<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/NCT04399772</url>
  </required_header>
  <id_info>
    <org_study_id>69712</org_study_id>
    <nct_id>NCT04399772</nct_id>
  </id_info>
  <brief_title>COgNitive FuncTional Therapy+ for Chronic Low Back paIn</brief_title>
  <acronym>CONFeTTI</acronym>
  <official_title>A COgNitive FuncTional Therapy+ Pathway Versus an Interdisciplinary Pain Management Pathway for Patients With Severe Chronic Low Back Pain (CONFeTTI Trial): a Randomized Controlled Trial of a Combined Physical/Psychological Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Curtin University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Manchester Metropolitan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Odense University Hospital</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>
      This study is a patient-blinded 2-arm randomized controlled trial (RCT) assessing the&#xD;
      effectiveness (in the short and long term) as well as total healthcare costs of a CFT+ (a&#xD;
      combined physiotherapist/psychologist intervention) pathway compared with interdisciplinary&#xD;
      pain management pathway (usual care) for patients with chronic low back pain referred to&#xD;
      interdisciplinary pain treatment.&#xD;
&#xD;
      The primary aim of this pragmatic randomized controlled trial (RCT) is to investigate if a&#xD;
      physiotherapy-led CFT pathway that includes psychologist support (CFT+) with the option of&#xD;
      additional usual care (if needed) is superior to the currently recommended interdisciplinary&#xD;
      pain management pathway (usual care) in reducing disability at 12 months in patients with&#xD;
      severe cLBP. In addition, an economic evaluation will investigate total health care costs of&#xD;
      the two pathways at 12 months.&#xD;
&#xD;
      In addition the study will explore changes in pain intensity, quality of life, thoughts and&#xD;
      beliefs about back pain, and analgesic consumption in patients randomized to the CFT+ pathway&#xD;
      compared with patients randomized to the interdisciplinary pain management pathway.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evidence suggests that chronic low back pain (LBP) is a multidimensional biopsychosocial&#xD;
      problem including various contributing factors, such as negative pain cognitions,&#xD;
      pain-related fear and emotional distress, avoidant and protective movement behaviors,and&#xD;
      unhelpful lifestyle factors such as activity avoidance and sleep problems. Current guidelines&#xD;
      recommend that patients with chronic LBP who do not benefit from primary care treatment&#xD;
      should be referred to interdisciplinary pain rehabilitation in secondary care settings.&#xD;
      However, such treatments are often expensive, not easily accessible, and have only modest&#xD;
      effects.&#xD;
&#xD;
      Cognitive Functional Therapy (CFT) is a newer physiotherapeutic treatment approach for&#xD;
      patients with chronic low back pain, involving all important elements for the individual&#xD;
      patient. Physical factors are handled via change in pain-provoking movement patterns.&#xD;
      Psychological factors are handled in relation to fear, avoidance behaviour,&#xD;
      catastrophization, stress, anxiety, depression and negative thoughts. Lifestyle factors are&#xD;
      addressed in relation to physical inactivity and sleep problems. The approach is&#xD;
      individualized and provides the patient with opportunities for action in relation to his or&#xD;
      her own situation via information, reflection, change of movement and training of functions&#xD;
      and physical level.&#xD;
&#xD;
      CFT has been shown to reduce fear and worry in patients with chronic low back pain compared&#xD;
      to other interventions, and the effect of CFT alone on patients with severe chronic low back&#xD;
      pain has been recently investigated in an observational pilot study (without randomization)&#xD;
      in our Pain Center (publication attached in link). In this study, we found a good and&#xD;
      clinically relevant effect of CFT compared to standard treatment in a University Hospital&#xD;
      Interdisciplinary Pain Center. In the pilot study, we noted that there were barriers to&#xD;
      optimal treatment engagement for some patients (e.g. lack of motivation), and that several&#xD;
      patients with high levels of psychological distress had limited benefits. Inclusion of early&#xD;
      psychologist support to assist in promoting behavioral change and directly target deeper&#xD;
      behavioral strategies could potentially improve patient adherence to the CFT intervention.&#xD;
&#xD;
      This fully-powered randomized controlled study compares effectiveness of this&#xD;
      physiotherapeutic intervention including psychologist support (CFT+) pathway with&#xD;
      effectiveness of interdisciplinary pain treatment (recommended care) pathway in patients with&#xD;
      severe chronic low back pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 27, 2020</start_date>
  <completion_date type="Anticipated">April 1, 2024</completion_date>
  <primary_completion_date type="Actual">March 1, 2023</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>
    <intervention_model_description>This study is a patient-blinded 2-arm randomized controlled trial with a parallel group design and 1:1 group allocation.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>This study has ethical approval that the patients involved are not aware that there is a difference between the two treatment strategies in the study. Patient masking in this study is done to ensure that included patients are as representative as possible.&#xD;
The randomization sequence is distributed and stored in sealed opaque envelopes handled only by an independent study secretary who has no other involvement in the trial. All outcome measurements are completed via an electronic questionnaire system sent via personal links to the patients' official digital inbox, e-Boks (used by public hospitals, municipalities and other institutions to send official documents to citizens of Denmark). The researcher responsible for the statistical analyzes are blinded to group allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain-related disability during the last 7 days</measure>
    <time_frame>Change from baseline to 12 months</time_frame>
    <description>Proportion of patients who have an improvement of 8 points or more on the Oswestry Disability Index (ODI) at 12 months. The ODI assesses pain-related disability within the last 7 days, asking patients to reflect on their ability to manage their everyday life despite their back pain for these domains: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and travelling. Each domain is scored on a 0-5 scale. The index is calculated by dividing the summed score by the total possible score multiplied by 100 and expressed as a percentage with 100 representing the greatest disability.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Trajectory of Pain-related disability during the last 7 days</measure>
    <time_frame>Assessed after 0, 3, 6, 9, and 12 months</time_frame>
    <description>Assessed with the Oswestry Disability Index (ODI) that asks patients to choose statements that reflect their ability to manage their everyday life despite their back pain for these domains: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and travelling. Each domain is scored on a 0-5 scale. The index is calculated by dividing the summed score by the total possible score multiplied by 100 and expressed as a percentage with 100 representing the greatest disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average pain intensity during the last 24 hours</measure>
    <time_frame>Assessed at 0, 3, 6, 9, and 12 months</time_frame>
    <description>Assessed by asking the participants about the level of average pain during the last 24 hours on a 11 point rating scale, ranging from 0-10 (0 = &quot;no pain&quot; and 10 = &quot;worst pain&quot;) using the 5th item from the Brief Pain Inventory Short Form. A lower score indicates lower pain intensity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>Assessed at 0, 3 and 12 months</time_frame>
    <description>Measured by European Quality of Life 5 Dimensions (EQ-5D-3L) and the Visual Analogue Scale (EQ-VAS).&#xD;
For the 5 dimensions the EQ5D-3L asks the participants to rate their ability for each domain (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), respectively on a 1-3 Verbal Rating Scale, a score of 1 indicating no problems/severity, and a score of 3 indicating extreme problems/severity. The EQ-VAS asks the participant to rate their overall health 'today' on a 0-100 VAS. A higher score indicates a better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of pain catastrophization</measure>
    <time_frame>Assessed at 0, 3 and 12 months</time_frame>
    <description>Measured by the Pain Catastrophizing Scale; asking participants to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on a 5-point Likert scale with 0 = not at all and 4 = all the time. The score is 0 to 52 with a higher score indicating a high level of pain catastrophizing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of patient enablement</measure>
    <time_frame>Assessed at 0, 3 and 12 months</time_frame>
    <description>Measured by the Patient Enablement Instrument for Back Pain; asking participants to indicate on a 11 point rating scale, ranging from 0-10 (0 = &quot;to a very low degree&quot; and 10 = &quot;to a very high degree&quot;) the degree to which they during the past week were able to 1) Cope with life, 2) Understand your back problem, 3) Cope with your back problem, 4) Keep your back healthy, 5) Feel confident about your health, and 6) Help yourself.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Economical evaluation</measure>
    <time_frame>Assessed at 12 months</time_frame>
    <description>The economic evaluation of the RCT will estimate the cost per quality adjusted life year (QALY) gained from the CFT+ intervention, compared to interdisciplinary pain program treatment. The economic analyses will utilize the EQ5D data collected during the trial for the utility weights, and total healthcare costs will be obtained from linking the trial data to Danish registries.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analgesics</measure>
    <time_frame>Assessed at 0, 3 and 12 months</time_frame>
    <description>Use of analgesics (opioids, NSAIDs, Paracetamol, TCA) within the last week reported by the patient by a Yes or No answer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse reactions</measure>
    <time_frame>Assessed at 3, 6, 9 and 12 months</time_frame>
    <description>Assessed by asking the patient to report the occurence of any serious adverse reactions or adverse reactions during the last 3 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Patient Global Impression of Change</measure>
    <time_frame>Assessed at 3, 6, 9 and 12 months</time_frame>
    <description>The Patient Global Impression of Change (PGIC) scale using Likert scale responses (1=much worse, 2=worse, 3=a little worse, 4=neither worse nor better, 5=a little better, 6=better, 7=much better).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Depression (for patient description)</measure>
    <time_frame>Baseline</time_frame>
    <description>Depressive symptoms are assessed using the Patient Health Questionnaire-9 (PHQ-9). Nine items related to the core symptoms of depression are assessed on a 4-point Likert scale, ranging from 0 = 'not at all' to 3 = 'nearly every day', getting a score between 0 and 27 with a higher score indicating higher depression severity.</description>
  </other_outcome>
  <other_outcome>
    <measure>Anxiety (for patient description)</measure>
    <time_frame>Baseline</time_frame>
    <description>Anxiety symptoms are assessed with the Generalized Anxiety Disorder-7 (GAD-7) questionnaire. Seven items are assessed on a 4-point Likert scale, ranging from 0 = 'not at all' to 3 = 'nearly every day', getting a score between 0 and 21 with a higher score indicating higher anxiety severity.</description>
  </other_outcome>
  <other_outcome>
    <measure>Kinesiophobia (for patient description)</measure>
    <time_frame>Baseline</time_frame>
    <description>Kinesiophobia is assessed using the 17-item Tampa Scale of Kinesiophobia (TSK) questionnaire. Each of the 17 items is rated on a 4-point Likert scale with 1 = 'strongly disagree' and 4 = 'strongly agree', getting a score between 17 and 68 with a higher score indicating higher levels of fear of movement/kinesiophobia</description>
  </other_outcome>
  <other_outcome>
    <measure>Pain distribution (for patient description)</measure>
    <time_frame>Baseline</time_frame>
    <description>Self-reported drawing on body chart</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">176</enrollment>
  <condition>Chronic Low-back Pain</condition>
  <arm_group>
    <arm_group_label>Cognitive Functional Therapy+ pathway</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment is performed by a CFT trained physiotherapists and a psychologist in the Pain Center. Patients receive max 10 consultations over 3 months. The first two sessions is combined with the physiotherapist and psychologist who investigates potential maintaining factors for pain and disability in the patient's everyday life. Remaining sessions are run by the physiotherapist, and the treatment is individually tailored to the needs of the individual patient, aiming to provide the patient with skills in dealing with his / her own situation via information, reflection, change of movement and training of functions and physical level. The psychologist provide extra support for 2-3 sessions to reinforce the physiotherapist work.The ethical committee made blinding conditional on a possibility of usual care after CFT+ if: the patient does not feel ready to stop treatment AND analgesic treatment is inappropriate OR the social situation is problematic OR significant psychological distress.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Interdisciplinary pain management pathway</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment at the Interdisciplinary University Pain Center are based on elements from cognitive-behavioral therapy, Acceptance and Commitment Therapy, and Mindfulness-Based Stress Reduction programs.&#xD;
Treatment can be diverse, but based on an individual assessment it consists of a combination of (1) medical treatment with a specialist pain consultant+specialist pain nurse (ie, individual adjustment of analgesics to improve effect and reduce side effects) AND (2) one or more of the following: individual consultations with a specialist pain psychologist, physiotherapist or social worker with cognitive-behavioral therapy training as well as participation in a group program with relaxation therapy, acceptance and commitment therapy or standardized mindfulness-based stress reduction programs. On average patients in the pain center receives 9-10 sessions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Functional Therapy+ pathway</intervention_name>
    <description>The CFT+ intervention comprises 4 main components: (1) making sense of pain: context-based patient education focusing on the multidimensional nature of pain and disability, while reducing the threat of structural damage and correcting unhelpful beliefs; (2) exposure with control: graded exposure to painful, feared, or avoided activities with body relaxation; (3) lifestyle changes: encouraged to perform physical activity based on preference and taught strategies to manage stress and poor sleep, (4) focus on coping strategies in life and how these strategies influence the current situation.&#xD;
After CFT+, patients can be offered the comparator pathway should that be clinically indicated from these criteria: the patient does not feel ready to stop treatment AND Analgesic treatment is inappropriate OR Social situation is problematic OR Significantly psychological distress that requires further treatment by psychologist. This decision is based on a multidisciplinary team conference.</description>
    <arm_group_label>Cognitive Functional Therapy+ pathway</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Interdisciplinary pain management pathway</intervention_name>
    <description>Treatment at the Interdisciplinary University Pain Center are based on elements from cognitive-behavioral therapy, Acceptance and Commitment Therapy, and Mindfulness-Based Stress Reduction programs.&#xD;
Individualized combination of (1) medical treatment with a specialist pain consultant+specialist pain nurse (ie, individual adjustment of analgesics to improve effect and reduce side effects), (2) one or more of the following: individual consultations with a specialist pain psychologist, physiotherapist or social worker with cognitive-behavioral therapy training as well as participation in a group program with relaxation therapy, acceptance and commitment therapy or standardized mindfulness-based stress reduction programs.</description>
    <arm_group_label>Interdisciplinary pain management pathway</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged 18-75 years referred to interdisciplinary pain management at the Pain&#xD;
             Center&#xD;
&#xD;
          -  Adequate Danish language skills&#xD;
&#xD;
          -  • Chronic low back pain (pain in the area between the 12th rib and buttock crease&#xD;
             lasting more than 6 months)&#xD;
&#xD;
          -  Low back pain self-reported as significant contributor to daily disability (Yes/No)&#xD;
&#xD;
          -  Low back pain intensity &gt; 4 on 0-10 numerical rating scale&#xD;
&#xD;
          -  Provide consent that data collected via questionnaires and registries can be used for&#xD;
             research purposes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previously attended an interdisciplinary pain management program&#xD;
&#xD;
          -  Wheel chair bound&#xD;
&#xD;
          -  Suicidal ideation - evaluated using Patient Health Questionnaire-9 (Item 9 has to be&#xD;
             answered &quot;never&quot;)&#xD;
&#xD;
          -  Self-reported former/ present addictive drug or alcohol behavior&#xD;
&#xD;
          -  Self-reported current pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Henrik B Vægter, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Odense University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pain Center, University Hospital Odense</name>
      <address>
        <city>Odense</city>
        <state>Funen</state>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <link>
    <url>https://journals.lww.com/painrpts/pages/articleviewer.aspx?year=2020&amp;issue=02000&amp;article=00004&amp;type=Fulltext</url>
    <description>CFT pilot study in the Pain Center</description>
  </link>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>March 9, 2023</last_update_submitted>
  <last_update_submitted_qc>March 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Odense University Hospital</investigator_affiliation>
    <investigator_full_name>Henrik Bjarke Vægter</investigator_full_name>
    <investigator_title>Professor in Physiotherapy</investigator_title>
  </responsible_party>
  <keyword>Low back pain</keyword>
  <keyword>Cognitive Functional Therapy</keyword>
  <keyword>Interdisciplinary pain management</keyword>
  <keyword>RCT</keyword>
  <keyword>Disability</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04399772
org study id: 69712
nct id: NCT04399772
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a patient-blinded 2-arm randomized controlled trial (RCT) assessing the
      effectiveness (in the short and long term) as well as total healthcare costs of a CFT+ (a
      combined physiotherapist/psychologist intervention) pathway compared with interdisciplinary
      pain management pathway (usual care) for patients with chronic low back pain referred to
      interdisciplinary pain treatment.

      The primary aim of this pragmatic randomized controlled trial (RCT) is to investigate if a
      physiotherapy-led CFT pathway that includes psychologist support (CFT+) with the option of
      additional usual care (if needed) is superior to the currently recommended interdisciplinary
      pain management pathway (usual care) in reducing disability at 12 months in patients with
      severe cLBP. In addition, an economic evaluation will investigate total health care costs of
      the two pathways at 12 months.

      In addition the study will explore changes in pain intensity, quality of life, thoughts and
      beliefs about back pain, and analgesic consumption in patients randomized to the CFT+ pathway
      compared with patients randomized to the interdisciplinary pain management pathway.
Evidence suggests that chronic low back pain (LBP) is a multidimensional biopsychosocial
      problem including various contributing factors, such as negative pain cognitions,
      pain-related fear and emotional distress, avoidant and protective movement behaviors,and
      unhelpful lifestyle factors such as activity avoidance and sleep problems. Current guidelines
      recommend that patients with chronic LBP who do not benefit from primary care treatment
      should be referred to interdisciplinary pain rehabilitation in secondary care settings.
      However, such treatments are often expensive, not easily accessible, and have only modest
      effects.

      Cognitive Functional Therapy (CFT) is a newer physiotherapeutic treatment approach for
      patients with chronic low back pain, involving all important elements for the individual
      patient. Physical factors are handled via change in pain-provoking movement patterns.
      Psychological factors are handled in relation to fear, avoidance behaviour,
      catastrophization, stress, anxiety, depression and negative thoughts. Lifestyle factors are
      addressed in relation to physical inactivity and sleep problems. The approach is
      individualized and provides the patient with opportunities for action in relation to his or
      her own situation via information, reflection, change of movement and training of functions
      and physical level.

      CFT has been shown to reduce fear and worry in patients with chronic low back pain compared
      to other interventions, and the effect of CFT alone on patients with severe chronic low back
      pain has been recently investigated in an observational pilot study (without randomization)
      in our Pain Center (publication attached in link). In this study, we found a good and
      clinically relevant effect of CFT compared to standard treatment in a University Hospital
      Interdisciplinary Pain Center. In the pilot study, we noted that there were barriers to
      optimal treatment engagement for some patients (e.g. lack of motivation), and that several
      patients with high levels of psychological distress had limited benefits. Inclusion of early
      psychologist support to assist in promoting behavioral change and directly target deeper
      behavioral strategies could potentially improve patient adherence to the CFT intervention.

      This fully-powered randomized controlled study compares effectiveness of this
      physiotherapeutic intervention including psychologist support (CFT+) pathway with
      effectiveness of interdisciplinary pain treatment (recommended care) pathway in patients with
      severe chronic low back pain.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study is a patient-blinded 2-arm randomized controlled trial with a parallel group design and 1:1 group allocation.
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: This study has ethical approval that the patients involved are not aware that there is a difference between the two treatment strategies in the study. Patient masking in this study is done to ensure that included patients are as representative as possible.
The randomization sequence is distributed and stored in sealed opaque envelopes handled only by an independent study secretary who has no other involvement in the trial. All outcome measurements are completed via an electronic questionnaire system sent via personal links to the patients' official digital inbox, e-Boks (used by public hospitals, municipalities and other institutions to send official documents to citizens of Denmark). The researcher responsible for the statistical analyzes are blinded to group allocation.
measure: Pain-related disability during the last 7 days
time frame: Change from baseline to 12 months
description: Proportion of patients who have an improvement of 8 points or more on the Oswestry Disability Index (ODI) at 12 months. The ODI assesses pain-related disability within the last 7 days, asking patients to reflect on their ability to manage their everyday life despite their back pain for these domains: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and travelling. Each domain is scored on a 0-5 scale. The index is calculated by dividing the summed score by the total possible score multiplied by 100 and expressed as a percentage with 100 representing the greatest disability.
measure: Trajectory of Pain-related disability during the last 7 days
time frame: Assessed after 0, 3, 6, 9, and 12 months
description: Assessed with the Oswestry Disability Index (ODI) that asks patients to choose statements that reflect their ability to manage their everyday life despite their back pain for these domains: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and travelling. Each domain is scored on a 0-5 scale. The index is calculated by dividing the summed score by the total possible score multiplied by 100 and expressed as a percentage with 100 representing the greatest disability.
measure: Average pain intensity during the last 24 hours
time frame: Assessed at 0, 3, 6, 9, and 12 months
description: Assessed by asking the participants about the level of average pain during the last 24 hours on a 11 point rating scale, ranging from 0-10 (0 = "no pain" and 10 = "worst pain") using the 5th item from the Brief Pain Inventory Short Form. A lower score indicates lower pain intensity.
measure: Health-related quality of life
time frame: Assessed at 0, 3 and 12 months
description: Measured by European Quality of Life 5 Dimensions (EQ-5D-3L) and the Visual Analogue Scale (EQ-VAS).
For the 5 dimensions the EQ5D-3L asks the participants to rate their ability for each domain (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), respectively on a 1-3 Verbal Rating Scale, a score of 1 indicating no problems/severity, and a score of 3 indicating extreme problems/severity. The EQ-VAS asks the participant to rate their overall health 'today' on a 0-100 VAS. A higher score indicates a better quality of life.
measure: Level of pain catastrophization
time frame: Assessed at 0, 3 and 12 months
description: Measured by the Pain Catastrophizing Scale; asking participants to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on a 5-point Likert scale with 0 = not at all and 4 = all the time. The score is 0 to 52 with a higher score indicating a high level of pain catastrophizing.
measure: Level of patient enablement
time frame: Assessed at 0, 3 and 12 months
description: Measured by the Patient Enablement Instrument for Back Pain; asking participants to indicate on a 11 point rating scale, ranging from 0-10 (0 = "to a very low degree" and 10 = "to a very high degree") the degree to which they during the past week were able to 1) Cope with life, 2) Understand your back problem, 3) Cope with your back problem, 4) Keep your back healthy, 5) Feel confident about your health, and 6) Help yourself.
measure: Economical evaluation
time frame: Assessed at 12 months
description: The economic evaluation of the RCT will estimate the cost per quality adjusted life year (QALY) gained from the CFT+ intervention, compared to interdisciplinary pain program treatment. The economic analyses will utilize the EQ5D data collected during the trial for the utility weights, and total healthcare costs will be obtained from linking the trial data to Danish registries.
measure: Analgesics
time frame: Assessed at 0, 3 and 12 months
description: Use of analgesics (opioids, NSAIDs, Paracetamol, TCA) within the last week reported by the patient by a Yes or No answer.
measure: Adverse reactions
time frame: Assessed at 3, 6, 9 and 12 months
description: Assessed by asking the patient to report the occurence of any serious adverse reactions or adverse reactions during the last 3 months.
measure: The Patient Global Impression of Change
time frame: Assessed at 3, 6, 9 and 12 months
description: The Patient Global Impression of Change (PGIC) scale using Likert scale responses (1=much worse, 2=worse, 3=a little worse, 4=neither worse nor better, 5=a little better, 6=better, 7=much better).
measure: Depression (for patient description)
time frame: Baseline
description: Depressive symptoms are assessed using the Patient Health Questionnaire-9 (PHQ-9). Nine items related to the core symptoms of depression are assessed on a 4-point Likert scale, ranging from 0 = 'not at all' to 3 = 'nearly every day', getting a score between 0 and 27 with a higher score indicating higher depression severity.
measure: Anxiety (for patient description)
time frame: Baseline
description: Anxiety symptoms are assessed with the Generalized Anxiety Disorder-7 (GAD-7) questionnaire. Seven items are assessed on a 4-point Likert scale, ranging from 0 = 'not at all' to 3 = 'nearly every day', getting a score between 0 and 21 with a higher score indicating higher anxiety severity.
measure: Kinesiophobia (for patient description)
time frame: Baseline
description: Kinesiophobia is assessed using the 17-item Tampa Scale of Kinesiophobia (TSK) questionnaire. Each of the 17 items is rated on a 4-point Likert scale with 1 = 'strongly disagree' and 4 = 'strongly agree', getting a score between 17 and 68 with a higher score indicating higher levels of fear of movement/kinesiophobia
measure: Pain distribution (for patient description)
time frame: Baseline
description: Self-reported drawing on body chart
arm group label: Cognitive Functional Therapy+ pathway
arm group type: Experimental
description: Treatment is performed by a CFT trained physiotherapists and a psychologist in the Pain Center. Patients receive max 10 consultations over 3 months. The first two sessions is combined with the physiotherapist and psychologist who investigates potential maintaining factors for pain and disability in the patient's everyday life. Remaining sessions are run by the physiotherapist, and the treatment is individually tailored to the needs of the individual patient, aiming to provide the patient with skills in dealing with his / her own situation via information, reflection, change of movement and training of functions and physical level. The psychologist provide extra support for 2-3 sessions to reinforce the physiotherapist work.The ethical committee made blinding conditional on a possibility of usual care after CFT+ if: the patient does not feel ready to stop treatment AND analgesic treatment is inappropriate OR the social situation is problematic OR significant psychological distress.
arm group label: Interdisciplinary pain management pathway
arm group type: Active Comparator
description: Treatment at the Interdisciplinary University Pain Center are based on elements from cognitive-behavioral therapy, Acceptance and Commitment Therapy, and Mindfulness-Based Stress Reduction programs.
Treatment can be diverse, but based on an individual assessment it consists of a combination of (1) medical treatment with a specialist pain consultant+specialist pain nurse (ie, individual adjustment of analgesics to improve effect and reduce side effects) AND (2) one or more of the following: individual consultations with a specialist pain psychologist, physiotherapist or social worker with cognitive-behavioral therapy training as well as participation in a group program with relaxation therapy, acceptance and commitment therapy or standardized mindfulness-based stress reduction programs. On average patients in the pain center receives 9-10 sessions.
intervention type: Behavioral
intervention name: Cognitive Functional Therapy+ pathway
description: The CFT+ intervention comprises 4 main components: (1) making sense of pain: context-based patient education focusing on the multidimensional nature of pain and disability, while reducing the threat of structural damage and correcting unhelpful beliefs; (2) exposure with control: graded exposure to painful, feared, or avoided activities with body relaxation; (3) lifestyle changes: encouraged to perform physical activity based on preference and taught strategies to manage stress and poor sleep, (4) focus on coping strategies in life and how these strategies influence the current situation.
After CFT+, patients can be offered the comparator pathway should that be clinically indicated from these criteria: the patient does not feel ready to stop treatment AND Analgesic treatment is inappropriate OR Social situation is problematic OR Significantly psychological distress that requires further treatment by psychologist. This decision is based on a multidisciplinary team conference.
arm group label: Cognitive Functional Therapy+ pathway
intervention type: Behavioral
intervention name: Interdisciplinary pain management pathway
description: Treatment at the Interdisciplinary University Pain Center are based on elements from cognitive-behavioral therapy, Acceptance and Commitment Therapy, and Mindfulness-Based Stress Reduction programs.
Individualized combination of (1) medical treatment with a specialist pain consultant+specialist pain nurse (ie, individual adjustment of analgesics to improve effect and reduce side effects), (2) one or more of the following: individual consultations with a specialist pain psychologist, physiotherapist or social worker with cognitive-behavioral therapy training as well as participation in a group program with relaxation therapy, acceptance and commitment therapy or standardized mindfulness-based stress reduction programs.
arm group label: Interdisciplinary pain management pathway
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Henrik B Vægter, PhD
role: Principal Investigator
affiliation: Odense University Hospital
facility: 
country: Denmark
url: https://journals.lww.com/painrpts/pages/articleviewer.aspx?year=2020&issue=02000&article=00004&type=Fulltext
description: CFT pilot study in the Pain Center
responsible party type: Principal Investigator
investigator affiliation: Odense University Hospital
investigator full name: Henrik Bjarke Vægter
investigator title: Professor in Physiotherapy
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: No