<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/NCT01699334</url>
  </required_header>
  <id_info>
    <org_study_id>8011-170712</org_study_id>
    <nct_id>NCT01699334</nct_id>
  </id_info>
  <brief_title>Effectiveness of an Educational Video Following Acute Whiplash Trauma</brief_title>
  <official_title>Effectiveness of an Educational Video Following Acute Whiplash Trauma: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aarhus University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine the effect of an educational video on intensity of&#xD;
      neck pain, disability, illness perceptions and work ability following acute whiplash trauma&#xD;
      caused by motor vehicle accidents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Whiplash injuries affect 1-3 per 1000 inhabitants each year (Jansen et al. 2008). Most&#xD;
      patients only experience transitory neck complaints and recover within weeks. However, an&#xD;
      estimated 10% will develop severe persistent pain seriously affecting long term well-being&#xD;
      and work ability. The exact mechanisms behind the variation in recovery remain elusive, and&#xD;
      our knowledge on how to prevent the transition from acute to chronic neck pain is sparse.&#xD;
      Guidelines for management of acute whiplash emphasize the importance of patient information,&#xD;
      but there is limited evidence as to how information should be provided in order to improve&#xD;
      recovery. Nevertheless, recent studies indicate that patient education by video may be a&#xD;
      beneficial method to improve early management of neck pain (Oliveira et al. 2006, Brison et&#xD;
      al. 2005).&#xD;
&#xD;
      Using a randomized controlled design this study aims to determine the efficacy of an&#xD;
      educational video concerning whiplash injuries in comparison with an active comparator&#xD;
      condition consisting of a relaxation video. The anticipated study population is 300&#xD;
      consecutive patients with acute neck complaints following motor vehicle accidents recruited&#xD;
      at two major Emergency Departments in Denmark.&#xD;
&#xD;
      Following completion of the standard care in the emergency room, patients who have given&#xD;
      consent to participate are randomized to either intervention (educational video) or&#xD;
      comparison group (relaxation video). Randomization is achieved by emergency room staff&#xD;
      handing out sequentially numbered, sealed envelopes, which have been prepared at the Research&#xD;
      Clinic for Functional Disorders and Psychosomatics. The randomization list is&#xD;
      computer-generated in blocks of 20 and stratified according to place of treatment&#xD;
      (participating emergency wards). The envelope contains a letter with a personal code giving&#xD;
      the participant access to a secure website on which to view the video at home.&#xD;
&#xD;
      The educational video will explain the nature of whiplash injuries and provide a&#xD;
      biopsychosocial model for neck pain incorporating both physiological and&#xD;
      cognitive-behavioural aspects, reassurance and basic advice on pain relief. The comparison&#xD;
      condition is a relaxation video detailing simple relaxation exercises such as breathing&#xD;
      exercises which can be safely used by whiplash patients. The relaxation video contains no&#xD;
      explanatory information concerning whiplash injuries or the related symptoms.&#xD;
&#xD;
      The participants are followed for 12 months after visiting the emergency room. Self-report&#xD;
      data are obtained from questionnaires at 1-week, 3- and 12-month follow-up. Data on health&#xD;
      care use and absence from work due to illness will be retrieved from public registers&#xD;
      throughout the follow-up period. The study has been approved by The Central Region Committees&#xD;
      on Biomedical Research Ethics, Denmark and the Danish Data Protection Agency. The project is&#xD;
      funded by a single grant from the Tryg Foundation, Denmark.&#xD;
&#xD;
      The transition from acute to chronic pain after whiplash trauma poses a threat to the&#xD;
      well-being of the individual as well as leading to extensive health care costs and loss of&#xD;
      work days (Leth-Petersen &amp; Rotger 2009, Holm et al. 1999). The development of cost-effective&#xD;
      preventive interventions which can be added to the usual treatment in the early stages of&#xD;
      whiplash associated disorders could potentially contribute to reducing suffering for patients&#xD;
      and financial costs for society. This study will hopefully contribute to the development of&#xD;
      effective and evidence-based treatment of whiplash associated disorders. In the long term,&#xD;
      the study may also aid the development of patient education for other patient groups at risk&#xD;
      of developing a chronic disorder.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">May 2019</completion_date>
  <primary_completion_date type="Actual">December 2017</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intensity of neck pain</measure>
    <time_frame>3 months after visit to emergency room</time_frame>
    <description>11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-rated level of recovery (Patient Global Impression of Change)</measure>
    <time_frame>3 and 12 months after visit to emergency room</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-rated physical level of functioning (SF-36)</measure>
    <time_frame>3 and 12 months after visit to emergency room</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-rated neck disability (Copenhagen Neck Functional Disability Scale)</measure>
    <time_frame>3 and 12 months after visit to emergency room</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Illness perceptions (The Brief Illness Perceptions Questionnaire)</measure>
    <time_frame>3 and 12 months after visit to emergency room</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain-related fear of movement (The Tampa Scale for Kinesiophobia)</measure>
    <time_frame>3 and 12 months after visit to emergency room</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial functioning (screening for anxiety, depression and somatisation by relevant subscales from Symptom Checklist,SCL-90)</measure>
    <time_frame>3 and 12 months after visit to emergency room</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of sick days (days off work due to illness) retrieved from Danish public registry (the DREAM database)</measure>
    <time_frame>12 month period after visit to emergency room</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health care use retrieved from The National Patient Register and the National Health Service Register (consultations with GPs, specialists, physiotherapists, dentists, emergency services) and The Danish Medicine Agency (medicine consumption)</measure>
    <time_frame>12 month period after visit to emergency room</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensity of neck pain (NRS 0-10)</measure>
    <time_frame>12 months after visit to emergency room</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">269</enrollment>
  <condition>Whiplash Injuries</condition>
  <arm_group>
    <arm_group_label>Psychoeducational video</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Relaxation video</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychoeducational video</intervention_name>
    <description>The educational video will explain the nature of whiplash injuries and provide a biopsychosocial model for neck pain incorporating both physiological and cognitive-behavioural aspects, reassurance and basic advice on pain relief.</description>
    <arm_group_label>Psychoeducational video</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Relaxation video</intervention_name>
    <description>The comparison condition is a relaxation video detailing simple relaxation exercises such as breathing exercises which can be safely used by whiplash patients. The relaxation video contains no explanatory information concerning whiplash injuries or the related symptoms.</description>
    <arm_group_label>Relaxation video</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Involved in a motor vehicle accident (as a passenger or driver of the vehicle)&#xD;
&#xD;
          -  Subjective neck complaints (neck pain, headache or reduced range of motion)&#xD;
&#xD;
          -  Treatment in emergency room within 72 hours of accident&#xD;
&#xD;
          -  Diagnosed with a distortion of the neck (ICD-10 S13.4)&#xD;
&#xD;
          -  No other major injuries&#xD;
&#xD;
          -  Age 18-60 years&#xD;
&#xD;
          -  Able&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fracture or dislocation&#xD;
&#xD;
          -  Head trauma (loss of consciousness, concussion)&#xD;
&#xD;
          -  Substance abuse (narcotics, alcohol, medicine)&#xD;
&#xD;
          -  Severe acute psychiatric disorder, previous episodes of psychosis or if the patient is&#xD;
             suicidal&#xD;
&#xD;
          -  Dementia, mental retardation&#xD;
&#xD;
          -  Active systemic disease (cancer, rheumatoid arthritis, neurological disorders)&#xD;
&#xD;
          -  Lack of informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Per Fink, DMSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Aarhus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <reference>
    <citation>Brison RJ, Hartling L, Dostaler S, Leger A, Rowe BH, Stiell I, Pickett W. A randomized controlled trial of an educational intervention to prevent the chronic pain of whiplash associated disorders following rear-end motor vehicle collisions. Spine (Phila Pa 1976). 2005 Aug 15;30(16):1799-807. doi: 10.1097/01.brs.0000174115.58954.17.</citation>
    <PMID>16103847</PMID>
  </reference>
  <reference>
    <citation>Oliveira A, Gevirtz R, Hubbard D. A psycho-educational video used in the emergency department provides effective treatment for whiplash injuries. Spine (Phila Pa 1976). 2006 Jul 1;31(15):1652-7. doi: 10.1097/01.brs.0000224172.45828.e3.</citation>
    <PMID>16816758</PMID>
  </reference>
  <reference>
    <citation>Whiplash injuries: diagnosis and early management. The Swedish Society of Medicine and the Whiplash Commission Medical Task Force. Eur Spine J. 2008 Oct;17 Suppl 3(Suppl 3):355-358. doi: 10.1007/s00586-008-0767-x. No abstract available.</citation>
    <PMID>18820955</PMID>
  </reference>
  <reference>
    <citation>Leth-Petersen S, Rotger GP. Long-term labour-market performance of whiplash claimants. J Health Econ. 2009 Sep;28(5):996-1011. doi: 10.1016/j.jhealeco.2009.06.013. Epub 2009 Jul 8.</citation>
    <PMID>19683817</PMID>
  </reference>
  <reference>
    <citation>Holm L, Cassidy JD, Sjogren Y, Nygren A. Impairment and work disability due to whiplash injury following traffic collisions. An analysis of insurance material from the Swedish Road Traffic Injury Commission. Scand J Public Health. 1999 Jun;27(2):116-23. doi: 10.1080/140349499445301.</citation>
    <PMID>10421720</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>September 25, 2019</last_update_submitted>
  <last_update_submitted_qc>September 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Whiplash injuries</keyword>
  <keyword>patient education</keyword>
  <keyword>illness perceptions</keyword>
  <keyword>RCT</keyword>
  <keyword>motor vehicle accidents</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/NCT01699334
org study id: 8011-170712
nct id: NCT01699334
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to examine the effect of an educational video on intensity of
      neck pain, disability, illness perceptions and work ability following acute whiplash trauma
      caused by motor vehicle accidents.
Whiplash injuries affect 1-3 per 1000 inhabitants each year (Jansen et al. 2008). Most
      patients only experience transitory neck complaints and recover within weeks. However, an
      estimated 10% will develop severe persistent pain seriously affecting long term well-being
      and work ability. The exact mechanisms behind the variation in recovery remain elusive, and
      our knowledge on how to prevent the transition from acute to chronic neck pain is sparse.
      Guidelines for management of acute whiplash emphasize the importance of patient information,
      but there is limited evidence as to how information should be provided in order to improve
      recovery. Nevertheless, recent studies indicate that patient education by video may be a
      beneficial method to improve early management of neck pain (Oliveira et al. 2006, Brison et
      al. 2005).

      Using a randomized controlled design this study aims to determine the efficacy of an
      educational video concerning whiplash injuries in comparison with an active comparator
      condition consisting of a relaxation video. The anticipated study population is 300
      consecutive patients with acute neck complaints following motor vehicle accidents recruited
      at two major Emergency Departments in Denmark.

      Following completion of the standard care in the emergency room, patients who have given
      consent to participate are randomized to either intervention (educational video) or
      comparison group (relaxation video). Randomization is achieved by emergency room staff
      handing out sequentially numbered, sealed envelopes, which have been prepared at the Research
      Clinic for Functional Disorders and Psychosomatics. The randomization list is
      computer-generated in blocks of 20 and stratified according to place of treatment
      (participating emergency wards). The envelope contains a letter with a personal code giving
      the participant access to a secure website on which to view the video at home.

      The educational video will explain the nature of whiplash injuries and provide a
      biopsychosocial model for neck pain incorporating both physiological and
      cognitive-behavioural aspects, reassurance and basic advice on pain relief. The comparison
      condition is a relaxation video detailing simple relaxation exercises such as breathing
      exercises which can be safely used by whiplash patients. The relaxation video contains no
      explanatory information concerning whiplash injuries or the related symptoms.

      The participants are followed for 12 months after visiting the emergency room. Self-report
      data are obtained from questionnaires at 1-week, 3- and 12-month follow-up. Data on health
      care use and absence from work due to illness will be retrieved from public registers
      throughout the follow-up period. The study has been approved by The Central Region Committees
      on Biomedical Research Ethics, Denmark and the Danish Data Protection Agency. The project is
      funded by a single grant from the Tryg Foundation, Denmark.

      The transition from acute to chronic pain after whiplash trauma poses a threat to the
      well-being of the individual as well as leading to extensive health care costs and loss of
      work days (Leth-Petersen & Rotger 2009, Holm et al. 1999). The development of cost-effective
      preventive interventions which can be added to the usual treatment in the early stages of
      whiplash associated disorders could potentially contribute to reducing suffering for patients
      and financial costs for society. This study will hopefully contribute to the development of
      effective and evidence-based treatment of whiplash associated disorders. In the long term,
      the study may also aid the development of patient education for other patient groups at risk
      of developing a chronic disorder.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Intensity of neck pain
time frame: 3 months after visit to emergency room
description: 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain)
measure: Self-rated level of recovery (Patient Global Impression of Change)
time frame: 3 and 12 months after visit to emergency room
measure: Self-rated physical level of functioning (SF-36)
time frame: 3 and 12 months after visit to emergency room
measure: Self-rated neck disability (Copenhagen Neck Functional Disability Scale)
time frame: 3 and 12 months after visit to emergency room
measure: Illness perceptions (The Brief Illness Perceptions Questionnaire)
time frame: 3 and 12 months after visit to emergency room
measure: Pain-related fear of movement (The Tampa Scale for Kinesiophobia)
time frame: 3 and 12 months after visit to emergency room
measure: Psychosocial functioning (screening for anxiety, depression and somatisation by relevant subscales from Symptom Checklist,SCL-90)
time frame: 3 and 12 months after visit to emergency room
measure: Number of sick days (days off work due to illness) retrieved from Danish public registry (the DREAM database)
time frame: 12 month period after visit to emergency room
measure: Health care use retrieved from The National Patient Register and the National Health Service Register (consultations with GPs, specialists, physiotherapists, dentists, emergency services) and The Danish Medicine Agency (medicine consumption)
time frame: 12 month period after visit to emergency room
measure: Intensity of neck pain (NRS 0-10)
time frame: 12 months after visit to emergency room
arm group label: Psychoeducational video
arm group type: Experimental
arm group label: Relaxation video
arm group type: Active Comparator
intervention type: Behavioral
intervention name: Psychoeducational video
description: The educational video will explain the nature of whiplash injuries and provide a biopsychosocial model for neck pain incorporating both physiological and cognitive-behavioural aspects, reassurance and basic advice on pain relief.
arm group label: Psychoeducational video
intervention type: Other
intervention name: Relaxation video
description: The comparison condition is a relaxation video detailing simple relaxation exercises such as breathing exercises which can be safely used by whiplash patients. The relaxation video contains no explanatory information concerning whiplash injuries or the related symptoms.
arm group label: Relaxation video
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Per Fink, DMSc
role: Principal Investigator
affiliation: University of Aarhus
facility: 
country: Denmark
citation: Brison RJ, Hartling L, Dostaler S, Leger A, Rowe BH, Stiell I, Pickett W. A randomized controlled trial of an educational intervention to prevent the chronic pain of whiplash associated disorders following rear-end motor vehicle collisions. Spine (Phila Pa 1976). 2005 Aug 15;30(16):1799-807. doi: 10.1097/01.brs.0000174115.58954.17.
PMID: 16103847
citation: Oliveira A, Gevirtz R, Hubbard D. A psycho-educational video used in the emergency department provides effective treatment for whiplash injuries. Spine (Phila Pa 1976). 2006 Jul 1;31(15):1652-7. doi: 10.1097/01.brs.0000224172.45828.e3.
PMID: 16816758
citation: Whiplash injuries: diagnosis and early management. The Swedish Society of Medicine and the Whiplash Commission Medical Task Force. Eur Spine J. 2008 Oct;17 Suppl 3(Suppl 3):355-358. doi: 10.1007/s00586-008-0767-x. No abstract available.
PMID: 18820955
citation: Leth-Petersen S, Rotger GP. Long-term labour-market performance of whiplash claimants. J Health Econ. 2009 Sep;28(5):996-1011. doi: 10.1016/j.jhealeco.2009.06.013. Epub 2009 Jul 8.
PMID: 19683817
citation: Holm L, Cassidy JD, Sjogren Y, Nygren A. Impairment and work disability due to whiplash injury following traffic collisions. An analysis of insurance material from the Swedish Road Traffic Injury Commission. Scand J Public Health. 1999 Jun;27(2):116-23. doi: 10.1080/140349499445301.
PMID: 10421720
responsible party type: Sponsor
mesh term: Whiplash Injuries