<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/NCT04479384</url>
  </required_header>
  <id_info>
    <org_study_id>201910 EN PEDERSEN M PROTOCOL</org_study_id>
    <nct_id>NCT04479384</nct_id>
  </id_info>
  <brief_title>The Immediate Effect of an Osteopathic Manual Treatment on Blood Pressure in Adults With Hypertension - a Pilot Study.</brief_title>
  <official_title>The Immediate Effect of an Osteopathic Manual Treatment on Blood Pressure in Adults With Hypertension - a Pilot Study</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>
      The aim of this study was to determine if 4 manual osteopathic treatment techniques; Spinal&#xD;
      manipulation, stretch intrathoracic fascia, sternum recoil and cranial base release has an&#xD;
      immediate effect on blood pressure (BP) in hypertensive adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      30 hypertensive adults (age=50.76±8.66 years, height= 1.75±0.082 m, weight=89.5±19.08 kg),&#xD;
      were randomly assigned into one of two equally sized groups; a non- intervention and an&#xD;
      intervention group in which patients received 4 manual techniques. Outcome measures included&#xD;
      systolic- and diastolic BP pre-treatment and post-treatment 1-,5-, and 10-minutes. Two-way&#xD;
      mixed ANOVA was used for statistical analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2019</start_date>
  <completion_date type="Actual">May 1, 2020</completion_date>
  <primary_completion_date type="Actual">January 30, 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Systolic and diastolic blood pressure baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Systolic blood pressure and diastolic blood pressure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systolic and diastolic blood pressure post 1-minute</measure>
    <time_frame>Post 1-minute</time_frame>
    <description>Systolic blood pressure and diastolic blood pressure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systolic and diastolic blood pressure post 5-minute</measure>
    <time_frame>Post 5-minute</time_frame>
    <description>Systolic blood pressure and diastolic blood pressure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systolic and diastolic blood pressure post 10-minute</measure>
    <time_frame>Post 10-minute</time_frame>
    <description>Systolic blood pressure and diastolic blood pressure</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>High Blood Pressure</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Thoracic manipulation T1-T5 if somatic dysfunction. Intrathoracic fascia stretch x 3. Recoil sternum x 3. Cranial base release - 4 steps.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Supine position 10 minutes on the bench.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual therapy - osteopathic techniques</intervention_name>
    <description>HVLAT if any somatic dysfunction in T1-T5&#xD;
Stretch intrathoracic fascia x 3&#xD;
Recoil sternum x 3&#xD;
Cranial base release, 4 phases</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults 18-60 years old.&#xD;
&#xD;
          -  Primary hypertension.&#xD;
&#xD;
          -  Hypertension not more than grade 2, defined as: Systolic BP from 135-174 mmHg and&#xD;
             diastolic BP from 85-104 mmHg.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypertension grade 3, defined as: Systolic BP from &gt;175 mmHg and diastolic BP &gt;105&#xD;
             mmHg, due to high risk of developing stroke, apoplexy and myocardial infarct.&#xD;
&#xD;
          -  Positive hepato-jugular-reflux test, as a safety-test, to test pathological conditions&#xD;
             of the heart.&#xD;
&#xD;
          -  History of liver, kidney or known heart diseases, diagnosed by family physician as&#xD;
             these conditions can contribute to secondary hypertension.&#xD;
&#xD;
          -  Presence of contraindications for manual treatment, such as (but not limited to);&#xD;
             infections, neurological symptoms, inflammation, haemophilia, ankylosis, prosthesis,&#xD;
             pregnancy, cancer, osteoporosis, trauma and the use of blood-thinning medicines or&#xD;
             corticosteroids.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mette Pedersen, BSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>International Academy of Osteopathy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Næstved Rygcenter</name>
      <address>
        <city>Næstved</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hypertension</keyword>
  <keyword>Manual techniques</keyword>
  <keyword>Blood Pressure</keyword>
  <keyword>Osteopathy</keyword>
  <keyword>Treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</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/NCT04479384
org study id: 201910 EN PEDERSEN M PROTOCOL
nct id: NCT04479384
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to determine if 4 manual osteopathic treatment techniques; Spinal
      manipulation, stretch intrathoracic fascia, sternum recoil and cranial base release has an
      immediate effect on blood pressure (BP) in hypertensive adults.
30 hypertensive adults (age=50.76±8.66 years, height= 1.75±0.082 m, weight=89.5±19.08 kg),
      were randomly assigned into one of two equally sized groups; a non- intervention and an
      intervention group in which patients received 4 manual techniques. Outcome measures included
      systolic- and diastolic BP pre-treatment and post-treatment 1-,5-, and 10-minutes. Two-way
      mixed ANOVA was used for statistical analysis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Systolic and diastolic blood pressure baseline
time frame: Baseline
description: Systolic blood pressure and diastolic blood pressure
measure: Systolic and diastolic blood pressure post 1-minute
time frame: Post 1-minute
description: Systolic blood pressure and diastolic blood pressure
measure: Systolic and diastolic blood pressure post 5-minute
time frame: Post 5-minute
description: Systolic blood pressure and diastolic blood pressure
measure: Systolic and diastolic blood pressure post 10-minute
time frame: Post 10-minute
description: Systolic blood pressure and diastolic blood pressure
arm group label: Intervention group
arm group type: Experimental
description: Thoracic manipulation T1-T5 if somatic dysfunction. Intrathoracic fascia stretch x 3. Recoil sternum x 3. Cranial base release - 4 steps.
arm group label: Control group
arm group type: No Intervention
description: Supine position 10 minutes on the bench.
intervention type: Other
intervention name: Manual therapy - osteopathic techniques
description: HVLAT if any somatic dysfunction in T1-T5
Stretch intrathoracic fascia x 3
Recoil sternum x 3
Cranial base release, 4 phases
arm group label: Intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Mette Pedersen, BSc
role: Principal Investigator
affiliation: International Academy of Osteopathy
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Hypertension