<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/NCT01690234</url>
  </required_header>
  <id_info>
    <org_study_id>H-C-2008-112</org_study_id>
    <nct_id>NCT01690234</nct_id>
  </id_info>
  <brief_title>Early Coordinated Multidisciplinary Intervention to Prevent Sickness Absence and Labor Market Exclusion in Patients With Low Back Pain.</brief_title>
  <acronym>TIKI</acronym>
  <official_title>Early Coordinated Multidisciplinary Intervention to Prevent Sickness Absence and Labor Market Exclusion in Patients With Low Back Pain. A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Back and Rehabilitation Center, Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Back and Rehabilitation Center, Copenhagen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In Denmark the number of patients, sick listed for more than four weeks is increasing, and&#xD;
      patients suffering from musculoskeletal disorders make one third of the total amount of&#xD;
      long-term absenteeism. Compared to other diagnoses, patients suffering from musculoskeletal&#xD;
      diseases, including low back pain, are less likely to return to work after a period of sick&#xD;
      leave. It seems that a multidisciplinary intervention, including cooperation between the&#xD;
      health sector, the social sector and in the work place, has a positive effect on days off&#xD;
      work due to musculoskeletal disorders and particularly low back pain. The aim of this study&#xD;
      is to evaluate the effect of a work oriented multidisciplinary intervention.&#xD;
&#xD;
      A randomized controlled trial will include 770 patients with low back pain. The study&#xD;
      population consists of patients, who are sick listed or at risk of sick leave due to LBP.&#xD;
&#xD;
      The control group is treated with usual care in a team with participation of a&#xD;
      physiotherapist, a chiropractor, a rheumatologist and a local employed social worker The&#xD;
      Intervention group is treated with usual care and in addition intervention of a psychologist,&#xD;
      an occupational physician, an ergonomist and a social worker from the local sickness benefit&#xD;
      office. The treating physiotherapist will be the RTW-coordinator. Outcome will be reported at&#xD;
      the end of treatment as well as 6 and 12 months follow up. The primary outcome is number of&#xD;
      days of work. Secondary outcomes are disability, pain, and quality of life.&#xD;
&#xD;
      This large RCT study is testing the effectiveness of a preventive intervention targeting&#xD;
      patients on short term sick leave or at risk being sick listed because of low back pain. We&#xD;
      have developed a novel multidisciplinary team structure using the treating physiotherapist as&#xD;
      the return to work coordinator, and having the case manager from the sickness benefit office&#xD;
      participating in team meetings.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2009</start_date>
  <completion_date type="Anticipated">October 2014</completion_date>
  <primary_completion_date type="Actual">September 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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of days off work</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disability</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">770</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Multidisciplinary intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Early coordinated multidisciplinary intervention. Physiotherapist, chiropractor, rheumatologist, psychologist, occupational physician, ergonomist and social worker/case manager.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention from physiotherapist, chiropractor, rheumatologist and social worker.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Multidisciplinary intervention</intervention_name>
    <description>Early coordinated multidisciplinary intervention. Physiotherapist, chiropractor, rheumatologist, psychologist, occupational physician, ergonomist and social worker/case manager.</description>
    <arm_group_label>Multidisciplinary intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>Intervention from physiotherapist, chiropractor, rheumatologist and social worker.</description>
    <arm_group_label>Usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Working age adults 18-65&#xD;
&#xD;
          -  Low back pain (longer than 2 weeks)&#xD;
&#xD;
          -  Sicklisted or at risk&#xD;
&#xD;
          -  Employed or unemployed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe comorbidity&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Difficulties in reading Danish language&#xD;
&#xD;
          -  Application for early retirement&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tom Petersen, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Back and Rehabilitaion Center Copenhagen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Annette Fisker, PT, PhDstud</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Copenhagen, Department of Public Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tom Petersen, PT, PhD</last_name>
    <phone>+4535304974</phone>
    <email>tom.petersen@suf.kk.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Inge Lis Goethgen, Head</last_name>
    <phone>+4535304950</phone>
    <email>MW53@suf.kk.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Back and Rehabilitation Center Copenhagen</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tom Petersen, PT, PhD</last_name>
      <phone>+4535304974</phone>
      <email>tom.petersen@suf.kk.dk</email>
    </contact>
    <contact_backup>
      <last_name>Inge Lis Goethgen, Head</last_name>
      <phone>+4535304950</phone>
      <email>MW53@suf.kk.dk</email>
    </contact_backup>
    <investigator>
      <last_name>Tom Petersen, PT, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>September 19, 2012</last_update_submitted>
  <last_update_submitted_qc>September 19, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 21, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Back and Rehabilitation Center, Copenhagen</investigator_affiliation>
    <investigator_full_name>Tom Petersen</investigator_full_name>
    <investigator_title>Physiotherapist</investigator_title>
  </responsible_party>
  <keyword>Low back pain</keyword>
  <keyword>Return to work</keyword>
  <keyword>Sickness absence</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Multidisciplinary intervention</keyword>
  <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/NCT01690234
org study id: H-C-2008-112
nct id: NCT01690234
lead sponsor: 
has dmc: No
In Denmark the number of patients, sick listed for more than four weeks is increasing, and
      patients suffering from musculoskeletal disorders make one third of the total amount of
      long-term absenteeism. Compared to other diagnoses, patients suffering from musculoskeletal
      diseases, including low back pain, are less likely to return to work after a period of sick
      leave. It seems that a multidisciplinary intervention, including cooperation between the
      health sector, the social sector and in the work place, has a positive effect on days off
      work due to musculoskeletal disorders and particularly low back pain. The aim of this study
      is to evaluate the effect of a work oriented multidisciplinary intervention.

      A randomized controlled trial will include 770 patients with low back pain. The study
      population consists of patients, who are sick listed or at risk of sick leave due to LBP.

      The control group is treated with usual care in a team with participation of a
      physiotherapist, a chiropractor, a rheumatologist and a local employed social worker The
      Intervention group is treated with usual care and in addition intervention of a psychologist,
      an occupational physician, an ergonomist and a social worker from the local sickness benefit
      office. The treating physiotherapist will be the RTW-coordinator. Outcome will be reported at
      the end of treatment as well as 6 and 12 months follow up. The primary outcome is number of
      days of work. Secondary outcomes are disability, pain, and quality of life.

      This large RCT study is testing the effectiveness of a preventive intervention targeting
      patients on short term sick leave or at risk being sick listed because of low back pain. We
      have developed a novel multidisciplinary team structure using the treating physiotherapist as
      the return to work coordinator, and having the case manager from the sickness benefit office
      participating in team meetings.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Number of days off work
time frame: 12 months
measure: Disability
time frame: 12 months
arm group label: Multidisciplinary intervention
arm group type: Experimental
description: Early coordinated multidisciplinary intervention. Physiotherapist, chiropractor, rheumatologist, psychologist, occupational physician, ergonomist and social worker/case manager.
arm group label: Usual care
arm group type: Active Comparator
description: Intervention from physiotherapist, chiropractor, rheumatologist and social worker.
intervention type: Procedure
intervention name: Multidisciplinary intervention
description: Early coordinated multidisciplinary intervention. Physiotherapist, chiropractor, rheumatologist, psychologist, occupational physician, ergonomist and social worker/case manager.
arm group label: Multidisciplinary intervention
intervention type: Procedure
intervention name: Usual care
description: Intervention from physiotherapist, chiropractor, rheumatologist and social worker.
arm group label: Usual care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Tom Petersen, PT, PhD
role: Principal Investigator
affiliation: Back and Rehabilitaion Center Copenhagen
last name: Annette Fisker, PT, PhDstud
role: Principal Investigator
affiliation: University of Copenhagen, Department of Public Health
last name: Tom Petersen, PT, PhD
phone: +4535304974
email: tom.petersen@suf.kk.dk
last name: Inge Lis Goethgen, Head
phone: +4535304950
email: MW53@suf.kk.dk
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Back and Rehabilitation Center, Copenhagen
investigator full name: Tom Petersen
investigator title: Physiotherapist
mesh term: Back Pain
mesh term: Low Back Pain