<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/NCT03273868</url>
  </required_header>
  <id_info>
    <org_study_id>Protocole IFEC 2017-01</org_study_id>
    <nct_id>NCT03273868</nct_id>
  </id_info>
  <brief_title>The Effect of a Single Spinal Manipulation on Cardiovascular Autonomic Activity</brief_title>
  <official_title>The Effect of a Single Spinal Manipulation on Cardiovascular Autonomic Activity in Healthy Subjects: a Randomized, Cross-over, Sham-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Franco Europeen de Chiropratique</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>French chiropractic research fund</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institut Franco Europeen de Chiropratique</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the effect of a single high-velocity low-amplitude spinal manipulation&#xD;
      on both cardiovascular autonomic activity and pressure pain thresholds.&#xD;
&#xD;
      It is a cross-over study, thus each participant will undergo both interventions (spinal&#xD;
      manipulation and sham manipulation). Both interventions will be separated by a 48 h wash-out&#xD;
      period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Several systematic reviews have shown that spinal manipulations may have an immediate effect&#xD;
      on autonomic nervous system activity (e.g. increase in skin sympathetic nerve activity) and&#xD;
      on sensitivity to experimentally-induced pain (e.g. increase in pressure pain threshold).&#xD;
&#xD;
      It is generally unknown i) if these supposed effects last after the immediate post&#xD;
      intervention period and ii) if there is a statistical relationship between them, considering&#xD;
      that pain and autonomic networks are closely connected and interact at the peripheral, spinal&#xD;
      and supra-spinal levels.&#xD;
&#xD;
      The primary aim of the study is to assess every single effect immediatly and at short-term&#xD;
      after the intervention.&#xD;
&#xD;
      The secondary aim is to assess the bivariate statistical relationship between cardiovascular&#xD;
      autonomic activity and sensitivity to experimentally-induced pain after the intervention.&#xD;
&#xD;
      Cardiovascular autonomic nervous system activity is assessed with both heart rate and&#xD;
      systolic blood variabilities&#xD;
&#xD;
      Sensitivity to experimentally-induced pain is measured using pressure pain threshold.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 11, 2017</start_date>
  <completion_date type="Actual">October 30, 2018</completion_date>
  <primary_completion_date type="Actual">October 30, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Heart rate variability (HRV)</measure>
    <time_frame>Baseline, + 5 minutes, + 15 minutes, + 30 minutes</time_frame>
    <description>Frequency and Time-domain analyses of HRV from 5-minutes ECG recording</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Local (T5) and distal (L4) Pressure pain thresholds (PPT)</measure>
    <time_frame>Baseline, immediatly after intervention, + 12 minutes, + 25 minutes, + 35 minutes</time_frame>
    <description>The mean of 3 successives PPT in kilopascal</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Systolic blood pressure variability</measure>
    <time_frame>Baseline, + 5 minutes, + 15 minutes, + 30 minutes</time_frame>
    <description>Frequency analysis in the low frequency band of systolic blood pressure variability from 5-minutes recording</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Manipulation, Spinal</condition>
  <arm_group>
    <arm_group_label>High velocity low amplitude manipulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham manipulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High velocity low amplitude manipulation</intervention_name>
    <description>The researcher manually applies a preload force on the T5/T6 level followed by a single posterior to anterior thrust.</description>
    <arm_group_label>High velocity low amplitude manipulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham manipulation</intervention_name>
    <description>The researcher manually applies a preload force on the right scapula followed by a single lateral thrust.</description>
    <arm_group_label>Sham manipulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  First-year chiropractic student at IFEC&#xD;
&#xD;
          -  Volunteer&#xD;
&#xD;
          -  Healthy (no pain, no disease)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Counter indications to spinal manipulation&#xD;
&#xD;
          -  Drugs intakes (pain killers or beta-blockers)&#xD;
&#xD;
          -  Food, Caffeine and tobacco intakes during the previous hour&#xD;
&#xD;
          -  Alcohol intake and performance of strenuous physical activity the day of the&#xD;
             experimentation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Institut Franco Européen de Chiropraxie</name>
      <address>
        <city>Ivry-sur-Seine</city>
        <state>Val De Marne</state>
        <zip>94220</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>September 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>March 1, 2019</last_update_submitted>
  <last_update_submitted_qc>March 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Institut Franco Europeen de Chiropratique</investigator_affiliation>
    <investigator_full_name>Mathieu Picchiottino</investigator_full_name>
    <investigator_title>Chiropractor, PhD student</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03273868
org study id: Protocole IFEC 2017-01
nct id: NCT03273868
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study evaluates the effect of a single high-velocity low-amplitude spinal manipulation
      on both cardiovascular autonomic activity and pressure pain thresholds.

      It is a cross-over study, thus each participant will undergo both interventions (spinal
      manipulation and sham manipulation). Both interventions will be separated by a 48 h wash-out
      period.
Several systematic reviews have shown that spinal manipulations may have an immediate effect
      on autonomic nervous system activity (e.g. increase in skin sympathetic nerve activity) and
      on sensitivity to experimentally-induced pain (e.g. increase in pressure pain threshold).

      It is generally unknown i) if these supposed effects last after the immediate post
      intervention period and ii) if there is a statistical relationship between them, considering
      that pain and autonomic networks are closely connected and interact at the peripheral, spinal
      and supra-spinal levels.

      The primary aim of the study is to assess every single effect immediatly and at short-term
      after the intervention.

      The secondary aim is to assess the bivariate statistical relationship between cardiovascular
      autonomic activity and sensitivity to experimentally-induced pain after the intervention.

      Cardiovascular autonomic nervous system activity is assessed with both heart rate and
      systolic blood variabilities

      Sensitivity to experimentally-induced pain is measured using pressure pain threshold.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Outcomes Assessor)
measure: Heart rate variability (HRV)
time frame: Baseline, + 5 minutes, + 15 minutes, + 30 minutes
description: Frequency and Time-domain analyses of HRV from 5-minutes ECG recording
measure: Local (T5) and distal (L4) Pressure pain thresholds (PPT)
time frame: Baseline, immediatly after intervention, + 12 minutes, + 25 minutes, + 35 minutes
description: The mean of 3 successives PPT in kilopascal
measure: Systolic blood pressure variability
time frame: Baseline, + 5 minutes, + 15 minutes, + 30 minutes
description: Frequency analysis in the low frequency band of systolic blood pressure variability from 5-minutes recording
arm group label: High velocity low amplitude manipulation
arm group type: Experimental
arm group label: Sham manipulation
arm group type: Sham Comparator
intervention type: Other
intervention name: High velocity low amplitude manipulation
description: The researcher manually applies a preload force on the T5/T6 level followed by a single posterior to anterior thrust.
arm group label: High velocity low amplitude manipulation
intervention type: Other
intervention name: Sham manipulation
description: The researcher manually applies a preload force on the right scapula followed by a single lateral thrust.
arm group label: Sham manipulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Institut Franco Europeen de Chiropratique
investigator full name: Mathieu Picchiottino
investigator title: Chiropractor, PhD student
sharing ipd: Undecided