<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/NCT01733277</url>
  </required_header>
  <id_info>
    <org_study_id>A122-MER12H</org_study_id>
    <nct_id>NCT01733277</nct_id>
  </id_info>
  <brief_title>Osteoarthritis Structural Changes Assessed by Magnetic Resonance Imaging and Neuropathic Pain in Knee Osteoarthritis</brief_title>
  <official_title>A Cross-sectional Study to Explore the Osteoarthritis Structural Changes Assessed by MRI That Are Biomarkers of Neuropathic Pain in Knee Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ArthroLab Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ArthroLab Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to identify osteoarthritis (OA) structural changes, as&#xD;
      assessed by MRI, that best correlate with the presence of neuropathic pain (NP) using the&#xD;
      PainDETECT questionnaire (PainDETECT ≥ 13) on a population of patients with OA of the knee&#xD;
      experiencing moderate to severe pain (VAS ≥ 40 mm).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a multicentre, cross-sectional observational pilot study. The presence of NP&#xD;
      was determined based on use of the PainDETECT questionnaire (score 1 to 38), the score of&#xD;
      which was defined for the purpose of the study as ≥ 13. A total of 50 OA patients with&#xD;
      moderate to severe pain (VAS ≥ 40), 25 without the presence of NP (OA/NP-) (PainDETECT score&#xD;
      &lt; 13), and 25 with the presence of NP (OA/NP+) (PainDETECT score ≥ 13) were enrolled. Since&#xD;
      this is a pilot study, we arbitrarily determined the number of patients at 50, which&#xD;
      represents 25 patients per arm, a number deemed sufficient to identify the knee OA structural&#xD;
      changes that could be preferentially associated with NP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Osteoarthritis Structural Changes Assessed by Quantitative Magnetic Resonance Imaging With and Without Neuropathic Pain</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Variation in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores (Total, Pain, Function, Stiffness) and the Presence or Absence of Neuropathic Pain</measure>
    <time_frame>Baseline</time_frame>
    <description>The WOMAC measures pain (score range 0-20), stiffness (score range 0-8), and functional limitation (score range 0-68) for a Total (cumulative score range 0-96) where the higher the score the worst the pain.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Correlation Between the Presence of Neuropathic Pain and Biological Marker of Inflammation (CRP)</measure>
    <time_frame>Baseline</time_frame>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Neuropathic Pain</condition>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>With neuropathic pain (PainDETECT ≥ 13)</arm_group_label>
    <description>Magnetic Resonance Imaging (MRI)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No neuropathic pain (PainDETECT&lt;13)</arm_group_label>
    <description>Magnetic Resonance Imaging (MRI)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Magnetic Resonance Imaging (MRI)</intervention_name>
    <description>All participants from both arms will be subjected to MRI</description>
    <arm_group_label>No neuropathic pain (PainDETECT&lt;13)</arm_group_label>
    <arm_group_label>With neuropathic pain (PainDETECT ≥ 13)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Presence or absence of neuropathic pain on a population of patients with OA of the knee&#xD;
        experiencing moderate to severe pain (VAS ≥ 40 mm)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals of either sex, aged 40 years and more;&#xD;
&#xD;
          -  Followed in an ambulatory clinic;&#xD;
&#xD;
          -  Presenting with primary OA of the knee according to American College of Rheumatology&#xD;
             (ACR) criteria;&#xD;
&#xD;
          -  With an OA of radiological stages 2 and 3 according to Kellgren-Lawrence;&#xD;
&#xD;
          -  Knee pain for at least 1 month out of the 3 months preceding the study;&#xD;
&#xD;
          -  Visual Analog Scale (VAS) of pain while walking on a flat surface ≥ 40 mm;&#xD;
&#xD;
          -  Agrees to sign the Informed Consent Form;&#xD;
&#xD;
          -  Not taking part in another clinical trial;&#xD;
&#xD;
          -  Agrees to respect the protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other bone and articular diseases (antecedents and/or current signs);&#xD;
&#xD;
          -  Presenting with isolated knee lateral compartment OA defined by joint space loss in&#xD;
             the lateral compartment only;&#xD;
&#xD;
          -  Knee surgery on the study knee;&#xD;
&#xD;
          -  Comorbidities that restrict knee function;&#xD;
&#xD;
          -  Had received any investigational drug within 30 days or 5 half lives (whichever is&#xD;
             greater) prior to entering the study;&#xD;
&#xD;
          -  Unable to give informed consent;&#xD;
&#xD;
          -  Counter-indication to an MRI examination;&#xD;
&#xD;
          -  Baseline Visit cartilage volume cannot be calculated from the MRI due to advanced OA&#xD;
             or any other technical reason;&#xD;
&#xD;
          -  Abnormal findings and or any other condition, which, in the Investigator's judgment&#xD;
             might increase the risk to the subject or decrease the chance of obtaining&#xD;
             satisfactory data through MRI to achieve the objectives of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Pierre Raynauld, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Université de Montréal</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut de Rhumatologie de Montréal</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2L-1S6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de Rhumatologie St. Louis</name>
      <address>
        <city>Quebec</city>
        <zip>G1W 4R4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>November 16, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <results_first_submitted>February 7, 2014</results_first_submitted>
  <results_first_submitted_qc>May 30, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 2, 2014</results_first_posted>
  <last_update_submitted>May 30, 2014</last_update_submitted>
  <last_update_submitted_qc>May 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 2, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neuropathic pain</keyword>
  <keyword>Knee osteoarthritis</keyword>
  <keyword>MRI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
    <mesh_term>Neuralgia</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Presence of Neuropathic Pain</title>
          <description>Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)&#xD;
MRI</description>
        </group>
        <group group_id="P2">
          <title>Absence of Neuropathic Pain</title>
          <description>Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT &lt; 13)&#xD;
MRI</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Presence of Neuropathic Pain</title>
          <description>Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)&#xD;
MRI</description>
        </group>
        <group group_id="B2">
          <title>Absence of Neuropathic Pain</title>
          <description>Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT &lt; 13)&#xD;
MRI</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
            <count group_id="B2" value="25"/>
            <count group_id="B3" value="50"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>40-90 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>PainDetect (0-38)</title>
          <description>The presence of neuropathic was determined based on use of PainDETECT questionnaire which can discriminate patients with neuropathic knee pain (score ≥ 13; the higher the score, the worst is the pain).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21.1" spread="5.4"/>
                    <measurement group_id="B2" value="8.1" spread="2.6"/>
                    <measurement group_id="B3" value="14.6" spread="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>VAS Pain (0-100)</title>
          <description>Visual Analogue Scale (VAS) for global knee pain (0 mm = no pain, 100 mm = most severe pain)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67" spread="13"/>
                    <measurement group_id="B2" value="62" spread="14"/>
                    <measurement group_id="B3" value="64" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Osteoarthritis Structural Changes Assessed by Quantitative Magnetic Resonance Imaging With and Without Neuropathic Pain</title>
        <time_frame>Baseline</time_frame>
        <population>Number of participant analyzed Per-protocol</population>
        <group_list>
          <group group_id="O1">
            <title>Presence of Neuropathic Pain</title>
            <description>Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)&#xD;
MRI</description>
          </group>
          <group group_id="O2">
            <title>Absence of Neuropathic Pain</title>
            <description>Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT &lt; 13)&#xD;
MRI</description>
          </group>
        </group_list>
        <measure>
          <title>Osteoarthritis Structural Changes Assessed by Quantitative Magnetic Resonance Imaging With and Without Neuropathic Pain</title>
          <population>Number of participant analyzed Per-protocol</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Partial Meniscal Extrusion (Medial)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Partial Meniscal Extrusion (Lateral)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bone Marrow Lesions (Lateral Plateau)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Variation in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores (Total, Pain, Function, Stiffness) and the Presence or Absence of Neuropathic Pain</title>
        <description>The WOMAC measures pain (score range 0-20), stiffness (score range 0-8), and functional limitation (score range 0-68) for a Total (cumulative score range 0-96) where the higher the score the worst the pain.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Presence of Neuropathic Pain</title>
            <description>Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)&#xD;
MRI</description>
          </group>
          <group group_id="O2">
            <title>Absence of Neuropathic Pain</title>
            <description>Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT &lt; 13)&#xD;
MRI</description>
          </group>
        </group_list>
        <measure>
          <title>Variation in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores (Total, Pain, Function, Stiffness) and the Presence or Absence of Neuropathic Pain</title>
          <description>The WOMAC measures pain (score range 0-20), stiffness (score range 0-8), and functional limitation (score range 0-68) for a Total (cumulative score range 0-96) where the higher the score the worst the pain.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>WOMAC (total: 0-96)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62" spread="15"/>
                    <measurement group_id="O2" value="45" spread="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WOMAC (Pain: 0-20)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59" spread="15"/>
                    <measurement group_id="O2" value="43" spread="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WOMAC (Stiffness: 0-8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62" spread="19"/>
                    <measurement group_id="O2" value="51" spread="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WOMAC (Function: 0-68)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62" spread="16"/>
                    <measurement group_id="O2" value="45" spread="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Correlation Between the Presence of Neuropathic Pain and Biological Marker of Inflammation (CRP)</title>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Presence of Neuropathic Pain</title>
            <description>Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)&#xD;
MRI</description>
          </group>
          <group group_id="O2">
            <title>Absence of Neuropathic Pain</title>
            <description>Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT &lt; 13)&#xD;
MRI</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation Between the Presence of Neuropathic Pain and Biological Marker of Inflammation (CRP)</title>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7" spread="6.6"/>
                    <measurement group_id="O2" value="4.3" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Presence of Neuropathic Pain</title>
          <description>Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)&#xD;
MRI</description>
        </group>
        <group group_id="E2">
          <title>Absence of Neuropathic Pain</title>
          <description>Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT &lt; 13)&#xD;
MRI</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Jean-Pierre Pelletier</name_or_title>
      <organization>ArthroLab Inc.</organization>
      <phone>15148908000 ext 26666</phone>
      <email>dr@jppelletier.ca</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01733277
org study id: A122-MER12H
nct id: NCT01733277
lead sponsor: 
has dmc: No
The primary objective of this study is to identify osteoarthritis (OA) structural changes, as
      assessed by MRI, that best correlate with the presence of neuropathic pain (NP) using the
      PainDETECT questionnaire (PainDETECT ≥ 13) on a population of patients with OA of the knee
      experiencing moderate to severe pain (VAS ≥ 40 mm).
This study is a multicentre, cross-sectional observational pilot study. The presence of NP
      was determined based on use of the PainDETECT questionnaire (score 1 to 38), the score of
      which was defined for the purpose of the study as ≥ 13. A total of 50 OA patients with
      moderate to severe pain (VAS ≥ 40), 25 without the presence of NP (OA/NP-) (PainDETECT score
      < 13), and 25 with the presence of NP (OA/NP+) (PainDETECT score ≥ 13) were enrolled. Since
      this is a pilot study, we arbitrarily determined the number of patients at 50, which
      represents 25 patients per arm, a number deemed sufficient to identify the knee OA structural
      changes that could be preferentially associated with NP.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Osteoarthritis Structural Changes Assessed by Quantitative Magnetic Resonance Imaging With and Without Neuropathic Pain
time frame: Baseline
measure: Variation in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores (Total, Pain, Function, Stiffness) and the Presence or Absence of Neuropathic Pain
time frame: Baseline
description: The WOMAC measures pain (score range 0-20), stiffness (score range 0-8), and functional limitation (score range 0-68) for a Total (cumulative score range 0-96) where the higher the score the worst the pain.
measure: Correlation Between the Presence of Neuropathic Pain and Biological Marker of Inflammation (CRP)
time frame: Baseline
arm group label: With neuropathic pain (PainDETECT ≥ 13)
description: Magnetic Resonance Imaging (MRI)
arm group label: No neuropathic pain (PainDETECT<13)
description: Magnetic Resonance Imaging (MRI)
intervention type: Other
intervention name: Magnetic Resonance Imaging (MRI)
description: All participants from both arms will be subjected to MRI
arm group label: No neuropathic pain (PainDETECT<13)
arm group label: With neuropathic pain (PainDETECT ≥ 13)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 90 Years
healthy volunteers: No
last name: Jean-Pierre Raynauld, MD
role: Principal Investigator
affiliation: Université de Montréal
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Neuralgia
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 