<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/NCT03750474</url>
  </required_header>
  <id_info>
    <org_study_id>K180403J</org_study_id>
    <secondary_id>2017-A02799-44</secondary_id>
    <nct_id>NCT03750474</nct_id>
  </id_info>
  <brief_title>Comparison of the Stiffness of the Lumbar Back Muscles Between Low Back Pain and Healthy Controls</brief_title>
  <acronym>PARA-ELASTO</acronym>
  <official_title>Comparison of the Stiffness of the Lumbar Back Muscles Between Low Back Pain and Healthy Controls Using Magnetic Resonance Elastography and Shear Wave Elastography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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>
      Chronic low back pain remains a major public health issue. Low back pain is frequently&#xD;
      associated with stiffness changes of the lumbar back muscles. The techniques which assess the&#xD;
      stiffness of the back muscles are poorly reliable and do not allow the quantification of&#xD;
      stiffness changes. Elastography (magnetic resonance imaging and ultrasound) can be used to&#xD;
      objectively and non-invasively quantify in vivo tissue elasticity. The aim of the&#xD;
      investigator's study is to compare the stiffness in the main lumbar back muscles (i.e. the&#xD;
      erector spinae and the multifidus) by using magnetic resonance elastography and shear wave&#xD;
      elastography.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      &quot;Chronic low back pain (CLBP) is commonly associated with increased trunk stiffness detected&#xD;
      by quick release methods and motion track systems as well as increased back muscles stiffness&#xD;
      identified by manual palpatory procedures or strain elastography. However, these techniques&#xD;
      are qualitative and operator dependent, hence they remain poorly reliable.&#xD;
&#xD;
      Over the last decade, imaging techniques have become very helpful to characterize the&#xD;
      biomechanical properties of tissues in vivo. Today, supersonic shear wave elastography (SWE)&#xD;
      allows real time mapping of the elastic shear modulus. Also, magnetic resonance allows&#xD;
      mapping and quantifying stiffness within a large volume of tissue. Elastography is efficient&#xD;
      in the characterization of passive and active muscle forces, in highlighting the influence of&#xD;
      muscle stiffness on joint stiffness and in showing stiffness changes related to muscle&#xD;
      diseases Imaging plays a key role in the management of CLBP; It allows to reach specific&#xD;
      radiological diagnosis such as tumor, inflammatory, or arthritis. However, in many cases, MRI&#xD;
      did not find a specific cause to low back pain and the low back pain is reported as&#xD;
      &quot;non-specific&quot;. Myofascial disorders are also responsible for non-specific CLBP.&#xD;
&#xD;
      The main objective of this study is to compare the shear modulus of the main lumbar back&#xD;
      muscles (erector spinae and multifidus) between patients with low back pain and healthy&#xD;
      controls.&#xD;
&#xD;
      Second objectives are to assess: the relationship between the stiffness of the back muscles&#xD;
      and clinical stiffness, the influence of age and sex on the elasticity of the back muscles,&#xD;
      the relationship between the surface of the paravertebral muscles and the elasticity; the&#xD;
      relationship between the elasticity of the hypaxial muscles (in front of the spine) and the&#xD;
      epaxial muscles (behind the spine =back muscles), the relationship between fatty infiltration&#xD;
      and elasticity of the back muscles, the relationship between inflammation / edema of back&#xD;
      muscles and stiffness of the back muscles, the influence of the muscular stretching on the&#xD;
      elasticity of the paravertebral muscles, the difference of elasticity in the direction of the&#xD;
      muscle fibers (oblique coronal) and perpendicular (axial), the stiffness difference the&#xD;
      between the right and left muscles, the role of different postures on muscle elasticity, the&#xD;
      relationship between the elasticity of the back muscles and the intensity and type of pain,&#xD;
      the relationship between the elasticity of the paravertebral muscles and disco-vertebral and&#xD;
      / or posterior apophyseal pathology.&#xD;
&#xD;
      The inclusion of 26 patients and 26 controls will demonstrate a difference in mean elasticity&#xD;
      modulus of 1.1 standard deviation (between patients and controls), with 90% and an alpha risk&#xD;
      of 5%.&#xD;
&#xD;
      Patients will undergo an MRI (sagittal Short Inversion Time Inversion Recovery (STIR) and T1,&#xD;
      coronal STIR and axial T1) in the management of low back pain. At the end of their&#xD;
      examination, two elastography-sequences will be performed (axial and coronal plane). After&#xD;
      the MRI, the patient will undergo a shear wave sonoelastography.&#xD;
&#xD;
      Healthy controls will undergo an MRI (sagittal T1 and T2) and two elastography-sequences&#xD;
      (axial and coronal plane). After the MRI, the patient will undergo a an shear wave&#xD;
      sonoelastography .&#xD;
&#xD;
      Healthy controls will be recruited in the hospital and university. Patients will be included&#xD;
      when the appointment for MRI was made. Signed informant consent will be obtained after oral&#xD;
      and written information.&#xD;
&#xD;
      The data manager will be trained to complete the case report form (CRF) and questionnaires;&#xD;
      CRF and questionnaire. The entries that are not done according to procedure will result in&#xD;
      inaccurate research data and inadequate source documentation. All data collected in the CRF&#xD;
      will be scanned in a timely manner, then saved in an Exel folder, and initialized and dated&#xD;
      by the data manager. Scanned data will be saved to the local database and on Universal Serial&#xD;
      Bus (USB) disk. Computers designated for data entry, export and scanning will be password&#xD;
      protected.&#xD;
&#xD;
      Data reported as missing, unavailable, non-reported, uninterpretable, or considered missing&#xD;
      because of data inconsistency or out-of-range results were excluded.&#xD;
&#xD;
      Descriptive and comparative statistics will be done. The shear modulus will be compared&#xD;
      between cases and controls using a Student's test (or Wilcoxon's test). For the secondary&#xD;
      criteria, the comparison between qualitative variables will be made using the Chi² test, the&#xD;
      comparison between a quantitative variable and a qualitative variable with a Student test (or&#xD;
      Wilcoxon) or a one-way analysis of variance ( or Kruskal-Wallis test), the association&#xD;
      between quantitative variables with the calculation of the Pearson (or Spearman) coefficient,&#xD;
      depending on the conditions of application.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2018</start_date>
  <completion_date type="Anticipated">May 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stiffness mapping and measurement of the shear modulus (m/s) in the multifidus and the erector spinae (1) with magnetic resonance elastography (Aera; 1,5T)</measure>
    <time_frame>18 months</time_frame>
    <description>First, the subjects undergoes a magnetic resonance elastography in decubitus in two postures: at rest and with stretching of back muscles (hip flexion). Then, stiffness will be measurement with sonography in several postures: prone position, upright, bending forward, bending backward.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">52</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>patient with chronic low back pain</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>magnetic resonance elastography and shear wave elastography of the back muscles</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy controls</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>magnetic resonance elastography and shear wave elastography of the back muscles</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>magnetic resonance elastography and shear wave elastography</intervention_name>
    <description>magnetic resonance elastography and shear wave elastography of the back muscles</description>
    <arm_group_label>healthy controls</arm_group_label>
    <arm_group_label>patient with chronic low back pain</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria for patient&#xD;
&#xD;
          -  Chronic low back pain (defined as low back pain for more than 3 months)&#xD;
&#xD;
          -  Lumbar MRI without planned injection in chronic low back pain assessment&#xD;
&#xD;
          -  Age between 18 and 80 years&#xD;
&#xD;
          -  Ability to keep still in an MRI machine&#xD;
&#xD;
          -  No contraindication to MRI&#xD;
&#xD;
          -  No major sporting activity within 48 hours prior to the exam&#xD;
&#xD;
          -  Informed and written consent&quot;&#xD;
&#xD;
        Inclusion criteria for Health control&#xD;
&#xD;
          -  No lumbar pain symptomatology, no lumbar static disorder, known neuromuscular&#xD;
             pathology&#xD;
&#xD;
          -  Age between 18 and 80 years&#xD;
&#xD;
          -  Ability to keep still in an MRI machine&#xD;
&#xD;
          -  No contraindication to MRI&#xD;
&#xD;
          -  Informed and written consent&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Inability to keep still in an MRI machine&#xD;
&#xD;
          -  Intercurrent illness that may interfere with exam results&#xD;
&#xD;
          -  Concomitant use of medications that may alter muscle metabolism&#xD;
&#xD;
          -  Need to inject contrast during MRI&#xD;
&#xD;
          -  Non-affiliation to a social security&#xD;
&#xD;
          -  Minors, protected adults, persons unable to consent, persons under the protection of&#xD;
             justice&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maud CREZE, PHU</last_name>
    <role>Principal Investigator</role>
    <affiliation>APHP</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Maud CREZE</last_name>
    <phone>0145213377</phone>
    <email>maud.creze@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maud CREZE, PHU</last_name>
    <phone>0145213377</phone>
    <email>maud.creze@aphp.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hopital Bicêtre - Radiology Department</name>
      <address>
        <city>Le Kremlin-Bicêtre</city>
        <zip>94270</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Maud CREZE</last_name>
      <phone>01.45.21.33.73</phone>
      <email>Maud.creze@aphp.fr</email>
    </contact>
    <investigator>
      <last_name>Maud CREZE, PHU</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 21, 2018</last_update_submitted>
  <last_update_submitted_qc>November 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>elastography; magnetic resonance imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03750474
org study id: K180403J
secondary id: 2017-A02799-44
nct id: NCT03750474
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chronic low back pain remains a major public health issue. Low back pain is frequently
      associated with stiffness changes of the lumbar back muscles. The techniques which assess the
      stiffness of the back muscles are poorly reliable and do not allow the quantification of
      stiffness changes. Elastography (magnetic resonance imaging and ultrasound) can be used to
      objectively and non-invasively quantify in vivo tissue elasticity. The aim of the
      investigator's study is to compare the stiffness in the main lumbar back muscles (i.e. the
      erector spinae and the multifidus) by using magnetic resonance elastography and shear wave
      elastography.
"Chronic low back pain (CLBP) is commonly associated with increased trunk stiffness detected
      by quick release methods and motion track systems as well as increased back muscles stiffness
      identified by manual palpatory procedures or strain elastography. However, these techniques
      are qualitative and operator dependent, hence they remain poorly reliable.

      Over the last decade, imaging techniques have become very helpful to characterize the
      biomechanical properties of tissues in vivo. Today, supersonic shear wave elastography (SWE)
      allows real time mapping of the elastic shear modulus. Also, magnetic resonance allows
      mapping and quantifying stiffness within a large volume of tissue. Elastography is efficient
      in the characterization of passive and active muscle forces, in highlighting the influence of
      muscle stiffness on joint stiffness and in showing stiffness changes related to muscle
      diseases Imaging plays a key role in the management of CLBP; It allows to reach specific
      radiological diagnosis such as tumor, inflammatory, or arthritis. However, in many cases, MRI
      did not find a specific cause to low back pain and the low back pain is reported as
      "non-specific". Myofascial disorders are also responsible for non-specific CLBP.

      The main objective of this study is to compare the shear modulus of the main lumbar back
      muscles (erector spinae and multifidus) between patients with low back pain and healthy
      controls.

      Second objectives are to assess: the relationship between the stiffness of the back muscles
      and clinical stiffness, the influence of age and sex on the elasticity of the back muscles,
      the relationship between the surface of the paravertebral muscles and the elasticity; the
      relationship between the elasticity of the hypaxial muscles (in front of the spine) and the
      epaxial muscles (behind the spine =back muscles), the relationship between fatty infiltration
      and elasticity of the back muscles, the relationship between inflammation / edema of back
      muscles and stiffness of the back muscles, the influence of the muscular stretching on the
      elasticity of the paravertebral muscles, the difference of elasticity in the direction of the
      muscle fibers (oblique coronal) and perpendicular (axial), the stiffness difference the
      between the right and left muscles, the role of different postures on muscle elasticity, the
      relationship between the elasticity of the back muscles and the intensity and type of pain,
      the relationship between the elasticity of the paravertebral muscles and disco-vertebral and
      / or posterior apophyseal pathology.

      The inclusion of 26 patients and 26 controls will demonstrate a difference in mean elasticity
      modulus of 1.1 standard deviation (between patients and controls), with 90% and an alpha risk
      of 5%.

      Patients will undergo an MRI (sagittal Short Inversion Time Inversion Recovery (STIR) and T1,
      coronal STIR and axial T1) in the management of low back pain. At the end of their
      examination, two elastography-sequences will be performed (axial and coronal plane). After
      the MRI, the patient will undergo a shear wave sonoelastography.

      Healthy controls will undergo an MRI (sagittal T1 and T2) and two elastography-sequences
      (axial and coronal plane). After the MRI, the patient will undergo a an shear wave
      sonoelastography .

      Healthy controls will be recruited in the hospital and university. Patients will be included
      when the appointment for MRI was made. Signed informant consent will be obtained after oral
      and written information.

      The data manager will be trained to complete the case report form (CRF) and questionnaires;
      CRF and questionnaire. The entries that are not done according to procedure will result in
      inaccurate research data and inadequate source documentation. All data collected in the CRF
      will be scanned in a timely manner, then saved in an Exel folder, and initialized and dated
      by the data manager. Scanned data will be saved to the local database and on Universal Serial
      Bus (USB) disk. Computers designated for data entry, export and scanning will be password
      protected.

      Data reported as missing, unavailable, non-reported, uninterpretable, or considered missing
      because of data inconsistency or out-of-range results were excluded.

      Descriptive and comparative statistics will be done. The shear modulus will be compared
      between cases and controls using a Student's test (or Wilcoxon's test). For the secondary
      criteria, the comparison between qualitative variables will be made using the Chi² test, the
      comparison between a quantitative variable and a qualitative variable with a Student test (or
      Wilcoxon) or a one-way analysis of variance ( or Kruskal-Wallis test), the association
      between quantitative variables with the calculation of the Pearson (or Spearman) coefficient,
      depending on the conditions of application.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Stiffness mapping and measurement of the shear modulus (m/s) in the multifidus and the erector spinae (1) with magnetic resonance elastography (Aera; 1,5T)
time frame: 18 months
description: First, the subjects undergoes a magnetic resonance elastography in decubitus in two postures: at rest and with stretching of back muscles (hip flexion). Then, stiffness will be measurement with sonography in several postures: prone position, upright, bending forward, bending backward.
arm group label: patient with chronic low back pain
arm group type: Experimental
description: magnetic resonance elastography and shear wave elastography of the back muscles
arm group label: healthy controls
arm group type: Other
description: magnetic resonance elastography and shear wave elastography of the back muscles
intervention type: Diagnostic Test
intervention name: magnetic resonance elastography and shear wave elastography
description: magnetic resonance elastography and shear wave elastography of the back muscles
arm group label: healthy controls
arm group label: patient with chronic low back pain
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Maud CREZE, PHU
role: Principal Investigator
affiliation: APHP
last name: Maud CREZE
phone: 0145213377
email: maud.creze@aphp.fr
last name: Maud CREZE, PHU
phone: 0145213377
email: maud.creze@aphp.fr
facility: 
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: No