<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/NCT02193373</url>
  </required_header>
  <id_info>
    <org_study_id>BHS-1044</org_study_id>
    <nct_id>NCT02193373</nct_id>
  </id_info>
  <brief_title>Study of Osteopathic Manipulative Medicine on the Autonomic Nervous System</brief_title>
  <official_title>What is the Best Osteopathic Manipulative Medicine (OMM) Approach to Affect Autonomic Nervous System (ANS) Control of Heart Rate Variability (HRV)?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>New York Institute of Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>New York Institute of Technology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose this study is to determine which manual medicine technique or combination of&#xD;
      techniques has the greatest effect on the natural changes in heart rate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study intends to examine how three different OMM techniques, sub-occipital release,&#xD;
      rib-raising, and stellate ganglion release, impact autonomic nervous system tone. Subjects&#xD;
      will be randomly assigned to one of four cohort groups, receiving either sub-occipital&#xD;
      release, rib-raising, stellate ganglion release or all three treatment techniques. A shift&#xD;
      towards sympathetic tone will be induced in all subjects using a tilted-to-seated-position&#xD;
      test (Tilt-Seated Position test) and cognitive challenge test, consisting of computerized&#xD;
      questions that become progressively more difficult, and which subjects are asked to answer as&#xD;
      quickly and accurately as possible. These stress tests will be induced twice, once without&#xD;
      any OMM treatment and a second time with the designated OMM treatment(s). The&#xD;
      sympathetic-dependent response to orthostatic change and cognitive challenges will be&#xD;
      determined by Fourier analysis of heart rate variability, recorded using an EKG attached to&#xD;
      each subject.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">May 2018</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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Heart Rate Variability</measure>
    <time_frame>one hour</time_frame>
    <description>The participant will lay on a table with electrocardiogram leads recording heart rate while an investigator manually engages the soft tissue on different areas of the participant's head, neck, or back.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of Diet and sleep on Heart Rate Variability</measure>
    <time_frame>Three days</time_frame>
    <description>heart rate</description>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">126</enrollment>
  <condition>Osteopathic Manual Manipulation of Neurovascular Regulation</condition>
  <arm_group>
    <arm_group_label>Sub-Occipital Release</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Osteopathic Manual Medicine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rib-Raising</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Osteopathic Manual Medicine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stellate Ganglion Release</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Osteopathic Manual Medicine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>All techniques</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Osteopathic Manual Medicine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>All Techniques-S</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham Osteopathic Manual Medicine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sub-Occipital Release-S</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham Osteopathic Manual Medicine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rib-Raising-S</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham Osteopathic Manual Medicine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stellate Ganglion Release -S</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham Osteopathic Manual Medicine</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Osteopathic Manual Medicine</intervention_name>
    <description>Osteopathic Manual Medicine</description>
    <arm_group_label>All techniques</arm_group_label>
    <arm_group_label>Rib-Raising</arm_group_label>
    <arm_group_label>Stellate Ganglion Release</arm_group_label>
    <arm_group_label>Sub-Occipital Release</arm_group_label>
    <other_name>Sub-Occipital Release</other_name>
    <other_name>Rib-Raising</other_name>
    <other_name>Stellate Ganglion Release</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham</intervention_name>
    <description>Osteopathic Manual Medicine</description>
    <arm_group_label>All Techniques-S</arm_group_label>
    <arm_group_label>Rib-Raising-S</arm_group_label>
    <arm_group_label>Stellate Ganglion Release -S</arm_group_label>
    <arm_group_label>Sub-Occipital Release-S</arm_group_label>
    <other_name>Sham sub-occipital release</other_name>
    <other_name>Sham stellate ganglion release</other_name>
    <other_name>Sham rib raising</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy Individual capable of giving consent between the ages of 20-50&#xD;
&#xD;
          -  Normal blood pressure as defined by the Seventh Report of US National Committee on&#xD;
             Prevention, Detection, Education and Treatment of High Blood Pressure&#xD;
&#xD;
          -  Normal EKG&#xD;
&#xD;
          -  Normal Heart Rate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic Cardiovascular Disease (including but not limited to: congestive heart&#xD;
             failure, previous myocardial infarction, any cardiomyopathy, any arrhythmia, or&#xD;
             previous cardiac surgery)&#xD;
&#xD;
          -  Hypertension as defined by the Seventh Report of US National Committee on Prevention,&#xD;
             Detection, Education and Treatment of High Blood Pressure or hypertensive medications&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Asthma&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Current or recent illness (within the past 7 days)&#xD;
&#xD;
          -  Any manipulative therapies within the previous 7 days (including but not limited to:&#xD;
             osteopathic manipulative treatment, massage or acupuncture)&#xD;
&#xD;
          -  Well conditioned athletes (such as long distance runners)&#xD;
&#xD;
          -  Anyone who fails to have an increased heart rate with the passive tilt test (50&#xD;
             degrees head-up)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jayme D Mancini, PhD, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>New York Institute of Technology, College of Osteopathic Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Theodore Flaum, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>New York Institute of Technology, College of Osteopathic Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York Institute of Technology College of Osteopathic Medicine Academic Health Care Center</name>
      <address>
        <city>Old Westbury</city>
        <state>New York</state>
        <zip>11568</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Henderson AT, Fisher JF, Blair J, Shea C, Li TS, Bridges KG. Effects of rib raising on the autonomic nervous system: a pilot study using noninvasive biomarkers. J Am Osteopath Assoc. 2010 Jun;110(6):324-30.</citation>
    <PMID>20606239</PMID>
  </reference>
  <reference>
    <citation>Shi X, Rehrer S, Prajapati P, Stoll ST, Gamber RG, Downey HF. Effect of cranial osteopathic manipulative medicine on cerebral tissue oxygenation. J Am Osteopath Assoc. 2011 Dec;111(12):660-6.</citation>
    <PMID>22182951</PMID>
  </reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>July 1, 2019</last_update_submitted>
  <last_update_submitted_qc>July 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Osteopathic Manipulative Medicine</keyword>
  <keyword>Autonomic Nervous System</keyword>
  <keyword>Heart Rate Variability</keyword>
  <keyword>Sub-Occipital Release</keyword>
  <keyword>Rib-Raising</keyword>
  <keyword>Stellate Ganglion Release</keyword>
  <!-- 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/NCT02193373
org study id: BHS-1044
nct id: NCT02193373
lead sponsor: 
has dmc: No
The purpose this study is to determine which manual medicine technique or combination of
      techniques has the greatest effect on the natural changes in heart rate.
This study intends to examine how three different OMM techniques, sub-occipital release,
      rib-raising, and stellate ganglion release, impact autonomic nervous system tone. Subjects
      will be randomly assigned to one of four cohort groups, receiving either sub-occipital
      release, rib-raising, stellate ganglion release or all three treatment techniques. A shift
      towards sympathetic tone will be induced in all subjects using a tilted-to-seated-position
      test (Tilt-Seated Position test) and cognitive challenge test, consisting of computerized
      questions that become progressively more difficult, and which subjects are asked to answer as
      quickly and accurately as possible. These stress tests will be induced twice, once without
      any OMM treatment and a second time with the designated OMM treatment(s). The
      sympathetic-dependent response to orthostatic change and cognitive challenges will be
      determined by Fourier analysis of heart rate variability, recorded using an EKG attached to
      each subject.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Heart Rate Variability
time frame: one hour
description: The participant will lay on a table with electrocardiogram leads recording heart rate while an investigator manually engages the soft tissue on different areas of the participant's head, neck, or back.
measure: Effect of Diet and sleep on Heart Rate Variability
time frame: Three days
description: heart rate
arm group label: Sub-Occipital Release
arm group type: Active Comparator
description: Osteopathic Manual Medicine
arm group label: Rib-Raising
arm group type: Active Comparator
description: Osteopathic Manual Medicine
arm group label: Stellate Ganglion Release
arm group type: Active Comparator
description: Osteopathic Manual Medicine
arm group label: All techniques
arm group type: Active Comparator
description: Osteopathic Manual Medicine
arm group label: All Techniques-S
arm group type: Sham Comparator
description: Sham Osteopathic Manual Medicine
arm group label: Sub-Occipital Release-S
arm group type: Sham Comparator
description: Sham Osteopathic Manual Medicine
arm group label: Rib-Raising-S
arm group type: Sham Comparator
description: Sham Osteopathic Manual Medicine
arm group label: Stellate Ganglion Release -S
arm group type: Sham Comparator
description: Sham Osteopathic Manual Medicine
intervention type: Other
intervention name: Osteopathic Manual Medicine
description: Osteopathic Manual Medicine
arm group label: All techniques
arm group label: Rib-Raising
arm group label: Stellate Ganglion Release
arm group label: Sub-Occipital Release
other name: Sub-Occipital Release
other name: Rib-Raising
other name: Stellate Ganglion Release
intervention type: Other
intervention name: Sham
description: Osteopathic Manual Medicine
arm group label: All Techniques-S
arm group label: Rib-Raising-S
arm group label: Stellate Ganglion Release -S
arm group label: Sub-Occipital Release-S
other name: Sham sub-occipital release
other name: Sham stellate ganglion release
other name: Sham rib raising
criteria: 
gender: All
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jayme D Mancini, PhD, DO
role: Principal Investigator
affiliation: New York Institute of Technology, College of Osteopathic Medicine
last name: Theodore Flaum, DO
role: Principal Investigator
affiliation: New York Institute of Technology, College of Osteopathic Medicine
facility: 
country: United States
citation: Henderson AT, Fisher JF, Blair J, Shea C, Li TS, Bridges KG. Effects of rib raising on the autonomic nervous system: a pilot study using noninvasive biomarkers. J Am Osteopath Assoc. 2010 Jun;110(6):324-30.
PMID: 20606239
citation: Shi X, Rehrer S, Prajapati P, Stoll ST, Gamber RG, Downey HF. Effect of cranial osteopathic manipulative medicine on cerebral tissue oxygenation. J Am Osteopath Assoc. 2011 Dec;111(12):660-6.
PMID: 22182951
responsible party type: Sponsor