xml: <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/NCT05994118</url>
    </required_header>
    <id_info>
      <org_study_id>0044-20-NHR</org_study_id>
      <nct_id>NCT05994118</nct_id>
    </id_info>
    <brief_title>Physiological, Cognitive, and Personal Features in the Link Between Placebo-effect and Variability of Pain Reports</brief_title>
    <official_title>Exploring the Role of Physiological, Cognitive, and Personal Features in the Link Between Placebo-effect and Variability of Pain Reports</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Haifa</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Western Galilee Hospital-Nahariya</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Haifa</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 attempt to identify whether and how factors known or considered to be related with&#xD;
        analgesic placebo effect or variability of pain reports separately, may contribute to their&#xD;
        coupling. Among these factors - personal traits such as optimism, focus of attention,&#xD;
        suggestibility, and short-term memory along with characteristics of stress and relaxation.&#xD;
        Additionally, the role of pain sensitivity and the individual's pain modulation profile in&#xD;
        the relationship between analgesic placebo effect and variability of pain reports will be&#xD;
        examined.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Data will be collected from 130 patients with non-specific chronic back pain that will be&#xD;
        recruited for a prospective cross-sectional study. To characterize the main study variables,&#xD;
        the participants will undergo the Focused analgesia selection test (FAST) which evaluates&#xD;
        within-subjects variability of pain reports, and placebo manipulation containing&#xD;
        administration of an inert injection accompanied by a verbal suggestion, which is expected to&#xD;
        produce placebo effects. The involvement of additional factors considered associated with the&#xD;
        within-subjects variability of pain reports and the placebo response will be explored. Stress&#xD;
        and well-being characteristics will be examined by measuring cortisol levels in saliva and in&#xD;
        hair, salivary level of Secretory Immune globulin A (SIgA), and an autonomic nervous system&#xD;
        function and a stress perception questionnaire. Personal traits such as suggestibility,&#xD;
        optimism, and Focus of attention, will be examined using questionnaires. Memory will be&#xD;
        assessed by memory task, and factors related to the pain modulation system will be examined&#xD;
        using psychophysical tests, and a pain sensitivity questionnaire.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 21, 2021</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">September 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>Single Group Assignment</intervention_model>
      <intervention_model_description>Subcutaneous injection of Saline solution (NACL 0.9%) in the buttock</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Reduction of pain following placebo injection</measure>
      <time_frame>Half an hour after injection</time_frame>
      <description>The reduction in pain intensity on the 0-100 numerical rating scale (NRS) after normal saline injection</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Within-subjects variability of day-to-day clinical pain reports</measure>
      <time_frame>7 days before study visit</time_frame>
      <description>The variance of within person pain scores reported on a 0-100 Visual Analog Scale VAS during 7 days via pain-dairy at baseline</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The Focused Analgesia selection task (FAST)</measure>
      <time_frame>Once, at baseline</time_frame>
      <description>Experimental paradigm which allow calculation of within-subjects variability of pain reports in response to thermal stimuli</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Pain modulation - Temporal Summation</measure>
      <time_frame>Once, at baseline</time_frame>
      <description>Change in pain intensity on the 0-100 numerical rating scale (NRS) in response to the first and last electrical noxious stimuli</description>
    </other_outcome>
    <other_outcome>
      <measure>Pain modulation - Conditioned pain modulation</measure>
      <time_frame>Once, at baseline</time_frame>
      <description>Change in pain intensity on the 0-100 numerical rating scale (NRS) in response to concurrent noxious stimuli</description>
    </other_outcome>
    <other_outcome>
      <measure>Biological markers - cortisol</measure>
      <time_frame>1 day (Before and after administration of saline)</time_frame>
      <description>Saliva cortisol levels</description>
    </other_outcome>
    <other_outcome>
      <measure>Biological markers - secretory IgA</measure>
      <time_frame>1 day (Before and after administration of saline)</time_frame>
      <description>Saliva secretory IgA level</description>
    </other_outcome>
    <other_outcome>
      <measure>Biological markers - oxytocin</measure>
      <time_frame>1 day (Before and after administration of saline)</time_frame>
      <description>Saliva oxytocin level</description>
    </other_outcome>
    <other_outcome>
      <measure>Autonomic measures - Heart rate variability</measure>
      <time_frame>1 day (Before and after administration of saline)</time_frame>
      <description>As measured by a monitor</description>
    </other_outcome>
    <other_outcome>
      <measure>Autonomic measures - blood pressure</measure>
      <time_frame>1 day (Before and after administration of saline)</time_frame>
      <description>As measured by a monitor</description>
    </other_outcome>
    <other_outcome>
      <measure>Short-term memory</measure>
      <time_frame>Once, at baseline</time_frame>
      <description>via the Digit Span test</description>
    </other_outcome>
    <other_outcome>
      <measure>Pain sensitivity via QST</measure>
      <time_frame>1 day (Before and after administration of saline)</time_frame>
      <description>Mechanical pain thresholds</description>
    </other_outcome>
    <other_outcome>
      <measure>Questionnaire - Optimism</measure>
      <time_frame>Once, at baseline</time_frame>
      <description>Via the life orientation test revised (LOT-R)</description>
    </other_outcome>
    <other_outcome>
      <measure>Questionnaire - pain sensitivity</measure>
      <time_frame>Once, at baseline</time_frame>
      <description>Via the pain sensitivity questionnaire (PSQ)</description>
    </other_outcome>
    <other_outcome>
      <measure>Questionnaire - interoceptive awareness</measure>
      <time_frame>Once, at baseline</time_frame>
      <description>Via the Multidimensional assessment of interoceptive awareness (MAIA questionnaire)</description>
    </other_outcome>
    <other_outcome>
      <measure>Questionnaire - direction of attention</measure>
      <time_frame>Once, at baseline</time_frame>
      <description>Via the Self consciousness scale revised</description>
    </other_outcome>
    <other_outcome>
      <measure>Questionnaire Body awareness</measure>
      <time_frame>Once, at baseline</time_frame>
      <description>via the body awareness Questionnaire (BAQ)</description>
    </other_outcome>
    <other_outcome>
      <measure>Questionnaire - suggestibility</measure>
      <time_frame>Once, at baseline</time_frame>
      <description>Via the short suggestibility scale (SSS)</description>
    </other_outcome>
    <other_outcome>
      <measure>Questionnaire - expectations</measure>
      <time_frame>Once, at baseline</time_frame>
      <description>via the expect Questionnaire</description>
    </other_outcome>
    <other_outcome>
      <measure>Questionnaire - perceived stress</measure>
      <time_frame>Once, at baseline</time_frame>
      <description>via the perceived stress scale</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Chronic Back Pain</condition>
    <arm_group>
      <arm_group_label>Normal Saline</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>0.5 milliliter of NACL 0.9% subcutaneous saline injection</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Magnetized Normal Saline</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>0.5 milliliter of magnetized NACL 0.9% subcutaneous saline injection</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>NaCl 0.9% (normal saline)</intervention_name>
      <description>Subcutaneous normal saline injection</description>
      <arm_group_label>Normal Saline</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Magnetized Normal Saline</intervention_name>
      <description>Magnetized Normal Saline</description>
      <arm_group_label>Magnetized Normal Saline</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Literate adults&#xD;
  &#xD;
            -  Aged 18 - 80 years&#xD;
  &#xD;
            -  A diagnosis of chronic back pain&#xD;
  &#xD;
            -  Sufferings from back pain during the last 3 months or more, with an intensity of 3 or&#xD;
               more on a 0-10 NRS&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Mental retardation or cognitive impairment&#xD;
  &#xD;
            -  Pregnancy or breast-feeding&#xD;
  &#xD;
            -  Malignancy and a diagnosis of malignant disease&#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>Roi Treister, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Haifa</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Roi Treister, PhD</last_name>
      <phone>0533839935</phone>
      <email>rtreister@univ.haifa.ac.il</email>
    </overall_contact>
    <location>
      <facility>
        <name>Galilee Medical center</name>
        <address>
          <city>Nahariyya</city>
          <zip>2210001</zip>
          <country>Israel</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Adi Shani, MA</last_name>
        <phone>+972-524239112</phone>
        <email>a.eilat888@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Israel</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>April 13, 2022</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Back Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Once published, the data (without any personal identification) will be available upon request</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05994118
  org study id: 0044-20-NHR
  nct id: NCT05994118
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study attempt to identify whether and how factors known or considered to be related with
        analgesic placebo effect or variability of pain reports separately, may contribute to their
        coupling. Among these factors - personal traits such as optimism, focus of attention,
        suggestibility, and short-term memory along with characteristics of stress and relaxation.
        Additionally, the role of pain sensitivity and the individual's pain modulation profile in
        the relationship between analgesic placebo effect and variability of pain reports will be
        examined.
  Data will be collected from 130 patients with non-specific chronic back pain that will be
        recruited for a prospective cross-sectional study. To characterize the main study variables,
        the participants will undergo the Focused analgesia selection test (FAST) which evaluates
        within-subjects variability of pain reports, and placebo manipulation containing
        administration of an inert injection accompanied by a verbal suggestion, which is expected to
        produce placebo effects. The involvement of additional factors considered associated with the
        within-subjects variability of pain reports and the placebo response will be explored. Stress
        and well-being characteristics will be examined by measuring cortisol levels in saliva and in
        hair, salivary level of Secretory Immune globulin A (SIgA), and an autonomic nervous system
        function and a stress perception questionnaire. Personal traits such as suggestibility,
        optimism, and Focus of attention, will be examined using questionnaires. Memory will be
        assessed by memory task, and factors related to the pain modulation system will be examined
        using psychophysical tests, and a pain sensitivity questionnaire.
  allocation: Randomized
  intervention model: Single Group Assignment
  intervention model description: Subcutaneous injection of Saline solution (NACL 0.9%) in the buttock
  primary purpose: Basic Science
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Reduction of pain following placebo injection
  time frame: Half an hour after injection
  description: The reduction in pain intensity on the 0-100 numerical rating scale (NRS) after normal saline injection
  measure: Within-subjects variability of day-to-day clinical pain reports
  time frame: 7 days before study visit
  description: The variance of within person pain scores reported on a 0-100 Visual Analog Scale VAS during 7 days via pain-dairy at baseline
  measure: The Focused Analgesia selection task (FAST)
  time frame: Once, at baseline
  description: Experimental paradigm which allow calculation of within-subjects variability of pain reports in response to thermal stimuli
  measure: Pain modulation - Temporal Summation
  time frame: Once, at baseline
  description: Change in pain intensity on the 0-100 numerical rating scale (NRS) in response to the first and last electrical noxious stimuli
  measure: Pain modulation - Conditioned pain modulation
  time frame: Once, at baseline
  description: Change in pain intensity on the 0-100 numerical rating scale (NRS) in response to concurrent noxious stimuli
  measure: Biological markers - cortisol
  time frame: 1 day (Before and after administration of saline)
  description: Saliva cortisol levels
  measure: Biological markers - secretory IgA
  time frame: 1 day (Before and after administration of saline)
  description: Saliva secretory IgA level
  measure: Biological markers - oxytocin
  time frame: 1 day (Before and after administration of saline)
  description: Saliva oxytocin level
  measure: Autonomic measures - Heart rate variability
  time frame: 1 day (Before and after administration of saline)
  description: As measured by a monitor
  measure: Autonomic measures - blood pressure
  time frame: 1 day (Before and after administration of saline)
  description: As measured by a monitor
  measure: Short-term memory
  time frame: Once, at baseline
  description: via the Digit Span test
  measure: Pain sensitivity via QST
  time frame: 1 day (Before and after administration of saline)
  description: Mechanical pain thresholds
  measure: Questionnaire - Optimism
  time frame: Once, at baseline
  description: Via the life orientation test revised (LOT-R)
  measure: Questionnaire - pain sensitivity
  time frame: Once, at baseline
  description: Via the pain sensitivity questionnaire (PSQ)
  measure: Questionnaire - interoceptive awareness
  time frame: Once, at baseline
  description: Via the Multidimensional assessment of interoceptive awareness (MAIA questionnaire)
  measure: Questionnaire - direction of attention
  time frame: Once, at baseline
  description: Via the Self consciousness scale revised
  measure: Questionnaire Body awareness
  time frame: Once, at baseline
  description: via the body awareness Questionnaire (BAQ)
  measure: Questionnaire - suggestibility
  time frame: Once, at baseline
  description: Via the short suggestibility scale (SSS)
  measure: Questionnaire - expectations
  time frame: Once, at baseline
  description: via the expect Questionnaire
  measure: Questionnaire - perceived stress
  time frame: Once, at baseline
  description: via the perceived stress scale
  arm group label: Normal Saline
  arm group type: Placebo Comparator
  description: 0.5 milliliter of NACL 0.9% subcutaneous saline injection
  arm group label: Magnetized Normal Saline
  arm group type: Active Comparator
  description: 0.5 milliliter of magnetized NACL 0.9% subcutaneous saline injection
  intervention type: Other
  intervention name: NaCl 0.9% (normal saline)
  description: Subcutaneous normal saline injection
  arm group label: Normal Saline
  intervention type: Other
  intervention name: Magnetized Normal Saline
  description: Magnetized Normal Saline
  arm group label: Magnetized Normal Saline
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Roi Treister, PhD
  role: Principal Investigator
  affiliation: University of Haifa
  last name: Roi Treister, PhD
  phone: 0533839935
  email: rtreister@univ.haifa.ac.il
  facility: 
  status: Recruiting
  contact: 
  country: Israel
  responsible party type: Sponsor
  mesh term: Back Pain
  sharing ipd: Yes
  ipd description: Once published, the data (without any personal identification) will be available upon request