<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/NCT03039296</url>
  </required_header>
  <id_info>
    <org_study_id>5N/2016</org_study_id>
    <nct_id>NCT03039296</nct_id>
  </id_info>
  <brief_title>EuroPainClinics® Study IV (Prospective Observational Study)</brief_title>
  <acronym>EPCSIV</acronym>
  <official_title>EuroPainClinics® Study IV (Prospective Observational Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Europainclinics z.ú.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Europainclinics z.ú.</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>
      In this prospective observational trial the effect of the Endoscopic rhizotomy microinvasive&#xD;
      therapy should be examined in (approximately 150) adult patients with low back pain positive&#xD;
      for facet joint pain component.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Facet joint pain encompasses a significant portion of possible sources of pain in patients&#xD;
      with vertebrogenic algic syndrome. A typical symptom is intermittent radiation of pain in the&#xD;
      back and legs. The cause of this pain is irritation of the medial branch of the dorsal nerve&#xD;
      root, which innervates a facet joint. Confirmation of the source of pain involves using a&#xD;
      local anaesthetic to block the medial branches of several vertebral areas. If, through this&#xD;
      test, the facet joints are determined to be the source of pain the patient's condition is&#xD;
      indicated for radiofrequency ablation of the nerve branches.&#xD;
&#xD;
      EuroPainClinics® Study IV (EPCS IV) is a prospective observational comparative study that&#xD;
      will use pain scales to analyse changes in the neurological status of nerves of patients who&#xD;
      undergo the minimally invasive procedure: radiofrequency nerve ablation and cryoablation of&#xD;
      the lumber facet joints.&#xD;
&#xD;
      The study aims to investigate documented clinical results of the neurological conditions of&#xD;
      patients, to compare pain scales and the use of analgesics over a number of time periods:&#xD;
      prior to the procedure, 6 weeks post-procedure, as well as 6 and 12 months post-procedure.&#xD;
      The data will be subsequently statistically analysed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The low number of participants was enrolled in to the clinical trial&#xD;
  </why_stopped>
  <start_date type="Actual">February 3, 2017</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>4 Years</target_duration>
  <primary_outcome>
    <measure>Pain as assessed by the Visual analogue scale</measure>
    <time_frame>4 years</time_frame>
    <description>All acquired information will be noted in to the special anonymous protocol</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain localization as assessed by note of radiating dermatome as neurologic examination</measure>
    <time_frame>4 years</time_frame>
    <description>All acquired information will be noted in to the special anonymous protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain progress as assessed by global pain scale</measure>
    <time_frame>4 years</time_frame>
    <description>All acquired information will be noted in to the special anonymous protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in analgesics drugs consumption as assessed by equianalgesic dose ratios for opioids</measure>
    <time_frame>4 years</time_frame>
    <description>All acquired information will be noted in to the special anonymous protocol</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">4</enrollment>
  <condition>Low Back Pain</condition>
  <condition>Facet Joint Pain</condition>
  <arm_group>
    <arm_group_label>One side endoscopic rhizotomy</arm_group_label>
    <description>Endoscopic rhizotomy will be provided only on one back side according pain</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Both sides endoscopic rhizotomy</arm_group_label>
    <description>Endoscopic rhizotomy will be provided on both back sides according pain</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic rhizotomy</intervention_name>
    <description>Endoscopic rhizotomy (facet joint denervation) is carried out through the insertion of an endoscope to the medial spinal nerve area with the help of mobile C-arm x-ray guidance. The tissue surrounding the medial nerves is endoscopically visualized and dissected with a sterile grasper to expose the nerve structure. Finally, a radiofrequency probe is used to ablate the problematic medial branch nerve under direct endoscopic control. The procedure is concluded with the removal of the endoscope and the small incision is closed with 1-2 skin sutures.</description>
    <arm_group_label>Both sides endoscopic rhizotomy</arm_group_label>
    <arm_group_label>One side endoscopic rhizotomy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study aims to investigate documented clinical results of the neurological conditions of&#xD;
        patients, to compare pain scales and the use of analgesics over a number of time periods:&#xD;
        prior to the procedure, 6 weeks post-procedure, as well as 6 and 12 months post-procedure.&#xD;
        The data will be subsequently statistically analysed.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who undergo Endoscopic rhizotomy therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ladislav Kočan, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>europainclinicsstudy@gmail.com</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Europainclinics</name>
      <address>
        <city>Košice</city>
        <zip>04011</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Slovakia</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>December 30, 2021</last_update_submitted>
  <last_update_submitted_qc>December 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Low back pain</keyword>
  <keyword>Facet joints</keyword>
  <keyword>Endoscopic rhizotomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthralgia</mesh_term>
    <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/NCT03039296
org study id: 5N/2016
nct id: NCT03039296
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this prospective observational trial the effect of the Endoscopic rhizotomy microinvasive
      therapy should be examined in (approximately 150) adult patients with low back pain positive
      for facet joint pain component.
Facet joint pain encompasses a significant portion of possible sources of pain in patients
      with vertebrogenic algic syndrome. A typical symptom is intermittent radiation of pain in the
      back and legs. The cause of this pain is irritation of the medial branch of the dorsal nerve
      root, which innervates a facet joint. Confirmation of the source of pain involves using a
      local anaesthetic to block the medial branches of several vertebral areas. If, through this
      test, the facet joints are determined to be the source of pain the patient's condition is
      indicated for radiofrequency ablation of the nerve branches.

      EuroPainClinics® Study IV (EPCS IV) is a prospective observational comparative study that
      will use pain scales to analyse changes in the neurological status of nerves of patients who
      undergo the minimally invasive procedure: radiofrequency nerve ablation and cryoablation of
      the lumber facet joints.

      The study aims to investigate documented clinical results of the neurological conditions of
      patients, to compare pain scales and the use of analgesics over a number of time periods:
      prior to the procedure, 6 weeks post-procedure, as well as 6 and 12 months post-procedure.
      The data will be subsequently statistically analysed.
observational model: Cohort
time perspective: Prospective
measure: Pain as assessed by the Visual analogue scale
time frame: 4 years
description: All acquired information will be noted in to the special anonymous protocol
measure: Pain localization as assessed by note of radiating dermatome as neurologic examination
time frame: 4 years
description: All acquired information will be noted in to the special anonymous protocol
measure: Pain progress as assessed by global pain scale
time frame: 4 years
description: All acquired information will be noted in to the special anonymous protocol
measure: Changes in analgesics drugs consumption as assessed by equianalgesic dose ratios for opioids
time frame: 4 years
description: All acquired information will be noted in to the special anonymous protocol
arm group label: One side endoscopic rhizotomy
description: Endoscopic rhizotomy will be provided only on one back side according pain
arm group label: Both sides endoscopic rhizotomy
description: Endoscopic rhizotomy will be provided on both back sides according pain
intervention type: Procedure
intervention name: Endoscopic rhizotomy
description: Endoscopic rhizotomy (facet joint denervation) is carried out through the insertion of an endoscope to the medial spinal nerve area with the help of mobile C-arm x-ray guidance. The tissue surrounding the medial nerves is endoscopically visualized and dissected with a sterile grasper to expose the nerve structure. Finally, a radiofrequency probe is used to ablate the problematic medial branch nerve under direct endoscopic control. The procedure is concluded with the removal of the endoscope and the small incision is closed with 1-2 skin sutures.
arm group label: Both sides endoscopic rhizotomy
arm group label: One side endoscopic rhizotomy
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Ladislav Kočan, MD PhD
role: Study Director
affiliation: europainclinicsstudy@gmail.com
facility: 
country: Slovakia
responsible party type: Sponsor
mesh term: Arthralgia
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: Undecided