<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/NCT04411095</url>
  </required_header>
  <id_info>
    <org_study_id>InternationalIAO</org_study_id>
    <nct_id>NCT04411095</nct_id>
  </id_info>
  <brief_title>The Effect of the Release of the Intrathoracic Fascia on Thoracic Rotation Mobility</brief_title>
  <official_title>The Effect of the Release of the Intrathoracic Fascia on Thoracic Rotation Mobility</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>International Academy of Osteopathy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>International Academy of Osteopathy</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>
      Testing the effect of a specific stretch technique versus sham treatment, to objectify the&#xD;
      influence of that specific technique on thoracic rotation mobility.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects in the experimental group will undergo a technique for stretching the intrathoracic&#xD;
      fascia. Before and after, a measurement will be performed with a goniometer, to see if there&#xD;
      is a difference in thoracic rotation mobility.&#xD;
&#xD;
      Subjects in the placebo group get a different technique, where the hands of the therapists&#xD;
      are simply placed on the thorax, but no manoeuvre will be performed. Before and after, there&#xD;
      is a measurement in thoracic rotation mobility.&#xD;
&#xD;
      Data will be compared and statistical analyse will be done to see of there is a difference in&#xD;
      rotation. So the hypothesis that stretching intrathoracic fascia has an effect on thoracic&#xD;
      rotation mobility, will be accepted or rejected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 28, 2020</start_date>
  <completion_date type="Actual">April 1, 2020</completion_date>
  <primary_completion_date type="Actual">April 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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in thoracic rotation mobility</measure>
    <time_frame>Before and immediately after the test</time_frame>
    <description>Change from baseline rotation, left and right, to rotation immediately after the test</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Fascia; Inflammation</condition>
  <condition>Thoracic</condition>
  <condition>Rotation</condition>
  <arm_group>
    <arm_group_label>Stretching of intrathoracic fascia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A technique will be used to stretch the intrathoracic fascia. The subject lies in his/her back, and a flexion of the upper cervical spine is combined with a retraction movement of the lower cervical and upper thoracic spine, this in combination with inspiration.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test without stretching</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A placebo technique is performed by positioning the hands of the therapist on the thorax without pressure or performing a technique. Similar as the stretching technique, a deep inspiration is performed by the patient, for each of the intrathoracic cilinders. This without performing a retraction of the lower cervical and upper thoracic spine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Measuring thoracic rotation mobility</intervention_name>
    <description>Measuring the thoracic rotation mobility with a goniometer, from a standardized position</description>
    <arm_group_label>Stretching of intrathoracic fascia</arm_group_label>
    <arm_group_label>Test without stretching</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects between the age of 18 and 65&#xD;
&#xD;
          -  Both men and women&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Structural disease of cervical or/and thoracic spine and/or head and/or thorax&#xD;
&#xD;
          -  Acute mobility restriction of cervical and/or thoracic spine&#xD;
&#xD;
          -  Acute and/or intense pain&#xD;
&#xD;
          -  A history of trauma and/or operation on cervical and/or thoracic spine&#xD;
&#xD;
          -  Treatment for cancer like chemo or radiation&#xD;
&#xD;
          -  Baby's and children&#xD;
&#xD;
          -  Elderly people&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>IAO Administration</last_name>
    <role>Study Director</role>
    <affiliation>The International Academy of Osteopathy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Practice for fysiotherapy and osteopathy</name>
      <address>
        <city>Scherpenheuvel</city>
        <state>Vlaams-brabant</state>
        <zip>3270</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>April 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fasciitis</mesh_term>
    <mesh_term>Inflammation</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/NCT04411095
org study id: InternationalIAO
nct id: NCT04411095
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Testing the effect of a specific stretch technique versus sham treatment, to objectify the
      influence of that specific technique on thoracic rotation mobility.
Subjects in the experimental group will undergo a technique for stretching the intrathoracic
      fascia. Before and after, a measurement will be performed with a goniometer, to see if there
      is a difference in thoracic rotation mobility.

      Subjects in the placebo group get a different technique, where the hands of the therapists
      are simply placed on the thorax, but no manoeuvre will be performed. Before and after, there
      is a measurement in thoracic rotation mobility.

      Data will be compared and statistical analyse will be done to see of there is a difference in
      rotation. So the hypothesis that stretching intrathoracic fascia has an effect on thoracic
      rotation mobility, will be accepted or rejected.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in thoracic rotation mobility
time frame: Before and immediately after the test
description: Change from baseline rotation, left and right, to rotation immediately after the test
arm group label: Stretching of intrathoracic fascia
arm group type: Experimental
description: A technique will be used to stretch the intrathoracic fascia. The subject lies in his/her back, and a flexion of the upper cervical spine is combined with a retraction movement of the lower cervical and upper thoracic spine, this in combination with inspiration.
arm group label: Test without stretching
arm group type: Placebo Comparator
description: A placebo technique is performed by positioning the hands of the therapist on the thorax without pressure or performing a technique. Similar as the stretching technique, a deep inspiration is performed by the patient, for each of the intrathoracic cilinders. This without performing a retraction of the lower cervical and upper thoracic spine.
intervention type: Other
intervention name: Measuring thoracic rotation mobility
description: Measuring the thoracic rotation mobility with a goniometer, from a standardized position
arm group label: Stretching of intrathoracic fascia
arm group label: Test without stretching
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: IAO Administration
role: Study Director
affiliation: The International Academy of Osteopathy
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Fasciitis
mesh term: Inflammation
sharing ipd: No