<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/NCT02240303</url>
  </required_header>
  <id_info>
    <org_study_id>201400471</org_study_id>
    <nct_id>NCT02240303</nct_id>
  </id_info>
  <brief_title>Pain, Brain and Mobility Study</brief_title>
  <acronym>PBAM</acronym>
  <official_title>Central and Peripheral Mechanisms Predicting Clinical Pain and Physical Performance in Older Adults</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this project will be to document the central and peripheral mechanisms, which may&#xD;
      predict clinical pain characteristics and associated physical performance in older adults.&#xD;
      Although chronic pain is common among older adults, there is limited understanding on the&#xD;
      processing of pain and the mechanisms by which it affects physical function in these&#xD;
      individuals. The first aim of this study will be to examine predictors of clinical pain in&#xD;
      older adults. These will include a comprehensive somatosensory assessment battery including&#xD;
      mechanical and thermal detection and pain thresholds in older adults with and without chronic&#xD;
      pain. The investigators will also assess basal cognitive and physical function to determine&#xD;
      their associations with chronic pain. Finally, brain structure and function will be assessed&#xD;
      in these older adults with and without pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this research study is to learn more about how pain in older individuals&#xD;
      changes the brain and impacts a person's mobility and function. Pain is influenced by biology&#xD;
      (like hormones), psychology (thoughts and feelings), and habits (like sleep or exercise) that&#xD;
      may make older adults more likely to have higher or lower levels of pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Consolidated study with another protocol&#xD;
  </why_stopped>
  <start_date>April 2015</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Brain magnetic resonance imaging (MRI)</measure>
    <time_frame>Baseline and 12 months later</time_frame>
    <description>Differences in the MRI on the brain scans of participants with greater pain severity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Inflammatory markers in blood samples</measure>
    <time_frame>Baseline</time_frame>
    <description>To test the markers of pro-inflammatory (IL-1b, tumor necrosis factor (TNF-a)) and anti-inflammatory (IL-4, IL-10) with participants more sensitive to pain than the ones less sensitive to pain.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Mobility (gait speed)</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>Inverse dynamics will be used to calculate gait speed.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Clinical Pain</condition>
  <condition>Brain and Mobility Changes</condition>
  <arm_group>
    <arm_group_label>Chronic Pain Group</arm_group_label>
    <description>Participants that experience chronic pain will have the following procedures performed: A sensory assessment called quantitative sensory testing or QST that will assess in detail your ability to feel sensations due to touch, vibration, and changes in temperature on the skin; Pressure sense will be produced by a device that will be pressed against the skin for several seconds; Pinprick pressure will be applied to determine if the pain can be rated; a Physical Performance test will be performed; and an magnetic resonance imaging (MRI) will be done. In addition, blood sample, blood pressure, heart rate, and skin temperature will be taken during the procedures.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Chronic Pain Group</arm_group_label>
    <description>Participants that do not experience chronic pain will have the following procedures performed: A sensory assessment called quantitative sensory testing or QST that will assess in detail your ability to feel sensations due to touch, vibration, and changes in temperature on the skin; Pressure sense will be produced by a device that will be pressed against the skin for several seconds; Pinprick pressure will be applied to determine if the pain can be rated; a Physical Performance test will be performed; and an magnetic resonance imaging (MRI) will be done. In addition, blood sample, blood pressure, heart rate, and skin temperature will be taken during the procedures.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Quantitative Sensory Testing (QST)</intervention_name>
    <description>Participants in both groups will have a sensory assessment called quantitative sensory testing or QST that will assess in detail your ability to feel sensations due to touch, vibration, and changes in temperature on the skin.</description>
    <arm_group_label>Chronic Pain Group</arm_group_label>
    <arm_group_label>No Chronic Pain Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Physical Performance</intervention_name>
    <description>Participants in both groups will have a Physical Performance test.</description>
    <arm_group_label>Chronic Pain Group</arm_group_label>
    <arm_group_label>No Chronic Pain Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Magnetic Resonance Imaging (MRI)</intervention_name>
    <description>Participants in both groups will have an magnetic resonance imaging (MRI).</description>
    <arm_group_label>Chronic Pain Group</arm_group_label>
    <arm_group_label>No Chronic Pain Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood Sample</intervention_name>
    <description>Participants in both groups will have blood samples taken.</description>
    <arm_group_label>Chronic Pain Group</arm_group_label>
    <arm_group_label>No Chronic Pain Group</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma samples will be stored.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Older adults&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 65 years and older&#xD;
&#xD;
          -  Willingness to participate in all study procedures&#xD;
&#xD;
          -  Cognitively intact as defined by 3MS score &gt; 80&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Failure to provide informed consent;&#xD;
&#xD;
          -  Contraindications to MRI, such as claustrophobia, heart pacemaker / defibrillator,&#xD;
             heart valve prosthesis, aneurysm clip, metallic stent, neurostimulation system,&#xD;
             cochlear implants or inner ear prosthesis, insulin pump or other infusion pump, metal&#xD;
             slivers in the orbital area/eye socket&#xD;
&#xD;
          -  Active treatment for cancer or history of cancer in the past year&#xD;
&#xD;
          -  Severe cardiac disease, including New York Heart Association (NYHA) Class III or IV&#xD;
             congestive heart failure, clinically significant aortic stenosis, history of cardiac&#xD;
             arrest or stroke, use of a cardiac defibrillator, or uncontrolled angina;&#xD;
&#xD;
          -  Previous stroke with upper and/or lower extremities involvement within the last 6&#xD;
             months&#xD;
&#xD;
          -  History of life-threatening cardiac arrhythmias, stroke, severe Parkinson's disease or&#xD;
             severe neurological disorders likely to interfere with physical function&#xD;
&#xD;
          -  Renal disease requiring dialysis&#xD;
&#xD;
          -  Lung disease requiring steroids&#xD;
&#xD;
          -  Inability to reliably rate pain intensity&#xD;
&#xD;
          -  Current use of tobacco products&#xD;
&#xD;
          -  Uncontrolled hypertension (BP of greater than 150/99 mm Hg)&#xD;
&#xD;
          -  Serious systemic disease that restrict normal daily activities&#xD;
&#xD;
          -  Neurological problems with significant changes in somatosensory and pain perception at&#xD;
             the intended stimulation sites,&#xD;
&#xD;
          -  Uncontrolled psychiatric condition (e.g., experiencing symptoms of schizophrenia,&#xD;
             bipolar disorder, etc.) or hospitalization within the preceding year for psychiatric&#xD;
             illness&#xD;
&#xD;
          -  Daily use of narcotic medication&#xD;
&#xD;
          -  Lower extremity amputation&#xD;
&#xD;
          -  Uncontrolled diabetes (self-reported medication use and/or HA1C value)&#xD;
&#xD;
          -  A known diagnosis of dementia&#xD;
&#xD;
          -  Inability to communicate because of severe hearing loss or speech disorder;&#xD;
&#xD;
          -  Severe visual impairment, which would preclude completion of the assessments and/or&#xD;
             intervention.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yenisel Cruz-Almeida, MSPH, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <last_update_submitted>February 16, 2016</last_update_submitted>
  <last_update_submitted_qc>February 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pain</keyword>
  <keyword>mobility</keyword>
  <keyword>brain</keyword>
  <keyword>cognition</keyword>
  <!-- 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/NCT02240303
org study id: 201400471
nct id: NCT02240303
lead sponsor: 
has dmc: No
The aim of this project will be to document the central and peripheral mechanisms, which may
      predict clinical pain characteristics and associated physical performance in older adults.
      Although chronic pain is common among older adults, there is limited understanding on the
      processing of pain and the mechanisms by which it affects physical function in these
      individuals. The first aim of this study will be to examine predictors of clinical pain in
      older adults. These will include a comprehensive somatosensory assessment battery including
      mechanical and thermal detection and pain thresholds in older adults with and without chronic
      pain. The investigators will also assess basal cognitive and physical function to determine
      their associations with chronic pain. Finally, brain structure and function will be assessed
      in these older adults with and without pain.
The purpose of this research study is to learn more about how pain in older individuals
      changes the brain and impacts a person's mobility and function. Pain is influenced by biology
      (like hormones), psychology (thoughts and feelings), and habits (like sleep or exercise) that
      may make older adults more likely to have higher or lower levels of pain.
time perspective: Prospective
measure: Brain magnetic resonance imaging (MRI)
time frame: Baseline and 12 months later
description: Differences in the MRI on the brain scans of participants with greater pain severity
measure: Inflammatory markers in blood samples
time frame: Baseline
description: To test the markers of pro-inflammatory (IL-1b, tumor necrosis factor (TNF-a)) and anti-inflammatory (IL-4, IL-10) with participants more sensitive to pain than the ones less sensitive to pain.
measure: Mobility (gait speed)
time frame: Baseline and 12 months
description: Inverse dynamics will be used to calculate gait speed.
arm group label: Chronic Pain Group
description: Participants that experience chronic pain will have the following procedures performed: A sensory assessment called quantitative sensory testing or QST that will assess in detail your ability to feel sensations due to touch, vibration, and changes in temperature on the skin; Pressure sense will be produced by a device that will be pressed against the skin for several seconds; Pinprick pressure will be applied to determine if the pain can be rated; a Physical Performance test will be performed; and an magnetic resonance imaging (MRI) will be done. In addition, blood sample, blood pressure, heart rate, and skin temperature will be taken during the procedures.
arm group label: No Chronic Pain Group
description: Participants that do not experience chronic pain will have the following procedures performed: A sensory assessment called quantitative sensory testing or QST that will assess in detail your ability to feel sensations due to touch, vibration, and changes in temperature on the skin; Pressure sense will be produced by a device that will be pressed against the skin for several seconds; Pinprick pressure will be applied to determine if the pain can be rated; a Physical Performance test will be performed; and an magnetic resonance imaging (MRI) will be done. In addition, blood sample, blood pressure, heart rate, and skin temperature will be taken during the procedures.
intervention type: Procedure
intervention name: Quantitative Sensory Testing (QST)
description: Participants in both groups will have a sensory assessment called quantitative sensory testing or QST that will assess in detail your ability to feel sensations due to touch, vibration, and changes in temperature on the skin.
arm group label: Chronic Pain Group
arm group label: No Chronic Pain Group
intervention type: Procedure
intervention name: Physical Performance
description: Participants in both groups will have a Physical Performance test.
arm group label: Chronic Pain Group
arm group label: No Chronic Pain Group
intervention type: Procedure
intervention name: Magnetic Resonance Imaging (MRI)
description: Participants in both groups will have an magnetic resonance imaging (MRI).
arm group label: Chronic Pain Group
arm group label: No Chronic Pain Group
intervention type: Procedure
intervention name: Blood Sample
description: Participants in both groups will have blood samples taken.
arm group label: Chronic Pain Group
arm group label: No Chronic Pain Group
Plasma samples will be stored.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Yenisel Cruz-Almeida, MSPH, PhD
role: Principal Investigator
affiliation: University of Florida
country: United States
responsible party type: Sponsor