<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/NCT03784196</url>
  </required_header>
  <id_info>
    <org_study_id>PI16/0132</org_study_id>
    <nct_id>NCT03784196</nct_id>
  </id_info>
  <brief_title>Changes of Pain Sensitivity During Rehabilitation of Patients Suffering From Whiplash Associated Disorders</brief_title>
  <official_title>Whiplash Associated Disorders - Sensory Changes During Rehabilitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad San Jorge</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aalborg University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidad San Jorge</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 study investigates the sensory profile of people suffering from whiplash associated&#xD;
      disorders (WAD) during rehabilitation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Altered pain sensitivity is commonly reported in WAD populations when compared to a healthy&#xD;
      control group but how/if this changes over time during rehabilitation is unclear. This study&#xD;
      investigates the effect of 2 weeks rehabilitation protocol on pain sensitivity in a group&#xD;
      suffering from WAD compared to a healthy control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 16, 2016</start_date>
  <completion_date type="Actual">October 22, 2019</completion_date>
  <primary_completion_date type="Actual">April 22, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Changes in Pressure Pain Thresholds</measure>
    <time_frame>Baseline, 2 weeks, 6 months</time_frame>
    <description>Changes in pressure pain thresholds will be determined with pressure algometry bilaterally over the neck and leg. PPT is defined as the exact time point where the pressure is first being perceived at painful.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Conditioned Pain Modulation</measure>
    <time_frame>Baseline, 2 weeks, 6 months</time_frame>
    <description>Changes in condition pain modulation (CPM) will be measures by recording PPT bilaterally over the neck and leg prior to and following a painful stimuli (a pressure cuff is inflated around the upper arm to create the conditioned stimulus). CPM value is calculated by subtracting raw PPT (without painful stimuli) from PPT under the conditioned stimulus.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neck Disability Index (NDI)</measure>
    <time_frame>Baseline, 2 weeks, 6 months</time_frame>
    <description>A validated and reliable questionnaire that estimates the impact of neck pain on normal daily activities (self-rated disability). NDI consists of 10 dimensions that all are score from 0-5 giving a maximum score of 50. The overall score indicates the level of disability. Below 5 = no disability whereas increased scores indicates increased levels of disability.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">44</enrollment>
  <condition>Whiplash</condition>
  <condition>Whiplash Injury</condition>
  <condition>Neck Pain</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Acute Whiplash Associated Disorders</arm_group_label>
    <description>People suffering from acute WAD at the time of recruitment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy controls</arm_group_label>
    <description>Participants with no neck pain during the past 6 months, chronic pain or other medical disorders relevant to this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conservative rehabilitation</intervention_name>
    <description>WAD participants underwent 2-weeks rehabilitation.</description>
    <arm_group_label>Acute Whiplash Associated Disorders</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Acute WAD following a motor vehicle accident (MVA) and age- and sex-matched healthy&#xD;
        controls.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        WAD&#xD;
&#xD;
          -  No more than 3 weeks since MVA/WAD&#xD;
&#xD;
          -  WAD grade II defined by Quebec Task Force classification&#xD;
&#xD;
        Controls • Being healthy and free from any pain specific to the low back and/or in general&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Applies for both groups:&#xD;
&#xD;
          -  Pain related to a specific pathology such as spinal stenosis, metastasis, fracture,&#xD;
             nerve lesions or injuries to the brain etc.&#xD;
&#xD;
          -  Previous painful condition (including neck pain) in the previous 6 months.&#xD;
&#xD;
          -  Prior surgery in the neck or shoulder area.&#xD;
&#xD;
          -  Radiculopathy.&#xD;
&#xD;
          -  Multiple painful sites/areas unrelated to the neck pain.&#xD;
&#xD;
          -  Operation to the spine.&#xD;
&#xD;
          -  Any neurological or systemic diseases which can affect the outcome measures.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Lack of ability to cooperate.&#xD;
&#xD;
        Additional exclusion criteria for Controls:&#xD;
&#xD;
        • No current or previous history of on-going pain, defined as pain in the neck/shoulder&#xD;
        region and/or elsewhere during the past 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steffan W Christensen, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Aalborg University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidad San Jorge</name>
      <address>
        <city>Villanueva De Gállego</city>
        <state>Zaragoza</state>
        <zip>50830</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>November 9, 2020</last_update_submitted>
  <last_update_submitted_qc>November 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>WAD</keyword>
  <keyword>rehabilitation</keyword>
  <keyword>whiplash</keyword>
  <keyword>neck pain</keyword>
  <keyword>pain sensitivity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neck Pain</mesh_term>
    <mesh_term>Whiplash Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There are currently no plan on sharing data from this study with other researchers.</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/NCT03784196
org study id: PI16/0132
nct id: NCT03784196
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study investigates the sensory profile of people suffering from whiplash associated
      disorders (WAD) during rehabilitation.
Altered pain sensitivity is commonly reported in WAD populations when compared to a healthy
      control group but how/if this changes over time during rehabilitation is unclear. This study
      investigates the effect of 2 weeks rehabilitation protocol on pain sensitivity in a group
      suffering from WAD compared to a healthy control group.
observational model: Case-Control
time perspective: Prospective
measure: Changes in Pressure Pain Thresholds
time frame: Baseline, 2 weeks, 6 months
description: Changes in pressure pain thresholds will be determined with pressure algometry bilaterally over the neck and leg. PPT is defined as the exact time point where the pressure is first being perceived at painful.
measure: Changes in Conditioned Pain Modulation
time frame: Baseline, 2 weeks, 6 months
description: Changes in condition pain modulation (CPM) will be measures by recording PPT bilaterally over the neck and leg prior to and following a painful stimuli (a pressure cuff is inflated around the upper arm to create the conditioned stimulus). CPM value is calculated by subtracting raw PPT (without painful stimuli) from PPT under the conditioned stimulus.
measure: Neck Disability Index (NDI)
time frame: Baseline, 2 weeks, 6 months
description: A validated and reliable questionnaire that estimates the impact of neck pain on normal daily activities (self-rated disability). NDI consists of 10 dimensions that all are score from 0-5 giving a maximum score of 50. The overall score indicates the level of disability. Below 5 = no disability whereas increased scores indicates increased levels of disability.
arm group label: Acute Whiplash Associated Disorders
description: People suffering from acute WAD at the time of recruitment.
arm group label: Healthy controls
description: Participants with no neck pain during the past 6 months, chronic pain or other medical disorders relevant to this study.
intervention type: Other
intervention name: Conservative rehabilitation
description: WAD participants underwent 2-weeks rehabilitation.
arm group label: Acute Whiplash Associated Disorders
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Steffan W Christensen, PhD
role: Study Director
affiliation: Aalborg University
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Neck Pain
mesh term: Whiplash Injuries
sharing ipd: No
ipd description: There are currently no plan on sharing data from this study with other researchers.