<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/NCT03002181</url>
  </required_header>
  <id_info>
    <org_study_id>PNE Edu</org_study_id>
    <nct_id>NCT03002181</nct_id>
  </id_info>
  <brief_title>Pain Neurophysiology Education for Sport Therapy Students</brief_title>
  <official_title>The Effect of Pain Neurophysiology Education on Sport Therapy Students Knowledge, Attitudes and Clinical Behaviour Towards Athletes With Chronic Pain: a Randomised Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Teesside University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Teesside University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The effect of a 70 minute Pain Neurophysiology Education session on Sport Therapy Students&#xD;
      Knowledge, Attitudes and Clinical Behaviour Towards Athletes With Chronic Pain&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This single-blind, randomised control trial aims to investigate the effect of a brief 70&#xD;
      minute Pain Neurophysiology Education session on sport therapy students knowledge, attitudes&#xD;
      and clinical behaviour towards athletes with chronic pain. Participants will be selected from&#xD;
      first year undergraduate and postgraduate sport therapy cohorts. Random number generator will&#xD;
      assign participants into two subgroups. Group 1 will receive a control education on clinical&#xD;
      'red flags'. Red flags are questions that are routinely asked by therapists in clinical&#xD;
      practice to screen for sinister pathology. Group 2 will receive education called 'Pain&#xD;
      Neurophysiology Education' (taken from the Explain Pain publication). This mode of education&#xD;
      uses the neurophysiology of pain to explain the experience, and has been used as an&#xD;
      educational tool for patient, healthcare practitioners and students alike. Data collection&#xD;
      (completion of three questionnaires) will take place immediately prior, and immediately after&#xD;
      each education session.&#xD;
&#xD;
      The change in these outcomes pre and post intervention will subsequently be compared between&#xD;
      groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 2016</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>Parallel Assignment</intervention_model>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Neurophysiology Quiz. (knowledge)</measure>
    <time_frame>Outcome measure assessed IMMEDIATELY post intervention, on the same day. NO FOLLOW UP.</time_frame>
    <description>A 13 point validated questionnaire assessing participant knowledge of contemporary pain knowledge.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Health Care Pain Attitudes and Impairment Relationship Scale. (attitudes)</measure>
    <time_frame>Outcome measure assessed IMMEDIATELY post intervention, on the same day. NO FOLLOW UP.</time_frame>
    <description>A 13 item validated likert-scale questionnaire to measure health care professionals attitudes towards the ability of patients with pain to function despite their pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Vignette. (clinical recommendations)</measure>
    <time_frame>Outcome measure assessed IMMEDIATELY post intervention, on the same day. NO FOLLOW UP.</time_frame>
    <description>A case vignette is a validated proxy measure of clinical behaviour, and is assessed by multiple choice recommendations following a case scenario. This recommendations are weighted as either 'appropriate' or 'inappropriate' based on current clinical guidelines.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Knowledge</condition>
  <condition>Attitude</condition>
  <condition>Behavior</condition>
  <arm_group>
    <arm_group_label>PNE group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pain neurophysiology education group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Red Flag group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Red Flags education group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Education</intervention_name>
    <description>70 minute education session.</description>
    <arm_group_label>PNE group</arm_group_label>
    <arm_group_label>Red Flag group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1st year undergraduate sport therapy students&#xD;
&#xD;
          -  1st year postgraduate, pre-registration sport therapy students&#xD;
&#xD;
          -  Enrolled at Teesside University, UK.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous detailed pain education on either PNE or Red Flags.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>December 22, 2016</last_update_submitted>
  <last_update_submitted_qc>December 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Teesside University</investigator_affiliation>
    <investigator_full_name>Neil Maguire</investigator_full_name>
    <investigator_title>Graduate Tutor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No identifiable data was used in the current study</ipd_description>
  </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/NCT03002181
org study id: PNE Edu
nct id: NCT03002181
lead sponsor: 
has dmc: No
The effect of a 70 minute Pain Neurophysiology Education session on Sport Therapy Students
      Knowledge, Attitudes and Clinical Behaviour Towards Athletes With Chronic Pain
This single-blind, randomised control trial aims to investigate the effect of a brief 70
      minute Pain Neurophysiology Education session on sport therapy students knowledge, attitudes
      and clinical behaviour towards athletes with chronic pain. Participants will be selected from
      first year undergraduate and postgraduate sport therapy cohorts. Random number generator will
      assign participants into two subgroups. Group 1 will receive a control education on clinical
      'red flags'. Red flags are questions that are routinely asked by therapists in clinical
      practice to screen for sinister pathology. Group 2 will receive education called 'Pain
      Neurophysiology Education' (taken from the Explain Pain publication). This mode of education
      uses the neurophysiology of pain to explain the experience, and has been used as an
      educational tool for patient, healthcare practitioners and students alike. Data collection
      (completion of three questionnaires) will take place immediately prior, and immediately after
      each education session.

      The change in these outcomes pre and post intervention will subsequently be compared between
      groups.
allocation: Randomized
intervention model: Parallel Assignment
masking: Double (Investigator, Outcomes Assessor)
measure: Pain Neurophysiology Quiz. (knowledge)
time frame: Outcome measure assessed IMMEDIATELY post intervention, on the same day. NO FOLLOW UP.
description: A 13 point validated questionnaire assessing participant knowledge of contemporary pain knowledge.
measure: The Health Care Pain Attitudes and Impairment Relationship Scale. (attitudes)
time frame: Outcome measure assessed IMMEDIATELY post intervention, on the same day. NO FOLLOW UP.
description: A 13 item validated likert-scale questionnaire to measure health care professionals attitudes towards the ability of patients with pain to function despite their pain.
measure: Clinical Vignette. (clinical recommendations)
time frame: Outcome measure assessed IMMEDIATELY post intervention, on the same day. NO FOLLOW UP.
description: A case vignette is a validated proxy measure of clinical behaviour, and is assessed by multiple choice recommendations following a case scenario. This recommendations are weighted as either 'appropriate' or 'inappropriate' based on current clinical guidelines.
arm group label: PNE group
arm group type: Experimental
description: Pain neurophysiology education group.
arm group label: Red Flag group
arm group type: Experimental
description: Red Flags education group.
intervention type: Other
intervention name: Education
description: 70 minute education session.
arm group label: PNE group
arm group label: Red Flag group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Teesside University
investigator full name: Neil Maguire
investigator title: Graduate Tutor
sharing ipd: No
ipd description: No identifiable data was used in the current study