<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/NCT01675700</url>
  </required_header>
  <id_info>
    <org_study_id>122975</org_study_id>
    <nct_id>NCT01675700</nct_id>
  </id_info>
  <brief_title>Topical Nitrates for Myofascial Trigger Points</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>GF Strong Rehabilitation Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GF Strong Rehabilitation Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether a topical nitroglycerine patch applied&#xD;
      daily over a trapezius trigger point can improve patients' symptoms.&#xD;
&#xD;
      If there is improvement, this open label study will help determine the degree of improvement&#xD;
      and contribute to the design of a larger double blind placebo controlled trial.&#xD;
&#xD;
      We would consider moving forward to a large randomized trial if:&#xD;
&#xD;
        -  The intervention is acceptable to patients (&gt;= 70%) and&#xD;
&#xD;
        -  Compliance is satisfactory (&gt;=80%) and&#xD;
&#xD;
        -  We find preliminary evidence of efficacy, i.e. average reduction in pain of 20mm on the&#xD;
           VAS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2009</start_date>
  <completion_date type="Actual">December 2009</completion_date>
  <primary_completion_date type="Actual">July 2009</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain at the time of clinic visit and over the previous week as measured by a Visual Analog Scale, VAS, for pain and a pressure algometer measurement to obtain pressure pain thresholds over the patients trigger point.</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>As another secondary outcome we will ask the participants whether the benefits of the treatment are good enough that they would continue using the nitroglycerin patch. This will be a yes or no response.</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Myofascial Trigger Points</condition>
  <arm_group>
    <arm_group_label>Myofascial trigger point</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients diagnosed with myofascial trigger points who will receive a nitroglycerin patch over the trigger point.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nitroglycerin patch</intervention_name>
    <description>Nitroglycerin 0.1 mg/hr patch</description>
    <arm_group_label>Myofascial trigger point</arm_group_label>
    <other_name>Nitro-Dur 0.1</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion criteria include age between 19 and 65 years old, myofascial pain lasting at&#xD;
             least 6 months, and a myofascial trigger point point in the trapezius muscle.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Our exclusion criteria include symptomatic disc herniation, symptomatic cervical&#xD;
             osteoarthritis, systemic infection, malignancy, collapsed vertebra, thoracic outlet&#xD;
             syndrome, temporomandibular joint dysfunction, collagen-vascular disease, or brachial&#xD;
             plexopathy. Patients with ongoing litigation regarding their symptoms are not eligible&#xD;
             for this study. Also excluded are patients with underlying cardiac disease,&#xD;
             hypotension, or medical conditions that may not allow them to tolerate the use of&#xD;
             vasodilators, and those who use phosphodiesterase inhibitors.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hubert A Anton, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>August 28, 2012</last_update_submitted>
  <last_update_submitted_qc>August 28, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 30, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>GF Strong Rehabilitation Centre</investigator_affiliation>
    <investigator_full_name>Anibal Bohorquez</investigator_full_name>
    <investigator_title>Medical Resident</investigator_title>
  </responsible_party>
  <keyword>Myofascial pain</keyword>
  <keyword>Trigger point</keyword>
  <keyword>Nitroglycerin</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nitroglycerin</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/NCT01675700
org study id: 122975
nct id: NCT01675700
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether a topical nitroglycerine patch applied
      daily over a trapezius trigger point can improve patients' symptoms.

      If there is improvement, this open label study will help determine the degree of improvement
      and contribute to the design of a larger double blind placebo controlled trial.

      We would consider moving forward to a large randomized trial if:

        -  The intervention is acceptable to patients (>= 70%) and

        -  Compliance is satisfactory (>=80%) and

        -  We find preliminary evidence of efficacy, i.e. average reduction in pain of 20mm on the
           VAS.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pain at the time of clinic visit and over the previous week as measured by a Visual Analog Scale, VAS, for pain and a pressure algometer measurement to obtain pressure pain thresholds over the patients trigger point.
time frame: 1 month
measure: As another secondary outcome we will ask the participants whether the benefits of the treatment are good enough that they would continue using the nitroglycerin patch. This will be a yes or no response.
time frame: 1 month
arm group label: Myofascial trigger point
arm group type: Experimental
description: Patients diagnosed with myofascial trigger points who will receive a nitroglycerin patch over the trigger point.
intervention type: Drug
intervention name: Nitroglycerin patch
description: Nitroglycerin 0.1 mg/hr patch
arm group label: Myofascial trigger point
other name: Nitro-Dur 0.1
criteria: 
gender: All
minimum age: 19 Years
maximum age: 65 Years
healthy volunteers: No
last name: Hubert A Anton, MD
role: Principal Investigator
affiliation: University of British Columbia
responsible party type: Principal Investigator
investigator affiliation: GF Strong Rehabilitation Centre
investigator full name: Anibal Bohorquez
investigator title: Medical Resident
mesh term: Nitroglycerin