<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/NCT02204319</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-13-21</org_study_id>
    <nct_id>NCT02204319</nct_id>
  </id_info>
  <brief_title>Cold Laser: A Modality to Promote Vulvar Healing and Pain Relief</brief_title>
  <official_title>Cold Laser: A Modality to Promote Vulvar Healing and Pain Relief</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ProHealth Care, Inc</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ProHealth Care, Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of this pilot study are to demonstrate effectiveness of application of the&#xD;
      Erchonia Laser (manufactured by Erchonia Corporation),a non-invasive, non-significant risk&#xD;
      low level laser red diode light therapy device, in providing relief of pain symptoms in&#xD;
      patients with provoked and non- provoked vulvar vestibulitis; to reduce the frequency of use&#xD;
      of oral medications to manage pain symptoms; and to reduce the debilitating affect vulvar&#xD;
      vestibulitis has on the patient's daily activities, relationships and emotional well-being.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the current proposed pilot study, application of a low level laser light device,&#xD;
      manufactured by Erchonia Corporation, to reduce the pain of vulvar vestibulitis will be&#xD;
      evaluated. The Erchonia Laser device will emit three independent 7 milliWatt, 635 nanometer&#xD;
      red light diodes in a hand-held device and is a variable frequency pulsed wave device.&#xD;
&#xD;
      Erchonia low level lasers have been determined safe and effective and non-significant risk&#xD;
      (NSR) by the Food and Drug Administration (FDA) for application for numerous and various pain&#xD;
      reduction indications, providing justification for the anticipated safety and effectiveness&#xD;
      of application of the Erchonia Laser to reduce pain in patients with vulvar vestibulitis. The&#xD;
      FDA has granted 510(k) clearances for Erchonia low level laser devices for five pain&#xD;
      reduction indications, all cleared under Product Code 'NHN', defined as: &quot;A light based&#xD;
      non-laser device that emits energy in infrared or other wavelengths, provides non-heating and&#xD;
      non-thermal effect, and is indicated for adjunctive use in pain therapy or related&#xD;
      indication. It does not provide therapeutic topical heating.&quot;&#xD;
&#xD;
      The research will be conducted at ProHealth Care; Inc. across four campuses. Patients will be&#xD;
      seen in private rooms in the therapy departments.&#xD;
&#xD;
      All study staff are licensed in the field of either Occupational Therapy or Physical therapy&#xD;
      (2 in each) with the advanced continuing education necessary to call them a &quot;specialist&quot; in&#xD;
      the treatment of pelvic floor disorders. All investigators will complete CITI training for&#xD;
      research.&#xD;
&#xD;
      Subjects will be referred into the ProHealth Care system via a prescription for pelvic floor&#xD;
      therapy signed by a licensed medical professional with the expertise to diagnose Vulvar&#xD;
      vestibulitis. Written information regarding the study and proposed treatment will also be&#xD;
      mailed to a larger group of pelvic floor therapists in the greater Milwaukee Wisconsin region&#xD;
      through a &quot;Pelvic Floor Study Group&quot; list informing them of the need for subjects with this&#xD;
      diagnosis so that they may inform their clients of the availability of such research. These&#xD;
      clients may then request a referral from their private health care provider.&#xD;
&#xD;
      The pilot study will be completed in twelve months following the commitment of ProHealth&#xD;
      Care, Inc. Institutional Review Board as well as procurement of initial funding through&#xD;
      grants applied for during 2013. There will be 10 patients enrolled in the pilot study.&#xD;
&#xD;
      Patients will be screened after they are referred by their physician for physical therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</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>Percent Improvement Change in Visual Analogue Pain Scale (VAS) Calculated With Q-tip Palpation Over 6 Sites From Baseline Visit to Follow up at Two Week From Last Visit</measure>
    <time_frame>Average of all sites Compared from baseline visit and at 8 week (from start) follow up</time_frame>
    <description>III. Q-tip testing:&#xD;
. Q-tip pressure will be applied at the following areas, in the exact order listed: 2:00, 10:00, 5:00, 7:00, 12:00, and 6:00. An average VAS report of pain taken overall and compared from first baseline visit to end of study re-assessment two weeks following last treatment.&#xD;
• Pain intensity marked an a line with a point between 0-100 on the Visual Analogue Scale (VAS). A separate rating is recorded for each of the 6 numbered areas (see box 1 for reference). 100 is maximum pain level and 0 is no pain measured in centimeters per FDA guidelines for pain calculation on the VAS</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Patient Specific Functional Scale Questionnaire</measure>
    <time_frame>Baseline, and two weeks following last treatment at Week 8</time_frame>
    <description>Questionnaire that measures on a 0-10 scale (0= No function, and 10= normal function) one function that most impacts the patient's present symptoms (vaginal penetration/intercourse chosen as most important and pertinent) Measured amount of point change on the scale.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in the Vulvar Pain Functional Scale Questionnaire</measure>
    <time_frame>Baseline, and after last treatment visit at Week 8</time_frame>
    <description>Questionnaire of eleven questions involving specific functions that may impart pain in the vulvar region and patient response to present tolerance level. Questions have 4-5 answer choices weighted on a 0-3 scale of impairment, with 3 being worst.&#xD;
Worst reported score of functional impact =33. No functional impact = 0</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Vulvar Vestibulitis</condition>
  <condition>Vestibulodynia</condition>
  <arm_group>
    <arm_group_label>Cold Laser Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cold laser used off of the body over the vulvar involved area. The device to be used in this study is the Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 milliWatt, 635 nanometer red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device. Weekly visits x 6 with 5 minute treatments over vulva and sacral nerve roots each.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cold laser</intervention_name>
    <description>Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 milliWatt, 635 nanometer red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device.</description>
    <arm_group_label>Cold Laser Treatment</arm_group_label>
    <other_name>The Erchonia Laser device</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Female&#xD;
&#xD;
               -  18 years or older&#xD;
&#xD;
               -  Current diagnosis of provoked or non-provoked vulvar vestibulitis made by a&#xD;
                  suitably qualified medical professional&#xD;
&#xD;
               -  Vulvar pain is chronic, defined as having been present for at least 3 months.&#xD;
&#xD;
               -  Visual Analog Score for typical vulvar pain is at least 30/100 Patient has been&#xD;
                  stabilized on all hormonal interventions (i.e., birth control pills, topical or&#xD;
                  oral estrogen agents) and will not be altered for the course of the treatment&#xD;
                  protocol of this study.&#xD;
&#xD;
               -  Subject is willing and able to decrease use of current pain relief medication to&#xD;
                  manage vulvar pain throughout study participation, and is willing and able to&#xD;
                  refrain from engaging in other non-study treatments to manage her vulvar&#xD;
                  vestibulitis symptoms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Vulvar dermatoses such as lichen sclerosis, squamous cell hyperplasia, or lichen&#xD;
             planus&#xD;
&#xD;
               -  Active vaginal or pelvic infection, herpetic infections, vulvar cancer and/or&#xD;
                  treatment for cancer&#xD;
&#xD;
               -  Previous vestibulectomy or other surgical or procedural interventions (for&#xD;
                  vestibulitis ) to the treatment area&#xD;
&#xD;
               -  Active infection, wound or other external trauma to the areas to be treated with&#xD;
                  the laser&#xD;
&#xD;
               -  Other neurological disorders such as Multiple Sclerosis&#xD;
&#xD;
               -  Photosensitivity disorder&#xD;
&#xD;
               -  Pregnant or planning pregnancy prior to study end&#xD;
&#xD;
               -  Serious mental health illness, developmental disability or cognitive impairment&#xD;
                  that may preclude adequate comprehension of the consent form or ability to record&#xD;
                  study measures&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Linda A LaBorde, BS PT</last_name>
    <role>Principal Investigator</role>
    <affiliation>ProHealth Care, Inc</affiliation>
  </overall_official>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>March 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <results_first_submitted>October 4, 2016</results_first_submitted>
  <results_first_submitted_qc>May 31, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">July 2, 2017</results_first_posted>
  <last_update_submitted>May 31, 2017</last_update_submitted>
  <last_update_submitted_qc>May 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>provoked or non-provoked vulvar vestibulitis</keyword>
  <keyword>low level laser light device</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vulvodynia</mesh_term>
    <mesh_term>Vulvar Vestibulitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cold Laser Treatment</title>
          <description>Cold laser used off of the body over the vulvar involved area. The device to be used in this study is the Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 mW, 635 nm red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device. Weekly visits x 6 with 5 minute treatments over vulva and sacral nerve roots each.&#xD;
Cold laser: Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 mW, 635 nm red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7">3 did not complete study.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>seven completed study and three withdrew</population>
      <group_list>
        <group group_id="B1">
          <title>Cold Laser Recipients</title>
          <description>10 enrolled in the study. Seven completed the study and three withdrew. Each participant received six cold laser light therapy treatments and were assessed pre and post treatment with Q tip testing at each treatment visit. There was also a two week follow up scheduled for re-assessment.&#xD;
Treatment for each patient was not standardized since there were four therapists involved in data collection and treatment. The treatments included manual therapy mobilizations, neuromuscular rehabilitation with or without EMG biofeedback, home care training which may have included lubricant usage, dilator training, and exercises for the pelvic floor as well as methods of pain relieving modalities.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Improvement Change in Visual Analogue Pain Scale (VAS) Calculated With Q-tip Palpation Over 6 Sites From Baseline Visit to Follow up at Two Week From Last Visit</title>
        <description>III. Q-tip testing:&#xD;
. Q-tip pressure will be applied at the following areas, in the exact order listed: 2:00, 10:00, 5:00, 7:00, 12:00, and 6:00. An average VAS report of pain taken overall and compared from first baseline visit to end of study re-assessment two weeks following last treatment.&#xD;
• Pain intensity marked an a line with a point between 0-100 on the Visual Analogue Scale (VAS). A separate rating is recorded for each of the 6 numbered areas (see box 1 for reference). 100 is maximum pain level and 0 is no pain measured in centimeters per FDA guidelines for pain calculation on the VAS</description>
        <time_frame>Average of all sites Compared from baseline visit and at 8 week (from start) follow up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cold Laser Treatment</title>
            <description>Cold laser used off of the body over the vulvar involved area. The device to be used in this study is the Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 mW, 635 nm red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device. Weekly visits x 6 with 5 minute treatments over vulva and sacral nerve roots each.&#xD;
Cold laser: Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 mW, 635 nm red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Improvement Change in Visual Analogue Pain Scale (VAS) Calculated With Q-tip Palpation Over 6 Sites From Baseline Visit to Follow up at Two Week From Last Visit</title>
          <description>III. Q-tip testing:&#xD;
. Q-tip pressure will be applied at the following areas, in the exact order listed: 2:00, 10:00, 5:00, 7:00, 12:00, and 6:00. An average VAS report of pain taken overall and compared from first baseline visit to end of study re-assessment two weeks following last treatment.&#xD;
• Pain intensity marked an a line with a point between 0-100 on the Visual Analogue Scale (VAS). A separate rating is recorded for each of the 6 numbered areas (see box 1 for reference). 100 is maximum pain level and 0 is no pain measured in centimeters per FDA guidelines for pain calculation on the VAS</description>
          <units>percent change from first to last Rx</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.52" spread="24.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Patient Specific Functional Scale Questionnaire</title>
        <description>Questionnaire that measures on a 0-10 scale (0= No function, and 10= normal function) one function that most impacts the patient's present symptoms (vaginal penetration/intercourse chosen as most important and pertinent) Measured amount of point change on the scale.</description>
        <time_frame>Baseline, and two weeks following last treatment at Week 8</time_frame>
        <population>women average 26+/- 5.533 Years of age who were not pregnant with appropriate diagnoses</population>
        <group_list>
          <group group_id="O1">
            <title>Cold Laser Treatment</title>
            <description>Cold laser used off of the body over the vulvar involved area. The device to be used in this study is the Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 mW, 635 nm red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device. Weekly visits x 6 with 5 minute treatments over vulva and sacral nerve roots each.&#xD;
Cold laser: Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 mW, 635 nm red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Patient Specific Functional Scale Questionnaire</title>
          <description>Questionnaire that measures on a 0-10 scale (0= No function, and 10= normal function) one function that most impacts the patient's present symptoms (vaginal penetration/intercourse chosen as most important and pertinent) Measured amount of point change on the scale.</description>
          <population>women average 26+/- 5.533 Years of age who were not pregnant with appropriate diagnoses</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.25" spread="1.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in the Vulvar Pain Functional Scale Questionnaire</title>
        <description>Questionnaire of eleven questions involving specific functions that may impart pain in the vulvar region and patient response to present tolerance level. Questions have 4-5 answer choices weighted on a 0-3 scale of impairment, with 3 being worst.&#xD;
Worst reported score of functional impact =33. No functional impact = 0</description>
        <time_frame>Baseline, and after last treatment visit at Week 8</time_frame>
        <population>women average age of 26 +/- 5.533 Years with appropriate diagnoses</population>
        <group_list>
          <group group_id="O1">
            <title>Cold Laser Recipients</title>
            <description>10 enrolled in the study. Seven completed the study and three withdrew. Each participant received six cold laser light therapy treatments and were assessed pre and post treatment with Q tip testing. There was a two week follow up scheduled for assessment.&#xD;
Treatment for each patient was not standardized since there were four therapists involved in data collection and treatment. The treatments included manual therapy mobilizations, neuromuscular rehabilitation with or without EMG biofeedback, home care training which may have included lubricant usage, dilator training, and exercises for the pelvic floor as well as methods of pain relieving modalities.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Vulvar Pain Functional Scale Questionnaire</title>
          <description>Questionnaire of eleven questions involving specific functions that may impart pain in the vulvar region and patient response to present tolerance level. Questions have 4-5 answer choices weighted on a 0-3 scale of impairment, with 3 being worst.&#xD;
Worst reported score of functional impact =33. No functional impact = 0</description>
          <population>women average age of 26 +/- 5.533 Years with appropriate diagnoses</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.89" spread="2.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Cold Laser Light Therapy</title>
          <description>The laser unit emits three independent 7 mW, 635 nm red light diodes in a hand-held device and is a variable frequency pulsed wave device. Erchonia low level lasers have been determined safe and effective and non-significant risk (NSR) by the Food and Drug Administration (FDA) for application for numerous and various pain reduction indications, providing justification for the anticipated safety and effectiveness of application The cold laser was administered over 10 minutes as follows: 5 minutes at the area of sacral nerve roots 2-4 in the side-lying position- hertz settings: 14, 8, 12, 28; and 5 minutes at the vulva in the lithotomy position, hertz settings 2: 9,16,33,60 while the outer labia were held open by the therapist. A sweeping motion was used during administration. The laser head was positioned approximately 3 inches from the skin surface and did not touch the skin. The patient wore safety goggles while the laser treatment was provided.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="07"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Early termination leading to small numbers of subjects analyzed were the choice of the participant to end participation. One participant became pregnant during the study. Other reasons were related to participant cost of healthcare visits.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Linda LaBorde PT</name_or_title>
      <organization>ProHealth Care</organization>
      <phone>262-928-5139</phone>
      <email>linda.laborde@phci.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02204319
org study id: IRB-13-21
nct id: NCT02204319
lead sponsor: 
has dmc: No
The objectives of this pilot study are to demonstrate effectiveness of application of the
      Erchonia Laser (manufactured by Erchonia Corporation),a non-invasive, non-significant risk
      low level laser red diode light therapy device, in providing relief of pain symptoms in
      patients with provoked and non- provoked vulvar vestibulitis; to reduce the frequency of use
      of oral medications to manage pain symptoms; and to reduce the debilitating affect vulvar
      vestibulitis has on the patient's daily activities, relationships and emotional well-being.
In the current proposed pilot study, application of a low level laser light device,
      manufactured by Erchonia Corporation, to reduce the pain of vulvar vestibulitis will be
      evaluated. The Erchonia Laser device will emit three independent 7 milliWatt, 635 nanometer
      red light diodes in a hand-held device and is a variable frequency pulsed wave device.

      Erchonia low level lasers have been determined safe and effective and non-significant risk
      (NSR) by the Food and Drug Administration (FDA) for application for numerous and various pain
      reduction indications, providing justification for the anticipated safety and effectiveness
      of application of the Erchonia Laser to reduce pain in patients with vulvar vestibulitis. The
      FDA has granted 510(k) clearances for Erchonia low level laser devices for five pain
      reduction indications, all cleared under Product Code 'NHN', defined as: "A light based
      non-laser device that emits energy in infrared or other wavelengths, provides non-heating and
      non-thermal effect, and is indicated for adjunctive use in pain therapy or related
      indication. It does not provide therapeutic topical heating."

      The research will be conducted at ProHealth Care; Inc. across four campuses. Patients will be
      seen in private rooms in the therapy departments.

      All study staff are licensed in the field of either Occupational Therapy or Physical therapy
      (2 in each) with the advanced continuing education necessary to call them a "specialist" in
      the treatment of pelvic floor disorders. All investigators will complete CITI training for
      research.

      Subjects will be referred into the ProHealth Care system via a prescription for pelvic floor
      therapy signed by a licensed medical professional with the expertise to diagnose Vulvar
      vestibulitis. Written information regarding the study and proposed treatment will also be
      mailed to a larger group of pelvic floor therapists in the greater Milwaukee Wisconsin region
      through a "Pelvic Floor Study Group" list informing them of the need for subjects with this
      diagnosis so that they may inform their clients of the availability of such research. These
      clients may then request a referral from their private health care provider.

      The pilot study will be completed in twelve months following the commitment of ProHealth
      Care, Inc. Institutional Review Board as well as procurement of initial funding through
      grants applied for during 2013. There will be 10 patients enrolled in the pilot study.

      Patients will be screened after they are referred by their physician for physical therapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percent Improvement Change in Visual Analogue Pain Scale (VAS) Calculated With Q-tip Palpation Over 6 Sites From Baseline Visit to Follow up at Two Week From Last Visit
time frame: Average of all sites Compared from baseline visit and at 8 week (from start) follow up
description: III. Q-tip testing:
. Q-tip pressure will be applied at the following areas, in the exact order listed: 2:00, 10:00, 5:00, 7:00, 12:00, and 6:00. An average VAS report of pain taken overall and compared from first baseline visit to end of study re-assessment two weeks following last treatment.
• Pain intensity marked an a line with a point between 0-100 on the Visual Analogue Scale (VAS). A separate rating is recorded for each of the 6 numbered areas (see box 1 for reference). 100 is maximum pain level and 0 is no pain measured in centimeters per FDA guidelines for pain calculation on the VAS
measure: Change in Patient Specific Functional Scale Questionnaire
time frame: Baseline, and two weeks following last treatment at Week 8
description: Questionnaire that measures on a 0-10 scale (0= No function, and 10= normal function) one function that most impacts the patient's present symptoms (vaginal penetration/intercourse chosen as most important and pertinent) Measured amount of point change on the scale.
measure: Change in the Vulvar Pain Functional Scale Questionnaire
time frame: Baseline, and after last treatment visit at Week 8
description: Questionnaire of eleven questions involving specific functions that may impart pain in the vulvar region and patient response to present tolerance level. Questions have 4-5 answer choices weighted on a 0-3 scale of impairment, with 3 being worst.
Worst reported score of functional impact =33. No functional impact = 0
arm group label: Cold Laser Treatment
arm group type: Experimental
description: Cold laser used off of the body over the vulvar involved area. The device to be used in this study is the Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 milliWatt, 635 nanometer red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device. Weekly visits x 6 with 5 minute treatments over vulva and sacral nerve roots each.
intervention type: Device
intervention name: Cold laser
description: Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 milliWatt, 635 nanometer red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device.
arm group label: Cold Laser Treatment
other name: The Erchonia Laser device
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Linda A LaBorde, BS PT
role: Principal Investigator
affiliation: ProHealth Care, Inc
responsible party type: Sponsor
mesh term: Vulvodynia
mesh term: Vulvar Vestibulitis
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Early termination leading to small numbers of subjects analyzed were the choice of the participant to end participation. One participant became pregnant during the study. Other reasons were related to participant cost of healthcare visits.
point of contact: 