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/NCT06008899</url>
    </required_header>
    <id_info>
      <org_study_id>629</org_study_id>
      <nct_id>NCT06008899</nct_id>
    </id_info>
    <brief_title>Efficacy of Ultrasound-assisted Caudal Epidural Pulsed Radiofrequency for Anal Pain in Cancer Patients,</brief_title>
    <official_title>Efficacy of Ultrasound-assisted Caudal Epidural Pulsed Radiofrequency for Anal and Perineal Pain in Cancer Patients, a Prospective Randomized Clinical Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Our primary goal will be to investigate the analgesic efficacy of ultrasound (US)-assisted&#xD;
        caudal epidural PRF (pulsed radiofrequency)( stimulation in patients with perineal or anal&#xD;
        pain cancer patients using (visual analog scale (VAS) scores from 0 to 10 at the baseline&#xD;
        (pretreatment), two, four, and eight weeks; secondary outcomes will be the effects on opioid&#xD;
        use and total opioid use in the 24 h, quality of life, patient satisfaction and opioid and&#xD;
        intervention related side effects.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 25, 2023</start_date>
    <completion_date type="Anticipated">August 2024</completion_date>
    <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>visual analog scale (VAS) score 4 weeks post-intervention</measure>
      <time_frame>8 weeks</time_frame>
      <description>Our primary goal will be to investigate the analgesic efficacy of ultrasound-assisted caudal epidural PRF stimulation in patients with perineal or anal pain cancer patients using VAS scores from 0 to 10 at the baseline (pretreatment), two, four, and eight weeks</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Perineal Pain</condition>
    <arm_group>
      <arm_group_label>ultrasound (US) assisted caudal epidural pulsed radiofrequency</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>conventional medical treatment</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>US assisted caudal epidural pulsed radiofrequency</intervention_name>
      <description>patients will receive US assisted caudal epidural pulsed radiofrequency and followed up to 8 weeks</description>
      <arm_group_label>ultrasound (US) assisted caudal epidural pulsed radiofrequency</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  American Society of Anesthesiology physical status of I or III (ASA), of both sex&#xD;
  &#xD;
            -  cancer-related anal or perineal pain&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  coagulopathies&#xD;
  &#xD;
            -  allergies to the contrast dye&#xD;
  &#xD;
            -  patients with moderate or significant cardiac/respiratory disease or hepatic&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Fatma Adel El sherif,MD</investigator_full_name>
      <investigator_title>associate professor of anesthesia, intensive care and pain management</investigator_title>
    </responsible_party>
    <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/NCT06008899
  org study id: 629
  nct id: NCT06008899
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Our primary goal will be to investigate the analgesic efficacy of ultrasound (US)-assisted
        caudal epidural PRF (pulsed radiofrequency)( stimulation in patients with perineal or anal
        pain cancer patients using (visual analog scale (VAS) scores from 0 to 10 at the baseline
        (pretreatment), two, four, and eight weeks; secondary outcomes will be the effects on opioid
        use and total opioid use in the 24 h, quality of life, patient satisfaction and opioid and
        intervention related side effects.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: visual analog scale (VAS) score 4 weeks post-intervention
  time frame: 8 weeks
  description: Our primary goal will be to investigate the analgesic efficacy of ultrasound-assisted caudal epidural PRF stimulation in patients with perineal or anal pain cancer patients using VAS scores from 0 to 10 at the baseline (pretreatment), two, four, and eight weeks
  arm group label: ultrasound (US) assisted caudal epidural pulsed radiofrequency
  arm group type: Active Comparator
  arm group label: conventional medical treatment
  arm group type: No Intervention
  intervention type: Procedure
  intervention name: US assisted caudal epidural pulsed radiofrequency
  description: patients will receive US assisted caudal epidural pulsed radiofrequency and followed up to 8 weeks
  arm group label: ultrasound (US) assisted caudal epidural pulsed radiofrequency
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Fatma Adel El sherif,MD
  investigator title: associate professor of anesthesia, intensive care and pain management
  sharing ipd: No