<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/NCT03776708</url>
  </required_header>
  <id_info>
    <org_study_id>InstitutFEC</org_study_id>
    <nct_id>NCT03776708</nct_id>
  </id_info>
  <brief_title>Effect of Spinal Manipulation on Experimental Pain in Asymptomatic Subjects.</brief_title>
  <official_title>What is the Regional and Remote Effect of Spinal Manipulation on Pressure Pain Threshold in Asymptomatic Subjects Over Time: A Randomized Placebo-controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Franco Europeen de Chiropratique</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Franco Europeen de Chiropratique</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>
      Spinal manipulation is often used for its effect on pain, but more information is needed&#xD;
      concerning its mechanisms of action.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects&#xD;
      should be challenged by a validated sham procedure, regionally and remotely over time.&#xD;
      Further information is needed concerning its duration and its size.&#xD;
&#xD;
      Research questions:&#xD;
&#xD;
        1. What is the regional effect of spinal manipulation on the pressure pain threshold in&#xD;
           asymptomatic subjects, when compared to a valid sham procedure?&#xD;
&#xD;
        2. What is the remote effect of spinal manipulation on the pressure pain threshold in&#xD;
           asymptomatic subjects, when compared to a valid sham procedure?&#xD;
&#xD;
        3. What is the duration of the effect of spinal manipulation on the pressure pain threshold&#xD;
           in asymptomatic subjects?&#xD;
&#xD;
        4. What is the size of the effect of spinal manipulation on the pressure pain threshold in&#xD;
           asymptomatic subjects over time?&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Actual">December 1, 2018</completion_date>
  <primary_completion_date type="Actual">December 1, 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of the Pressure Pain threshold</measure>
    <time_frame>The change of the Pressure Pain Threshold is assessed from baseline to immediately after spinal manipulation, and then every fifteen minutes for about an hour.</time_frame>
    <description>Pressure Pain Threshold is defined as the minimal pressure that provokes a pain or a discomfort. It is considered as a valid and objective method, with a good reliability.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Spinal Manipulation</condition>
  <arm_group>
    <arm_group_label>Spinal manipulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The spinal manipulation is located between the fifth and eighth thoracic vertebrae, on a level and a side pain-free to a light palpation. The maneuver is of high velocity and low amplitude, oriented posterior to anterior, on the transverse process area of the chosen thoracic vertebrae.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham procedure</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The sham procedure is a manual contact on both inferior angles of the scapulae by the chiropractor. After a short tensioning, a slight movement with low velocity and low amplitude is done, respecting scapula-thoracic sliding plans laterally, without repercussion on the spine. It is considered by us to be a &quot;credible&quot; sham procedure, as it resembles an actual act of thoracic manipulation, and it has been validated, with questionnaires.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Spinal manipulation</intervention_name>
    <description>Spinal manipulation is defined as a quick, passive and forced manoeuvre applied to spinal joints, and sometimes followed by a characteristic cracking sound. It can be compared to a mobilisation, which is a passive manual therapy as well, but is applied slower and repetitively on the joints. Spinal manipulation has been shown to have a significant clinical impact in the treatment of musculoskeletal pain</description>
    <arm_group_label>Spinal manipulation</arm_group_label>
    <other_name>Spinal manipulative therapy</other_name>
    <other_name>Adjustment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham procedure</intervention_name>
    <description>The sham procedure is a manual contact on both inferior angles of the scapulae by the chiropractor. After a short tensioning, a slight movement with low velocity and low amplitude is done, respecting scapula-thoracic sliding plans laterally, without repercussion on the spine. It is considered by us to be a &quot;credible&quot; sham procedure, as it resembles an actual act of thoracic manipulation, and it has been validated, with questionnaires</description>
    <arm_group_label>Sham procedure</arm_group_label>
    <other_name>Placebo procedure</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The subjects must be young (18-30 years old)&#xD;
&#xD;
          -  asymptomatic (no pain in the tested area, but the study accepts pain elsewhere, as&#xD;
             long as it is less than 1/10 on the BOX-scale).&#xD;
&#xD;
          -  Chiropractic students.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subjects must not be reporting any spinal pain lasting more than a month&#xD;
&#xD;
          -  and/or having taken painkillers 24h prior to the study.&#xD;
&#xD;
          -  Contra-indications to the spinal manipulation (instability, fracture, malformation,&#xD;
             bone or ligament fragility, and inflammations).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charlotte Leboeuf-Yde, DC, MPH, PhD, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Institut Franco Européen de Chiropraxie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut Franco Européen de chiropraxie (iFEC)</name>
      <address>
        <city>Ivry-sur-Seine</city>
        <state>Val De Marne</state>
        <zip>94200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>October 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>December 17, 2018</last_update_submitted>
  <last_update_submitted_qc>December 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</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>Margaux Honoré</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>pressure pain threshold</keyword>
  <keyword>asymptomatic subjects</keyword>
  <keyword>duration</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/NCT03776708
org study id: InstitutFEC
nct id: NCT03776708
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Spinal manipulation is often used for its effect on pain, but more information is needed
      concerning its mechanisms of action.
The effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects
      should be challenged by a validated sham procedure, regionally and remotely over time.
      Further information is needed concerning its duration and its size.

      Research questions:

        1. What is the regional effect of spinal manipulation on the pressure pain threshold in
           asymptomatic subjects, when compared to a valid sham procedure?

        2. What is the remote effect of spinal manipulation on the pressure pain threshold in
           asymptomatic subjects, when compared to a valid sham procedure?

        3. What is the duration of the effect of spinal manipulation on the pressure pain threshold
           in asymptomatic subjects?

        4. What is the size of the effect of spinal manipulation on the pressure pain threshold in
           asymptomatic subjects over time?
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change of the Pressure Pain threshold
time frame: The change of the Pressure Pain Threshold is assessed from baseline to immediately after spinal manipulation, and then every fifteen minutes for about an hour.
description: Pressure Pain Threshold is defined as the minimal pressure that provokes a pain or a discomfort. It is considered as a valid and objective method, with a good reliability.
arm group label: Spinal manipulation
arm group type: Experimental
description: The spinal manipulation is located between the fifth and eighth thoracic vertebrae, on a level and a side pain-free to a light palpation. The maneuver is of high velocity and low amplitude, oriented posterior to anterior, on the transverse process area of the chosen thoracic vertebrae.
arm group label: Sham procedure
arm group type: Sham Comparator
description: The sham procedure is a manual contact on both inferior angles of the scapulae by the chiropractor. After a short tensioning, a slight movement with low velocity and low amplitude is done, respecting scapula-thoracic sliding plans laterally, without repercussion on the spine. It is considered by us to be a "credible" sham procedure, as it resembles an actual act of thoracic manipulation, and it has been validated, with questionnaires.
intervention type: Other
intervention name: Spinal manipulation
description: Spinal manipulation is defined as a quick, passive and forced manoeuvre applied to spinal joints, and sometimes followed by a characteristic cracking sound. It can be compared to a mobilisation, which is a passive manual therapy as well, but is applied slower and repetitively on the joints. Spinal manipulation has been shown to have a significant clinical impact in the treatment of musculoskeletal pain
arm group label: Spinal manipulation
other name: Spinal manipulative therapy
other name: Adjustment
intervention type: Other
intervention name: Sham procedure
description: The sham procedure is a manual contact on both inferior angles of the scapulae by the chiropractor. After a short tensioning, a slight movement with low velocity and low amplitude is done, respecting scapula-thoracic sliding plans laterally, without repercussion on the spine. It is considered by us to be a "credible" sham procedure, as it resembles an actual act of thoracic manipulation, and it has been validated, with questionnaires
arm group label: Sham procedure
other name: Placebo procedure
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Charlotte Leboeuf-Yde, DC, MPH, PhD, Professor
role: Study Director
affiliation: Institut Franco Européen de Chiropraxie
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Institut Franco Europeen de Chiropratique
investigator full name: Margaux Honoré
investigator title: Principal investigator