xml: <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/NCT05972395</url>
    </required_header>
    <id_info>
      <org_study_id>LBP01</org_study_id>
      <nct_id>NCT05972395</nct_id>
    </id_info>
    <brief_title>Conditioned Pain Modulation in Localized vs Widespread Chronic Low Back Pain</brief_title>
    <official_title>Determining if Conditioned Pain Modulation Differs Between Individuals With Localized Versus Widespread Mechanical Pain Hypersensitivity in Chronic Low Back Pain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ahram Canadian University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ahram Canadian University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study aims to compare function of the body's endogenous pain modulation system between&#xD;
        people with localized low back pain versus widespread body pain. Endogenous pain modulation&#xD;
        refers to the body's natural ability to inhibit one pain stimulus by applying a second pain&#xD;
        stimulus. This study will assess pain inhibition by measuring pressure pain thresholds at the&#xD;
        low back before and during cold water hand immersion. The researchers hypothesize that those&#xD;
        with widespread body pain will have worse functioning of pain inhibition compared to those&#xD;
        with localized low back pain only. The results may provide insights into personalized chronic&#xD;
        pain management approaches.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Chronic low back pain (CLBP) is highly prevalent worldwide. Impairments in conditioned pain&#xD;
        modulation (CPM) have been documented in CLBP populations. CPM refers to endogenous pain&#xD;
        inhibition, where one noxious stimulus inhibits pain from a second noxious stimulus. This&#xD;
        relies on descending inhibitory pathways. However, it is unknown whether CPM alterations&#xD;
        differ between individuals with localized versus widespread mechanical pain hypersensitivity.&#xD;
        The aim of this cross-sectional quantitative sensory testing study is to compare CPM function&#xD;
        between localized and widespread CLBP subgroups. A sample of 75 adults with CLBP of at least&#xD;
        3 months duration will be recruited from a chronic pain clinic. Based on pressure pain&#xD;
        threshold mapping at the low back and distal sites, participants will be classified as having&#xD;
        localized or widespread mechanical hyperalgesia.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">July 28, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 25, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Conditioned Pain Modulation</measure>
      <time_frame>Baseline</time_frame>
      <description>Percent change in pressure pain threshold at the lumbar region during cold water hand immersion conditioning stimulus compared to baseline pressure pain threshold at the lumbar region without the conditioning stimulus.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pressure Pain Thresholds</measure>
      <time_frame>baseline</time_frame>
      <description>Pressure pain thresholds measured in kg/cm2 using a pressure algometer at the lumbar spine and distal sites including the upper trapezius and thumbnail.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">75</enrollment>
    <condition>Chronic Low-back Pain</condition>
    <arm_group>
      <arm_group_label>Localized CLBP</arm_group_label>
      <description>Chronic low back pain &gt;3 months with localized pressure pain hyperalgesia</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Widespread CLBP</arm_group_label>
      <description>Chronic low back pain &gt;3 months with widespread pressure pain hyperalgesia</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Localized vs Widespread Mechanical Pain Hypersensitivity</intervention_name>
      <description>Based on pressure pain threshold mapping, participants will be classified as having either localized mechanical pain hyperalgesia (hyperalgesia limited to the lumbosacral region) or widespread mechanical pain hyperalgesia (hyperalgesia extending beyond the lumbosacral region).</description>
      <arm_group_label>Localized CLBP</arm_group_label>
      <arm_group_label>Widespread CLBP</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adults with chronic nonspecific LBP stratified by localized vs widespread mechanical&#xD;
          hyperalgesia&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Ages 18-60 years&#xD;
  &#xD;
            -  Chronic LBP &gt;3 months&#xD;
  &#xD;
            -  Average LBP intensity ≥4/10&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Known LBP pathologies&#xD;
  &#xD;
            -  Previous lumbar surgery&#xD;
  &#xD;
            -  Neuropathic LBP&#xD;
  &#xD;
            -  Comorbid generalized pain conditions&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Amal Fawzy, Ph.d</last_name>
      <role>Study Chair</role>
      <affiliation>Faculty of Physical Therapy, Ahram Canadian University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mohamed M ElMeligie, Ph.d</last_name>
      <phone>+201064442032</phone>
      <email>mohamed.elmeligie@acu.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Outpatient clinic of faculty of physical therapy, Ahram Canadian University</name>
        <address>
          <city>Al Ḩayy Ath Thāmin</city>
          <state>Giza</state>
          <zip>3221405</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mohamed M ElMeligie, Ph.d</last_name>
        <phone>01064442032</phone>
        <email>mohamed.elmeligie@acu.edu.eg</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ahram Canadian University</investigator_affiliation>
      <investigator_full_name>Mohamed Magdy ElMeligie</investigator_full_name>
      <investigator_title>Lecturer of Physical Therapy and Director of Electromyography Lab</investigator_title>
    </responsible_party>
    <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>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05972395
  org study id: LBP01
  nct id: NCT05972395
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to compare function of the body's endogenous pain modulation system between
        people with localized low back pain versus widespread body pain. Endogenous pain modulation
        refers to the body's natural ability to inhibit one pain stimulus by applying a second pain
        stimulus. This study will assess pain inhibition by measuring pressure pain thresholds at the
        low back before and during cold water hand immersion. The researchers hypothesize that those
        with widespread body pain will have worse functioning of pain inhibition compared to those
        with localized low back pain only. The results may provide insights into personalized chronic
        pain management approaches.
  Chronic low back pain (CLBP) is highly prevalent worldwide. Impairments in conditioned pain
        modulation (CPM) have been documented in CLBP populations. CPM refers to endogenous pain
        inhibition, where one noxious stimulus inhibits pain from a second noxious stimulus. This
        relies on descending inhibitory pathways. However, it is unknown whether CPM alterations
        differ between individuals with localized versus widespread mechanical pain hypersensitivity.
        The aim of this cross-sectional quantitative sensory testing study is to compare CPM function
        between localized and widespread CLBP subgroups. A sample of 75 adults with CLBP of at least
        3 months duration will be recruited from a chronic pain clinic. Based on pressure pain
        threshold mapping at the low back and distal sites, participants will be classified as having
        localized or widespread mechanical hyperalgesia.
  observational model: Other
  time perspective: Cross-Sectional
  measure: Conditioned Pain Modulation
  time frame: Baseline
  description: Percent change in pressure pain threshold at the lumbar region during cold water hand immersion conditioning stimulus compared to baseline pressure pain threshold at the lumbar region without the conditioning stimulus.
  measure: Pressure Pain Thresholds
  time frame: baseline
  description: Pressure pain thresholds measured in kg/cm2 using a pressure algometer at the lumbar spine and distal sites including the upper trapezius and thumbnail.
  arm group label: Localized CLBP
  description: Chronic low back pain >3 months with localized pressure pain hyperalgesia
  arm group label: Widespread CLBP
  description: Chronic low back pain >3 months with widespread pressure pain hyperalgesia
  intervention type: Other
  intervention name: Localized vs Widespread Mechanical Pain Hypersensitivity
  description: Based on pressure pain threshold mapping, participants will be classified as having either localized mechanical pain hyperalgesia (hyperalgesia limited to the lumbosacral region) or widespread mechanical pain hyperalgesia (hyperalgesia extending beyond the lumbosacral region).
  arm group label: Localized CLBP
  arm group label: Widespread CLBP
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Amal Fawzy, Ph.d
  role: Study Chair
  affiliation: Faculty of Physical Therapy, Ahram Canadian University
  last name: Mohamed M ElMeligie, Ph.d
  phone: +201064442032
  email: mohamed.elmeligie@acu.edu.eg
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Ahram Canadian University
  investigator full name: Mohamed Magdy ElMeligie
  investigator title: Lecturer of Physical Therapy and Director of Electromyography Lab
  mesh term: Back Pain
  mesh term: Low Back Pain
  sharing ipd: No