<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/NCT01694134</url>
  </required_header>
  <id_info>
    <org_study_id>8833</org_study_id>
    <nct_id>NCT01694134</nct_id>
  </id_info>
  <brief_title>Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies.</brief_title>
  <acronym>MODISC</acronym>
  <official_title>Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The treatment of chronic low back pain is a major objective of public healthcare, because it&#xD;
      causes an important number of sick leaves. A correlation between clinical observations and an&#xD;
      inflammatory discopathy has been underlined, but there is currently any reference treatment.&#xD;
      In this study, the main objective is to assess the efficacy of an intradiscal injection of&#xD;
      corticoids versus local anaesthetic on the treatment of pain of patients with low back pain&#xD;
      associated to a Modic I discopathy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, controlled, single-blind with two arms (anaesthetic versus corticoids)&#xD;
      trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 12, 2012</start_date>
  <completion_date type="Actual">March 20, 2017</completion_date>
  <primary_completion_date type="Actual">March 20, 2017</primary_completion_date>
  <phase>Phase 3</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>Pain assessment: VAS</measure>
    <time_frame>1 month</time_frame>
    <description>The pain will be assessed by the visual analog scale (VAS).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain assessment: VAS</measure>
    <time_frame>1 week, 2 weeks, 3 weeks, 3 months, 6 months</time_frame>
    <description>The pain will be assessed by the visual analog scale (VAS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessment: SF-36</measure>
    <time_frame>1 month, 3 months, 6 months</time_frame>
    <description>Quality of life will be assessed by the self-questionnaire SF-36.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consumption of analgesics and NSAIDs assessment</measure>
    <time_frame>1 month, 3 months,6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specific low back pain parameters assessment</measure>
    <time_frame>1 month, 3 months,6 months</time_frame>
    <description>Low back pain parameters will be assessed by the Dallas scale.The Dallas Pain Questionnaire (DPQ) assesses the impact of low back pain (LBP) on four components (0-100) of daily life .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specific low back pain parameters assessment</measure>
    <time_frame>1 month, 3 months,6 months</time_frame>
    <description>Low back pain parameters will be assessed by the Oswestry scale. The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Employment status</measure>
    <time_frame>1 month, 3 months,6 months</time_frame>
    <description>Employment or non-employment status will be noted</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Low Back Pain</condition>
  <condition>Lumbago</condition>
  <condition>Modic I Discopathy</condition>
  <arm_group>
    <arm_group_label>Corticoids</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A group of patients will receive an intradiscal injection of Hydrocortancyl.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Local anaesthetic</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>A group of patients will receive an intradiscal injection of Lidocaine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydrocortancyl.</intervention_name>
    <description>Patients will receive an intradiscal injection of hydrocortancyl.</description>
    <arm_group_label>Corticoids</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine</intervention_name>
    <arm_group_label>Local anaesthetic</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 and 80 years&#xD;
&#xD;
          -  Signed Informed consent&#xD;
&#xD;
          -  Low back pain for more than 6 months associated with Modic I discopathy (diagnosed by&#xD;
             MRI)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Past history of lumbar surgery&#xD;
&#xD;
          -  Patient under anticoagulant or antisludge treatment, or with coagulation troubles&#xD;
&#xD;
          -  Patient with unbalanced diabetes mellitus (blood glucose &gt; 1.30 g/l)&#xD;
&#xD;
          -  Patient with unstabilized high blood pressure (&gt; 160/95 mmHg)&#xD;
&#xD;
          -  Patient with evolving infection&#xD;
&#xD;
          -  Patient with iodine allergy or one of the Hydrocortancyl® or Lidocaine components&#xD;
&#xD;
          -  Porphyria, hypersensitivity to local anaesthetic&#xD;
&#xD;
          -  Patient with sphincter troubles showing a cauda equine syndrome&#xD;
&#xD;
          -  Untreated psychotic state&#xD;
&#xD;
          -  Pregnant women or of childbearing age without effective contraception means&#xD;
&#xD;
          -  Impossible 6 months follow-up&#xD;
&#xD;
          -  Participation to another trial&#xD;
&#xD;
          -  Vulnerable persons protected by the law&#xD;
&#xD;
          -  Persons under guardianship&#xD;
&#xD;
          -  Persons unable to express their consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital University of Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>September 22, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>January 30, 2020</last_update_submitted>
  <last_update_submitted_qc>January 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Discopathy</keyword>
  <keyword>Modic I</keyword>
  <keyword>Corticoids</keyword>
  <keyword>Local Anaesthetic</keyword>
  <keyword>Intradiscal injection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intervertebral Disc Displacement</mesh_term>
    <mesh_term>Intervertebral Disc Degeneration</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methylprednisolone Acetate</mesh_term>
    <mesh_term>Methylprednisolone</mesh_term>
    <mesh_term>Methylprednisolone Hemisuccinate</mesh_term>
    <mesh_term>Prednisolone</mesh_term>
    <mesh_term>Prednisolone acetate</mesh_term>
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Prednisolone hemisuccinate</mesh_term>
    <mesh_term>Prednisolone phosphate</mesh_term>
  </intervention_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/NCT01694134
org study id: 8833
nct id: NCT01694134
lead sponsor: 
has dmc: No
The treatment of chronic low back pain is a major objective of public healthcare, because it
      causes an important number of sick leaves. A correlation between clinical observations and an
      inflammatory discopathy has been underlined, but there is currently any reference treatment.
      In this study, the main objective is to assess the efficacy of an intradiscal injection of
      corticoids versus local anaesthetic on the treatment of pain of patients with low back pain
      associated to a Modic I discopathy.
This is a randomized, controlled, single-blind with two arms (anaesthetic versus corticoids)
      trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Pain assessment: VAS
time frame: 1 month
description: The pain will be assessed by the visual analog scale (VAS).
measure: Pain assessment: VAS
time frame: 1 week, 2 weeks, 3 weeks, 3 months, 6 months
description: The pain will be assessed by the visual analog scale (VAS).
measure: Quality of life assessment: SF-36
time frame: 1 month, 3 months, 6 months
description: Quality of life will be assessed by the self-questionnaire SF-36.
measure: Consumption of analgesics and NSAIDs assessment
time frame: 1 month, 3 months,6 months
measure: Specific low back pain parameters assessment
time frame: 1 month, 3 months,6 months
description: Low back pain parameters will be assessed by the Dallas scale.The Dallas Pain Questionnaire (DPQ) assesses the impact of low back pain (LBP) on four components (0-100) of daily life .
measure: Specific low back pain parameters assessment
time frame: 1 month, 3 months,6 months
description: Low back pain parameters will be assessed by the Oswestry scale. The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
measure: Employment status
time frame: 1 month, 3 months,6 months
description: Employment or non-employment status will be noted
arm group label: Corticoids
arm group type: Active Comparator
description: A group of patients will receive an intradiscal injection of Hydrocortancyl.
arm group label: Local anaesthetic
arm group type: Sham Comparator
description: A group of patients will receive an intradiscal injection of Lidocaine.
intervention type: Drug
intervention name: Hydrocortancyl.
description: Patients will receive an intradiscal injection of hydrocortancyl.
arm group label: Corticoids
intervention type: Drug
intervention name: Lidocaine
arm group label: Local anaesthetic
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Intervertebral Disc Displacement
mesh term: Intervertebral Disc Degeneration
mesh term: Low Back Pain
mesh term: Methylprednisolone Acetate
mesh term: Methylprednisolone
mesh term: Methylprednisolone Hemisuccinate
mesh term: Prednisolone
mesh term: Prednisolone acetate
mesh term: Lidocaine
mesh term: Prednisolone hemisuccinate
mesh term: Prednisolone phosphate