<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/NCT04422795</url>
  </required_header>
  <id_info>
    <org_study_id>20-03021647</org_study_id>
    <nct_id>NCT04422795</nct_id>
  </id_info>
  <brief_title>The Evaluation of External Thermomechanical Stimulation for Pain Reduction in Patients Undergoing Nail Injection</brief_title>
  <official_title>The Evaluation of External Thermomechanical Stimulation for Pain Reduction in Patients Undergoing Nail Injection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Weill Medical College of Cornell University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the efficacy and safety of a thermomechanical device&#xD;
      delivering vibration and cold stimuli in lowering pain during intramatricial nail injections&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Due to reallocation of resources, this study could not be initiated&#xD;
  </why_stopped>
  <start_date type="Anticipated">February 2024</start_date>
  <completion_date type="Anticipated">July 2025</completion_date>
  <primary_completion_date type="Anticipated">February 2025</primary_completion_date>
  <phase>Phase 4</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The level of pain and change in pain between each time point will be assessed using the Wong-Baker FACES scale with use of thermomechanical device delivering stimuli, without delivering stimuli, and with use of ethyl chloride skin refrigerant spray.</measure>
    <time_frame>prior to treatment, immediately after the needle insertion, during infiltration and 5 seconds after needle extraction</time_frame>
    <description>Pain will be self-reported, using the Wong-Baker FACES (0-10, with 0 representing absence of pain and 10 unbearable pain). Participants will be questioned about their level of pain in their nail prior to treatment, immediately after the needle insertion, during infiltration, and 5 seconds after needle extraction</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with at least one adverse event</measure>
    <time_frame>Patients will be followed for 3 days following their nail injection</time_frame>
    <description>Adverse events will only include those that are determined to be related to the study device</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Nail Diseases</condition>
  <arm_group>
    <arm_group_label>External thermomechanical device delivering stimuli</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The thermomechanical device is placed on the digit proximally to the injection site with the ice wings frozen and the vibration mechanism switched on.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>External thermomechanical device without delivering stimuli</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The thermomechanical device is placed on the digit proximally to the injection site with the ice wings at room temperature (unfrozen) and the vibration mechanism switched off.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nail injection with ethyl chloride skin refrigerant spray</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ethyl chloride skin refrigerant spray is applied to the area of injection immediately before needle insertion</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>External thermomechanical device delivering cold and vibration stimuli</intervention_name>
    <description>the thermomechanical device will be placed on the digit 2 cm proximally to the injection site with the ice wings frozen and the vibration mechanism switched on, delivering vibration and cold stimuli to the area for 30 seconds before the intramatricial injection and until needle withdrawal</description>
    <arm_group_label>External thermomechanical device delivering stimuli</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>External thermomechanical device without delivering cold and vibration stimuli</intervention_name>
    <description>the thermomechanical device will be placed on the digit 2 cm proximally to the injection site with the ice wings at unfrozen and the vibration mechanism switched off, for 30 seconds before the intramatricial injection and until needle withdrawal</description>
    <arm_group_label>External thermomechanical device without delivering stimuli</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ethyl chloride skin refrigerant spray</intervention_name>
    <description>Ethyl chloride skin refrigerant spray is applied to the area of injection for 3 seconds immediately before needle insertion</description>
    <arm_group_label>Nail injection with ethyl chloride skin refrigerant spray</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women aged 18 years or older&#xD;
&#xD;
          -  Must understand and voluntarily sign an informed consent form&#xD;
&#xD;
          -  All patients undergoing intramatricial nail injections at the Weill Cornell Medicine&#xD;
             (WCM) Department of Dermatology&#xD;
&#xD;
          -  Willingness to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability of the patient to provide written informed consent for any reason&#xD;
&#xD;
          -  Failure to have nail injection performed&#xD;
&#xD;
          -  Likely inability to comply with the study protocol or cooperate fully with the&#xD;
             research team&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shari R Lipner, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Weill Cornell Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>April 5, 2023</last_update_submitted>
  <last_update_submitted_qc>April 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nails</keyword>
  <keyword>Thermomechanical stimulation</keyword>
  <keyword>Intralesional injection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nail Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ethyl Chloride</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04422795
org study id: 20-03021647
nct id: NCT04422795
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of this study is to assess the efficacy and safety of a thermomechanical device
      delivering vibration and cold stimuli in lowering pain during intramatricial nail injections
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: The level of pain and change in pain between each time point will be assessed using the Wong-Baker FACES scale with use of thermomechanical device delivering stimuli, without delivering stimuli, and with use of ethyl chloride skin refrigerant spray.
time frame: prior to treatment, immediately after the needle insertion, during infiltration and 5 seconds after needle extraction
description: Pain will be self-reported, using the Wong-Baker FACES (0-10, with 0 representing absence of pain and 10 unbearable pain). Participants will be questioned about their level of pain in their nail prior to treatment, immediately after the needle insertion, during infiltration, and 5 seconds after needle extraction
measure: Number of participants with at least one adverse event
time frame: Patients will be followed for 3 days following their nail injection
description: Adverse events will only include those that are determined to be related to the study device
arm group label: External thermomechanical device delivering stimuli
arm group type: Experimental
description: The thermomechanical device is placed on the digit proximally to the injection site with the ice wings frozen and the vibration mechanism switched on.
arm group label: External thermomechanical device without delivering stimuli
arm group type: Placebo Comparator
description: The thermomechanical device is placed on the digit proximally to the injection site with the ice wings at room temperature (unfrozen) and the vibration mechanism switched off.
arm group label: Nail injection with ethyl chloride skin refrigerant spray
arm group type: Active Comparator
description: Ethyl chloride skin refrigerant spray is applied to the area of injection immediately before needle insertion
intervention type: Device
intervention name: External thermomechanical device delivering cold and vibration stimuli
description: the thermomechanical device will be placed on the digit 2 cm proximally to the injection site with the ice wings frozen and the vibration mechanism switched on, delivering vibration and cold stimuli to the area for 30 seconds before the intramatricial injection and until needle withdrawal
arm group label: External thermomechanical device delivering stimuli
intervention type: Device
intervention name: External thermomechanical device without delivering cold and vibration stimuli
description: the thermomechanical device will be placed on the digit 2 cm proximally to the injection site with the ice wings at unfrozen and the vibration mechanism switched off, for 30 seconds before the intramatricial injection and until needle withdrawal
arm group label: External thermomechanical device without delivering stimuli
intervention type: Drug
intervention name: Ethyl chloride skin refrigerant spray
description: Ethyl chloride skin refrigerant spray is applied to the area of injection for 3 seconds immediately before needle insertion
arm group label: Nail injection with ethyl chloride skin refrigerant spray
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shari R Lipner, MD, PhD
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Nail Diseases
mesh term: Ethyl Chloride
sharing ipd: No