<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/NCT03005691</url>
  </required_header>
  <id_info>
    <org_study_id>GFSM-HNP</org_study_id>
    <nct_id>NCT03005691</nct_id>
  </id_info>
  <brief_title>Central Sensitization in Chronic Whiplash Patients</brief_title>
  <official_title>Central Sensitization in Chronic Whiplash Patients: Metabolite Concentrations in the Anterior Cingulate Cortex and Periacueductal Gray Matter</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Castilla-La Mancha</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Nacional de Parapléjicos de Toledo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Castilla-La Mancha</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether the metabolite concentrations within the&#xD;
      anterior cingulate cortex and periaqueductal gray matter predict the intensity and&#xD;
      interference of neuropathic pain after the development of chronic whiplash syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Persistent chronic pain is a common symptom of whiplash leading to reduced quality of life.&#xD;
      Little information is available regarding changes in brain processing areas and change in&#xD;
      central sensitization to noxious input during the chronic phase of whiplash. Metabolite&#xD;
      concentrations in the anterior cingulate cortex and periaqueductal gray matter may be&#xD;
      predictors of neuropathic pain and these changes may explain the development of central&#xD;
      sensitization in people with chronic whiplash.&#xD;
&#xD;
      Until now, there is not any study that show this approach.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">May 2017</completion_date>
  <primary_completion_date type="Anticipated">March 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Metabolite concentrations</measure>
    <time_frame>Baseline at 0 min</time_frame>
    <description>The metabolite concentrations will be measured by magnetic resonance (spectroscopy)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Conditioned Pain Modulation</measure>
    <time_frame>Baseline at 0 min</time_frame>
    <description>Conditioned Pain Modulation will be measured by a Pathway system (Medoc Ltd)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brief Pain Inventory</measure>
    <time_frame>Baseline at 0 min</time_frame>
    <description>Brief Pain Inventory (BPI), it is used to evaluate the subject's perception of pain severity and its interference.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurophatic Pain Symptoms Inventory</measure>
    <time_frame>Baseline at 0 min</time_frame>
    <description>Neurophatic Pain Symptoms Inventory (NPSI), it is used to detect paresthesia/dysaesthesia, evoked pain and paroxysmal pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain Catastrophizing Helplessness Subscale</measure>
    <time_frame>Baseline at 0 min</time_frame>
    <description>Pain Catastrophizing Helplessness Subscale it is used to assess the catastrophizing score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neck Disability Index</measure>
    <time_frame>Baseline at 0 min</time_frame>
    <description>Neck Disability Index (NDI), it is used to assess the disability after whiplash syndrome</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Whiplash-Pain</arm_group_label>
    <description>Subjects with chronic whiplash syndrome and pain. The inclusion criteria for pain include the presence of daily pain during the previous 8 weeks. Specifically, pain will be diagnosed based on the pain intensity measured on the 0 to 10 numerical rating scale. The minimum will be 2 points. Subjects will be recruited between the 4 months until 2 years after the whiplash.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Whiplash-no Pain</arm_group_label>
    <description>Subjects with chronic whiplash syndrome and pain. The inclusion criteria for pain include the ausence of daily pain during the previous 8 weeks. Specifically, pain will be diagnosed based on the pain intensity measured on the 0 to 10 numerical rating scale. The maximun will be 2 points. Subjects will be recruited between the 4 months until 2 years after the whiplash.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-injured</arm_group_label>
    <description>Subjects without whiplash syndrome. The inclusion criteria are defined as a absence of previous or actual symptoms or signs of neck pain.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Spectroscopy</intervention_name>
    <description>Spectroscopy is a noninvasive method to assess brain chemistry. The signal of the hydrogen atom attached to a certain molecule or metabolite has a particular frequency associated with a given metabolite. The utility of Spectroscopy is based on the fact thet the nuclei of atoms have magnetic properties that can be used to obtain chemical information regarding both the type of molecule and it is concentration.&#xD;
The subjects will be scanned on a 3-T Siemens system and an 12-channel phased-array coil will be used to provide an optimum signal-to-noise ratio for spectroscopy data.</description>
    <arm_group_label>Non-injured</arm_group_label>
    <arm_group_label>Whiplash-Pain</arm_group_label>
    <arm_group_label>Whiplash-no Pain</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaires</intervention_name>
    <description>Questionnaires are important to assess the chronic pain and their impact in the quality of life. For this reason, we will assess the Brief Pain Inventory (BPI), it is used to evaluate the subject's perception of pain severity and its interference. Moreover, we will assess neuropathic pain symptoms with the NPSI to detect paresthesia/dysaesthesia, evoked pain and paroxysmal pain. The catastrophizing score will be measured with the Pain Catastrophizing Helplessness Subscale. Also,we will assess the disability after whiplash using the Neck Disability Index.</description>
    <arm_group_label>Non-injured</arm_group_label>
    <arm_group_label>Whiplash-Pain</arm_group_label>
    <arm_group_label>Whiplash-no Pain</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conditioned Pain Modulation</intervention_name>
    <description>Conditioned Pain Modulation over the tenar eminence. The test will be a heat tonic stimulus which evoke a 3-pain intensity. The conditioning stimulus will be a cold water immersion (12ºC)</description>
    <arm_group_label>Non-injured</arm_group_label>
    <arm_group_label>Whiplash-Pain</arm_group_label>
    <arm_group_label>Whiplash-no Pain</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have suffered whiplash syndrome. By one hand, patients with chronic pain&#xD;
        (minimun 8 weeks) and 2 points or more of pain intensity. By the other hand, patiens&#xD;
        without pain (2 points or less of pain intensity).&#xD;
&#xD;
        By last, subjects without whiplash syndrome.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Whiplash syndrome&#xD;
&#xD;
          -  Chronic pain&#xD;
&#xD;
          -  Age between 18 to 65 years&#xD;
&#xD;
          -  4 months to 2 years after the whiplash syndrome&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neurological disease&#xD;
&#xD;
          -  Claustrophobia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Diego Serrano-Muñoz, MsC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Nacional de Parapléjicos, Toledo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Diego Serrano-Muñoz, MsC</last_name>
    <phone>+34 925 24 77 00</phone>
    <phone_ext>783</phone_ext>
    <email>dserranomu@externas.sescam.jccm.es</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Julian Taylor-Green, PhD</last_name>
    <phone>+34 925 24 77 00</phone>
    <phone_ext>109</phone_ext>
    <email>jscott@sescam.org</email>
  </overall_contact_backup>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>December 28, 2016</last_update_submitted>
  <last_update_submitted_qc>December 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>metabolite</keyword>
  <keyword>central sensitization</keyword>
  <keyword>whiplash</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Whiplash Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>To publish in impact journals</ipd_description>
  </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/NCT03005691
org study id: GFSM-HNP
nct id: NCT03005691
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine whether the metabolite concentrations within the
      anterior cingulate cortex and periaqueductal gray matter predict the intensity and
      interference of neuropathic pain after the development of chronic whiplash syndrome.
Persistent chronic pain is a common symptom of whiplash leading to reduced quality of life.
      Little information is available regarding changes in brain processing areas and change in
      central sensitization to noxious input during the chronic phase of whiplash. Metabolite
      concentrations in the anterior cingulate cortex and periaqueductal gray matter may be
      predictors of neuropathic pain and these changes may explain the development of central
      sensitization in people with chronic whiplash.

      Until now, there is not any study that show this approach.
observational model: Cohort
time perspective: Cross-Sectional
measure: Metabolite concentrations
time frame: Baseline at 0 min
description: The metabolite concentrations will be measured by magnetic resonance (spectroscopy)
measure: Conditioned Pain Modulation
time frame: Baseline at 0 min
description: Conditioned Pain Modulation will be measured by a Pathway system (Medoc Ltd)
measure: Brief Pain Inventory
time frame: Baseline at 0 min
description: Brief Pain Inventory (BPI), it is used to evaluate the subject's perception of pain severity and its interference.
measure: Neurophatic Pain Symptoms Inventory
time frame: Baseline at 0 min
description: Neurophatic Pain Symptoms Inventory (NPSI), it is used to detect paresthesia/dysaesthesia, evoked pain and paroxysmal pain.
measure: Pain Catastrophizing Helplessness Subscale
time frame: Baseline at 0 min
description: Pain Catastrophizing Helplessness Subscale it is used to assess the catastrophizing score
measure: Neck Disability Index
time frame: Baseline at 0 min
description: Neck Disability Index (NDI), it is used to assess the disability after whiplash syndrome
arm group label: Whiplash-Pain
description: Subjects with chronic whiplash syndrome and pain. The inclusion criteria for pain include the presence of daily pain during the previous 8 weeks. Specifically, pain will be diagnosed based on the pain intensity measured on the 0 to 10 numerical rating scale. The minimum will be 2 points. Subjects will be recruited between the 4 months until 2 years after the whiplash.
arm group label: Whiplash-no Pain
description: Subjects with chronic whiplash syndrome and pain. The inclusion criteria for pain include the ausence of daily pain during the previous 8 weeks. Specifically, pain will be diagnosed based on the pain intensity measured on the 0 to 10 numerical rating scale. The maximun will be 2 points. Subjects will be recruited between the 4 months until 2 years after the whiplash.
arm group label: Non-injured
description: Subjects without whiplash syndrome. The inclusion criteria are defined as a absence of previous or actual symptoms or signs of neck pain.
intervention type: Radiation
intervention name: Spectroscopy
description: Spectroscopy is a noninvasive method to assess brain chemistry. The signal of the hydrogen atom attached to a certain molecule or metabolite has a particular frequency associated with a given metabolite. The utility of Spectroscopy is based on the fact thet the nuclei of atoms have magnetic properties that can be used to obtain chemical information regarding both the type of molecule and it is concentration.
The subjects will be scanned on a 3-T Siemens system and an 12-channel phased-array coil will be used to provide an optimum signal-to-noise ratio for spectroscopy data.
arm group label: Non-injured
arm group label: Whiplash-Pain
arm group label: Whiplash-no Pain
intervention type: Other
intervention name: Questionnaires
description: Questionnaires are important to assess the chronic pain and their impact in the quality of life. For this reason, we will assess the Brief Pain Inventory (BPI), it is used to evaluate the subject's perception of pain severity and its interference. Moreover, we will assess neuropathic pain symptoms with the NPSI to detect paresthesia/dysaesthesia, evoked pain and paroxysmal pain. The catastrophizing score will be measured with the Pain Catastrophizing Helplessness Subscale. Also,we will assess the disability after whiplash using the Neck Disability Index.
arm group label: Non-injured
arm group label: Whiplash-Pain
arm group label: Whiplash-no Pain
intervention type: Procedure
intervention name: Conditioned Pain Modulation
description: Conditioned Pain Modulation over the tenar eminence. The test will be a heat tonic stimulus which evoke a 3-pain intensity. The conditioning stimulus will be a cold water immersion (12ºC)
arm group label: Non-injured
arm group label: Whiplash-Pain
arm group label: Whiplash-no Pain
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Diego Serrano-Muñoz, MsC
role: Principal Investigator
affiliation: Hospital Nacional de Parapléjicos, Toledo
last name: Diego Serrano-Muñoz, MsC
phone: +34 925 24 77 00
phone ext: 783
email: dserranomu@externas.sescam.jccm.es
last name: Julian Taylor-Green, PhD
phone: +34 925 24 77 00
phone ext: 109
email: jscott@sescam.org
responsible party type: Sponsor
mesh term: Chronic Pain
mesh term: Whiplash Injuries
sharing ipd: Yes
ipd description: To publish in impact journals