<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/NCT01716767</url>
  </required_header>
  <id_info>
    <org_study_id>IRMA07</org_study_id>
    <nct_id>NCT01716767</nct_id>
  </id_info>
  <brief_title>Acute Effect of Topical Menthol on Carpal Tunnel Syndrome</brief_title>
  <acronym>IRMA</acronym>
  <official_title>Acute Effect of Topical Menthol on Pain Symptoms in Slaughterhouse Workers With Symptoms of Carpal Tunnel Syndrome: Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Research Centre for the Working Environment, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Marquette University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Research Centre for the Working Environment, Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Topical menthol gels are classified 'topical analgesics' and are used to relieve pain of the&#xD;
      musculoskeletal system. However, double-blind randomized controlled trials are lacking. Here&#xD;
      the investigators examine - in a double-blind randomized controlled cross-over trial - the&#xD;
      acute effect of topical menthol (Biofreeze) and placebo (gel with a menthol scent) on pain&#xD;
      symptoms in slaughterhouse workers with symptoms of Carpal Tunnel Syndrome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in arm/hand pain intensity (scale 0-10) during work</measure>
    <time_frame>change from before to after (average of 1,2 and 3 hours after) application of the gel</time_frame>
    <description>the participant rates &quot;pain intensity during the last hour&quot; on a scale from 0-10 immediately before, and 1,2,3 hours after application of the gel. The primary outcome is the change from before to after (average of 1,2 and 3 hours after) application of the gel</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>GROC</measure>
    <time_frame>3 hours after application of the gel</time_frame>
    <description>Global Rating of Change (GROC) on a scale from - 5(much worsening of pain) to 5(much improvement of pain)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Carpal Tunnel Syndrome</condition>
  <arm_group>
    <arm_group_label>Menthol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Biofreeze topical gel containing 3.5% menthol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Topical gel containing a menthol scent, but no active menthol</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Menthol</intervention_name>
    <description>The gel will be applied at 2.5 ml per 500 cm2 to the hand, wrist and forearm</description>
    <arm_group_label>Menthol</arm_group_label>
    <other_name>Topical analgesic</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>The gel will be applied at 2.5 ml per 500 cm2 to the hand, wrist and forearm</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  positive Phalen test&#xD;
&#xD;
          -  positive Tinel test&#xD;
&#xD;
          -  nocturnal hand/wrist pain&#xD;
&#xD;
          -  pain intensity of at least 4 in the hand/wrist&#xD;
&#xD;
          -  the pain should have lasted at least 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  life-threatening disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>67 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lars L Andersen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Research Centre for the Working Environment</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>June 27, 2013</last_update_submitted>
  <last_update_submitted_qc>June 27, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 28, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Research Centre for the Working Environment, Denmark</investigator_affiliation>
    <investigator_full_name>Lars L. Andersen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Carpal tunnel syndrome</keyword>
  <keyword>hand pain</keyword>
  <keyword>wrist pain</keyword>
  <keyword>arm pain</keyword>
  <keyword>topical menthol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carpal Tunnel Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Analgesics</mesh_term>
    <mesh_term>Menthol</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01716767
org study id: IRMA07
nct id: NCT01716767
lead sponsor: 
collaborator: 
has dmc: No
Topical menthol gels are classified 'topical analgesics' and are used to relieve pain of the
      musculoskeletal system. However, double-blind randomized controlled trials are lacking. Here
      the investigators examine - in a double-blind randomized controlled cross-over trial - the
      acute effect of topical menthol (Biofreeze) and placebo (gel with a menthol scent) on pain
      symptoms in slaughterhouse workers with symptoms of Carpal Tunnel Syndrome.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in arm/hand pain intensity (scale 0-10) during work
time frame: change from before to after (average of 1,2 and 3 hours after) application of the gel
description: the participant rates "pain intensity during the last hour" on a scale from 0-10 immediately before, and 1,2,3 hours after application of the gel. The primary outcome is the change from before to after (average of 1,2 and 3 hours after) application of the gel
measure: GROC
time frame: 3 hours after application of the gel
description: Global Rating of Change (GROC) on a scale from - 5(much worsening of pain) to 5(much improvement of pain)
arm group label: Menthol
arm group type: Experimental
description: Biofreeze topical gel containing 3.5% menthol
arm group label: Placebo
arm group type: Placebo Comparator
description: Topical gel containing a menthol scent, but no active menthol
intervention type: Other
intervention name: Menthol
description: The gel will be applied at 2.5 ml per 500 cm2 to the hand, wrist and forearm
arm group label: Menthol
other name: Topical analgesic
intervention type: Other
intervention name: Placebo
description: The gel will be applied at 2.5 ml per 500 cm2 to the hand, wrist and forearm
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 67 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lars L Andersen, PhD
role: Principal Investigator
affiliation: Professor
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: National Research Centre for the Working Environment, Denmark
investigator full name: Lars L. Andersen
investigator title: Principal Investigator
mesh term: Carpal Tunnel Syndrome
mesh term: Syndrome
mesh term: Analgesics
mesh term: Menthol