<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/NCT02220543</url>
  </required_header>
  <id_info>
    <org_study_id>14-3-019</org_study_id>
    <nct_id>NCT02220543</nct_id>
  </id_info>
  <brief_title>Chronic Low Back Pain Rehabilitation in Primary Care: an RCT</brief_title>
  <official_title>The Effectiveness of a Biopsychosocial Rehabilitation Program in Primary Care (Back on Track) Versus Primary Care as Usual in Patients With Chronic Low Back Pain in Which Psychosocial Factors Minimally Influence Daily Life Functioning: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Adelante, Centre of Expertise in Rehabilitation and Audiology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Province of Limburg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CZ Fonds</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Maastricht University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the effectiveness and cost-effectiveness of a new&#xD;
      primary care intervention &quot;Back on Track&quot; as compared to usual primary care in patients with&#xD;
      non-specific chronic low back pain in which disability levels are moderate and the role of&#xD;
      psychosocial factors to this disability is at maximum low (classified as WPN2).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quebec Back Pain Disability Scale (QBPDS)</measure>
    <time_frame>Change in functional disability between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up</time_frame>
    <description>The QBPDS is a 20-itemed questionnaire designed to determine the individuals' functional disability level (ranging from 0-100). A higher score reflects higher disability.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Credibility and Expectancy Questionnaire (CEQ)</measure>
    <time_frame>Directly after the first treatment (in the first week of the intervention)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQol-5D (EQ-5D)</measure>
    <time_frame>Change in quality of life between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>Change in anxiety and depression between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Catastrophizing Scale (PCS)</measure>
    <time_frame>Change in catastrophizing between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numeric Rating Scale (NRS)</measure>
    <time_frame>Change in pain intensity between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tampa Scale of Kinesiophobia</measure>
    <time_frame>Change in kinesiophobia between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Self-Efficacy Questionnaire (PSEQ)</measure>
    <time_frame>Change in self-efficacy between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Perceived Effect (GPE)</measure>
    <time_frame>Global perceived effect at post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TiC-P)</measure>
    <time_frame>Medical consumption at pre-treatment (baseline), post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up after the end of the treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social demographic questionnaire</measure>
    <time_frame>pre-treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment questionnaire</measure>
    <time_frame>Post-treatment (with an expected average of 8 weeks)</time_frame>
    <description>This questionnaire contains only one question and asks patients directly after the treatment program has finished (post-treatment) to indicate whether they think they have received the new intervention or care as usual.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Low Back Pain</condition>
  <condition>Chronic Pain</condition>
  <condition>Musculoskeletal Pain</condition>
  <arm_group>
    <arm_group_label>Back on Track intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Back on Track intervention is a biopsychosocial primary care intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Primary care as usual</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Primary care as usual comprises maximally 12 individual regular physical therapy sessions for a maximum of 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Back on Track intervention</intervention_name>
    <description>Biopsychosocial primary care intervention based on multidisciplinary pain rehabiliation programs. The Back on Track intervention comprises 4 individual sessions and 8 group sessions.</description>
    <arm_group_label>Back on Track intervention</arm_group_label>
    <arm_group_label>Primary care as usual</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Primary care as usual</intervention_name>
    <description>Regular physical therapy in primary care. Physical therapists are recommended by their profession (the Royal Dutch Society for Physical Therapy) to work according to a profession-specific guideline for the treatment of patients with low back pain in primary care settings. Maximally 12 individual sessions (30 minutes each) for a maximum of 8 weeks.</description>
    <arm_group_label>Back on Track intervention</arm_group_label>
    <arm_group_label>Primary care as usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic low back pain; defined as pain between scapulae and gluteal region, whether or&#xD;
             not with radiation towards one or both legs, present for at least three months.&#xD;
&#xD;
          -  Presence of contributing social and psychological factors, however not complex (WPN2&#xD;
             classification)&#xD;
&#xD;
          -  Age between 18 and 65 year&#xD;
&#xD;
          -  Sufficient knowledge of the Dutch language&#xD;
&#xD;
          -  Acceptance towards the biopsychosocial approach instead of biomedical approach&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic low back pain attributable to e.g. infection, tumour, osteoporosis, fracture,&#xD;
             structural deformation, inflammatory process, radicular syndrome or cauda equina&#xD;
             syndrome&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Any suspicion of an (underlying) psychiatric disease, for which psychiatric treatment&#xD;
             is better suited, according to the expert opinion of the consultant in rehabilitation&#xD;
             medicine.&#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>Ivan PJ Huijnen, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maastricht University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fysiotherapie Giessen-Ploemen</name>
      <address>
        <city>Bunde</city>
        <state>Limburg</state>
        <zip>6241 DK</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fysiohof</name>
      <address>
        <city>Maastricht</city>
        <state>Limburg</state>
        <zip>6216 PJ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fysio Zuyd Caberg</name>
      <address>
        <city>Maastricht</city>
        <state>Limburg</state>
        <zip>6217 CR</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fysiotherapiepraktijk Yvonne Janss</name>
      <address>
        <city>Maastricht</city>
        <state>Limburg</state>
        <zip>6227 BG</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICM Fysio</name>
      <address>
        <city>Maastricht</city>
        <state>Limburg</state>
        <zip>6229 EZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fysiotherapie Breuers</name>
      <address>
        <city>Margraten</city>
        <state>Limburg</state>
        <zip>6269 BL</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fysiotherapie Abbink</name>
      <address>
        <city>Ulestraten</city>
        <state>Limburg</state>
        <zip>6235 BG</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fysio Valkenburg</name>
      <address>
        <city>Valkenburg</city>
        <state>Limburg</state>
        <zip>6301 GH</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <reference>
    <citation>Vlaeyen JWS, Linton SJ. Fear-avoidance and its consequences in chronic musculoskeletal pain: a state of the art. Pain. 2000 Apr;85(3):317-332. doi: 10.1016/S0304-3959(99)00242-0.</citation>
    <PMID>10781906</PMID>
  </reference>
  <reference>
    <citation>Lindstrom I, Ohlund C, Eek C, Wallin L, Peterson LE, Fordyce WE, Nachemson AL. The effect of graded activity on patients with subacute low back pain: a randomized prospective clinical study with an operant-conditioning behavioral approach. Phys Ther. 1992 Apr;72(4):279-90; discussion 291-3. doi: 10.1093/ptj/72.4.279.</citation>
    <PMID>1533941</PMID>
  </reference>
  <reference>
    <citation>Leeuw M, Goossens MEJB, van Breukelen GJP, de Jong JR, Heuts PHTG, Smeets RJEM, Koke AJA, Vlaeyen JWS. Exposure in vivo versus operant graded activity in chronic low back pain patients: results of a randomized controlled trial. Pain. 2008 Aug 15;138(1):192-207. doi: 10.1016/j.pain.2007.12.009. Epub 2008 Feb 1.</citation>
    <PMID>18242858</PMID>
  </reference>
  <reference>
    <citation>Lamb SE, Hansen Z, Lall R, Castelnuovo E, Withers EJ, Nichols V, Potter R, Underwood MR; Back Skills Training Trial investigators. Group cognitive behavioural treatment for low-back pain in primary care: a randomised controlled trial and cost-effectiveness analysis. Lancet. 2010 Mar 13;375(9718):916-23. doi: 10.1016/S0140-6736(09)62164-4. Epub 2010 Feb 25.</citation>
    <PMID>20189241</PMID>
  </reference>
  <reference>
    <citation>Macedo LG, Smeets RJ, Maher CG, Latimer J, McAuley JH. Graded activity and graded exposure for persistent nonspecific low back pain: a systematic review. Phys Ther. 2010 Jun;90(6):860-79. doi: 10.2522/ptj.20090303. Epub 2010 Apr 15.</citation>
    <PMID>20395306</PMID>
  </reference>
  <reference>
    <citation>Brunner E, De Herdt A, Minguet P, Baldew SS, Probst M. Can cognitive behavioural therapy based strategies be integrated into physiotherapy for the prevention of chronic low back pain? A systematic review. Disabil Rehabil. 2013 Jan;35(1):1-10. doi: 10.3109/09638288.2012.683848. Epub 2012 May 21.</citation>
    <PMID>22607157</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>August 28, 2017</last_update_submitted>
  <last_update_submitted_qc>August 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cognitive behavioral therapy</keyword>
  <keyword>Primary health care</keyword>
  <keyword>Physical Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Pain</mesh_term>
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
    <mesh_term>Chronic 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/NCT02220543
org study id: 14-3-019
nct id: NCT02220543
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The aim of this study is to evaluate the effectiveness and cost-effectiveness of a new
      primary care intervention "Back on Track" as compared to usual primary care in patients with
      non-specific chronic low back pain in which disability levels are moderate and the role of
      psychosocial factors to this disability is at maximum low (classified as WPN2).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Quebec Back Pain Disability Scale (QBPDS)
time frame: Change in functional disability between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up
description: The QBPDS is a 20-itemed questionnaire designed to determine the individuals' functional disability level (ranging from 0-100). A higher score reflects higher disability.
measure: Credibility and Expectancy Questionnaire (CEQ)
time frame: Directly after the first treatment (in the first week of the intervention)
measure: EuroQol-5D (EQ-5D)
time frame: Change in quality of life between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up
measure: Hospital Anxiety and Depression Scale (HADS)
time frame: Change in anxiety and depression between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up
measure: Pain Catastrophizing Scale (PCS)
time frame: Change in catastrophizing between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up
measure: Numeric Rating Scale (NRS)
time frame: Change in pain intensity between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up
measure: Tampa Scale of Kinesiophobia
time frame: Change in kinesiophobia between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up
measure: Pain Self-Efficacy Questionnaire (PSEQ)
time frame: Change in self-efficacy between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up
measure: Global Perceived Effect (GPE)
time frame: Global perceived effect at post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up
measure: Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TiC-P)
time frame: Medical consumption at pre-treatment (baseline), post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up after the end of the treatment
measure: Social demographic questionnaire
time frame: pre-treatment
measure: Treatment questionnaire
time frame: Post-treatment (with an expected average of 8 weeks)
description: This questionnaire contains only one question and asks patients directly after the treatment program has finished (post-treatment) to indicate whether they think they have received the new intervention or care as usual.
arm group label: Back on Track intervention
arm group type: Experimental
description: Back on Track intervention is a biopsychosocial primary care intervention
arm group label: Primary care as usual
arm group type: Active Comparator
description: Primary care as usual comprises maximally 12 individual regular physical therapy sessions for a maximum of 8 weeks.
intervention type: Other
intervention name: Back on Track intervention
description: Biopsychosocial primary care intervention based on multidisciplinary pain rehabiliation programs. The Back on Track intervention comprises 4 individual sessions and 8 group sessions.
arm group label: Back on Track intervention
arm group label: Primary care as usual
intervention type: Other
intervention name: Primary care as usual
description: Regular physical therapy in primary care. Physical therapists are recommended by their profession (the Royal Dutch Society for Physical Therapy) to work according to a profession-specific guideline for the treatment of patients with low back pain in primary care settings. Maximally 12 individual sessions (30 minutes each) for a maximum of 8 weeks.
arm group label: Back on Track intervention
arm group label: Primary care as usual
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ivan PJ Huijnen, Dr.
role: Principal Investigator
affiliation: Maastricht University
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Netherlands
citation: Vlaeyen JWS, Linton SJ. Fear-avoidance and its consequences in chronic musculoskeletal pain: a state of the art. Pain. 2000 Apr;85(3):317-332. doi: 10.1016/S0304-3959(99)00242-0.
PMID: 10781906
citation: Lindstrom I, Ohlund C, Eek C, Wallin L, Peterson LE, Fordyce WE, Nachemson AL. The effect of graded activity on patients with subacute low back pain: a randomized prospective clinical study with an operant-conditioning behavioral approach. Phys Ther. 1992 Apr;72(4):279-90; discussion 291-3. doi: 10.1093/ptj/72.4.279.
PMID: 1533941
citation: Leeuw M, Goossens MEJB, van Breukelen GJP, de Jong JR, Heuts PHTG, Smeets RJEM, Koke AJA, Vlaeyen JWS. Exposure in vivo versus operant graded activity in chronic low back pain patients: results of a randomized controlled trial. Pain. 2008 Aug 15;138(1):192-207. doi: 10.1016/j.pain.2007.12.009. Epub 2008 Feb 1.
PMID: 18242858
citation: Lamb SE, Hansen Z, Lall R, Castelnuovo E, Withers EJ, Nichols V, Potter R, Underwood MR; Back Skills Training Trial investigators. Group cognitive behavioural treatment for low-back pain in primary care: a randomised controlled trial and cost-effectiveness analysis. Lancet. 2010 Mar 13;375(9718):916-23. doi: 10.1016/S0140-6736(09)62164-4. Epub 2010 Feb 25.
PMID: 20189241
citation: Macedo LG, Smeets RJ, Maher CG, Latimer J, McAuley JH. Graded activity and graded exposure for persistent nonspecific low back pain: a systematic review. Phys Ther. 2010 Jun;90(6):860-79. doi: 10.2522/ptj.20090303. Epub 2010 Apr 15.
PMID: 20395306
citation: Brunner E, De Herdt A, Minguet P, Baldew SS, Probst M. Can cognitive behavioural therapy based strategies be integrated into physiotherapy for the prevention of chronic low back pain? A systematic review. Disabil Rehabil. 2013 Jan;35(1):1-10. doi: 10.3109/09638288.2012.683848. Epub 2012 May 21.
PMID: 22607157
responsible party type: Sponsor
mesh term: Musculoskeletal Pain
mesh term: Back Pain
mesh term: Low Back Pain
mesh term: Chronic Pain