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/NCT06022484</url>
    </required_header>
    <id_info>
      <org_study_id>2023-005</org_study_id>
      <nct_id>NCT06022484</nct_id>
    </id_info>
    <brief_title>Magnetic Resonance Imaging and Acute Low Back Pain</brief_title>
    <official_title>How Many Days Will You Delay Before a MRI When You Have Low Back Pain?</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>International Institute of Behavioral Medicines</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>International Institute of Behavioral Medicines</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 is a behavioral observational study aimed at understanding the limit of tolerance (in&#xD;
        days) of ideally performing a Magnetic Resonance Imaging (MRI) by people with acute low back&#xD;
        pain. It consists of a short self-administered questionnaire. Relationships between low back&#xD;
        pain intensity, maladaptive thoughts and awaited days before ideally requesting a MRI will be&#xD;
        evaluated.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a behavioral observational study aimed at understanding the limit of tolerance (in&#xD;
        days) of ideally performing a Magnetic Resonance Imaging (MRI) by people with acute low back&#xD;
        pain (LBP) and by general practitioners (GP).&#xD;
  &#xD;
        Literature pointed out that LBP is a common occurrence in people, with high rates of&#xD;
        self-resolution in the absence of red flags (i.e. possible indicators of serious spinal&#xD;
        pathology).&#xD;
  &#xD;
        In Italy there is an over-prescription of MRI despite international guidelines go the&#xD;
        opposite way.&#xD;
  &#xD;
        The study consists of a short self-administered questionnaire which will be given to people&#xD;
        and GP to complete. In more details, the survey is made of 3 questions collecting information&#xD;
        on the limit of tolerance (in days) before requesting (people) and prescribing (GP) a MRI for&#xD;
        the lumbar tract of the spinal column.&#xD;
  &#xD;
        Further, participants will have to complete a self-administered pain intensity numerical&#xD;
        rating scale, along with catastrophizing and anxiety self-administered questionnaires.&#xD;
  &#xD;
        Descriptive statistics will be presented by taking into account the socio-demographic&#xD;
        characteristics of the sample being investigated. Statistical correlations between&#xD;
        participants' answers and the scores from the questionnaires will be also evaluated.&#xD;
  &#xD;
        This study investigates the relationships among acute low back pain, the intention of&#xD;
        persons/GP to request/prescribe a MRI despite the absence of red flags, mood disorders and&#xD;
        maladaptive thoughts.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Two questions on limit of tolerance</measure>
      <time_frame>Up to the first day</time_frame>
      <description>Design of questions which investigates the limit of tolerance of requesting and prescribing a MRI; score is expressed as &quot;number of days&quot; (neither min nor max values are stated a priori).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>NRS</measure>
      <time_frame>Up to the first day</time_frame>
      <description>pain intensity Numerical Rating Scale; score 0-10 with higher estimates indicating higher levels of pain intensity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PCS</measure>
      <time_frame>Up to the first day</time_frame>
      <description>Pain Catastrophizing Scale; score 0-52 with higher estimates indicating higher levels of catastrophizing.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ZUNG</measure>
      <time_frame>Up to the first day</time_frame>
      <description>Zung Self-Rating Anxiety Scale; score 20-80 with higher estimates indicating higher levels of anxiety</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Acute Low Back Pain</condition>
    <arm_group>
      <arm_group_label>People with acute low back pain</arm_group_label>
      <description>No intervention.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>General practitioners who treat people with acute low back pain</arm_group_label>
      <description>No intervention.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>The present study does not contain any intervention</intervention_name>
      <description>The present study does not contain any intervention</description>
      <arm_group_label>General practitioners who treat people with acute low back pain</arm_group_label>
      <arm_group_label>People with acute low back pain</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult people with acute low back pain (i.e., a pain lasting no more than 6 weeks).&#xD;
  &#xD;
          General practitioners who are involved in the managment of people with acute low back pain.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Having acute low back pain (i.e., a pain lasting no more than 6 weeks)&#xD;
  &#xD;
            -  Adult age&#xD;
  &#xD;
            -  Ability to understand the Italian language&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Mental deficits&#xD;
  &#xD;
            -  Refuse to adhere to the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Low back pain</keyword>
    <keyword>Magnetic Resonance Imaging</keyword>
    <keyword>Catastrophizing</keyword>
    <keyword>Anxiety</keyword>
    <keyword>Red flags</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>
  
  
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/NCT06022484
  org study id: 2023-005
  nct id: NCT06022484
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a behavioral observational study aimed at understanding the limit of tolerance (in
        days) of ideally performing a Magnetic Resonance Imaging (MRI) by people with acute low back
        pain. It consists of a short self-administered questionnaire. Relationships between low back
        pain intensity, maladaptive thoughts and awaited days before ideally requesting a MRI will be
        evaluated.
  This is a behavioral observational study aimed at understanding the limit of tolerance (in
        days) of ideally performing a Magnetic Resonance Imaging (MRI) by people with acute low back
        pain (LBP) and by general practitioners (GP).
  
        Literature pointed out that LBP is a common occurrence in people, with high rates of
        self-resolution in the absence of red flags (i.e. possible indicators of serious spinal
        pathology).
  
        In Italy there is an over-prescription of MRI despite international guidelines go the
        opposite way.
  
        The study consists of a short self-administered questionnaire which will be given to people
        and GP to complete. In more details, the survey is made of 3 questions collecting information
        on the limit of tolerance (in days) before requesting (people) and prescribing (GP) a MRI for
        the lumbar tract of the spinal column.
  
        Further, participants will have to complete a self-administered pain intensity numerical
        rating scale, along with catastrophizing and anxiety self-administered questionnaires.
  
        Descriptive statistics will be presented by taking into account the socio-demographic
        characteristics of the sample being investigated. Statistical correlations between
        participants' answers and the scores from the questionnaires will be also evaluated.
  
        This study investigates the relationships among acute low back pain, the intention of
        persons/GP to request/prescribe a MRI despite the absence of red flags, mood disorders and
        maladaptive thoughts.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Two questions on limit of tolerance
  time frame: Up to the first day
  description: Design of questions which investigates the limit of tolerance of requesting and prescribing a MRI; score is expressed as "number of days" (neither min nor max values are stated a priori).
  measure: NRS
  time frame: Up to the first day
  description: pain intensity Numerical Rating Scale; score 0-10 with higher estimates indicating higher levels of pain intensity
  measure: PCS
  time frame: Up to the first day
  description: Pain Catastrophizing Scale; score 0-52 with higher estimates indicating higher levels of catastrophizing.
  measure: ZUNG
  time frame: Up to the first day
  description: Zung Self-Rating Anxiety Scale; score 20-80 with higher estimates indicating higher levels of anxiety
  arm group label: People with acute low back pain
  description: No intervention.
  arm group label: General practitioners who treat people with acute low back pain
  description: No intervention.
  intervention type: Other
  intervention name: The present study does not contain any intervention
  description: The present study does not contain any intervention
  arm group label: General practitioners who treat people with acute low back pain
  arm group label: People with acute low back pain
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Back Pain
  mesh term: Low Back Pain
  sharing ipd: No