<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/NCT03785353</url>
  </required_header>
  <id_info>
    <org_study_id>ShenandoahU(2018-2019)</org_study_id>
    <nct_id>NCT03785353</nct_id>
  </id_info>
  <brief_title>The Effects of Pain Neuroscience Education in a Spanish-Speaking Population</brief_title>
  <official_title>The Effects of Pain Neuroscience Education in a Spanish-Speaking Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shenandoah University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shenandoah University</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>
      Pain Neuroscience Education (PNE) has been shown to be effective to alter beliefs and&#xD;
      decrease pain among individuals with musculoskeletal pain. Additionally, PNE has been shown&#xD;
      to alter beliefs among middle school children. This study plans to assess the effects of PNE&#xD;
      within a group of Spanish-speaking individuals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic pain is a topic of discussion that is becoming increasingly prevalent among&#xD;
      healthcare professionals. With the ever-growing opioid epidemic, there are a variety of&#xD;
      discussions on different modes of treatment other than opioid prescription. Pain neuroscience&#xD;
      education, or PNE, is one of these alternative treatment options. PNE focuses on a patient's&#xD;
      understanding of pain itself and relates this to the current pain they are experiencing. PNE&#xD;
      is often a discussion between provider and patient that utilizes a series of stories,&#xD;
      metaphors, and examples where pain is described from a point of view that is not strictly&#xD;
      medical. Recent literature suggests there is a lack of knowledge regarding pain in the United&#xD;
      States, particularly in the Spanish-speaking population. This population is also less likely&#xD;
      to seek a physician's advice for pain management. For these reasons, this study will focus on&#xD;
      the Spanish-speaking population within the Winchester community. Due to success within prior&#xD;
      PNE studies, this study will be conducted through a classroom lecture. The overarching&#xD;
      purpose of this study is to examine the change in knowledge of pain in the Spanish-speaking&#xD;
      population immediately following a PNE lecture composed of stories, metaphors, and examples&#xD;
      about pain. Because Spanish-speaking individuals are less likely to seek out a medical&#xD;
      provider, the study may support an additional treatment option for managing chronic pain. Not&#xD;
      only will this provide further research to support the benefits of PNE, but there is the&#xD;
      potential to modify a participant's perception of their own pain through this educational&#xD;
      lecture.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 26, 2019</start_date>
  <completion_date type="Actual">March 15, 2021</completion_date>
  <primary_completion_date type="Actual">March 27, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Participants will arrive at a location TBD on the day of data collection. Consent forms will be dispersed to participants, who will be able to ask any questions they may have before signing. A Spanish-speaking researcher will be available to answer those questions. After consent is received, each participant will draw a random number that will be used to link their responses to pre- and post-lecture surveys. After consent is received, a pre-test on pain knowledge and beliefs will be administered. A 30-minute Pain Neuroscience Education (PNE) lecture will be given to participants in Spanish. A post-test on pain knowledge and beliefs will be administered.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>R-NPQ</measure>
    <time_frame>Immediately post-lecture</time_frame>
    <description>Revised Neuroscience of Pain Questionnaire</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Pain</condition>
  <condition>Educational Problems</condition>
  <arm_group>
    <arm_group_label>PNE Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A group of Spanish-speaking individuals will listen to a translated lecture related to PNE (PNE lecture). They will fill out the R-NPQ pre and post the lecture.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PNE lecture</intervention_name>
    <description>A translated (from English to Spanish) lecture on Pain Neuroscience Education</description>
    <arm_group_label>PNE Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must speak Spanish at least 50% of the time at home OR Spanish must be&#xD;
             the first language learned. Participants must also be willing to sit and listen to&#xD;
             lecture and fill out quiz before and after.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any individual under the age of 18 will be excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sheri A Hale, PT, PhD, ATC</last_name>
    <role>Study Director</role>
    <affiliation>Shenandoah University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shenandoah University</name>
      <address>
        <city>Winchester</city>
        <state>Virginia</state>
        <zip>22601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Louw A, Podalak J, Zimney K, Schmidt S, Puentedura EJ. Can pain beliefs change in middle school students? A study of the effectiveness of pain neuroscience education. Physiother Theory Pract. 2018 Jul;34(7):542-550. doi: 10.1080/09593985.2017.1423142. Epub 2018 Jan 8.</citation>
    <PMID>29308954</PMID>
  </results_reference>
  <results_reference>
    <citation>Louw A, Zimney K, Puentedura EJ, Diener I. The efficacy of pain neuroscience education on musculoskeletal pain: A systematic review of the literature. Physiother Theory Pract. 2016 Jul;32(5):332-55. doi: 10.1080/09593985.2016.1194646. Epub 2016 Jun 28.</citation>
    <PMID>27351541</PMID>
  </results_reference>
  <results_reference>
    <citation>Louw A, Zimney K, O'Hotto C, Hilton S. The clinical application of teaching people about pain. Physiother Theory Pract. 2016 Jul;32(5):385-95. doi: 10.1080/09593985.2016.1194652. Epub 2016 Jun 28.</citation>
    <PMID>27351903</PMID>
  </results_reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>March 15, 2021</last_update_submitted>
  <last_update_submitted_qc>March 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shenandoah University</investigator_affiliation>
    <investigator_full_name>Aaron Hartstein</investigator_full_name>
    <investigator_title>Assistant Professor of Physical Therapy</investigator_title>
  </responsible_party>
  <keyword>Pain Neuroscience Education</keyword>
  <keyword>Spanish-speaking</keyword>
  <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/NCT03785353
org study id: ShenandoahU(2018-2019)
nct id: NCT03785353
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pain Neuroscience Education (PNE) has been shown to be effective to alter beliefs and
      decrease pain among individuals with musculoskeletal pain. Additionally, PNE has been shown
      to alter beliefs among middle school children. This study plans to assess the effects of PNE
      within a group of Spanish-speaking individuals.
Chronic pain is a topic of discussion that is becoming increasingly prevalent among
      healthcare professionals. With the ever-growing opioid epidemic, there are a variety of
      discussions on different modes of treatment other than opioid prescription. Pain neuroscience
      education, or PNE, is one of these alternative treatment options. PNE focuses on a patient's
      understanding of pain itself and relates this to the current pain they are experiencing. PNE
      is often a discussion between provider and patient that utilizes a series of stories,
      metaphors, and examples where pain is described from a point of view that is not strictly
      medical. Recent literature suggests there is a lack of knowledge regarding pain in the United
      States, particularly in the Spanish-speaking population. This population is also less likely
      to seek a physician's advice for pain management. For these reasons, this study will focus on
      the Spanish-speaking population within the Winchester community. Due to success within prior
      PNE studies, this study will be conducted through a classroom lecture. The overarching
      purpose of this study is to examine the change in knowledge of pain in the Spanish-speaking
      population immediately following a PNE lecture composed of stories, metaphors, and examples
      about pain. Because Spanish-speaking individuals are less likely to seek out a medical
      provider, the study may support an additional treatment option for managing chronic pain. Not
      only will this provide further research to support the benefits of PNE, but there is the
      potential to modify a participant's perception of their own pain through this educational
      lecture.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Participants will arrive at a location TBD on the day of data collection. Consent forms will be dispersed to participants, who will be able to ask any questions they may have before signing. A Spanish-speaking researcher will be available to answer those questions. After consent is received, each participant will draw a random number that will be used to link their responses to pre- and post-lecture surveys. After consent is received, a pre-test on pain knowledge and beliefs will be administered. A 30-minute Pain Neuroscience Education (PNE) lecture will be given to participants in Spanish. A post-test on pain knowledge and beliefs will be administered.
primary purpose: Health Services Research
masking: None (Open Label)
measure: R-NPQ
time frame: Immediately post-lecture
description: Revised Neuroscience of Pain Questionnaire
arm group label: PNE Group
arm group type: Experimental
description: A group of Spanish-speaking individuals will listen to a translated lecture related to PNE (PNE lecture). They will fill out the R-NPQ pre and post the lecture.
intervention type: Behavioral
intervention name: PNE lecture
description: A translated (from English to Spanish) lecture on Pain Neuroscience Education
arm group label: PNE Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sheri A Hale, PT, PhD, ATC
role: Study Director
affiliation: Shenandoah University
facility: 
country: United States
citation: Louw A, Podalak J, Zimney K, Schmidt S, Puentedura EJ. Can pain beliefs change in middle school students? A study of the effectiveness of pain neuroscience education. Physiother Theory Pract. 2018 Jul;34(7):542-550. doi: 10.1080/09593985.2017.1423142. Epub 2018 Jan 8.
PMID: 29308954
citation: Louw A, Zimney K, Puentedura EJ, Diener I. The efficacy of pain neuroscience education on musculoskeletal pain: A systematic review of the literature. Physiother Theory Pract. 2016 Jul;32(5):332-55. doi: 10.1080/09593985.2016.1194646. Epub 2016 Jun 28.
PMID: 27351541
citation: Louw A, Zimney K, O'Hotto C, Hilton S. The clinical application of teaching people about pain. Physiother Theory Pract. 2016 Jul;32(5):385-95. doi: 10.1080/09593985.2016.1194652. Epub 2016 Jun 28.
PMID: 27351903
responsible party type: Principal Investigator
investigator affiliation: Shenandoah University
investigator full name: Aaron Hartstein
investigator title: Assistant Professor of Physical Therapy
sharing ipd: No