<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/NCT04420052</url>
  </required_header>
  <id_info>
    <org_study_id>Osteonose</org_study_id>
    <secondary_id>2019-A02907-50</secondary_id>
    <nct_id>NCT04420052</nct_id>
  </id_info>
  <brief_title>Effects of Osteopathic Manipulative Treatment in Chronic Non-allergic Rhinosinusitis</brief_title>
  <official_title>Effects of Osteopathic Manipulative Treatment in Chronic Non-allergic Rhinosinusitis: a Randomised Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut des Hautes Etudes Osteopathiques de Nantes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut des Hautes Etudes Osteopathiques de Nantes</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 Rhinosinusitis (CRS) is a chronic condition with limited therapeutic options.&#xD;
      Moreover, the pathophysiology is poorly understood. The aim of this study is to evaluate the&#xD;
      efficacy of osteopathic manipulative treatment (OMT) in the course of this condition by&#xD;
      applying several techniques supposed to be related to the autonomic nervous system. Our&#xD;
      hypothesis is that these techniques could have beneficial effects on inflammation and head&#xD;
      symptoms in CRS.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      A sample of 90 patients diagnosed by ENT specialist will be randomly assigned to the OMT&#xD;
      group or the placebo group. The placebo procedure will consist in using light touch around&#xD;
      the nose, on the throat and on the thorax. Treatment and placebo protocols are composed of&#xD;
      two visits at day 0 and day 30.&#xD;
&#xD;
      A general practitioner will determine the eligibility for the study.&#xD;
&#xD;
      The outcomes include Peak Nasal Inspiratory Flow (PNIF) measured five times: at day 0, 30&#xD;
      (twice each, before and after treatment) and 180 (once). The two groups will be compared&#xD;
      regarding short and long term evolution.&#xD;
&#xD;
      The evolution of symptoms will be assessed by the Sino-nasal Outcome Test (SNOT-22) seven&#xD;
      times: at day 0, 30, 60, 90, 120, 150 and 180. This outcome will be analyzed using mixed&#xD;
      effect modelling&#xD;
&#xD;
      A Qualitative study will be conducted in the two groups to understand the patients'&#xD;
      experiences during care.&#xD;
&#xD;
      This protocol has been approved by a french ethic committee (Comité de Protection des&#xD;
      Personnes Sud Ouest et Outre-Mer II, 2020.04.09).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Statistical analysis details:&#xD;
&#xD;
      PNIF middle term evolution:&#xD;
&#xD;
      If the two groups can be compared regarding their socio-demographics characteristics, a&#xD;
      student's t-test will compare evolution (day 0 before treatment to day 30 before treatment)&#xD;
      of the PNIF between groups.&#xD;
&#xD;
      If characteristics are different, a multivariate linear model will be applied.&#xD;
&#xD;
      PNIF long term evolution:&#xD;
&#xD;
      The same tests will be made. The evolution will be assessed between day 0 (before treatment)&#xD;
      and day 180.&#xD;
&#xD;
      PNIF short term evolution:&#xD;
&#xD;
      The same tests will be made. The evolution will be assessed before and after treatment at day&#xD;
      0 and day 30.&#xD;
&#xD;
      SNOT-22 evolution:&#xD;
&#xD;
      Mixed effect model will assess the evolution of symptoms from day 0 to day 180&#xD;
&#xD;
      Response Shift detection:&#xD;
&#xD;
      For the SNOT-22, an Oort procedure will be performed in order to detect Response shift among&#xD;
      individuals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    COVID, death of investigator&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 1, 2021</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2022</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The care provider knows the assignment of patient. In order to know if the blinding was effective, at the end of each treatment, patient will have to tell if they were in the placebo or the OMT group</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in peak nasal inspiratory flow (PNIF)</measure>
    <time_frame>PNIF will be perform at day 0 (before treatment) and at day 30 (before treatment)</time_frame>
    <description>The aim of this outcome is to measure change in nasal airflow during maximal inspiration with a facial mask.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Sino-nasal Outcomes Test 22 (SNOT-22)</measure>
    <time_frame>Patients will complete the questionnaire at baseline (day 0), day 30, day 60, day 90, day 120, day 150 and day 180 to assess the change over time</time_frame>
    <description>This is a symptom-based rhinosinusitis questionnaire. Possible total scores range from 0 to 110, where a higher score indicates worse symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported experience of care</measure>
    <time_frame>Interview will occur at day 180</time_frame>
    <description>Individual interviews will enable to document the personal experience during effective or placebo treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sort term change in peak nasal inspiratory flow (PNIF)</measure>
    <time_frame>PNIF will be perform at day 0 (before and after treatment), day 30 (before and after treatment)</time_frame>
    <description>The aim of this outcome is to measure change before and after each treatment in nasal airflow during maximal inspiration with a facial mask.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>long term change in peak nasal inspiratory flow (PNIF)</measure>
    <time_frame>PNIF will be perform at day 0 (before treatment) and at day 180.</time_frame>
    <description>The aim of this outcome is to measure change in nasal airflow during maximal inspiration with a facial mask from base line to day 180.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Rhinosinusitis Chronic</condition>
  <arm_group>
    <arm_group_label>OMT group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Osteopathic manipulative treatment</intervention_name>
    <description>Osteopaths will executed several high velocity low amplitude (HVLA) techniques on the upper thoracic spine and cervical spine. These techniques are assumed to modulate the sympathetic cervical ganglia and reduce inflammation in chronic rhinosinusitis.&#xD;
This procedure takes around 15 minutes.</description>
    <arm_group_label>OMT group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo manipulation</intervention_name>
    <description>The osteopath will lay hands without movement on the nose, the throat and the thorax of patients.&#xD;
This procedure takes around 15 minutes.</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 18 and 50&#xD;
&#xD;
          -  Chronic rhinosinusitis diagnosed by ear, nose, and throat (ENT) specialist or general&#xD;
             practitioner&#xD;
&#xD;
          -  informed consent given&#xD;
&#xD;
          -  registered under french social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contraindication to spine manipulation&#xD;
&#xD;
          -  receiving other treatment for CRS during this study&#xD;
&#xD;
          -  being pregnant&#xD;
&#xD;
          -  being under legal protection&#xD;
&#xD;
          -  withdrawal of consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>sebastien cambier</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut des Hautes Etudes Osteopathiques de Nantes</affiliation>
  </overall_official>
  <overall_official>
    <last_name>maxime salmon, MsC</last_name>
    <role>Study Director</role>
    <affiliation>Institut des Hautes Etudes Osteopathiques de Nantes</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marie Moreau</last_name>
    <role>Study Chair</role>
    <affiliation>Institut des Hautes Etudes Osteopathiques de Nantes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cabinet ORL du Maine</name>
      <address>
        <city>Le Mans</city>
        <zip>72000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>July 29, 2023</last_update_submitted>
  <last_update_submitted_qc>July 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Osteopathic manipulative treatment</keyword>
  <keyword>Non-allergic</keyword>
  <keyword>rhinosinusitis</keyword>
  <keyword>Chronic Disease</keyword>
  <keyword>rhinitis</keyword>
  <keyword>sinusitis</keyword>
  <keyword>manual therapy</keyword>
  <keyword>osteopathy</keyword>
  <keyword>light touch</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sinusitis</mesh_term>
  </condition_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/NCT04420052
org study id: Osteonose
secondary id: 2019-A02907-50
nct id: NCT04420052
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chronic Rhinosinusitis (CRS) is a chronic condition with limited therapeutic options.
      Moreover, the pathophysiology is poorly understood. The aim of this study is to evaluate the
      efficacy of osteopathic manipulative treatment (OMT) in the course of this condition by
      applying several techniques supposed to be related to the autonomic nervous system. Our
      hypothesis is that these techniques could have beneficial effects on inflammation and head
      symptoms in CRS.

      Methods:

      A sample of 90 patients diagnosed by ENT specialist will be randomly assigned to the OMT
      group or the placebo group. The placebo procedure will consist in using light touch around
      the nose, on the throat and on the thorax. Treatment and placebo protocols are composed of
      two visits at day 0 and day 30.

      A general practitioner will determine the eligibility for the study.

      The outcomes include Peak Nasal Inspiratory Flow (PNIF) measured five times: at day 0, 30
      (twice each, before and after treatment) and 180 (once). The two groups will be compared
      regarding short and long term evolution.

      The evolution of symptoms will be assessed by the Sino-nasal Outcome Test (SNOT-22) seven
      times: at day 0, 30, 60, 90, 120, 150 and 180. This outcome will be analyzed using mixed
      effect modelling

      A Qualitative study will be conducted in the two groups to understand the patients'
      experiences during care.

      This protocol has been approved by a french ethic committee (Comité de Protection des
      Personnes Sud Ouest et Outre-Mer II, 2020.04.09).
Statistical analysis details:

      PNIF middle term evolution:

      If the two groups can be compared regarding their socio-demographics characteristics, a
      student's t-test will compare evolution (day 0 before treatment to day 30 before treatment)
      of the PNIF between groups.

      If characteristics are different, a multivariate linear model will be applied.

      PNIF long term evolution:

      The same tests will be made. The evolution will be assessed between day 0 (before treatment)
      and day 180.

      PNIF short term evolution:

      The same tests will be made. The evolution will be assessed before and after treatment at day
      0 and day 30.

      SNOT-22 evolution:

      Mixed effect model will assess the evolution of symptoms from day 0 to day 180

      Response Shift detection:

      For the SNOT-22, an Oort procedure will be performed in order to detect Response shift among
      individuals.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: The care provider knows the assignment of patient. In order to know if the blinding was effective, at the end of each treatment, patient will have to tell if they were in the placebo or the OMT group
measure: Change in peak nasal inspiratory flow (PNIF)
time frame: PNIF will be perform at day 0 (before treatment) and at day 30 (before treatment)
description: The aim of this outcome is to measure change in nasal airflow during maximal inspiration with a facial mask.
measure: Change in Sino-nasal Outcomes Test 22 (SNOT-22)
time frame: Patients will complete the questionnaire at baseline (day 0), day 30, day 60, day 90, day 120, day 150 and day 180 to assess the change over time
description: This is a symptom-based rhinosinusitis questionnaire. Possible total scores range from 0 to 110, where a higher score indicates worse symptoms.
measure: Patient-reported experience of care
time frame: Interview will occur at day 180
description: Individual interviews will enable to document the personal experience during effective or placebo treatment.
measure: Sort term change in peak nasal inspiratory flow (PNIF)
time frame: PNIF will be perform at day 0 (before and after treatment), day 30 (before and after treatment)
description: The aim of this outcome is to measure change before and after each treatment in nasal airflow during maximal inspiration with a facial mask.
measure: long term change in peak nasal inspiratory flow (PNIF)
time frame: PNIF will be perform at day 0 (before treatment) and at day 180.
description: The aim of this outcome is to measure change in nasal airflow during maximal inspiration with a facial mask from base line to day 180.
arm group label: OMT group
arm group type: Experimental
arm group label: Placebo group
arm group type: Placebo Comparator
intervention type: Other
intervention name: Osteopathic manipulative treatment
description: Osteopaths will executed several high velocity low amplitude (HVLA) techniques on the upper thoracic spine and cervical spine. These techniques are assumed to modulate the sympathetic cervical ganglia and reduce inflammation in chronic rhinosinusitis.
This procedure takes around 15 minutes.
arm group label: OMT group
intervention type: Other
intervention name: Placebo manipulation
description: The osteopath will lay hands without movement on the nose, the throat and the thorax of patients.
This procedure takes around 15 minutes.
arm group label: Placebo group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: sebastien cambier
role: Principal Investigator
affiliation: Institut des Hautes Etudes Osteopathiques de Nantes
last name: maxime salmon, MsC
role: Study Director
affiliation: Institut des Hautes Etudes Osteopathiques de Nantes
last name: Marie Moreau
role: Study Chair
affiliation: Institut des Hautes Etudes Osteopathiques de Nantes
facility: 
country: France
responsible party type: Sponsor
mesh term: Sinusitis