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/NCT05969288</url>
    </required_header>
    <id_info>
      <org_study_id>2023-004</org_study_id>
      <nct_id>NCT05969288</nct_id>
    </id_info>
    <brief_title>Low Back Pain and Osteopathy in Italian Young People</brief_title>
    <official_title>Presence of Low Back Pain and Willingness to Osteopathic Cures in Italian Young People</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 evaluating the presence of low back pain in&#xD;
        young people and the intention to undertake osteopathic treatments. It consists of a short&#xD;
        self-administered questionnaire which will be given to adolescents with&#xD;
        gnathological/orthodontics disorders to complete. Relationships between low back pain of&#xD;
        young individuals' answers with the intention to undertake osteopathic treatments will be&#xD;
        evaluated.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a behavioral observational study aimed at evaluating the presence of low back pain in&#xD;
        young people and the intention to undertake osteopathic treatments.&#xD;
  &#xD;
        Literature found out that low back pain is a common occurrence in young people. Adolescents&#xD;
        develop frequently gnathological/orthodontics disorders. In Italy, young individuals with low&#xD;
        back pain and gnathological/orthodontics disorders are frequently referred to osteopaths.&#xD;
  &#xD;
        In Literature there are not studies which correlate low back pain, osteopathic cures and&#xD;
        gnathological/orthodontics disorders as for young persons.&#xD;
  &#xD;
        The study consists of a short self-administered questionnaire which will be given to young&#xD;
        people to complete. In more details, the survey is made of 8 questions collecting information&#xD;
        on presence/intensity of low back pain, intention to have osteopathic treatments, and (in&#xD;
        that case) the satisfaction after the cures. Further, participants will have to complete a&#xD;
        self-administered pain intensity numerical rating scale.&#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;
        adolescents' answers and the pain intensity numerical rating scale will be also evaluated.&#xD;
  &#xD;
        This study investigates the relationships among low back pain, gnathological/orthodontics&#xD;
        disorders, and osteopathic cures.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>NRS</measure>
      <time_frame>At the moment of the assessment</time_frame>
      <description>Pain intensity Numerical Rating Scale: it a self-reported 11-point scale which evaluates pain intensity, varying from 0 (no pain at all) to 10 (the worst imaginable pain)</description>
    </primary_outcome>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Low Back Pain</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Behavioral survey</intervention_name>
      <description>Behavioral survey by administering a short self-administered questionnaire (read more in the &quot;Detailed description&quot; section).</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Young people with low back pain and gnathological/orthodontics disorders.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  common low back pain&#xD;
  &#xD;
            -  ability to read and understand the Italian language&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  any diagnosable cause of low back pain&#xD;
  &#xD;
            -  previous spinal surgery&#xD;
  &#xD;
            -  cognitive impairment&#xD;
  &#xD;
            -  refusal to adhere&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>11 Years</minimum_age>
      <maximum_age>30 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <results_reference>
      <citation>Salaffi F, Stancati A, Silvestri CA, Ciapetti A, Grassi W. Minimal clinically important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale. Eur J Pain. 2004 Aug;8(4):283-91. doi: 10.1016/j.ejpain.2003.09.004.</citation>
      <PMID>15207508</PMID>
    </results_reference>
    <results_reference>
      <citation>Chiarotto A, Koes BW. Nonspecific Low Back Pain. N Engl J Med. 2022 May 5;386(18):1732-1740. doi: 10.1056/NEJMcp2032396. No abstract available.</citation>
      <PMID>35507483</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 16, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>International Institute of Behavioral Medicines</investigator_affiliation>
      <investigator_full_name>Barbara Rocca</investigator_full_name>
      <investigator_title>Scientific Director</investigator_title>
    </responsible_party>
    <keyword>Low back pain</keyword>
    <keyword>Gnathology</keyword>
    <keyword>Orthodontics</keyword>
    <keyword>Osteopathy</keyword>
    <keyword>Young people</keyword>
    <keyword>Behavioral Medicine</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/NCT05969288
  org study id: 2023-004
  nct id: NCT05969288
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a behavioral observational study aimed at evaluating the presence of low back pain in
        young people and the intention to undertake osteopathic treatments. It consists of a short
        self-administered questionnaire which will be given to adolescents with
        gnathological/orthodontics disorders to complete. Relationships between low back pain of
        young individuals' answers with the intention to undertake osteopathic treatments will be
        evaluated.
  This is a behavioral observational study aimed at evaluating the presence of low back pain in
        young people and the intention to undertake osteopathic treatments.
  
        Literature found out that low back pain is a common occurrence in young people. Adolescents
        develop frequently gnathological/orthodontics disorders. In Italy, young individuals with low
        back pain and gnathological/orthodontics disorders are frequently referred to osteopaths.
  
        In Literature there are not studies which correlate low back pain, osteopathic cures and
        gnathological/orthodontics disorders as for young persons.
  
        The study consists of a short self-administered questionnaire which will be given to young
        people to complete. In more details, the survey is made of 8 questions collecting information
        on presence/intensity of low back pain, intention to have osteopathic treatments, and (in
        that case) the satisfaction after the cures. Further, participants will have to complete a
        self-administered pain intensity numerical rating scale.
  
        Descriptive statistics will be presented by taking into account the socio-demographic
        characteristics of the sample being investigated. Statistical correlations between
        adolescents' answers and the pain intensity numerical rating scale will be also evaluated.
  
        This study investigates the relationships among low back pain, gnathological/orthodontics
        disorders, and osteopathic cures.
  observational model: Cohort
  time perspective: Prospective
  measure: NRS
  time frame: At the moment of the assessment
  description: Pain intensity Numerical Rating Scale: it a self-reported 11-point scale which evaluates pain intensity, varying from 0 (no pain at all) to 10 (the worst imaginable pain)
  intervention type: Other
  intervention name: Behavioral survey
  description: Behavioral survey by administering a short self-administered questionnaire (read more in the "Detailed description" section).
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 11 Years
  maximum age: 30 Years
  healthy volunteers: No
  citation: Salaffi F, Stancati A, Silvestri CA, Ciapetti A, Grassi W. Minimal clinically important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale. Eur J Pain. 2004 Aug;8(4):283-91. doi: 10.1016/j.ejpain.2003.09.004.
  PMID: 15207508
  citation: Chiarotto A, Koes BW. Nonspecific Low Back Pain. N Engl J Med. 2022 May 5;386(18):1732-1740. doi: 10.1056/NEJMcp2032396. No abstract available.
  PMID: 35507483
  responsible party type: Principal Investigator
  investigator affiliation: International Institute of Behavioral Medicines
  investigator full name: Barbara Rocca
  investigator title: Scientific Director
  mesh term: Back Pain
  mesh term: Low Back Pain
  sharing ipd: No