD, Clauw DJ, Williams DA, Kileny PR, Gracely RH. A psychophysical study of auditory and pressure sensitivity in patients with fibromyalgia and healthy controls. J Pain. 2008 May;9(5):417-22. doi: 10.1016/j.jpain.2007.12.006. Epub 2008 Feb 15.
PMID: 18280211
citation: Frank MG, Fonken LK, Watkins LR, Maier SF. Microglia: Neuroimmune-sensors of stress. Semin Cell Dev Biol. 2019 Oct;94:176-185. doi: 10.1016/j.semcdb.2019.01.001. Epub 2019 Jan 9.
PMID: 30638704
citation: Geisser ME, Casey KL, Brucksch CB, Ribbens CM, Appleton BB, Crofford LJ. Perception of noxious and innocuous heat stimulation among healthy women and women with fibromyalgia: association with mood, somatic focus, and catastrophizing. Pain. 2003 Apr;102(3):243-250. doi: 10.1016/S0304-3959(02)00417-7.
PMID: 12670665
responsible party type: Sponsor
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
mesh term: Hypersensitivity
sharing ipd: No