<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/NCT02245919</url>
  </required_header>
  <id_info>
    <org_study_id>14-3-024</org_study_id>
    <nct_id>NCT02245919</nct_id>
  </id_info>
  <brief_title>Chronic Low Back Pain Rehabilitation in Primary Care: a Pilot Study</brief_title>
  <official_title>A Primary Care Biopsychosocial Intervention (Back on Track) for Patients With Chronic Low Back Pain in Which Psychosocial Factors Moderately Influence Daily Life Functioning: a Pilot Study</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>
      Up to now, only little research has been performed in tailoring treatment of patients with&#xD;
      chronic low back pain (CLBP). It would be interesting to evaluate a biopsychosocial&#xD;
      intervention in patients with a moderate to high level of disability and in whom the&#xD;
      contributing role of psychosocial factors to this disability is mild to moderate (WPN3-).&#xD;
      Nowadays, these patients receive cognitive behavioral-based treatments in multidisciplinary&#xD;
      rehabilitation settings but might also benefit from treatments based on these&#xD;
      multidisciplinary rehabilitation treatment principles when provided by specifically trained&#xD;
      primary care physical therapists. Therefore, the aims of this pilot-study are to evaluate the&#xD;
      feasibility of a specifically for primary care physiotherapist developed biopsychosocial&#xD;
      intervention (&quot;Back on Track&quot; intervention) in WPN3- classified patients, and to evaluate&#xD;
      whether this &quot;Back on Track&quot; intervention results in a significant improvement in functional&#xD;
      disability in this subgroup of patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">November 2017</completion_date>
  <primary_completion_date type="Actual">November 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</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 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>Tampa Scale of Kinesiophobia (TSK)</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>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</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social demographic questionnaire</measure>
    <time_frame>pre-treatment (baseline)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment satisfaction questionnaire</measure>
    <time_frame>post-treatment (with an expected average of 8 weeks)</time_frame>
    <description>This questionnaire will include questions about the patient's opinion regarding the intervention, the workbook, the consultant in rehabilitation medicine, the therapist(s), and the patient's perceived knowledge</description>
  </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>Protocol adherence</measure>
    <time_frame>All therapy sessions of the Back on Track intervention will be audio recorded (the intervention period of the trial will last approximately one year and 3 months)</time_frame>
    <description>Physiotherapists will audio record all therapy sessions. A random sample will be assessed for protocol adherence using a modified version of the protocol used by Leeuw et al (2009). This protocol includes essential treatment elements and raters will judge whether these essential treatments elements are provided during the therapy or not. Adherence will be regarded sufficient in case a percentage of 70% of the required treatment elements are provided during the treatment.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Chronic Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Back on Track intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A biopsychosocial primary care intervention based on multidisciplinary pain rehabilitation programs. The Back on Track intervention comprises 4 individual sessions and 8 group sessions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Back on Track intervention</intervention_name>
    <description>A biopsychosocial primary care intervention based on multidisciplinary pain rehabilitation 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>
  </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&#xD;
             (WPN3-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 Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fysiotherapie Abbink</name>
      <address>
        <city>Bunde</city>
        <state>Limburg</state>
        <zip>6235 BG</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>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_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>November 2017</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>February 1, 2018</last_update_submitted>
  <last_update_submitted_qc>February 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Low Back Pain</keyword>
  <keyword>Chronic Pain</keyword>
  <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>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/NCT02245919
org study id: 14-3-024
nct id: NCT02245919
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Up to now, only little research has been performed in tailoring treatment of patients with
      chronic low back pain (CLBP). It would be interesting to evaluate a biopsychosocial
      intervention in patients with a moderate to high level of disability and in whom the
      contributing role of psychosocial factors to this disability is mild to moderate (WPN3-).
      Nowadays, these patients receive cognitive behavioral-based treatments in multidisciplinary
      rehabilitation settings but might also benefit from treatments based on these
      multidisciplinary rehabilitation treatment principles when provided by specifically trained
      primary care physical therapists. Therefore, the aims of this pilot-study are to evaluate the
      feasibility of a specifically for primary care physiotherapist developed biopsychosocial
      intervention ("Back on Track" intervention) in WPN3- classified patients, and to evaluate
      whether this "Back on Track" intervention results in a significant improvement in functional
      disability in this subgroup of patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
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 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: Tampa Scale of Kinesiophobia (TSK)
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: 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
measure: Social demographic questionnaire
time frame: pre-treatment (baseline)
measure: Treatment satisfaction questionnaire
time frame: post-treatment (with an expected average of 8 weeks)
description: This questionnaire will include questions about the patient's opinion regarding the intervention, the workbook, the consultant in rehabilitation medicine, the therapist(s), and the patient's perceived knowledge
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: Protocol adherence
time frame: All therapy sessions of the Back on Track intervention will be audio recorded (the intervention period of the trial will last approximately one year and 3 months)
description: Physiotherapists will audio record all therapy sessions. A random sample will be assessed for protocol adherence using a modified version of the protocol used by Leeuw et al (2009). This protocol includes essential treatment elements and raters will judge whether these essential treatments elements are provided during the therapy or not. Adherence will be regarded sufficient in case a percentage of 70% of the required treatment elements are provided during the treatment.
arm group label: Back on Track intervention
arm group type: Experimental
description: A biopsychosocial primary care intervention based on multidisciplinary pain rehabilitation programs. The Back on Track intervention comprises 4 individual sessions and 8 group sessions.
intervention type: Other
intervention name: Back on Track intervention
description: A biopsychosocial primary care intervention based on multidisciplinary pain rehabilitation programs. The Back on Track intervention comprises 4 individual sessions and 8 group sessions.
arm group label: Back on Track intervention
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 Medical Center
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: Back Pain
mesh term: Low Back Pain