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/NCT05972369</url>
    </required_header>
    <id_info>
      <org_study_id>012/0701LBP02</org_study_id>
      <nct_id>NCT05972369</nct_id>
    </id_info>
    <brief_title>Sensory Nerve Function and Exercise Therapy Response in Chronic Low Back Pain</brief_title>
    <official_title>Comparing Sensory Nerve Conduction and Quantitative Sensory Testing Thresholds Between Matched Patients With Nonspecific Low Back Pain Categorized as Responders or Non-Responders to Exercise Therapy</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 observational study aims to compare measures of sensory nerve function between chronic&#xD;
        low back pain patients matched for baseline pain and disability levels who are then&#xD;
        classified as responders or non-responders after completing a 12-week tailored exercise&#xD;
        program. Measures collected include sural sensory nerve conduction, quantitative sensory&#xD;
        testing for pressure and heat pain thresholds, and psychosocial questionnaires. It is&#xD;
        hypothesized that baseline sensory nerve dysfunction may be associated with reduced response&#xD;
        to exercise therapy in chronic low back pain.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        While exercise is commonly prescribed for chronic nonspecific low back pain (NSLBP), patient&#xD;
        responses are variable. Differences in baseline sensory nerve function could plausibly&#xD;
        contribute to exercise therapy outcomes. This cross-sectional quantitative observational&#xD;
        study will investigate if baseline sensory nerve conduction amplitudes and quantitative&#xD;
        sensory testing (QST) pain thresholds differ between matched NSLBP patients later categorized&#xD;
        as responders or non-responders to a 12-week standardized exercise regime. A sample of 50&#xD;
        NSLBP participants with matched baseline pain and disability will undergo a tailored 12-week&#xD;
        exercise intervention and 6-month follow-up. Blinded assessors will perform post-intervention&#xD;
        sensory nerve conduction and QST measures. It is hypothesized that exercise therapy&#xD;
        responders will show greater improvements in sensory thresholds correlating with pain relief.&#xD;
        Results aim to elucidate neural factors associated with long-term exercise therapy outcomes&#xD;
        in chronic low back pain.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">March 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 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>Sural Sensory Nerve Conduction Amplitude</measure>
      <time_frame>Baseline</time_frame>
      <description>Baseline antidromic sural sensory nerve action potential amplitude (measured in microvolts) assessed through nerve conduction study.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Superficial Peroneal Sensory Nerve Conduction Amplitude</measure>
      <time_frame>Baseline</time_frame>
      <description>Baseline superficial peroneal sensory nerve action potential amplitude (measured in microvolts) assessed through nerve conduction study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pressure Pain Threshold</measure>
      <time_frame>Baseline</time_frame>
      <description>Pressure pain threshold (measured in kg/cm2) assessed using a pressure algometer at the lower back.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Heat Pain Threshold</measure>
      <time_frame>Baseline</time_frame>
      <description>Heat pain threshold (measured in °C) assessed using a thermode applied to the calf.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Chronic Low-back Pain</condition>
    <arm_group>
      <arm_group_label>Exercise Responders</arm_group_label>
      <description>≥30% improvement in pain with 12 weeks of prescribed exercise</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Exercise Non-responders</arm_group_label>
      <description>&lt;30% improvement in pain with 12 weeks of prescribed exercise</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>12-Week Tailored Exercise Intervention</intervention_name>
      <description>12-week individually tailored exercise therapy program based on patient presentation. Supervised physiotherapy plus home exercise</description>
      <arm_group_label>Exercise Non-responders</arm_group_label>
      <arm_group_label>Exercise Responders</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adults with chronic nonspecific low back pain matched for baseline pain and disability&#xD;
          levels.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults ages 20-60 years&#xD;
  &#xD;
            -  Nonspecific chronic low back pain &gt;3 months&#xD;
  &#xD;
            -  Baseline pain ≥6/10 and disability ≥40%&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Radicular leg pain&#xD;
  &#xD;
            -  Prior lumbar surgery&#xD;
  &#xD;
            -  Serious spinal pathology&#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 Director</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/NCT05972369
  org study id: 012/0701LBP02
  nct id: NCT05972369
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This observational study aims to compare measures of sensory nerve function between chronic
        low back pain patients matched for baseline pain and disability levels who are then
        classified as responders or non-responders after completing a 12-week tailored exercise
        program. Measures collected include sural sensory nerve conduction, quantitative sensory
        testing for pressure and heat pain thresholds, and psychosocial questionnaires. It is
        hypothesized that baseline sensory nerve dysfunction may be associated with reduced response
        to exercise therapy in chronic low back pain.
  While exercise is commonly prescribed for chronic nonspecific low back pain (NSLBP), patient
        responses are variable. Differences in baseline sensory nerve function could plausibly
        contribute to exercise therapy outcomes. This cross-sectional quantitative observational
        study will investigate if baseline sensory nerve conduction amplitudes and quantitative
        sensory testing (QST) pain thresholds differ between matched NSLBP patients later categorized
        as responders or non-responders to a 12-week standardized exercise regime. A sample of 50
        NSLBP participants with matched baseline pain and disability will undergo a tailored 12-week
        exercise intervention and 6-month follow-up. Blinded assessors will perform post-intervention
        sensory nerve conduction and QST measures. It is hypothesized that exercise therapy
        responders will show greater improvements in sensory thresholds correlating with pain relief.
        Results aim to elucidate neural factors associated with long-term exercise therapy outcomes
        in chronic low back pain.
  observational model: Other
  time perspective: Cross-Sectional
  measure: Sural Sensory Nerve Conduction Amplitude
  time frame: Baseline
  description: Baseline antidromic sural sensory nerve action potential amplitude (measured in microvolts) assessed through nerve conduction study.
  measure: Superficial Peroneal Sensory Nerve Conduction Amplitude
  time frame: Baseline
  description: Baseline superficial peroneal sensory nerve action potential amplitude (measured in microvolts) assessed through nerve conduction study.
  measure: Pressure Pain Threshold
  time frame: Baseline
  description: Pressure pain threshold (measured in kg/cm2) assessed using a pressure algometer at the lower back.
  measure: Heat Pain Threshold
  time frame: Baseline
  description: Heat pain threshold (measured in °C) assessed using a thermode applied to the calf.
  arm group label: Exercise Responders
  description: ≥30% improvement in pain with 12 weeks of prescribed exercise
  arm group label: Exercise Non-responders
  description: <30% improvement in pain with 12 weeks of prescribed exercise
  intervention type: Other
  intervention name: 12-Week Tailored Exercise Intervention
  description: 12-week individually tailored exercise therapy program based on patient presentation. Supervised physiotherapy plus home exercise
  arm group label: Exercise Non-responders
  arm group label: Exercise Responders
  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 Director
  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