<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/NCT02197741</url>
  </required_header>
  <id_info>
    <org_study_id>2014-15</org_study_id>
    <nct_id>NCT02197741</nct_id>
  </id_info>
  <brief_title>The Effect of an Additional Bolus Application in Patients With Intrathecal Opiate Administration - a Pilot Study</brief_title>
  <official_title>The Effect of an Additional Bolus Application in Patients With Intrathecal Opiate Administration - a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Swiss Paraplegic Centre Nottwil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Swiss Paraplegic Centre Nottwil</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      An additional, intermittent bolus application in patients with intrathecal opiate&#xD;
      administration for chronic pain syndrome may have a positive effect on the effectiveness of&#xD;
      the treatment. Thus, the effect of an additional, intermittent bolus application in patients&#xD;
      with intrathecal opiate administration was therefore investigated.&#xD;
&#xD;
      Patients already equipped with an intrathecal opiate pump were enrolled into the study. Each&#xD;
      patient was submitted to two treatment periods in randomly chosen order (cross-over design):&#xD;
      1. standard treatment (continuous opiate administration) and 2. continuous opiate&#xD;
      administration with intermittent opiate bolus application. Both treatment periods lasted 14&#xD;
      days. Patients were asked to record pain intensity, side effects and satisfaction with the&#xD;
      treatment.&#xD;
&#xD;
      The following hypotheses were tested:&#xD;
&#xD;
        -  The application of additional opiate boli results in significantly lower pain intensity.&#xD;
&#xD;
        -  The application of additional opiate boli does not result in a higher rate of adverse&#xD;
           Events.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>change in pain intensity</measure>
    <time_frame>day 0. day 14, day 28</time_frame>
    <description>numeric rating scale from 0 to10</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in satisfaction with treatment outcome</measure>
    <time_frame>day 0, day 14, day 28</time_frame>
    <description>numeric rating scale from 0 to 10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>side effects</measure>
    <time_frame>from day 0 to day 28</time_frame>
    <description>occurrence rate of side effects</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">10</enrollment>
  <condition>Chronic Pain Syndrome</condition>
  <arm_group>
    <arm_group_label>opiate without bolus</arm_group_label>
    <description>continuous opiate administration without bolus application</description>
  </arm_group>
  <arm_group>
    <arm_group_label>opiate with bolus</arm_group_label>
    <description>continuous opiate administration with additional bolus application</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>opiate with bolus</intervention_name>
    <arm_group_label>opiate with bolus</arm_group_label>
    <arm_group_label>opiate without bolus</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        individuals with chronic pain syndrome&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  chronic pain syndrome&#xD;
&#xD;
          -  intrathecal opiate pump&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  younger than 18 years&#xD;
&#xD;
          -  other (than opiate) intrathecal drug administration&#xD;
&#xD;
          -  discontent with intrathecal opiate therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tim Reck, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center for Pain Medicine</affiliation>
  </overall_official>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>November 21, 2016</last_update_submitted>
  <last_update_submitted_qc>November 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Opiate Alkaloids</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02197741
org study id: 2014-15
nct id: NCT02197741
lead sponsor: 
has dmc: No
An additional, intermittent bolus application in patients with intrathecal opiate
      administration for chronic pain syndrome may have a positive effect on the effectiveness of
      the treatment. Thus, the effect of an additional, intermittent bolus application in patients
      with intrathecal opiate administration was therefore investigated.

      Patients already equipped with an intrathecal opiate pump were enrolled into the study. Each
      patient was submitted to two treatment periods in randomly chosen order (cross-over design):
      1. standard treatment (continuous opiate administration) and 2. continuous opiate
      administration with intermittent opiate bolus application. Both treatment periods lasted 14
      days. Patients were asked to record pain intensity, side effects and satisfaction with the
      treatment.

      The following hypotheses were tested:

        -  The application of additional opiate boli results in significantly lower pain intensity.

        -  The application of additional opiate boli does not result in a higher rate of adverse
           Events.
observational model: Case-Crossover
time perspective: Prospective
measure: change in pain intensity
time frame: day 0. day 14, day 28
description: numeric rating scale from 0 to10
measure: change in satisfaction with treatment outcome
time frame: day 0, day 14, day 28
description: numeric rating scale from 0 to 10
measure: side effects
time frame: from day 0 to day 28
description: occurrence rate of side effects
arm group label: opiate without bolus
description: continuous opiate administration without bolus application
arm group label: opiate with bolus
description: continuous opiate administration with additional bolus application
intervention type: Drug
intervention name: opiate with bolus
arm group label: opiate with bolus
arm group label: opiate without bolus
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Tim Reck, MD
role: Principal Investigator
affiliation: Center for Pain Medicine
responsible party type: Sponsor
mesh term: Chronic Pain
mesh term: Opiate Alkaloids