<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/NCT03836248</url>
  </required_header>
  <id_info>
    <org_study_id>2018-A00395-50</org_study_id>
    <secondary_id>2018-A00395-50</secondary_id>
    <nct_id>NCT03836248</nct_id>
  </id_info>
  <brief_title>Study of the Contribution of Osteopathic Treatment to Classic Medical Management in Patients With Chronic Low Back Pain</brief_title>
  <official_title>Study of the Contribution of Osteopathic Treatment to Classic Medical Management in Patients With Chronic Low Back Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinique Pasteur</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinique Pasteur</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>
      The management of chronic low back pain is now part of a multi-disciplinary set of proposals&#xD;
      with the aim of adapting for each patient orientations of both medicated and non-medicated&#xD;
      care.&#xD;
&#xD;
      Very classically, analgesic treatment of stage I or II is of use, reinforced by the&#xD;
      occasional use of NSAIDs in the absence of contraindication. In this medical attempt of the&#xD;
      control of the pain associates a physical care (supervised exercises, physiotherapy care),&#xD;
      cognitive and behavioral therapy, multidisciplinary care.&#xD;
&#xD;
      Osteopathic treatment is a specific manual diagnostic and therapeutic procedure.&#xD;
&#xD;
      This study aims to evaluate the relevance of providing osteopathic treatment in combination&#xD;
      with classical medical treatment in the management of patients with chronic non-specific low&#xD;
      back pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective is to show that the addition of osteopathic treatment to classical&#xD;
      medical treatment decreases pain for patients with chronic nonspecific low back pain.&#xD;
&#xD;
      This goal will be evaluated at 3 months by comparing&#xD;
&#xD;
        -  the 3-month change in the level of pain observed in arm 3 (classical medical treatment +&#xD;
           osteopathic treatment) versus that observed in arm 1 (classical medical treatment), and&#xD;
&#xD;
        -  the 3-month change in the level of pain observed in arm 3 (classical medical treatment +&#xD;
           osteopathic treatment) versus that observed in arm 2 (classical medical treatment+ sham&#xD;
           osteopathic treatment ).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 2, 2019</start_date>
  <completion_date type="Anticipated">September 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2024</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>
    <intervention_model_description>Prospective monocentric study randomized into three parallel arms.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain VAS Visual Analog Scale</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>The primary outcome is the change in the VAS score on a 0-100 mm scale between Day 0 (before the placement of any osteopathic manipulations for Arm 3 ( or sham osteopathic treatment for Arm 2) and J90 ( after the last osteopathic treatment session for Arm 3 (sham osteopathic treatment for Arm 2)).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain VAS , level improvement</measure>
    <time_frame>Baseline, Day 15, Month 1, Month 2, Month 3, Month 6</time_frame>
    <description>The improvement of the pain level will be objectified by the measurement of the variation of the VAS score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relief Numerical scale</measure>
    <time_frame>Day 15, Month 1, Month 2, Month 3, Month 6</time_frame>
    <description>The intensity of relief will be objectified by measuring the variation of the &quot;relief&quot; score on a numerical scale. Numeric Scale Cotation between 0% (No Relief) to 100%(Full Relief)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug consumption</measure>
    <time_frame>Baseline, Day 15, Month 1, Month 2, Month 3, Month 6</time_frame>
    <description>Drug consumption will be collected by patients using a patient diary and converted to DDD ( Defined Daily Dose).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hand-Ground Distance and Schöber test</measure>
    <time_frame>Baseline, Day 15, Month 1, Month 2, Month 3, Month 6</time_frame>
    <description>The efficacy of functional and quality of life therapies will be assessed through functional clinical examinations (Hand-Ground Distance and Schöber test )</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oswestry score</measure>
    <time_frame>Baseline, Day 15, Month 1, Month 2, Month 3, Month 6</time_frame>
    <description>The efficacy of functional and quality of life therapies will be assessed through the self questionnaire: the Oswestry questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse event</measure>
    <time_frame>Day 15, Month 1, Month 2, Month 3, Month 6</time_frame>
    <description>Adverse events will be collected and analyzed for each arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elements of the osteopathic diagnosis</measure>
    <time_frame>Day 1, Day 7, Day 15, Month 1 Month 2</time_frame>
    <description>The elements of the osteopathic diagnosis will be collected by the treating osteopaths at the beginning and at the end of each treatment. Exploratory outcome, osteopathic diagnosis will be assessed by an internal osteopath questionnaire specifying anatomical localization of identified dysfunctions.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">199</enrollment>
  <condition>Chronic Low Back Pain</condition>
  <arm_group>
    <arm_group_label>1-Current practice Medication treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Medication treatment according to current practice.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2- Sham osteopathic treatment</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Medication treatment according to current practice + sham osteopathic treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3- Osteopathic treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Medication treatment according to current practice + osteopathic treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Osteopathic treatment</intervention_name>
    <description>5 osteopathic treatment sessions lasting 20 to 40 minutes. Each session include diagnosis according to the specific methodology &quot;geometric model of osteopathy&quot; and treatment of necessary elements and a control of osteopathic treatment at the end of the session.</description>
    <arm_group_label>3- Osteopathic treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham osteopathic treatment</intervention_name>
    <description>5 sham osteopathic treatment sessions lasting 20 to 40 minutes. Each session include diagnosis according to the specific methodology &quot;geometric model of osteopathy&quot; and only contacts for no intent to treat. At the end of the session a control of the sham osteopathic treatment is performed.</description>
    <arm_group_label>2- Sham osteopathic treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Current practice Medication treatment</intervention_name>
    <description>Analgesic medication of level 1 or a combination of level 1 and 2. Acetaminophen 1 g x 3 / day Ibuprofen 400mg x 3 / day</description>
    <arm_group_label>1-Current practice Medication treatment</arm_group_label>
    <arm_group_label>2- Sham osteopathic treatment</arm_group_label>
    <arm_group_label>3- Osteopathic treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with chronic non-specific low back pain: degenerative lumbalgia and low back&#xD;
             pain unrelated to anatomical lesions that have been evolving for more than 3 months.&#xD;
&#xD;
          -  Patient affiliated with a social security scheme or equivalent&#xD;
&#xD;
          -  Patient having signed the study informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with specific low back pain: patient with one of the following pathologies:&#xD;
             degenerative neurological pathology; infectious pathology; fracture vertebral lesion&#xD;
             less than 1 year; vertebral osteosynthesis material or canal narrowing.&#xD;
&#xD;
          -  Patient following a treatment of the Morphinic or Neuroleptic type.&#xD;
&#xD;
          -  Pregnant, breastfeeding or parturient woman&#xD;
&#xD;
          -  Patient participating in another clinical study&#xD;
&#xD;
          -  Protected patient: Major under some form of guardianship ; Hospitalized without&#xD;
             consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Barthélémy De Truchis de Varennes, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinique Pasteur</affiliation>
  </overall_official>
  <overall_official>
    <last_name>François Djabaku, DO</last_name>
    <role>Study Chair</role>
  </overall_official>
  <overall_official>
    <last_name>Barthélémy De Truchis de Varennes, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Clinique Pasteur</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Barthélémy De Truchis de Varennes, MD</last_name>
    <phone>+ 33 5 62 21 35 36</phone>
    <email>bdetruchis@clinique-pasteur.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Clinique Pasteur</name>
      <address>
        <city>Toulouse</city>
        <zip>31076</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Barthélémy De Truchis de Varennes, MD</last_name>
    </contact>
    <investigator>
      <last_name>Barthélémy De Truchis de Varennes, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sophie Pugliese, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>August 17, 2022</last_update_submitted>
  <last_update_submitted_qc>August 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Clinique Pasteur</investigator_affiliation>
    <investigator_full_name>Barthélémy de Truchis</investigator_full_name>
    <investigator_title>Principal investigator, MD</investigator_title>
  </responsible_party>
  <keyword>Osteopathic treatment</keyword>
  <keyword>Sham osteopathic treatment</keyword>
  <keyword>Low back pain</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/NCT03836248
org study id: 2018-A00395-50
secondary id: 2018-A00395-50
nct id: NCT03836248
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The management of chronic low back pain is now part of a multi-disciplinary set of proposals
      with the aim of adapting for each patient orientations of both medicated and non-medicated
      care.

      Very classically, analgesic treatment of stage I or II is of use, reinforced by the
      occasional use of NSAIDs in the absence of contraindication. In this medical attempt of the
      control of the pain associates a physical care (supervised exercises, physiotherapy care),
      cognitive and behavioral therapy, multidisciplinary care.

      Osteopathic treatment is a specific manual diagnostic and therapeutic procedure.

      This study aims to evaluate the relevance of providing osteopathic treatment in combination
      with classical medical treatment in the management of patients with chronic non-specific low
      back pain.
The primary objective is to show that the addition of osteopathic treatment to classical
      medical treatment decreases pain for patients with chronic nonspecific low back pain.

      This goal will be evaluated at 3 months by comparing

        -  the 3-month change in the level of pain observed in arm 3 (classical medical treatment +
           osteopathic treatment) versus that observed in arm 1 (classical medical treatment), and

        -  the 3-month change in the level of pain observed in arm 3 (classical medical treatment +
           osteopathic treatment) versus that observed in arm 2 (classical medical treatment+ sham
           osteopathic treatment ).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective monocentric study randomized into three parallel arms.
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Pain VAS Visual Analog Scale
time frame: Change from baseline to 3 months
description: The primary outcome is the change in the VAS score on a 0-100 mm scale between Day 0 (before the placement of any osteopathic manipulations for Arm 3 ( or sham osteopathic treatment for Arm 2) and J90 ( after the last osteopathic treatment session for Arm 3 (sham osteopathic treatment for Arm 2)).
measure: Pain VAS , level improvement
time frame: Baseline, Day 15, Month 1, Month 2, Month 3, Month 6
description: The improvement of the pain level will be objectified by the measurement of the variation of the VAS score.
measure: Relief Numerical scale
time frame: Day 15, Month 1, Month 2, Month 3, Month 6
description: The intensity of relief will be objectified by measuring the variation of the "relief" score on a numerical scale. Numeric Scale Cotation between 0% (No Relief) to 100%(Full Relief)
measure: Drug consumption
time frame: Baseline, Day 15, Month 1, Month 2, Month 3, Month 6
description: Drug consumption will be collected by patients using a patient diary and converted to DDD ( Defined Daily Dose).
measure: Hand-Ground Distance and Schöber test
time frame: Baseline, Day 15, Month 1, Month 2, Month 3, Month 6
description: The efficacy of functional and quality of life therapies will be assessed through functional clinical examinations (Hand-Ground Distance and Schöber test )
measure: Oswestry score
time frame: Baseline, Day 15, Month 1, Month 2, Month 3, Month 6
description: The efficacy of functional and quality of life therapies will be assessed through the self questionnaire: the Oswestry questionnaire.
measure: Adverse event
time frame: Day 15, Month 1, Month 2, Month 3, Month 6
description: Adverse events will be collected and analyzed for each arm.
measure: Elements of the osteopathic diagnosis
time frame: Day 1, Day 7, Day 15, Month 1 Month 2
description: The elements of the osteopathic diagnosis will be collected by the treating osteopaths at the beginning and at the end of each treatment. Exploratory outcome, osteopathic diagnosis will be assessed by an internal osteopath questionnaire specifying anatomical localization of identified dysfunctions.
arm group label: 1-Current practice Medication treatment
arm group type: Other
description: Medication treatment according to current practice.
arm group label: 2- Sham osteopathic treatment
arm group type: Sham Comparator
description: Medication treatment according to current practice + sham osteopathic treatment.
arm group label: 3- Osteopathic treatment
arm group type: Experimental
description: Medication treatment according to current practice + osteopathic treatment.
intervention type: Other
intervention name: Osteopathic treatment
description: 5 osteopathic treatment sessions lasting 20 to 40 minutes. Each session include diagnosis according to the specific methodology "geometric model of osteopathy" and treatment of necessary elements and a control of osteopathic treatment at the end of the session.
arm group label: 3- Osteopathic treatment
intervention type: Other
intervention name: Sham osteopathic treatment
description: 5 sham osteopathic treatment sessions lasting 20 to 40 minutes. Each session include diagnosis according to the specific methodology "geometric model of osteopathy" and only contacts for no intent to treat. At the end of the session a control of the sham osteopathic treatment is performed.
arm group label: 2- Sham osteopathic treatment
intervention type: Other
intervention name: Current practice Medication treatment
description: Analgesic medication of level 1 or a combination of level 1 and 2. Acetaminophen 1 g x 3 / day Ibuprofen 400mg x 3 / day
arm group label: 1-Current practice Medication treatment
arm group label: 2- Sham osteopathic treatment
arm group label: 3- Osteopathic treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: Barthélémy De Truchis de Varennes, MD
role: Principal Investigator
affiliation: Clinique Pasteur
last name: François Djabaku, DO
role: Study Chair
last name: Barthélémy De Truchis de Varennes, MD
role: Study Chair
affiliation: Clinique Pasteur
last name: Barthélémy De Truchis de Varennes, MD
phone: + 33 5 62 21 35 36
email: bdetruchis@clinique-pasteur.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Clinique Pasteur
investigator full name: Barthélémy de Truchis
investigator title: Principal investigator, MD
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: No