<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/NCT04439994</url>
  </required_header>
  <id_info>
    <org_study_id>N-20200015</org_study_id>
    <nct_id>NCT04439994</nct_id>
  </id_info>
  <brief_title>Activation of miRNA and Proteins After Acute Experimental Pain. (miRNA: Micro RNA)</brief_title>
  <acronym>miRNA</acronym>
  <official_title>Activation of Plasma miRNA and Proteins as a Result of Acute Experimental Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aalborg University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aalborg University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      In this experiment, the investigators would like to test the following:&#xD;
&#xD;
        1. Does acute pain induced by hypertonic injection cause changes in plasma miRNA and&#xD;
           protein expression ?&#xD;
&#xD;
        2. Can these canges correlate with the development of local hyperalgesia?&#xD;
&#xD;
        3. How does the plasma miRNA expression change over a duration of 24 hours post pain&#xD;
           induction ?&#xD;
&#xD;
        4. Which mRNA targets are potentially affected by acute pain?&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2020</start_date>
  <completion_date type="Actual">July 1, 2022</completion_date>
  <primary_completion_date type="Actual">July 1, 2021</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>
    <intervention_model_description>two groups of subjects: one group will receive hypertonic injection (0.1 ml) and the other group will receive isotonic saline injection (0.1 ml)</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>miRNA expression over time</measure>
    <time_frame>Before injection</time_frame>
    <description>Plasma miRNA evaluation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>miRNA expression over time</measure>
    <time_frame>30 minutes post-injection</time_frame>
    <description>Plasma miRNA evaluation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>miRNA expression over time</measure>
    <time_frame>3 hours post-injection</time_frame>
    <description>Plasma miRNA evaluation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>miRNA expression over time</measure>
    <time_frame>24 hours post-injection</time_frame>
    <description>Plasma miRNA evaluation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Protein expression over time</measure>
    <time_frame>Before injection</time_frame>
    <description>Plasma protein evaluation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Protein expression over time</measure>
    <time_frame>30 minutes post-injection</time_frame>
    <description>Plasma protein evaluation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Protein expression over time</measure>
    <time_frame>3 hours post-injection</time_frame>
    <description>Plasma protein evaluation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Protein expression over time</measure>
    <time_frame>24 hours post-injection</time_frame>
    <description>Plasma protein evaluation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of pain: visual analog scale</measure>
    <time_frame>20 minutes</time_frame>
    <description>Pain following capsaicin injection will be monitored for 20 minutes using a computerized 100 mm visual analog scale (eVAS software Aalborg University, Denmark), installed on a tablet.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Hypertonic Saline</condition>
  <condition>Isotonic Saline</condition>
  <arm_group>
    <arm_group_label>Hypertonic saline</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Each participant will be given i.d. in 0.1 mL volumes of a hypertonic saline solution. The subject will be blinded to the hypertonic/isotonic administration.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Isotonic Saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Each participant will be given i.d. in 0.1 mL volumes of a isotonic saline solution. The subject will be blinded to the hypertonic/isotonic administration.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>hypertonic saline</intervention_name>
    <description>The participant will be given i.d. in 0.1 mL volumes of a hypertonic saline solution</description>
    <arm_group_label>Hypertonic saline</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Saline injection</intervention_name>
    <description>The participant will be given i.d. in 0.1 mL volumes of a saline solution</description>
    <arm_group_label>Isotonic Saline</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood sampling</intervention_name>
    <description>Whole blood samples (5 mL per each time point, a total of 20 mL per subject) will be collected</description>
    <arm_group_label>Hypertonic saline</arm_group_label>
    <arm_group_label>Isotonic Saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy men and women in the age 18-80 years&#xD;
&#xD;
          -  Speak and understand English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute and chronic pain&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Drug addiction defined as the use of cannabis, opioids or other drugs&#xD;
&#xD;
          -  Present or previous history of neurological, dermatological, immunological,&#xD;
             musculoskeletal, cardiac disorder or mental illnesses that may affect the results&#xD;
             (e.g. Neuropathy, muscular pain in the upper extremities, etc.)&#xD;
&#xD;
          -  Lack of ability to cooperate&#xD;
&#xD;
          -  Current use of medications that may affect the trial, such as antipsychotics and pain&#xD;
             killers as well as systemic or topical steroids and anti-inflammatory drugs.&#xD;
&#xD;
          -  Skin diseases&#xD;
&#xD;
          -  Consumption of alcohol or painkillers 24 hours before the study days and between these&#xD;
&#xD;
          -  Participation in other trials within 1 week of study entry (4 weeks in the case of&#xD;
             pharmaceutical trials)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Aalborg University</name>
      <address>
        <city>Aalborg</city>
        <state>Nordjylland</state>
        <zip>92200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AAlborg University</name>
      <address>
        <city>Aalborg</city>
        <state>Nordjylland</state>
        <zip>9220</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>January 16, 2023</last_update_submitted>
  <last_update_submitted_qc>January 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aalborg University</investigator_affiliation>
    <investigator_full_name>Silvia Lo Vecchio</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT04439994
org study id: N-20200015
nct id: NCT04439994
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this experiment, the investigators would like to test the following:

        1. Does acute pain induced by hypertonic injection cause changes in plasma miRNA and
           protein expression ?

        2. Can these canges correlate with the development of local hyperalgesia?

        3. How does the plasma miRNA expression change over a duration of 24 hours post pain
           induction ?

        4. Which mRNA targets are potentially affected by acute pain?
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: two groups of subjects: one group will receive hypertonic injection (0.1 ml) and the other group will receive isotonic saline injection (0.1 ml)
primary purpose: Basic Science
masking: Single (Participant)
measure: miRNA expression over time
time frame: Before injection
description: Plasma miRNA evaluation
measure: miRNA expression over time
time frame: 30 minutes post-injection
description: Plasma miRNA evaluation
measure: miRNA expression over time
time frame: 3 hours post-injection
description: Plasma miRNA evaluation
measure: miRNA expression over time
time frame: 24 hours post-injection
description: Plasma miRNA evaluation
measure: Protein expression over time
time frame: Before injection
description: Plasma protein evaluation
measure: Protein expression over time
time frame: 30 minutes post-injection
description: Plasma protein evaluation
measure: Protein expression over time
time frame: 3 hours post-injection
description: Plasma protein evaluation
measure: Protein expression over time
time frame: 24 hours post-injection
description: Plasma protein evaluation
measure: Assessment of pain: visual analog scale
time frame: 20 minutes
description: Pain following capsaicin injection will be monitored for 20 minutes using a computerized 100 mm visual analog scale (eVAS software Aalborg University, Denmark), installed on a tablet.
arm group label: Hypertonic saline
arm group type: Active Comparator
description: Each participant will be given i.d. in 0.1 mL volumes of a hypertonic saline solution. The subject will be blinded to the hypertonic/isotonic administration.
arm group label: Isotonic Saline
arm group type: Placebo Comparator
description: Each participant will be given i.d. in 0.1 mL volumes of a isotonic saline solution. The subject will be blinded to the hypertonic/isotonic administration.
intervention type: Other
intervention name: hypertonic saline
description: The participant will be given i.d. in 0.1 mL volumes of a hypertonic saline solution
arm group label: Hypertonic saline
intervention type: Other
intervention name: Saline injection
description: The participant will be given i.d. in 0.1 mL volumes of a saline solution
arm group label: Isotonic Saline
intervention type: Procedure
intervention name: Blood sampling
description: Whole blood samples (5 mL per each time point, a total of 20 mL per subject) will be collected
arm group label: Hypertonic saline
arm group label: Isotonic Saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Aalborg University
investigator full name: Silvia Lo Vecchio
investigator title: Assistant Professor