<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/NCT02251444</url>
  </required_header>
  <id_info>
    <org_study_id>rehabilitation program LBP</org_study_id>
    <nct_id>NCT02251444</nct_id>
  </id_info>
  <brief_title>Regulation of Emotions and Coping Behaviour in Patients With Chronic Recurrent Low Back Pain</brief_title>
  <official_title>Emotionsregulation Und Bewältigungsverhalten in Zusammenhang Mit Ambulanter Rehabilitation Oder Physikalischer Therapie Bei Chronischem Rückenschmerz</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karl Landsteiner Institute of Remobilization and Functional Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karl Landsteiner Institute of Remobilization and Functional Health</source>
  <brief_summary>
    <textblock>
      This study investigates effects of a multidisciplinary rehabilitation program or physical&#xD;
      therapy in patients with chronic low back pain on emotion regulation and coping behaviour.&#xD;
&#xD;
      Hypothesis: Significant differences of negative emotions pre and post treatment and between&#xD;
      groups after intervention.&#xD;
&#xD;
      Standardised questionnaires are used for investigation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Emotionsregulations-Inventar ERI Emotion Regulation Questionnaire ERQ Positive and Negative&#xD;
      Affect Schedule PANAS Brief Symptom Inventory BSI-18&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    recruitment problems in the controle group&#xD;
  </why_stopped>
  <start_date>May 2014</start_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Emotion regulation before and after treatment</measure>
    <time_frame>6-8 months</time_frame>
    <description>Emotion regulation will be assessed with the questionnaire Emotionsregulations-Inventar ERI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Isometric muscle strenght before and after treatment</measure>
    <time_frame>6-8 months</time_frame>
    <description>The maximum voluntary isometric muscle strength of the lumbar extensor muscles will be assessed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain in the spine before and after treatment</measure>
    <time_frame>6-8 months</time_frame>
    <description>Pain will be assessed with Visual Analogue Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotion regulation before and after treatment</measure>
    <time_frame>6-8 months</time_frame>
    <description>Emotion regulation will be assessed with the Emotion Regulation Questionnaire ERQ</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Chronic Low Back Pain</condition>
  <arm_group>
    <arm_group_label>outpatient rehabilitation program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>whole-body resistance training, psychological interventions, sessions for information related to ergonomics and healthy alimentation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>physical therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>prescribed physical therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>outpatient rehabilitation program</intervention_name>
    <arm_group_label>outpatient rehabilitation program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>physical therapy</intervention_name>
    <arm_group_label>physical therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  chronic low back pain &gt; 3 months&#xD;
&#xD;
          -  VAS &gt;= 2&#xD;
&#xD;
          -  understanding of german language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  retired&#xD;
&#xD;
          -  psychiatric disorders&#xD;
&#xD;
          -  dementia&#xD;
&#xD;
          -  sick headache&#xD;
&#xD;
          -  chronic pain disease other than chronic low back pain&#xD;
&#xD;
          -  patients with general contraindications of the therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Karl Landsteiern Institute of Remobilisation and Functional Health</name>
      <address>
        <city>Vienna</city>
        <zip>1100</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>August 3, 2016</last_update_submitted>
  <last_update_submitted_qc>August 3, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 4, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karl Landsteiner Institute of Remobilization and Functional Health</investigator_affiliation>
    <investigator_full_name>Michael Quittan</investigator_full_name>
    <investigator_title>Prim. Univ. prof. Dr. Michael Quittan</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>
  <!-- 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/NCT02251444
org study id: rehabilitation program LBP
nct id: NCT02251444
lead sponsor: 
This study investigates effects of a multidisciplinary rehabilitation program or physical
      therapy in patients with chronic low back pain on emotion regulation and coping behaviour.

      Hypothesis: Significant differences of negative emotions pre and post treatment and between
      groups after intervention.

      Standardised questionnaires are used for investigation
Emotionsregulations-Inventar ERI Emotion Regulation Questionnaire ERQ Positive and Negative
      Affect Schedule PANAS Brief Symptom Inventory BSI-18
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Emotion regulation before and after treatment
time frame: 6-8 months
description: Emotion regulation will be assessed with the questionnaire Emotionsregulations-Inventar ERI
measure: Isometric muscle strenght before and after treatment
time frame: 6-8 months
description: The maximum voluntary isometric muscle strength of the lumbar extensor muscles will be assessed
measure: Pain in the spine before and after treatment
time frame: 6-8 months
description: Pain will be assessed with Visual Analogue Scale
measure: Emotion regulation before and after treatment
time frame: 6-8 months
description: Emotion regulation will be assessed with the Emotion Regulation Questionnaire ERQ
arm group label: outpatient rehabilitation program
arm group type: Experimental
description: whole-body resistance training, psychological interventions, sessions for information related to ergonomics and healthy alimentation
arm group label: physical therapy
arm group type: Active Comparator
description: prescribed physical therapy
intervention type: Procedure
intervention name: outpatient rehabilitation program
arm group label: outpatient rehabilitation program
intervention type: Procedure
intervention name: physical therapy
arm group label: physical therapy
criteria: 
gender: All
minimum age: 35 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Karl Landsteiner Institute of Remobilization and Functional Health
investigator full name: Michael Quittan
investigator title: Prim. Univ. prof. Dr. Michael Quittan
mesh term: Back Pain
mesh term: Low Back Pain