<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/NCT03806010</url>
  </required_header>
  <id_info>
    <org_study_id>15/LO/2094</org_study_id>
    <nct_id>NCT03806010</nct_id>
  </id_info>
  <brief_title>QST and Neuropathic Pain</brief_title>
  <official_title>A Prospective Open Labelled Study to Evaluate if Central Sensitization as Measured With QST Alters Following Chronic Pain Interventions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Barts &amp; The London NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Barts &amp; The London NHS Trust</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>
      To establish the sensory profile of patients using quantitative sensory testing (QST) and&#xD;
      questionnaires as well as the level of sensitisation using temporal summation and diffuse&#xD;
      noxious inhibitory control paradigms in all patients undergoing a chronic pain intervention&#xD;
      at Barts Health NHS Trust.&#xD;
&#xD;
      Primary objective- To identify the phenotype of responders and non-responders to a chronic&#xD;
      pain intervention using QST sensory profile as well as the sensitisation paradigms.&#xD;
&#xD;
      Secondary objective- To establish the correlation between sensory profile, and sensitisation&#xD;
      parameters as well as other measures of chronic pain as per Initiative on Methods,&#xD;
      Measurement and Pain Assessment in clinical trials (IMMPACT) recommendation.&#xD;
&#xD;
      Common interventions performed at Barts Health NHS Trust includes Neuromodulation, targeted&#xD;
      epidural steroid and/or radiofrequency treatment, 8% Capsaicin patch and pharmacological&#xD;
      interventions such as anti-neuropathic agent and opioids.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2016</start_date>
  <completion_date type="Actual">February 1, 2019</completion_date>
  <primary_completion_date type="Actual">February 1, 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>• To identify the phenotype of responders and non-responders to a chronic pain intervention using QST sensory profile as well as the sensitisation paradigms.</measure>
    <time_frame>QST changes at 4 weeks is taken as primary objective.</time_frame>
    <description>This is assessed by comparing and reporting any change in QST results before and after the intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>• To establish the correlation between sensory profile and sensitisation parameters as well as other measures of chronic pain as per Initiative on Methods, Measurement and Pain Assessment in clinical trials (IMMPACT) recommendation •</measure>
    <time_frame>2 weeks 3, 6 months and one year</time_frame>
    <description>QST changes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The effect on functionality and quality of life following chronic pain intervention</measure>
    <time_frame>2 weeks and 3, 6 months and 1 year.</time_frame>
    <description>QST changes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Whether central sensitisation can be used as a bedside biomarker to predict outcome after interventions for chronic pain (i.e. the more centrally sensitised the more superior improvement from treatment)</measure>
    <time_frame>2 weeks and 3, 6 months and 1 year</time_frame>
    <description>QST changes</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">10</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Quantitative sensory testing</arm_group_label>
    <description>QST will be performed at baseline two weeks and 2 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Quantitative sensory testing</intervention_name>
    <description>Quantitative sensory testing</description>
    <arm_group_label>Quantitative sensory testing</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Chronic pain of at leasr 6 months&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:• Male and female patients between the age of 18-80 years who have a&#xD;
        lumbar radiculopathy who have not undergone any spinal surgery.&#xD;
&#xD;
          -  Minimum baseline pain rating of 50mm on a 100mm NRS in the painful area&#xD;
&#xD;
          -  Chronic pain of at least 6 months&#xD;
&#xD;
          -  Subject satisfies standard criteria in the study centre for SCS implantation and the&#xD;
             NICE 159 criteria for management of intractable neuropathic pain.&#xD;
&#xD;
          -  Subject satisfies standard criteria in the study centre for ONS implantation and the&#xD;
             NICE 452 criteria for intractable chronic migraine.&#xD;
&#xD;
          -  Patients who have given their written informed consent.&#xD;
&#xD;
          -  Patient is able and willing to comply with study procedures and follow up schedule.&#xD;
&#xD;
        Exclusion Criteria:• Any inclusion criteria not met&#xD;
&#xD;
          -  Female patients of childbearing age who is or plans on becoming pregnant during the&#xD;
             course of the study&#xD;
&#xD;
          -  Patients who have undergone radiofrequency or injection therapy at or on a target&#xD;
             neural structure (DRG) during the past 90 days&#xD;
&#xD;
          -  Patients with diabetes or any underlying neurological condition.&#xD;
&#xD;
          -  Patients known to have a condition that in the investigator's judgment precludes&#xD;
             participation in the study.&#xD;
&#xD;
          -  Patients who have received an investigational drug or have used an investigational&#xD;
             device in the 30 days preceding to study entry&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>vIVEK mEHTA, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Barts NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dr Theresa Wodehouse</name>
      <address>
        <city>London</city>
        <state>Essex</state>
        <zip>ec1a 7be</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>August 10, 2020</last_update_submitted>
  <last_update_submitted_qc>August 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Quantitative sensory testing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03806010
org study id: 15/LO/2094
nct id: NCT03806010
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To establish the sensory profile of patients using quantitative sensory testing (QST) and
      questionnaires as well as the level of sensitisation using temporal summation and diffuse
      noxious inhibitory control paradigms in all patients undergoing a chronic pain intervention
      at Barts Health NHS Trust.

      Primary objective- To identify the phenotype of responders and non-responders to a chronic
      pain intervention using QST sensory profile as well as the sensitisation paradigms.

      Secondary objective- To establish the correlation between sensory profile, and sensitisation
      parameters as well as other measures of chronic pain as per Initiative on Methods,
      Measurement and Pain Assessment in clinical trials (IMMPACT) recommendation.

      Common interventions performed at Barts Health NHS Trust includes Neuromodulation, targeted
      epidural steroid and/or radiofrequency treatment, 8% Capsaicin patch and pharmacological
      interventions such as anti-neuropathic agent and opioids.
observational model: Cohort
time perspective: Prospective
measure: • To identify the phenotype of responders and non-responders to a chronic pain intervention using QST sensory profile as well as the sensitisation paradigms.
time frame: QST changes at 4 weeks is taken as primary objective.
description: This is assessed by comparing and reporting any change in QST results before and after the intervention.
measure: • To establish the correlation between sensory profile and sensitisation parameters as well as other measures of chronic pain as per Initiative on Methods, Measurement and Pain Assessment in clinical trials (IMMPACT) recommendation •
time frame: 2 weeks 3, 6 months and one year
description: QST changes
measure: The effect on functionality and quality of life following chronic pain intervention
time frame: 2 weeks and 3, 6 months and 1 year.
description: QST changes
measure: Whether central sensitisation can be used as a bedside biomarker to predict outcome after interventions for chronic pain (i.e. the more centrally sensitised the more superior improvement from treatment)
time frame: 2 weeks and 3, 6 months and 1 year
description: QST changes
arm group label: Quantitative sensory testing
description: QST will be performed at baseline two weeks and 2 months
intervention type: Procedure
intervention name: Quantitative sensory testing
description: Quantitative sensory testing
arm group label: Quantitative sensory testing
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: vIVEK mEHTA, MD
role: Principal Investigator
affiliation: Barts NHS Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Chronic Pain
sharing ipd: Undecided