<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/NCT03040245</url>
  </required_header>
  <id_info>
    <org_study_id>CHU 298</org_study_id>
    <nct_id>NCT03040245</nct_id>
  </id_info>
  <brief_title>Measuring the Impact of the French Version of the Whiplash Book</brief_title>
  <acronym>WHIPLASH</acronym>
  <official_title>Measuring the Impact of the French Version of the Whiplash Book on Both Treatment Approach and Fears and Beliefs Among Emergency Physicians</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CH Aurillac</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jacques Lacarin Hospital Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CH Moulins</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CH Montluçon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CH Issoire</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CH Thiers</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CH Ambert</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <brief_summary>
    <textblock>
      Whiplash trauma and the resulting whiplash associated disorders have been the subject of much&#xD;
      attention in the scientific literature and remain a major public health problem.&#xD;
&#xD;
      The most commonly encountered symptoms are neck pain, headache, low back pain, shoulder pain,&#xD;
      as well as visual impairment. It is not unusual for neck pain to become chronic, and when&#xD;
      this occurs, there may be serious consequences on a social, professional and financial level.&#xD;
&#xD;
      Even though the role of the initial episode should not be ignored, progression to chronic&#xD;
      pain is probably multifactorial and, like non-specific low back pain, psycho-social factors,&#xD;
      and in particular patient fears and belief, seem to play a relevant role, as do environmental&#xD;
      factors. The professional consensus is that it is useful to provide targeted information at&#xD;
      an early stage in whiplash settings in order to reduce mistaken fears and beliefs. A&#xD;
      preliminary study enabled the investigators to validate a French version of an information&#xD;
      booklet that draws on validated data from evidence-based medicine. The booklet was &quot;Le guide&#xD;
      du coup de fouet cervical,&quot; the French version of The Whiplash Book. This study showed that&#xD;
      fears and beliefs were considerably high in a population without neck problems who were&#xD;
      working in hospitals. It also revealed that simply providing information could help lessen&#xD;
      them.&#xD;
&#xD;
      Management following whiplash injury can make use of the recommendations as published in the&#xD;
      literature. Healthcare professionals must reassure and educate their patients that&#xD;
      post-traumatic pain is normal, and that they need to remain active and maintain physical&#xD;
      activity in order to improve their prognosis.&#xD;
&#xD;
      Only very few studies have evaluated the adherence of physicians or healthcare professionals&#xD;
      to the guidelines and to ways of changing their approach to treatment.&#xD;
&#xD;
      The main aim of this study was to determine what fears and beliefs physicians have about the&#xD;
      consequences of whiplash. The secondary aim was to measure the impact of a validated&#xD;
      information booklet on emergency physicians' approach to management following a whiplash&#xD;
      injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Once each of the department heads and the different physicians concerned had given their&#xD;
      agreement to take part in the study, an initial questionnaire folder (containing the WBQ and&#xD;
      FABQ) was sent by email and by post to each of the physicians drawn by randomization. Upon&#xD;
      inclusion, demographic data was collected from the physicians (gender, age, place of&#xD;
      practice, and length of time in practice), as well as any personal or family history of neck&#xD;
      pain or whiplash. The physicians were also asked how often they encountered cases of&#xD;
      whiplash.&#xD;
&#xD;
      Information about knowledge of whiplash injury was also sought. This included continuing&#xD;
      medical training or recent reading (within the previous 3 years), and in particular knowledge&#xD;
      of the different severity grades established by the Quebec Task Force classification, the&#xD;
      radiologic recommendations of the Canadian C-Spine Rule, and lastly the latest HAS&#xD;
      recommendation on physical therapy in post-whiplash neck pain.&#xD;
&#xD;
      Once the first questionnaire folder had been completed, a second folder was then sent to all&#xD;
      physicians participating in the study. The intervention group was instructed to complete the&#xD;
      questionnaires at least 48 hours after the intervention that is, after reading the&#xD;
      information booklet.&#xD;
&#xD;
      The same items were included as in the initial folder, with an additional questionnaire&#xD;
      enabling the intervention group to qualitatively assess the information booklet. If there was&#xD;
      no response, reminders were sent by email, then by telephone, and lastly by post.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2015</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">November 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>assessment of fears and beliefs in the sample of physicians tested using questionnaire WBQ (whiplash belief questionnaire)</measure>
    <time_frame>48 hours after reading the information booklet</time_frame>
    <description>For each statement, the physician must express his or her level of agreement or disagreement, with a score that varies from 9 to 45. The higher the score, the stronger the beliefs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>assessment of fears and beliefs in the sample of physicians tested using the FABQ (Fear Avoidance Belief questionnaire)</measure>
    <time_frame>48 hours after reading the information booklet</time_frame>
    <description>The FABQ (Fear Avoidance Belief questionnaire) comprises two independent scales: the physical activity FABQ and work FABQ</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measurement of the impact of a validated information booklet on emergency physicians' approach to management following a whiplash injury.</measure>
    <time_frame>10 days for control group or minimum 48 hours after reading the information booklet for interventional group</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-pharmacological management of a whiplash injury</measure>
    <time_frame>10 days for control group or minimum 48 hours after reading the information booklet for interventional group</time_frame>
    <description>Non-pharmacological management of a whiplash injury estimated by :&#xD;
Prescription of necklace (yes/no (%)) If yes, duration of prescription&#xD;
Prescription of physiotherapy sessions (%)&#xD;
Work cessation yes/no (%)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">95</enrollment>
  <condition>Whiplash Trauma</condition>
  <arm_group>
    <arm_group_label>intervention group</arm_group_label>
    <description>The intervention group was instructed to complete the questionnaires at least 48 hours after the intervention that is, after reading the information booklet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <description>The same items were included as in the initial folder, with an additional questionnaire enabling the intervention group to qualitatively assess the information booklet. If there was no response, reminders were sent by email, then by telephone, and lastly by post.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Whiplash book</intervention_name>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        emergency physicians&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  - Both sexes&#xD;
&#xD;
          -  Emergency medicine doctors&#xD;
&#xD;
          -  Doctors has given its consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emmanuel COUDEYRE</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>February 1, 2017</last_update_submitted>
  <last_update_submitted_qc>February 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Emergency physician</keyword>
  <keyword>Whiplash Book</keyword>
  <keyword>Whiplash trauma</keyword>
  <keyword>Fears</keyword>
  <keyword>Beliefs</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Whiplash Injuries</mesh_term>
  </condition_browse>
  <!-- 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/NCT03040245
org study id: CHU 298
nct id: NCT03040245
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
Whiplash trauma and the resulting whiplash associated disorders have been the subject of much
      attention in the scientific literature and remain a major public health problem.

      The most commonly encountered symptoms are neck pain, headache, low back pain, shoulder pain,
      as well as visual impairment. It is not unusual for neck pain to become chronic, and when
      this occurs, there may be serious consequences on a social, professional and financial level.

      Even though the role of the initial episode should not be ignored, progression to chronic
      pain is probably multifactorial and, like non-specific low back pain, psycho-social factors,
      and in particular patient fears and belief, seem to play a relevant role, as do environmental
      factors. The professional consensus is that it is useful to provide targeted information at
      an early stage in whiplash settings in order to reduce mistaken fears and beliefs. A
      preliminary study enabled the investigators to validate a French version of an information
      booklet that draws on validated data from evidence-based medicine. The booklet was "Le guide
      du coup de fouet cervical," the French version of The Whiplash Book. This study showed that
      fears and beliefs were considerably high in a population without neck problems who were
      working in hospitals. It also revealed that simply providing information could help lessen
      them.

      Management following whiplash injury can make use of the recommendations as published in the
      literature. Healthcare professionals must reassure and educate their patients that
      post-traumatic pain is normal, and that they need to remain active and maintain physical
      activity in order to improve their prognosis.

      Only very few studies have evaluated the adherence of physicians or healthcare professionals
      to the guidelines and to ways of changing their approach to treatment.

      The main aim of this study was to determine what fears and beliefs physicians have about the
      consequences of whiplash. The secondary aim was to measure the impact of a validated
      information booklet on emergency physicians' approach to management following a whiplash
      injury.
Once each of the department heads and the different physicians concerned had given their
      agreement to take part in the study, an initial questionnaire folder (containing the WBQ and
      FABQ) was sent by email and by post to each of the physicians drawn by randomization. Upon
      inclusion, demographic data was collected from the physicians (gender, age, place of
      practice, and length of time in practice), as well as any personal or family history of neck
      pain or whiplash. The physicians were also asked how often they encountered cases of
      whiplash.

      Information about knowledge of whiplash injury was also sought. This included continuing
      medical training or recent reading (within the previous 3 years), and in particular knowledge
      of the different severity grades established by the Quebec Task Force classification, the
      radiologic recommendations of the Canadian C-Spine Rule, and lastly the latest HAS
      recommendation on physical therapy in post-whiplash neck pain.

      Once the first questionnaire folder had been completed, a second folder was then sent to all
      physicians participating in the study. The intervention group was instructed to complete the
      questionnaires at least 48 hours after the intervention that is, after reading the
      information booklet.

      The same items were included as in the initial folder, with an additional questionnaire
      enabling the intervention group to qualitatively assess the information booklet. If there was
      no response, reminders were sent by email, then by telephone, and lastly by post.
observational model: Other
time perspective: Other
measure: assessment of fears and beliefs in the sample of physicians tested using questionnaire WBQ (whiplash belief questionnaire)
time frame: 48 hours after reading the information booklet
description: For each statement, the physician must express his or her level of agreement or disagreement, with a score that varies from 9 to 45. The higher the score, the stronger the beliefs
measure: assessment of fears and beliefs in the sample of physicians tested using the FABQ (Fear Avoidance Belief questionnaire)
time frame: 48 hours after reading the information booklet
description: The FABQ (Fear Avoidance Belief questionnaire) comprises two independent scales: the physical activity FABQ and work FABQ
measure: Measurement of the impact of a validated information booklet on emergency physicians' approach to management following a whiplash injury.
time frame: 10 days for control group or minimum 48 hours after reading the information booklet for interventional group
measure: Non-pharmacological management of a whiplash injury
time frame: 10 days for control group or minimum 48 hours after reading the information booklet for interventional group
description: Non-pharmacological management of a whiplash injury estimated by :
Prescription of necklace (yes/no (%)) If yes, duration of prescription
Prescription of physiotherapy sessions (%)
Work cessation yes/no (%)
arm group label: intervention group
description: The intervention group was instructed to complete the questionnaires at least 48 hours after the intervention that is, after reading the information booklet
arm group label: control group
description: The same items were included as in the initial folder, with an additional questionnaire enabling the intervention group to qualitatively assess the information booklet. If there was no response, reminders were sent by email, then by telephone, and lastly by post.
intervention type: Behavioral
intervention name: Whiplash book
arm group label: control group
arm group label: intervention group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 25 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Emmanuel COUDEYRE
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
facility: 
country: France
responsible party type: Sponsor
mesh term: Whiplash Injuries