<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/NCT04433299</url>
  </required_header>
  <id_info>
    <org_study_id>2019-00136</org_study_id>
    <nct_id>NCT04433299</nct_id>
  </id_info>
  <brief_title>Back Pain - Linking Phenotype to Pain Mechanism and Outcome.</brief_title>
  <official_title>Back Pain - Linking Phenotype to Pain Mechanism and Outcome.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Balgrist University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Balgrist University Hospital</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 investigate whether different clinical, psychophysical and neurophysiological phenotypes&#xD;
      can be identified among low back pain patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Low back pain patients will fill in a detailed questionnaire (incl. pain drawing) about their&#xD;
      pain. Some of them will undergo a standardized quantitative sensory testing protocol and an&#xD;
      fMRI procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2024</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>spatial pain extent</measure>
    <time_frame>baseline</time_frame>
    <description>spatial pain extent (body map)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>measures for central sensitization</measure>
    <time_frame>baseline</time_frame>
    <description>temporal summation and conditioned pain modulation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes in spatial pain extent</measure>
    <time_frame>changes from baseline to 3 months</time_frame>
    <description>changes in spatial pain extent (bodymap)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in measures for central sensitization</measure>
    <time_frame>changes from baseline to 3 months</time_frame>
    <description>changes in temporal summation and conditioned pain modulation</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>low back pain patients</arm_group_label>
    <description>no intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>controls</arm_group_label>
    <description>no intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no intervention, observational</intervention_name>
    <description>no intervention, observational</description>
    <arm_group_label>controls</arm_group_label>
    <arm_group_label>low back pain patients</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood sample (6 ml)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients between 18 and 80 with low back pain&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -primary complaint: low back pain clinically not attributable to red flags&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any major medical or psychiatric condition that affects pain sensitivity&#xD;
&#xD;
          -  contraindications to MRI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Petra Schweinhardt, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Balgrist University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lucas Tauschek, BSc</last_name>
    <phone>+41 44 386 57 11</phone>
    <email>lucas.tauschek@balgrist.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Brigitte Wirth, PhD</last_name>
    <phone>+41 44 386 57 03</phone>
    <email>brigitte.wirth@balgrist.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Balgrist University Hospital</name>
      <address>
        <city>Zürich</city>
        <state>Zurich</state>
        <zip>8008</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lucas Tauschek</last_name>
      <phone>+41 44 386 57 11</phone>
      <email>lucas.tauschek@balgrist.ch</email>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>September 21, 2019</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>August 14, 2023</last_update_submitted>
  <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>low back pain, phenotype</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back 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/NCT04433299
org study id: 2019-00136
nct id: NCT04433299
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To investigate whether different clinical, psychophysical and neurophysiological phenotypes
      can be identified among low back pain patients
Low back pain patients will fill in a detailed questionnaire (incl. pain drawing) about their
      pain. Some of them will undergo a standardized quantitative sensory testing protocol and an
      fMRI procedure.
observational model: Cohort
time perspective: Prospective
measure: spatial pain extent
time frame: baseline
description: spatial pain extent (body map)
measure: measures for central sensitization
time frame: baseline
description: temporal summation and conditioned pain modulation
measure: changes in spatial pain extent
time frame: changes from baseline to 3 months
description: changes in spatial pain extent (bodymap)
measure: changes in measures for central sensitization
time frame: changes from baseline to 3 months
description: changes in temporal summation and conditioned pain modulation
arm group label: low back pain patients
description: no intervention
arm group label: controls
description: no intervention
intervention type: Other
intervention name: no intervention, observational
description: no intervention, observational
arm group label: controls
arm group label: low back pain patients
blood sample (6 ml)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Petra Schweinhardt, MD, PhD
role: Principal Investigator
affiliation: Balgrist University Hospital
last name: Lucas Tauschek, BSc
phone: +41 44 386 57 11
email: lucas.tauschek@balgrist.ch
last name: Brigitte Wirth, PhD
phone: +41 44 386 57 03
email: brigitte.wirth@balgrist.ch
facility: 
status: Recruiting
contact: 
country: Switzerland
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: Undecided