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/NCT06030570</url>
    </required_header>
    <id_info>
      <org_study_id>S67679</org_study_id>
      <nct_id>NCT06030570</nct_id>
    </id_info>
    <brief_title>Effect of an Interdisciplinary Spine Rehabilitation Program</brief_title>
    <acronym>PROGRESS</acronym>
    <official_title>PROGRESS: The Effect of an Interdisciplinary Program for Rehabilitation for Spinal Disorders</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>KU Leuven</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>KU Leuven</source>
    <oversight_info>
      <has_dmc>No</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>
        The goal of this research project is to evaluate the effectiveness of the current&#xD;
        interdisciplinary rehabilitation program (Revita) and follow-up trajectory for chronic lumbar&#xD;
        spine disorders in the University Hospitals Leuven.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 22, 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Oswestry Disability Index (ODI)</measure>
      <time_frame>baseline - 6 months - 1 year</time_frame>
      <description>Change in functional impairment (before vs. after rehabilitation program)&#xD;
  minimum score: 0 maximum score: 100 a higher score corresponds with more functional impairment</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in pain</measure>
      <time_frame>baseline - 6 months - 1 year</time_frame>
      <description>Change in numeric rating scale (NRS) for low back/leg pain (before vs. after rehabilitation program)&#xD;
  minimum score: 0 maximum score: 10 a higher score corresponds with more pain</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Effect on quality of life</measure>
      <time_frame>baseline - 6 months - 1 year</time_frame>
      <description>Change in EuroQoL 5D (before vs. after rehabilitation program)&#xD;
  5 items with 3 levels Scale to assess health: 0-100 a higher score corresponds with better health</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effect on risk stratification tool</measure>
      <time_frame>baseline - 6 months - 1 year</time_frame>
      <description>Change in Örebro score (before vs. after rehabilitation program)&#xD;
  minimum score: 0 maximum score: 100 a higher score corresponds with a higher risk profile</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effect on anxiety and depression</measure>
      <time_frame>baseline - 6 months - 1 year</time_frame>
      <description>Change in Hospital Anxiety and Depression Scale (HADS) (before vs. after rehabilitation program)&#xD;
  minimum score: 0 maximum score: 21 (anxiety) - 21 (depression) a higher score corresponds with a higher suspicion for anxiety/depression</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effect on kinesiophobia</measure>
      <time_frame>baseline - 6 months - 1 year</time_frame>
      <description>Change in Tampa scale for Kinesiophobia (TSK) score (before vs. after rehabilitation program)&#xD;
  minimum score: 17 maximum score: 68 a higher score corresponds with an increasing degree of kinesiophobia</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effect on fear-avoidance beliefs</measure>
      <time_frame>baseline - 6 months - 1 year</time_frame>
      <description>Change in Fear Avoidance Beliefs Questionnaire (FABQ) score (before vs. after rehabilitation program)&#xD;
  minimum score: 0 maximum score: 96 a higher score corresponds with stronger fear avoidance beliefs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effect on body awareness</measure>
      <time_frame>baseline - 6 months - 1 year</time_frame>
      <description>Change in Fremantle Back Awareness Scale Questionnaire score (before vs. after rehabilitation program)&#xD;
  minimum score: 0 maximum score: 36 a higher score corresponds with a worse back-specific body perception</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment experience</measure>
      <time_frame>6 months - 1 year</time_frame>
      <description>Patient Global impression of change (PGIC)&#xD;
  minimum score: 1 maximum score: 7 a higher score corresponds with less impression of change</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Return to Work self-efficacy</measure>
      <time_frame>baseline - 6 months - 1 year</time_frame>
      <description>&quot;the Return to Work Self-Efficacy&quot; questionnaire&#xD;
  minimum score: 1 maximum score: 6 a higher score corresponds with a higher level of self-efficacy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Return to work</measure>
      <time_frame>baseline - 6 months - 1 year</time_frame>
      <description>number of days to return to work</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effect on functioning</measure>
      <time_frame>baseline - 6 months - 1 year</time_frame>
      <description>Change in Patient Specific Functional scale (PSFS)&#xD;
  minimum score: 0 maximum score: 10 a higher score corresponds with a better functional level</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effect on medication use</measure>
      <time_frame>baseline - 6 months - 1 year</time_frame>
      <description>Change in Medication Quantification Scale (MQS)&#xD;
  a higher score corresponds with a higher medication use</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Low Back Pain</condition>
    <condition>Spine Disease</condition>
    <arm_group>
      <arm_group_label>Subjects with low back pain</arm_group_label>
      <description>Patients of University Hospitals Leuven participating in the interdisciplinary spine rehabilitation program (REVITA)</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Rehabilitation program (Revita)</intervention_name>
      <description>Multidisciplinary programs in an outpatient hospital setting are coordinated by specialists in Physical and Rehabilitation Medicine. These programs combine a physical part (e.g., specific exercises, manual techniques) with at least one other element (psychological, social, educational or occupational intervention). In a multidisciplinary spine rehabilitation program, a maximum of 36 sessions over a maximum time period of 6 months is offered. Afterwards, a (monodisciplinary) follow-up trajectory (K15) is possible, consisting of maximum 104 sessions a year.</description>
      <arm_group_label>Subjects with low back pain</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with chronic spine problems in which a multidisciplinary approach is needed&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion criteria&#xD;
  &#xD;
            -  Adults, age &gt; 18 years&#xD;
  &#xD;
            -  Spine problem for &gt; 6 weeks, needing interdisciplinary care (risk factors, failure of&#xD;
               first line treatment, etc)&#xD;
  &#xD;
            -  Inclusion in Revita program&#xD;
  &#xD;
            -  Informed consent to participate&#xD;
  &#xD;
          Exclusion criteria&#xD;
  &#xD;
            -  Patients without sufficient understanding of the Dutch language&#xD;
  &#xD;
            -  Unable to participate in 2h rehabilitation sessions with exercises&#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>Sofie Rummens, MD</last_name>
      <phone>003216338700</phone>
      <email>sofie.rummens@uzleuven.be</email>
    </overall_contact>
    <location>
      <facility>
        <name>University Hospitals Leuven</name>
        <address>
          <city>Leuven</city>
          <zip>3000</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sofie Rummens, MD</last_name>
        <email>sofie.rummens@uzleuven.be</email>
      </contact>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universitaire Ziekenhuizen KU Leuven</investigator_affiliation>
      <investigator_full_name>Sofie Rummens</investigator_full_name>
      <investigator_title>Principal Investigator, Physical and Rehabilitation Medicine Specialist, PhD in Biomedical Sciences</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spinal Diseases</mesh_term>
      <mesh_term>Low Back Pain</mesh_term>
    </condition_browse>
    <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/NCT06030570
  org study id: S67679
  nct id: NCT06030570
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this research project is to evaluate the effectiveness of the current
        interdisciplinary rehabilitation program (Revita) and follow-up trajectory for chronic lumbar
        spine disorders in the University Hospitals Leuven.
  observational model: Case-Only
  time perspective: Prospective
  measure: Change in Oswestry Disability Index (ODI)
  time frame: baseline - 6 months - 1 year
  description: Change in functional impairment (before vs. after rehabilitation program)
  minimum score: 0 maximum score: 100 a higher score corresponds with more functional impairment
  measure: Change in pain
  time frame: baseline - 6 months - 1 year
  description: Change in numeric rating scale (NRS) for low back/leg pain (before vs. after rehabilitation program)
  minimum score: 0 maximum score: 10 a higher score corresponds with more pain
  measure: Effect on quality of life
  time frame: baseline - 6 months - 1 year
  description: Change in EuroQoL 5D (before vs. after rehabilitation program)
  5 items with 3 levels Scale to assess health: 0-100 a higher score corresponds with better health
  measure: Effect on risk stratification tool
  time frame: baseline - 6 months - 1 year
  description: Change in Örebro score (before vs. after rehabilitation program)
  minimum score: 0 maximum score: 100 a higher score corresponds with a higher risk profile
  measure: Effect on anxiety and depression
  time frame: baseline - 6 months - 1 year
  description: Change in Hospital Anxiety and Depression Scale (HADS) (before vs. after rehabilitation program)
  minimum score: 0 maximum score: 21 (anxiety) - 21 (depression) a higher score corresponds with a higher suspicion for anxiety/depression
  measure: Effect on kinesiophobia
  time frame: baseline - 6 months - 1 year
  description: Change in Tampa scale for Kinesiophobia (TSK) score (before vs. after rehabilitation program)
  minimum score: 17 maximum score: 68 a higher score corresponds with an increasing degree of kinesiophobia
  measure: Effect on fear-avoidance beliefs
  time frame: baseline - 6 months - 1 year
  description: Change in Fear Avoidance Beliefs Questionnaire (FABQ) score (before vs. after rehabilitation program)
  minimum score: 0 maximum score: 96 a higher score corresponds with stronger fear avoidance beliefs
  measure: Effect on body awareness
  time frame: baseline - 6 months - 1 year
  description: Change in Fremantle Back Awareness Scale Questionnaire score (before vs. after rehabilitation program)
  minimum score: 0 maximum score: 36 a higher score corresponds with a worse back-specific body perception
  measure: Treatment experience
  time frame: 6 months - 1 year
  description: Patient Global impression of change (PGIC)
  minimum score: 1 maximum score: 7 a higher score corresponds with less impression of change
  measure: Return to Work self-efficacy
  time frame: baseline - 6 months - 1 year
  description: "the Return to Work Self-Efficacy" questionnaire
  minimum score: 1 maximum score: 6 a higher score corresponds with a higher level of self-efficacy
  measure: Return to work
  time frame: baseline - 6 months - 1 year
  description: number of days to return to work
  measure: Effect on functioning
  time frame: baseline - 6 months - 1 year
  description: Change in Patient Specific Functional scale (PSFS)
  minimum score: 0 maximum score: 10 a higher score corresponds with a better functional level
  measure: Effect on medication use
  time frame: baseline - 6 months - 1 year
  description: Change in Medication Quantification Scale (MQS)
  a higher score corresponds with a higher medication use
  arm group label: Subjects with low back pain
  description: Patients of University Hospitals Leuven participating in the interdisciplinary spine rehabilitation program (REVITA)
  intervention type: Other
  intervention name: Rehabilitation program (Revita)
  description: Multidisciplinary programs in an outpatient hospital setting are coordinated by specialists in Physical and Rehabilitation Medicine. These programs combine a physical part (e.g., specific exercises, manual techniques) with at least one other element (psychological, social, educational or occupational intervention). In a multidisciplinary spine rehabilitation program, a maximum of 36 sessions over a maximum time period of 6 months is offered. Afterwards, a (monodisciplinary) follow-up trajectory (K15) is possible, consisting of maximum 104 sessions a year.
  arm group label: Subjects with low back pain
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Sofie Rummens, MD
  phone: 003216338700
  email: sofie.rummens@uzleuven.be
  facility: 
  status: Recruiting
  contact: 
  country: Belgium
  responsible party type: Principal Investigator
  investigator affiliation: Universitaire Ziekenhuizen KU Leuven
  investigator full name: Sofie Rummens
  investigator title: Principal Investigator, Physical and Rehabilitation Medicine Specialist, PhD in Biomedical Sciences
  mesh term: Spinal Diseases
  mesh term: Low Back Pain
  sharing ipd: No