<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/NCT03010384</url>
  </required_header>
  <id_info>
    <org_study_id>Reuma-2011</org_study_id>
    <nct_id>NCT03010384</nct_id>
  </id_info>
  <brief_title>Contact to a Physician Specialized in Social Medicine and Return to Work</brief_title>
  <official_title>Contact to a Physician Specialized in Social Medicine and the Impact on Return to Workforce in Patients Suspected of Disc Herniation? - a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kirsten Fonager</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aalborg University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to investigate the impact of a rehabilitation program including a&#xD;
      physician specialized in social medicine parallel to treatment for suspected spinal disc&#xD;
      herniation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In a two-year time period (2011 to 2012) 443 patients of suspected of disc herniation and&#xD;
      risk of low work ability - based on questionnaires participated in a randomized control&#xD;
      trial. The patients were randomized to either the intervention group (n=220) or control group&#xD;
      (n=223). The intervention group were invited to the Department of Social Medicine two to four&#xD;
      weeks after their first contact to Department of Rheumatology for a consultation with a&#xD;
      physician specialized in social medicine. Together with the patient a return-to-work (RTW)&#xD;
      schedule was made to ascertain the need for contact to the workplace (to adjust work&#xD;
      functions), municipality, general practitioner or short-term supportive consultations with a&#xD;
      psychologist. Throughout the intervention, the patients received their usual treatment from&#xD;
      the Department of Rheumatology like patients from the control group. Outcome was return to&#xD;
      the work force at one year follow up using information from a national registry.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Return to Work (register based information)</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">443</enrollment>
  <condition>Return to Work</condition>
  <condition>Musculoskeletal Disease</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Consultation with a physician specialized in social medicine. The consultation lasted about one hour. Together with the patient a return-to-work (RTW) schedule was made to ascertain the need for contact to the workplace (to adjust work functions), municipality, general practitioner or short-term supportive consultations with a psychologist. If relevant, patients were offered up till 5 sessions with a psychologist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard treatment from the Department of Rheumatology</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Rehabilitation program</intervention_name>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age ≥ 18 and &lt; 60 years old,&#xD;
&#xD;
          -  not receiving disability pension and not on maternity leave.&#xD;
&#xD;
          -  sick leave over the past year for more than ten days&#xD;
&#xD;
          -  low self-rated work ability for the next two years&#xD;
&#xD;
          -  health anxiety&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>January 3, 2017</last_update_submitted>
  <last_update_submitted_qc>January 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Aalborg University Hospital</investigator_affiliation>
    <investigator_full_name>Kirsten Fonager</investigator_full_name>
    <investigator_title>Consultant</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Diseases</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/NCT03010384
org study id: Reuma-2011
nct id: NCT03010384
lead sponsor: 
has dmc: No
The aim of this study was to investigate the impact of a rehabilitation program including a
      physician specialized in social medicine parallel to treatment for suspected spinal disc
      herniation.
In a two-year time period (2011 to 2012) 443 patients of suspected of disc herniation and
      risk of low work ability - based on questionnaires participated in a randomized control
      trial. The patients were randomized to either the intervention group (n=220) or control group
      (n=223). The intervention group were invited to the Department of Social Medicine two to four
      weeks after their first contact to Department of Rheumatology for a consultation with a
      physician specialized in social medicine. Together with the patient a return-to-work (RTW)
      schedule was made to ascertain the need for contact to the workplace (to adjust work
      functions), municipality, general practitioner or short-term supportive consultations with a
      psychologist. Throughout the intervention, the patients received their usual treatment from
      the Department of Rheumatology like patients from the control group. Outcome was return to
      the work force at one year follow up using information from a national registry.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Return to Work (register based information)
time frame: one year
arm group label: Intervention
arm group type: Active Comparator
description: Consultation with a physician specialized in social medicine. The consultation lasted about one hour. Together with the patient a return-to-work (RTW) schedule was made to ascertain the need for contact to the workplace (to adjust work functions), municipality, general practitioner or short-term supportive consultations with a psychologist. If relevant, patients were offered up till 5 sessions with a psychologist.
arm group label: Control
arm group type: No Intervention
description: Standard treatment from the Department of Rheumatology
intervention type: Other
intervention name: Rehabilitation program
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 59 Years
healthy volunteers: No
responsible party type: Sponsor-Investigator
investigator affiliation: Aalborg University Hospital
investigator full name: Kirsten Fonager
investigator title: Consultant
mesh term: Musculoskeletal Diseases