<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/NCT03837080</url>
  </required_header>
  <id_info>
    <org_study_id>JJStrossmayerU</org_study_id>
    <nct_id>NCT03837080</nct_id>
  </id_info>
  <brief_title>Nutrition Intervention for Chronic Pain Patients</brief_title>
  <acronym>NutChROPain</acronym>
  <official_title>Efficacy of Nutrition Education Tailored for Chronic Pain Patients on Pain Intensity and Quality of Life - A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Josip Juraj Strossmayer University of Osijek</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Osijek University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Josip Juraj Strossmayer University of Osijek</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The primary objective of the study is to determine the effectiveness of nutrition education&#xD;
      (individual and group) on the intensity of pain in patients suffering from chronic pain. The&#xD;
      secondary goal is to determine whether there is a change in the status of the patient's&#xD;
      nutrition, their quality of life, quality of life, and other indicators of the psychophysical&#xD;
      condition of the patient.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The underlying hypothesis of the study is that patients with chronic pain that go through a&#xD;
      series of nutrition education (individual and group) specifically tailored to fit their needs&#xD;
      (based on our preliminary findings), they increase the consumption of foods that have&#xD;
      antiinflammatory properties, which will result in lower levels of inflammatory cytokines in&#xD;
      the body (high sensitivity C-reactive protein (hs-CRP ), interleukin (IL) -2, IL-4 and IL-6),&#xD;
      and consequently reduce the intensity of pain. Also, weight loss in obese patients is&#xD;
      expected, and it will have an contributing effect of the intervention. Patient's quality of&#xD;
      life and indicators of their psychophysical condition (eg, depression level) are also&#xD;
      expected to improve.&#xD;
&#xD;
      Chronic pain patients who either attend Daily clinic (Control Arm) or the 4-week&#xD;
      multidisciplinary programme at the Department of Anesthesiology, Resuscitation and Intensive&#xD;
      Care (Intervention Arm) will be recruited. They will be followed for total of 8 weeks (4 week&#xD;
      intervention + 4 week follow-up).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 28, 2019</start_date>
  <completion_date type="Actual">February 12, 2020</completion_date>
  <primary_completion_date type="Actual">January 15, 2020</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>Single Group Assignment</intervention_model>
    <intervention_model_description>Cluster randomization (groups of patients will be randomly assigned to the Intervention or the Control arm)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The whole group will be randomized (cluster randomization) to either Intervention or Control arm. Each group consists of 8 to 12 patients.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in pain intensity after the intervention and after 4-week follow-up</measure>
    <time_frame>At inclusion, 4 weeks after the intervention, 4 weeks post-intervention</time_frame>
    <description>We will use simple, patient-based pain screening questionnaire called the painDETECT questionnaire (validated and widely used to assess pain intensity in chronic pain patients). The questionnaire is based on the scale from 1 (no pain) to 10 (extreme pain).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in high-sensitive C-reactive protein after the intervention and after 4-week follow-up</measure>
    <time_frame>At inclusion, 4 weeks after the intervention, 4 weeks post-intervention</time_frame>
    <description>high sensitive C-reactive protein (hs-CRP) (mg/L),</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in interleukines after the intervention and after 4-week follow-up</measure>
    <time_frame>At inclusion, 4 weeks after the intervention, 4 weeks post-intervention</time_frame>
    <description>IL-2 (pg/mL), IL-4 8pg/mL), IL-6 (pg/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in monocyte chemoattractant protein after the intervention and after 4-week follow-up</measure>
    <time_frame>At inclusion, 4 weeks after the intervention, 4 weeks post-intervention</time_frame>
    <description>Monocyte chemoattractant protein (MCP-1) (pg/mL)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in psychological status after the intervention and after 4-week follow-up</measure>
    <time_frame>At inclusion, 4 weeks after the intervention, 4 weeks post-intervention</time_frame>
    <description>Depression, Anxiety and Stress Scale (DASS-21) Questionnaire is a validate questionnaire freely accessible and will be scored according to the instruction manual.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Health-Related Quality of Life after the intervention and after 4-week follow-up</measure>
    <time_frame>At inclusion, 4 weeks after the intervention, 4 weeks post-intervention</time_frame>
    <description>The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. Total of 36 questions (items) are scored on a 0 to 100 range where higher score corresponds to better quality of life. Items are divided into a total of 8 scales and assess the following: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain and general health. For each scale scoring is done on a 0 to 100 range where higher scores correspond to better health.</description>
  </other_outcome>
  <other_outcome>
    <measure>Physical activity and sleep monitoring throughout the intervention and follow-up period</measure>
    <time_frame>Throughout the intervention and 4 weeks post-intervention</time_frame>
    <description>Wearable Health (fitness) device (MiFit) will be used to track patient's physical activity and sleep duration.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Pain Catastrophizing after the intervention and after 4-week follow-up</measure>
    <time_frame>At inclusion, 4 weeks after the intervention, 4 weeks post-intervention</time_frame>
    <description>The Pain Catastrophizing Scale (PCS) will be used to determine the change in patient's catastrophizing scale related to pain. The questionnaire is based on a scale from 1 (not at all) to 4 (all the time) and assess patient's preoccupation with the pain. The questionnaire will be scored according to the instruction manual.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">67</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Nutrition Education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants suffering from chronic pain enrolled in the 4-week Pain Management Clinic organized at the Department of Anesthesiology, Resuscitation and Intensive Care will go through a series of individual and group nutrition educations. Educations are specifically tailored for chronic pain patients, based on our preliminary findings on this group of patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants suffering from chronic pain enrolled in the 4-week Pain Management Clinic organized at the Department of Anesthesiology, Resuscitation and Intensive Care. Patients will receive all treatments (e.g. physical therapy) except the nutrition education.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nutrition Education</intervention_name>
    <description>Every patient will receive one individual and two group counselings on specific nutrition-related recommendations for chronic pain patients.</description>
    <arm_group_label>Nutrition Education</arm_group_label>
    <other_name>Chronic Pain Nutrition Education</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
          -  chronic low back pain with or without radiculopathy patients; non-cancer pain&#xD;
&#xD;
          -  BMI within the range &gt;18 and &lt;35 kg/m2&#xD;
&#xD;
          -  Croatian-speaking&#xD;
&#xD;
          -  referred to a multidisciplinary pain management center&#xD;
&#xD;
          -  able to report on their health and pain status (neurologically stable)&#xD;
&#xD;
          -  pain intensity on 0-10 visual analog scale ≥ 5 prior to treatment&#xD;
&#xD;
          -  magnetic resonance imaging (MRI) of the lumbar spine and electromyography (EMNG)&#xD;
             studies completed confirming clinical symptoms of low back pain with or without&#xD;
             radiculopathy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  younger than 18 or older than 80&#xD;
&#xD;
          -  cancer pain&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  disability (unable to walk)&#xD;
&#xD;
          -  inability to fill in questionnaires in Croatian&#xD;
&#xD;
          -  cognitive impairment&#xD;
&#xD;
          -  significant, symptomatic uncontrolled psychosis&#xD;
&#xD;
          -  psychiatric disorder&#xD;
&#xD;
          -  pain intensity on 0-10 visual analog scale &lt; 5 prior to treatment&#xD;
&#xD;
          -  severe somatic disorder (oncological disease, type 1 diabetes, hepatological or&#xD;
             nephrological)&#xD;
&#xD;
          -  undergoing current treatment for a major medical illness such as malignancy,&#xD;
             autoimmune or immune deficiency disorder&#xD;
&#xD;
          -  acute low back pain, or shorter than 6 months&#xD;
&#xD;
          -  clotting disorders&#xD;
&#xD;
          -  BMI &lt;18 or over 35 kg/m2&#xD;
&#xD;
          -  nutritional deficiency (e.g. iron deficiency anaemia, osteoporosis)&#xD;
&#xD;
          -  current or history of eating disorder (anorexia, bulimia or EDNOS)&#xD;
&#xD;
          -  current use of weight loss interventions (drugs; exercise interventions)&#xD;
&#xD;
          -  regular use of supplemental omega-3 fatty acids, gamma-linolenic acid or vitamin D&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ines Banjari, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Food and Nutrition Research, Faculty of Food Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Food and Nutrition Research, Faculty of Food Technology</name>
      <address>
        <city>Osijek</city>
        <zip>31000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Croatia</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>February 12, 2020</last_update_submitted>
  <last_update_submitted_qc>February 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Josip Juraj Strossmayer University of Osijek</investigator_affiliation>
    <investigator_full_name>Ines Banjari</investigator_full_name>
    <investigator_title>PhD, Associate Prof., Head of Department of Food and Nutrition Research</investigator_title>
  </responsible_party>
  <keyword>chronic pain</keyword>
  <keyword>nutrition education</keyword>
  <keyword>inflammatory biomarkers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>This project is the doctorate thesis project so all data sharing requests can be submitted after the defense by contacting the PI directly.</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>March 28, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03837080
org study id: JJStrossmayerU
nct id: NCT03837080
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The primary objective of the study is to determine the effectiveness of nutrition education
      (individual and group) on the intensity of pain in patients suffering from chronic pain. The
      secondary goal is to determine whether there is a change in the status of the patient's
      nutrition, their quality of life, quality of life, and other indicators of the psychophysical
      condition of the patient.
The underlying hypothesis of the study is that patients with chronic pain that go through a
      series of nutrition education (individual and group) specifically tailored to fit their needs
      (based on our preliminary findings), they increase the consumption of foods that have
      antiinflammatory properties, which will result in lower levels of inflammatory cytokines in
      the body (high sensitivity C-reactive protein (hs-CRP ), interleukin (IL) -2, IL-4 and IL-6),
      and consequently reduce the intensity of pain. Also, weight loss in obese patients is
      expected, and it will have an contributing effect of the intervention. Patient's quality of
      life and indicators of their psychophysical condition (eg, depression level) are also
      expected to improve.

      Chronic pain patients who either attend Daily clinic (Control Arm) or the 4-week
      multidisciplinary programme at the Department of Anesthesiology, Resuscitation and Intensive
      Care (Intervention Arm) will be recruited. They will be followed for total of 8 weeks (4 week
      intervention + 4 week follow-up).
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: Cluster randomization (groups of patients will be randomly assigned to the Intervention or the Control arm)
primary purpose: Treatment
masking: None (Open Label)
masking description: The whole group will be randomized (cluster randomization) to either Intervention or Control arm. Each group consists of 8 to 12 patients.
measure: Change in pain intensity after the intervention and after 4-week follow-up
time frame: At inclusion, 4 weeks after the intervention, 4 weeks post-intervention
description: We will use simple, patient-based pain screening questionnaire called the painDETECT questionnaire (validated and widely used to assess pain intensity in chronic pain patients). The questionnaire is based on the scale from 1 (no pain) to 10 (extreme pain).
measure: Change in high-sensitive C-reactive protein after the intervention and after 4-week follow-up
time frame: At inclusion, 4 weeks after the intervention, 4 weeks post-intervention
description: high sensitive C-reactive protein (hs-CRP) (mg/L),
measure: Change in interleukines after the intervention and after 4-week follow-up
time frame: At inclusion, 4 weeks after the intervention, 4 weeks post-intervention
description: IL-2 (pg/mL), IL-4 8pg/mL), IL-6 (pg/mL)
measure: Change in monocyte chemoattractant protein after the intervention and after 4-week follow-up
time frame: At inclusion, 4 weeks after the intervention, 4 weeks post-intervention
description: Monocyte chemoattractant protein (MCP-1) (pg/mL)
measure: Change in psychological status after the intervention and after 4-week follow-up
time frame: At inclusion, 4 weeks after the intervention, 4 weeks post-intervention
description: Depression, Anxiety and Stress Scale (DASS-21) Questionnaire is a validate questionnaire freely accessible and will be scored according to the instruction manual.
measure: Change in Health-Related Quality of Life after the intervention and after 4-week follow-up
time frame: At inclusion, 4 weeks after the intervention, 4 weeks post-intervention
description: The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. Total of 36 questions (items) are scored on a 0 to 100 range where higher score corresponds to better quality of life. Items are divided into a total of 8 scales and assess the following: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain and general health. For each scale scoring is done on a 0 to 100 range where higher scores correspond to better health.
measure: Physical activity and sleep monitoring throughout the intervention and follow-up period
time frame: Throughout the intervention and 4 weeks post-intervention
description: Wearable Health (fitness) device (MiFit) will be used to track patient's physical activity and sleep duration.
measure: Change in Pain Catastrophizing after the intervention and after 4-week follow-up
time frame: At inclusion, 4 weeks after the intervention, 4 weeks post-intervention
description: The Pain Catastrophizing Scale (PCS) will be used to determine the change in patient's catastrophizing scale related to pain. The questionnaire is based on a scale from 1 (not at all) to 4 (all the time) and assess patient's preoccupation with the pain. The questionnaire will be scored according to the instruction manual.
arm group label: Nutrition Education
arm group type: Experimental
description: Participants suffering from chronic pain enrolled in the 4-week Pain Management Clinic organized at the Department of Anesthesiology, Resuscitation and Intensive Care will go through a series of individual and group nutrition educations. Educations are specifically tailored for chronic pain patients, based on our preliminary findings on this group of patients.
arm group label: Control
arm group type: No Intervention
description: Participants suffering from chronic pain enrolled in the 4-week Pain Management Clinic organized at the Department of Anesthesiology, Resuscitation and Intensive Care. Patients will receive all treatments (e.g. physical therapy) except the nutrition education.
intervention type: Other
intervention name: Nutrition Education
description: Every patient will receive one individual and two group counselings on specific nutrition-related recommendations for chronic pain patients.
arm group label: Nutrition Education
other name: Chronic Pain Nutrition Education
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ines Banjari, PhD
role: Principal Investigator
affiliation: Department of Food and Nutrition Research, Faculty of Food Technology
facility: 
country: Croatia
responsible party type: Principal Investigator
investigator affiliation: Josip Juraj Strossmayer University of Osijek
investigator full name: Ines Banjari
investigator title: PhD, Associate Prof., Head of Department of Food and Nutrition Research
mesh term: Chronic Pain
sharing ipd: Undecided
ipd description: This project is the doctorate thesis project so all data sharing requests can be submitted after the defense by contacting the PI directly.
submitted: March 28, 2023