<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/NCT01726881</url>
  </required_header>
  <id_info>
    <org_study_id>SHEBA-12-9572-GZ-SMC</org_study_id>
    <nct_id>NCT01726881</nct_id>
  </id_info>
  <brief_title>Predicting Central Pain Among People With a Spinal Cord Injury by Evaluating Mechanisms Regulating Pain and Efficacy Testing of the TENS Apparatus</brief_title>
  <official_title>Predicting Central Pain Among People With a Spinal Cord Injury by Evaluating Mechanisms Regulating Pain and Efficacy Testing of the TENS Apparatus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheba Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      People with a Spinal Cord Injury can develop chronic pain within months of the injury. Up to&#xD;
      80% of the patients will develop chronic pain called &quot;central pain&quot; and describe the pain as:&#xD;
      burning, stabbing, or &quot;like electricity.&quot; Central pain mechanism is unknown and therefore&#xD;
      treatment is currently not effective.&#xD;
&#xD;
      It is hypothesized that chronic pain is associated with impaired function of the systems&#xD;
      regulating pain, however, this hypothesis has not been tested among Spinal Cord Injury&#xD;
      patients. Presence of such a connection, between the regulating system dysfunction and&#xD;
      central pain, will help both predicting the risk of central pain and develop a treatment.&#xD;
&#xD;
      The current research objective is to make several sensory measurements which will measure the&#xD;
      functioning mechanisms of regulation and control of the pain. These measurements are accepted&#xD;
      throughout the world and are based on psychophysical assessment of patients. these&#xD;
      Measurements are designed to assess whether Spinal Cord Injury chronic central pain patients&#xD;
      demonstrate impairment in the regulation of pain. Finding such a link between central pain&#xD;
      and impaired regulation could shed light on the mechanism of central pain. In addition, these&#xD;
      measurements are designed to assess whether fresh spinal cord injury patients that have not&#xD;
      yet developed central pain demonstrate impairment in the regulation of pain immediately after&#xD;
      the injury. By repeated assessments of pain regulation capabilities, which will be made to&#xD;
      fresh Spinal Cord Injury patients during the first months of injury, and comparing the&#xD;
      results of these measurements between those who will develop center pain and those who will&#xD;
      not, we could identify indicators for predicting the risk of central pain. Another goal of&#xD;
      the study is to investigate the efficacy of central pain treatment, using a TENS, when the&#xD;
      parameters of the TENS treatment will be built according to the level of functioning of the&#xD;
      regulating systems of the individual.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>December 2012</start_date>
  <completion_date type="Anticipated">August 2019</completion_date>
  <primary_completion_date type="Anticipated">August 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity to thermic pain</measure>
    <time_frame>5 minutes</time_frame>
    <description>Minimum temperature at which the patient reported pain. The subject will press a button once feeling pain. pain will be reported using a visual analog scale - a pain scale between 1-10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain suppression capability</measure>
    <time_frame>5 minutes</time_frame>
    <description>Reduction of pain in the presence of another stimulus. pain will be reported using a visual analog scale - a pain scale between 1-10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Habituation to tonic stimulation</measure>
    <time_frame>5 minutes</time_frame>
    <description>Gradient decrease in pain rating. pain will be reported using a visual analog scale - a pain scale between 1-10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Temporal summation of pain</measure>
    <time_frame>5 minutes</time_frame>
    <description>Standard rating of pain among several stimuli. pain will be reported using a visual analog scale - a pain scale between 1-10.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Pain</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Fresh Spinal Cord Injury patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Spinal Cord Injury patients that are currently admitted to the rehabilitation unit with three weeks or less since injury that will over go several tests and will fill out several questionnaires.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic Spinal Cord Injury patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Spinal Cord Injury patients with one year or more since injury that will over go several tests and will fill out several questionnaires</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Healthy subjects that will over go several tests and will fill out several questionnaires</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Thermal stimulation</intervention_name>
    <description>Stimulation using a Thermal Sensory Analyzer:&#xD;
2001, Maddock ltd., Israel.</description>
    <arm_group_label>Chronic Spinal Cord Injury patients</arm_group_label>
    <arm_group_label>Fresh Spinal Cord Injury patients</arm_group_label>
    <arm_group_label>Healthy volunteers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mechanical stimulation</intervention_name>
    <description>Stimulation using Semmes-Weinstein-Monofilament Touch Test Sensory Evaluators</description>
    <arm_group_label>Chronic Spinal Cord Injury patients</arm_group_label>
    <arm_group_label>Fresh Spinal Cord Injury patients</arm_group_label>
    <arm_group_label>Healthy volunteers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcutaneous Electrical Nerve Stimulator (TENS)</intervention_name>
    <description>A portable stimulator designed to Physical treatment of pain. TENS - Cedar rehab X2. Chattanooga group.USA.</description>
    <arm_group_label>Chronic Spinal Cord Injury patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  for all subjects:&#xD;
&#xD;
               -  age - 18-70&#xD;
&#xD;
               -  Cognitive status that allows voluntary cooperation understanding of instruction&#xD;
&#xD;
          -  for chronic Spinal Cord Injury subjects:&#xD;
&#xD;
               -  spinal cord injury (complete and incomplete)&#xD;
&#xD;
               -  height of injury - under 7th cervical vertebra&#xD;
&#xD;
               -  time since injury - one year or more.&#xD;
&#xD;
          -  for chronic Spinal Cord Injury subjects:&#xD;
&#xD;
               -  spinal cord injury (complete and incomplete)&#xD;
&#xD;
               -  height of injury - under under 7th cervical vertebra&#xD;
&#xD;
               -  time since injury - three weeks or less&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects suffering from the following conditions: pacemaker,pregnancy,cancer,&#xD;
             tuberculosis, thrombosis, metallic implants&#xD;
&#xD;
          -  systemic diseases that affect the sensory perception (such as diabetes)&#xD;
&#xD;
          -  patients with other neurological pathologies (such as head injury-TBI)&#xD;
&#xD;
          -  Pregnancy&#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>Gabriel Zeilig, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sheba Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sheba Medical Center rehabilitaion facility</name>
      <address>
        <city>Ramat Gan</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>November 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>August 27, 2018</last_update_submitted>
  <last_update_submitted_qc>August 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>chronic</keyword>
  <keyword>Spinal Cord Injury patients</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01726881
org study id: SHEBA-12-9572-GZ-SMC
nct id: NCT01726881
lead sponsor: 
has dmc: No
People with a Spinal Cord Injury can develop chronic pain within months of the injury. Up to
      80% of the patients will develop chronic pain called "central pain" and describe the pain as:
      burning, stabbing, or "like electricity." Central pain mechanism is unknown and therefore
      treatment is currently not effective.

      It is hypothesized that chronic pain is associated with impaired function of the systems
      regulating pain, however, this hypothesis has not been tested among Spinal Cord Injury
      patients. Presence of such a connection, between the regulating system dysfunction and
      central pain, will help both predicting the risk of central pain and develop a treatment.

      The current research objective is to make several sensory measurements which will measure the
      functioning mechanisms of regulation and control of the pain. These measurements are accepted
      throughout the world and are based on psychophysical assessment of patients. these
      Measurements are designed to assess whether Spinal Cord Injury chronic central pain patients
      demonstrate impairment in the regulation of pain. Finding such a link between central pain
      and impaired regulation could shed light on the mechanism of central pain. In addition, these
      measurements are designed to assess whether fresh spinal cord injury patients that have not
      yet developed central pain demonstrate impairment in the regulation of pain immediately after
      the injury. By repeated assessments of pain regulation capabilities, which will be made to
      fresh Spinal Cord Injury patients during the first months of injury, and comparing the
      results of these measurements between those who will develop center pain and those who will
      not, we could identify indicators for predicting the risk of central pain. Another goal of
      the study is to investigate the efficacy of central pain treatment, using a TENS, when the
      parameters of the TENS treatment will be built according to the level of functioning of the
      regulating systems of the individual.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Sensitivity to thermic pain
time frame: 5 minutes
description: Minimum temperature at which the patient reported pain. The subject will press a button once feeling pain. pain will be reported using a visual analog scale - a pain scale between 1-10.
measure: Pain suppression capability
time frame: 5 minutes
description: Reduction of pain in the presence of another stimulus. pain will be reported using a visual analog scale - a pain scale between 1-10.
measure: Habituation to tonic stimulation
time frame: 5 minutes
description: Gradient decrease in pain rating. pain will be reported using a visual analog scale - a pain scale between 1-10.
measure: Temporal summation of pain
time frame: 5 minutes
description: Standard rating of pain among several stimuli. pain will be reported using a visual analog scale - a pain scale between 1-10.
arm group label: Fresh Spinal Cord Injury patients
arm group type: Experimental
description: Spinal Cord Injury patients that are currently admitted to the rehabilitation unit with three weeks or less since injury that will over go several tests and will fill out several questionnaires.
arm group label: Chronic Spinal Cord Injury patients
arm group type: Experimental
description: Spinal Cord Injury patients with one year or more since injury that will over go several tests and will fill out several questionnaires
arm group label: Healthy volunteers
arm group type: Active Comparator
description: Healthy subjects that will over go several tests and will fill out several questionnaires
intervention type: Device
intervention name: Thermal stimulation
description: Stimulation using a Thermal Sensory Analyzer:
2001, Maddock ltd., Israel.
arm group label: Chronic Spinal Cord Injury patients
arm group label: Fresh Spinal Cord Injury patients
arm group label: Healthy volunteers
intervention type: Device
intervention name: Mechanical stimulation
description: Stimulation using Semmes-Weinstein-Monofilament Touch Test Sensory Evaluators
arm group label: Chronic Spinal Cord Injury patients
arm group label: Fresh Spinal Cord Injury patients
arm group label: Healthy volunteers
intervention type: Device
intervention name: Transcutaneous Electrical Nerve Stimulator (TENS)
description: A portable stimulator designed to Physical treatment of pain. TENS - Cedar rehab X2. Chattanooga group.USA.
arm group label: Chronic Spinal Cord Injury patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gabriel Zeilig, MD
role: Principal Investigator
affiliation: Sheba Hospital
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Spinal Cord Injuries