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/NCT05970081</url>
    </required_header>
    <id_info>
      <org_study_id>5215</org_study_id>
      <nct_id>NCT05970081</nct_id>
    </id_info>
    <brief_title>Effectiveness and Safety of Implantable Intrathecal Systems for Refractory Pain in Spain (INTRATHECAL-RENASED)</brief_title>
    <official_title>Effectiveness and Safety of Implantable Intrathecal Systems for the Treatment of Chronic Refractory Pain in Spain: Prospective Multicenter Study From the Spanish Pain Society Registry (INTRATHECAL-RENASED)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sociedad Espanola del Dolor</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sociedad Espanola del Dolor</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>
        Refractory pain is a prevalent condition that negatively affects patients' quality of life.&#xD;
        Intrathecal implantable systems have been proposed as a treatment option for refractory pain.&#xD;
        However, real-world data on the effectiveness and safety of these therapies in Spain are&#xD;
        scarce. This study aims to obtain real-world data on the effectiveness and safety of&#xD;
        intrathecal implantable systems for refractory pain treatment in Spain.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        All Spanish hospitals that implant intrathecal systems for refractory pain will be invited to&#xD;
        participate in the study. Patients will be recruited before the procedure, and before&#xD;
        providing data to the registry, the study will be explained to them, and they will sign an&#xD;
        informed consent form. Demographic data related to the pathology and procedure will be&#xD;
        collected. Follow-up will be conducted at three and twelve months after the procedure.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2025</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>1 Year</target_duration>
    <primary_outcome>
      <measure>Percentage of patients with at least 50 percent pain relief in the area of their predominant pain at one year</measure>
      <time_frame>Twelve months</time_frame>
      <description>Percentage of patients who experience a reduction of at least 50 percent in the intensity of their predominant pain compared to the initial value, assessed twelve months after the implantation of the intrathecal drug delivery system. Pain intensity will be measured using an 11-point Numeric Pain Rating Scale (NPRS), with a range from 0 (no pain) to 10 (maximum pain possible)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Percentage of patients with at least 50 percent pain relief in the area of their predominant pain at three months</measure>
      <time_frame>Three months</time_frame>
      <description>Percentage of patients who experience a reduction of at least 50 percent in the intensity of their predominant pain compared to the initial value, assessed three months after the implantation of the implantable intrathecal system. Pain intensity will be measured using an 11-point Numeric Pain Rating Scale (NPRS), with a range from 0 (no pain) to 10 (maximum pain possible)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of patients with at least 50 percent pain relief in the area of their non-predominant pain at one year</measure>
      <time_frame>Twelve months</time_frame>
      <description>Percentage of patients who experience a reduction of at least 50 percent in the intensity of their non-predominant pain compared to the initial value, assessed twelve months after the implantation of the intrathecal drug delivery system. Pain intensity will be measured using an 11-point Numeric Pain Rating Scale (NPRS), with a range from 0 (no pain) to 10 (maximum pain possible)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Compared change from baseline on health-related quality of life scores (EQ Index)</measure>
      <time_frame>Three and twelve months</time_frame>
      <description>The impact of the treatment on the patient's health-related quality of life will be evaluated using the EQ-5D-5L questionnaire at three and twelve months after implantation. The EQ-5D-5L assesses quality of life across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain is scored on a scale of 1 (no problems) to 5 (extreme problems), generating a 5-digit code that corresponds to the patient's health status.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Global Impression of Improvement (PGI-I)</measure>
      <time_frame>Three and twelve months</time_frame>
      <description>Assessment of clinical global impression of improvement using the PGI-I scale at three and twelve months after implantation of the intrathecal drug delivery system. The PGI-I score ranges from 1 (Very much better) through to 7 (Very much worse). The lower the score, the better the improvement.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Satisfaction</measure>
      <time_frame>Three and twelve months</time_frame>
      <description>Percentage of implanted subjects satisfied with the treatment at three and twelve months after the implantation of the intrathecal drug delivery system. Defined as indicating: &quot;since the start of the therapy has the pain improved? yes/no&quot;, &quot;Are you satisfied with the treatment?&quot; yes/no or &quot;would you agree to the treatment again?&quot; yes/no</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Adverse Events as a Measure of Safety</measure>
      <time_frame>Three and twelve months</time_frame>
      <description>Number and percentage of patients with adverse effects related to therapy at three and twelve months after implantation of the intrathecal drug delivery system.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">504</enrollment>
    <condition>Refractory Pain</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with refractory pain who are candidates for treatment with an implantable&#xD;
          intrathecal infusion system.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Chronic refractory pain patients candidates for treatment with an implantable&#xD;
               neurostimulation system.&#xD;
  &#xD;
            -  Accept to participate in the study and sign informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients in whom it would be difficult to complete follow-up.&#xD;
  &#xD;
            -  Insufficient understanding of the Spanish language.&#xD;
  &#xD;
            -  Pregnancy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Antonio Ojeda, MD</last_name>
      <phone>0034911729144</phone>
      <email>renased@sedolor.es</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hospital Regional Univeristario de Málaga</name>
        <address>
          <city>Málaga</city>
          <state>Andalucia</state>
          <zip>29010</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Mariano Fernández Baena, MD</last_name>
      </contact>
      <investigator>
        <last_name>Mariano Fernández Baena, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Hospital Clinic de Barcelona</name>
        <address>
          <city>Barcelona</city>
          <zip>08036</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Antonio Ojeda, MD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital Universitario de La Princesa</name>
        <address>
          <city>Madrid</city>
          <zip>28028</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Concepción Pérez, MD, PhD</last_name>
      </contact>
      <investigator>
        <last_name>Concepción Pérez, Md, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Hospital Universitario Puerta de Hierro Majadahonda</name>
        <address>
          <city>Madrid</city>
          <zip>28222</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Agustín Mendiola, MD, PhD</last_name>
      </contact>
      <investigator>
        <last_name>Agustin Mendiola, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Complexo Hospitalario Univeritario de Ourense</name>
        <address>
          <city>Ourense</city>
          <zip>32005</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Luz Cánovas Martínez, MD</last_name>
      </contact>
      <investigator>
        <last_name>Luz Cánovas Martínez, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Spain</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 1, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Intrathecal Drug Delivery</keyword>
    <keyword>Implantable Infusion Pump</keyword>
    <keyword>Refractory Pain</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Intractable</mesh_term>
    </condition_browse>
    <!-- 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/NCT05970081
  org study id: 5215
  nct id: NCT05970081
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Refractory pain is a prevalent condition that negatively affects patients' quality of life.
        Intrathecal implantable systems have been proposed as a treatment option for refractory pain.
        However, real-world data on the effectiveness and safety of these therapies in Spain are
        scarce. This study aims to obtain real-world data on the effectiveness and safety of
        intrathecal implantable systems for refractory pain treatment in Spain.
  All Spanish hospitals that implant intrathecal systems for refractory pain will be invited to
        participate in the study. Patients will be recruited before the procedure, and before
        providing data to the registry, the study will be explained to them, and they will sign an
        informed consent form. Demographic data related to the pathology and procedure will be
        collected. Follow-up will be conducted at three and twelve months after the procedure.
  observational model: Cohort
  time perspective: Prospective
  measure: Percentage of patients with at least 50 percent pain relief in the area of their predominant pain at one year
  time frame: Twelve months
  description: Percentage of patients who experience a reduction of at least 50 percent in the intensity of their predominant pain compared to the initial value, assessed twelve months after the implantation of the intrathecal drug delivery system. Pain intensity will be measured using an 11-point Numeric Pain Rating Scale (NPRS), with a range from 0 (no pain) to 10 (maximum pain possible)
  measure: Percentage of patients with at least 50 percent pain relief in the area of their predominant pain at three months
  time frame: Three months
  description: Percentage of patients who experience a reduction of at least 50 percent in the intensity of their predominant pain compared to the initial value, assessed three months after the implantation of the implantable intrathecal system. Pain intensity will be measured using an 11-point Numeric Pain Rating Scale (NPRS), with a range from 0 (no pain) to 10 (maximum pain possible)
  measure: Percentage of patients with at least 50 percent pain relief in the area of their non-predominant pain at one year
  time frame: Twelve months
  description: Percentage of patients who experience a reduction of at least 50 percent in the intensity of their non-predominant pain compared to the initial value, assessed twelve months after the implantation of the intrathecal drug delivery system. Pain intensity will be measured using an 11-point Numeric Pain Rating Scale (NPRS), with a range from 0 (no pain) to 10 (maximum pain possible)
  measure: Compared change from baseline on health-related quality of life scores (EQ Index)
  time frame: Three and twelve months
  description: The impact of the treatment on the patient's health-related quality of life will be evaluated using the EQ-5D-5L questionnaire at three and twelve months after implantation. The EQ-5D-5L assesses quality of life across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain is scored on a scale of 1 (no problems) to 5 (extreme problems), generating a 5-digit code that corresponds to the patient's health status.
  measure: Patient Global Impression of Improvement (PGI-I)
  time frame: Three and twelve months
  description: Assessment of clinical global impression of improvement using the PGI-I scale at three and twelve months after implantation of the intrathecal drug delivery system. The PGI-I score ranges from 1 (Very much better) through to 7 (Very much worse). The lower the score, the better the improvement.
  measure: Patient Satisfaction
  time frame: Three and twelve months
  description: Percentage of implanted subjects satisfied with the treatment at three and twelve months after the implantation of the intrathecal drug delivery system. Defined as indicating: "since the start of the therapy has the pain improved? yes/no", "Are you satisfied with the treatment?" yes/no or "would you agree to the treatment again?" yes/no
  measure: Number of Adverse Events as a Measure of Safety
  time frame: Three and twelve months
  description: Number and percentage of patients with adverse effects related to therapy at three and twelve months after implantation of the intrathecal drug delivery system.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Antonio Ojeda, MD
  phone: 0034911729144
  email: renased@sedolor.es
  facility: 
  status: Not yet recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  investigator: 
  facility: 
  status: Not yet recruiting
  contact: 
  investigator: 
  facility: 
  status: Not yet recruiting
  contact: 
  investigator: 
  country: Spain
  responsible party type: Sponsor
  mesh term: Pain, Intractable