<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/NCT01694199</url>
  </required_header>
  <id_info>
    <org_study_id>RBI.2012.003.P.2</org_study_id>
    <nct_id>NCT01694199</nct_id>
  </id_info>
  <brief_title>Pulsed Radiofrequency Energy to Treat Post-Bunionectomy Pain</brief_title>
  <official_title>A Multicenter, Randomized, Sham-Controlled, Double-Blinded Study to Evaluate the Analgesic Efficacy and Safety of Pulsed Radiofrequency Energy (PRFE) in Bunionectomy Surgery for the Treatment of Post-Operative Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Regenesis Biomedical, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Regenesis Biomedical, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multicenter, randomized, controlled, double-blind study to evaluate the use of 3 days of&#xD;
      pulsed radiofrequency energy (PRFE) to treat pain after bunionectomy surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The clinical study's primary objective is to compare the overall analgesic effect of the&#xD;
      Provant Therapy System (test device) to an identical sham device (placebo) in subjects&#xD;
      experiencing post-operative pain following first metatarsal bunion surgery. The study&#xD;
      hypothesis is that, over the first 72 hours (3 days) after the initial test device treatment,&#xD;
      subjects treated with an active test device will show a statistically significant difference&#xD;
      (reduction) in pain intensity scores when compared with subjects treated with a sham&#xD;
      (placebo) device. Treatment with the test device will continue through the 168 hour (7 day)&#xD;
      timepoint. Safety will be followed through 28 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    IDMC recommendation&#xD;
  </why_stopped>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Analgesic Efficacy (Via SPID 0-72 Hrs)</measure>
    <time_frame>Treatment with the test device twice per day, over 3 days (7 total treatments)</time_frame>
    <description>Sum of time-weighted Pain Intensity Differences (SPID). Pain relief was assessed at completion of first treatment, 45min,60min,90min,2hrs,3hrs,4hrs,6hrs following T0 and every 2hrs between 6AM to 10PM. After 10 PM and before 6AM, pain relief assessments were done every 4hrs. Subjects rated pain relief relative to baseline using a categorical scale: 0=none; 1=a little; 2=some; 3= a lot; 4 = complete. SPIDt = ∑PID x (time(t) - time(t-1)) x PID(i). A more negative SPID value means less pain. Total score of SPID ranged from a min value of -1091550.00 in the active arm and -2120130.00 in the sham arm and a max value of 603060.00 in the active arm and 1077630.00 in the sham arm. No absolute min and max scores were calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>TOTPAR-Pain Relief Experienced by Patients T0-72 Hours</measure>
    <time_frame>Treatment with the test device twice per day, over 3 days (7 total treatments)</time_frame>
    <description>Pain relief was assessed at completion of first study device treatment, 45 minutes, 60 minutes, 90 minutes, 2 hours, 3 hours, 4 hours, 6 hours following T0 (±5 mins). Thereafter, pain relief was assessed every 2 hours (±5 mins) between 6AM to 10PM throughout the in-patient treatment period. After 10 PM and before 6AM, pain relief assessments were done every 4 hours. Subjects rated pain relief relative to baseline pain intensity using a categorical scale: 0=none; 1=a little; 2=some; 3= a lot; 4 = complete. Based on these scores, a time weighted pain relief score was calculated, Total Pain Relief (TOTPAR). TOTPAR-Pain Relief = ∑PID x (time(t) - time(t-1)) x PID(i).&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid Consumption Measured in Morphine Equivalents T0-72 Hours</measure>
    <time_frame>Treatment with the test device twice per day, over 3 days (7 total treatments)</time_frame>
    <description>The total quantity of Supplemental Opioid analgesic administered throughout the study was recorded for each Subject. Opioid consumption prior to (T0) was not considered when calculating opioid consumption endpoints.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Assessed Pain Control at 72 Hours as Good, Very Good, or Excellent</measure>
    <time_frame>After 3 days of treatment (T0-72 hours)</time_frame>
    <description>Number of participants who assessed pain control at 72 hours as good, very good, or excellent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First Use of Supplemental Analgesic Medication</measure>
    <time_frame>Treatment with the test device twice per day, over 3 days (7 total treatments)</time_frame>
    <description>The time to first supplemental analgesic use was recorded. This was defined as the time from the initiation of the first study device treatment session (T0) to the time of administration of the first dose of post-T0 supplemental medication.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">139</enrollment>
  <condition>Post-operative Pain</condition>
  <arm_group>
    <arm_group_label>Active study device with PRFE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham study device with no PRFE</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pulsed Radiofrequency Energy (PRFE)</intervention_name>
    <description>The intervention is pulsed radiofrequencyenergy (PRFE).</description>
    <arm_group_label>Active study device with PRFE</arm_group_label>
    <other_name>Provant Therapy System</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>No Pulsed Radiofrequency Energy (PRFE)</intervention_name>
    <description>Sham (placebo) with no therapeutic device activity</description>
    <arm_group_label>Sham study device with no PRFE</arm_group_label>
    <other_name>Sham Provant Therapy System</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Pre-operative Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged 18-75 years old&#xD;
&#xD;
          -  Subject is scheduled to undergo primary, unilateral first metatarsal bunionectomy (no&#xD;
             collateral procedures) under regional/local anesthesia and sedation&#xD;
&#xD;
          -  Subject meets the criteria for American Society of Anesthesiologists (ASA) Physical&#xD;
             Status I or II.&#xD;
&#xD;
          -  Subject is willing to be confined at the investigative site for approximately 4 days&#xD;
             including the day of surgery.&#xD;
&#xD;
          -  Subject is able to communicate meaningfully in English in order to complete study&#xD;
             assessments and comply with all trial procedures.&#xD;
&#xD;
          -  Willingness to give written informed consent and to comply with all parts of the study&#xD;
             protocol.&#xD;
&#xD;
          -  Female Subjects of child bearing potential are eligible only if they are not pregnant&#xD;
             (negative pregnancy test at screening and before surgery), not lactating, and not&#xD;
             planning to become pregnant during the study.&#xD;
&#xD;
          -  Female Subjects must be post-menopausal, surgically sterile, abstinent, or practicing,&#xD;
             or agree to practice, an effective method of birth control if they are sexually active&#xD;
             for the duration of the study (effective methods of birth control include prescription&#xD;
             hormonal contraceptives, intrauterine devices, double-barrier methods, and/or male&#xD;
             partner sterilization).&#xD;
&#xD;
        Pre-Operative Exclusion Criteria:&#xD;
&#xD;
          -  Subject is scheduled to undergo Base wedge osteotomy, and/or Long-Z Hart bunionectomy&#xD;
             procedure or any other procedure that does not conform to the surgical protocol.&#xD;
&#xD;
          -  Subject has received any investigational drug within 1 month prior to the Screening&#xD;
             Visit or is enrolled in another clinical trial.&#xD;
&#xD;
          -  Subject has a history of drug abuse within 5 years of the screening visit, including a&#xD;
             history of opioid (narcotic) analgesic abuse.&#xD;
&#xD;
          -  Subject has a history of any clinically significant cardiac, respiratory (except mild&#xD;
             asthma), renal, hepatic, gastrointestinal, hematologic, endocrine or psychiatric&#xD;
             disease or disorder, or any uncontrolled medical illness that in the investigator's&#xD;
             judgment places the Subject at unacceptable risk for surgery or receipt of&#xD;
             investigational therapy.&#xD;
&#xD;
          -  Subject has an ongoing, uncontrolled painful condition that in the opinion of the&#xD;
             Investigator might have a confounding influence on the safety or efficacy analysis for&#xD;
             this study.&#xD;
&#xD;
          -  Subject has received systemic corticosteroid administration within 1 month prior to&#xD;
             surgery or is scheduled to receive systemic corticosteroid therapy at any time during&#xD;
             the course of the study.&#xD;
&#xD;
          -  Subject is unwilling to abstain from alcohol from at least midnight the night before&#xD;
             surgery through completion of all In-patient Treatment Period procedures and discharge&#xD;
             from the investigative site.&#xD;
&#xD;
          -  Subject is unwilling to refrain from smoking during his/her stay at the investigative&#xD;
             site.&#xD;
&#xD;
          -  Subject is currently receiving treatment, or has received treatment within the last&#xD;
             two weeks, with antipsychotic drugs, monoamine oxidase inhibitors, duloxetine,&#xD;
             gabapentin, carbamazepine, phenytoin, pregabalin or is receiving treatment with&#xD;
             antidepressants that are not on a stable dose (the same dose for &gt;1 month).&#xD;
&#xD;
          -  Subject has a history of malignancy within the past five years with the exception of&#xD;
             successfully treated non-metastatic basal cell or squamous cell carcinomas of the skin&#xD;
             and/or localized carcinoma in situ of the cervix.&#xD;
&#xD;
          -  Subject has current evidence of alcohol abuse (regularly drinks more than four units&#xD;
             of alcohol per day; 1 unit = ½ pint of beer, 1 glass of wine, or 1 ounce of spirit).&#xD;
&#xD;
          -  Infection (acute or chronic) involving the first metatarsal (or history of such&#xD;
             infection) or any other disease of the foot/ankle that in the opinion of the&#xD;
             investigator, places the Subject at increased risk for surgical complications or&#xD;
             receipt of the investigational therapy.&#xD;
&#xD;
          -  Implanted pacemaker, defibrillator, neurostimulator, bone stimulator, cochlear&#xD;
             implant, or other implanted device with metal lead(s).&#xD;
&#xD;
          -  Implanted metal in the index foot including planned intra-operative use of metallic&#xD;
             screw or fixation device.&#xD;
&#xD;
          -  History of malignancy in the treatment area.&#xD;
&#xD;
          -  Subjects who are taking any dosage strength of daily opioids for more than 30&#xD;
             consecutive days, within the past three months prior to surgery.&#xD;
&#xD;
          -  Subject with fibromyalgia, complex regional pain syndrome or other chronic pain&#xD;
             syndromes.&#xD;
&#xD;
          -  Subjects with neuropathic or sensory abnormalities of the lower extremities. Abnormal&#xD;
             vibratory sensation and/or Semmes-Weinstein monofilament tests.&#xD;
&#xD;
          -  Subject with BMI &gt; 38.&#xD;
&#xD;
          -  Subject with known hypersensitivity, intolerance or contraindication to acetaminophen,&#xD;
             oxycodone, morphine or any agent used in the anesthetic protocol that in the opinion&#xD;
             of the Investigator will put the Subject at increased risk.&#xD;
&#xD;
        Post-Operative Exclusion Criteria:&#xD;
&#xD;
          -  The Subject does not report a score of moderate or severe on a 4-point categorical&#xD;
             rating scale (with categories of none, mild, moderate, or severe) plus a score of ≥4&#xD;
             on an NPRS 11-point categorical rating scale within 8 hours after the end of surgery.&#xD;
             End of surgery is defined as time of last suture.&#xD;
&#xD;
          -  The Subject is not able to answer questions and follow commands.&#xD;
&#xD;
          -  The surgical procedure from incision to closure was longer than 2 hours.&#xD;
&#xD;
          -  The Subject has evidence of respiratory insufficiency, such as a respiratory rate that&#xD;
             is less than 8 breaths per minute and arterial oxygen saturation by pulse oximetry of&#xD;
             less than 95% with supplemental oxygen.&#xD;
&#xD;
          -  There have been any significant deviations from the surgical or anesthetic protocols&#xD;
             that would, in the opinion of the investigator, put the Subject at risk of&#xD;
             participation in the trial, confound the analgesic endpoints of the trial or cause&#xD;
             concern regarding the Subject's ability to participate in the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neil K. Singla, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lotus Clinical Research, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lotus Clinical Research</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chesapeake Research Group</name>
      <address>
        <city>Pasadena</city>
        <state>Maryland</state>
        <zip>21122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endeavor Clinical Trials</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <results_first_submitted>December 29, 2014</results_first_submitted>
  <results_first_submitted_qc>March 21, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 2, 2017</results_first_posted>
  <last_update_submitted>March 21, 2017</last_update_submitted>
  <last_update_submitted_qc>March 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pulsed Radiofrequency Energy (PRFE)</keyword>
  <keyword>Pain</keyword>
  <keyword>Postsurgical</keyword>
  <keyword>Opioids</keyword>
  <keyword>Pain relief</keyword>
  <keyword>Medical device</keyword>
  <keyword>Endorphins</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Active Study Device With PRFE</title>
          <description>This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.&#xD;
Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE).</description>
        </group>
        <group group_id="P2">
          <title>Sham Study Device With no PRFE</title>
          <description>This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.&#xD;
No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="71"/>
                <participants group_id="P2" count="68"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="71"/>
                <participants group_id="P2" count="68"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Active Study Device With PRFE</title>
          <description>This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.&#xD;
Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE).</description>
        </group>
        <group group_id="B2">
          <title>Sham Study Device With no PRFE</title>
          <description>This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.&#xD;
No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="71"/>
            <count group_id="B2" value="68"/>
            <count group_id="B3" value="139"/>
          </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="135"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46.2" spread="13.61"/>
                    <measurement group_id="B2" value="44.7" spread="13.35"/>
                    <measurement group_id="B3" value="45" spread="13.5"/>
                  </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="57"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="112"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="102"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="139"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Analgesic Efficacy (Via SPID 0-72 Hrs)</title>
        <description>Sum of time-weighted Pain Intensity Differences (SPID). Pain relief was assessed at completion of first treatment, 45min,60min,90min,2hrs,3hrs,4hrs,6hrs following T0 and every 2hrs between 6AM to 10PM. After 10 PM and before 6AM, pain relief assessments were done every 4hrs. Subjects rated pain relief relative to baseline using a categorical scale: 0=none; 1=a little; 2=some; 3= a lot; 4 = complete. SPIDt = ∑PID x (time(t) - time(t-1)) x PID(i). A more negative SPID value means less pain. Total score of SPID ranged from a min value of -1091550.00 in the active arm and -2120130.00 in the sham arm and a max value of 603060.00 in the active arm and 1077630.00 in the sham arm. No absolute min and max scores were calculated.</description>
        <time_frame>Treatment with the test device twice per day, over 3 days (7 total treatments)</time_frame>
        <population>P=0.3529</population>
        <group_list>
          <group group_id="O1">
            <title>Active Study Device With PRFE</title>
            <description>This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.&#xD;
Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE).</description>
          </group>
          <group group_id="O2">
            <title>Sham Study Device With no PRFE</title>
            <description>This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.&#xD;
No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Analgesic Efficacy (Via SPID 0-72 Hrs)</title>
          <description>Sum of time-weighted Pain Intensity Differences (SPID). Pain relief was assessed at completion of first treatment, 45min,60min,90min,2hrs,3hrs,4hrs,6hrs following T0 and every 2hrs between 6AM to 10PM. After 10 PM and before 6AM, pain relief assessments were done every 4hrs. Subjects rated pain relief relative to baseline using a categorical scale: 0=none; 1=a little; 2=some; 3= a lot; 4 = complete. SPIDt = ∑PID x (time(t) - time(t-1)) x PID(i). A more negative SPID value means less pain. Total score of SPID ranged from a min value of -1091550.00 in the active arm and -2120130.00 in the sham arm and a max value of 603060.00 in the active arm and 1077630.00 in the sham arm. No absolute min and max scores were calculated.</description>
          <population>P=0.3529</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-244890.0" lower_limit="-348835.75" upper_limit="-141359.18"/>
                    <measurement group_id="O2" value="-258030.00" lower_limit="-432672.70" upper_limit="-172230.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.3529</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>TOTPAR-Pain Relief Experienced by Patients T0-72 Hours</title>
        <description>Pain relief was assessed at completion of first study device treatment, 45 minutes, 60 minutes, 90 minutes, 2 hours, 3 hours, 4 hours, 6 hours following T0 (±5 mins). Thereafter, pain relief was assessed every 2 hours (±5 mins) between 6AM to 10PM throughout the in-patient treatment period. After 10 PM and before 6AM, pain relief assessments were done every 4 hours. Subjects rated pain relief relative to baseline pain intensity using a categorical scale: 0=none; 1=a little; 2=some; 3= a lot; 4 = complete. Based on these scores, a time weighted pain relief score was calculated, Total Pain Relief (TOTPAR). TOTPAR-Pain Relief = ∑PID x (time(t) - time(t-1)) x PID(i).&quot;</description>
        <time_frame>Treatment with the test device twice per day, over 3 days (7 total treatments)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active Study Device With PRFE</title>
            <description>This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.&#xD;
Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE).</description>
          </group>
          <group group_id="O2">
            <title>Sham Study Device With no PRFE</title>
            <description>This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.&#xD;
No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity</description>
          </group>
        </group_list>
        <measure>
          <title>TOTPAR-Pain Relief Experienced by Patients T0-72 Hours</title>
          <description>Pain relief was assessed at completion of first study device treatment, 45 minutes, 60 minutes, 90 minutes, 2 hours, 3 hours, 4 hours, 6 hours following T0 (±5 mins). Thereafter, pain relief was assessed every 2 hours (±5 mins) between 6AM to 10PM throughout the in-patient treatment period. After 10 PM and before 6AM, pain relief assessments were done every 4 hours. Subjects rated pain relief relative to baseline pain intensity using a categorical scale: 0=none; 1=a little; 2=some; 3= a lot; 4 = complete. Based on these scores, a time weighted pain relief score was calculated, Total Pain Relief (TOTPAR). TOTPAR-Pain Relief = ∑PID x (time(t) - time(t-1)) x PID(i).&quot;</description>
          <units>units on a scale</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="327974.79" lower_limit="280555.32" upper_limit="375394.26"/>
                    <measurement group_id="O2" value="364873.24" lower_limit="317014.18" upper_limit="412732.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2766</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Opioid Consumption Measured in Morphine Equivalents T0-72 Hours</title>
        <description>The total quantity of Supplemental Opioid analgesic administered throughout the study was recorded for each Subject. Opioid consumption prior to (T0) was not considered when calculating opioid consumption endpoints.</description>
        <time_frame>Treatment with the test device twice per day, over 3 days (7 total treatments)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active Study Device With PRFE</title>
            <description>This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.&#xD;
Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE).</description>
          </group>
          <group group_id="O2">
            <title>Sham Study Device With no PRFE</title>
            <description>This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.&#xD;
No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity</description>
          </group>
        </group_list>
        <measure>
          <title>Opioid Consumption Measured in Morphine Equivalents T0-72 Hours</title>
          <description>The total quantity of Supplemental Opioid analgesic administered throughout the study was recorded for each Subject. Opioid consumption prior to (T0) was not considered when calculating opioid consumption endpoints.</description>
          <units>Morphine Equivalents</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.30" lower_limit="23.23" upper_limit="33.87"/>
                    <measurement group_id="O2" value="20.30" lower_limit="19.21" upper_limit="27.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P=0.1467</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1467</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Assessed Pain Control at 72 Hours as Good, Very Good, or Excellent</title>
        <description>Number of participants who assessed pain control at 72 hours as good, very good, or excellent.</description>
        <time_frame>After 3 days of treatment (T0-72 hours)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active Study Device With PRFE</title>
            <description>This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.&#xD;
Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE).</description>
          </group>
          <group group_id="O2">
            <title>Sham Study Device With no PRFE</title>
            <description>This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.&#xD;
No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Assessed Pain Control at 72 Hours as Good, Very Good, or Excellent</title>
          <description>Number of participants who assessed pain control at 72 hours as good, very good, or excellent.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P = 0.5009</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.5009</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to First Use of Supplemental Analgesic Medication</title>
        <description>The time to first supplemental analgesic use was recorded. This was defined as the time from the initiation of the first study device treatment session (T0) to the time of administration of the first dose of post-T0 supplemental medication.</description>
        <time_frame>Treatment with the test device twice per day, over 3 days (7 total treatments)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active Study Device With PRFE</title>
            <description>This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.&#xD;
Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE).</description>
          </group>
          <group group_id="O2">
            <title>Sham Study Device With no PRFE</title>
            <description>This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.&#xD;
No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First Use of Supplemental Analgesic Medication</title>
          <description>The time to first supplemental analgesic use was recorded. This was defined as the time from the initiation of the first study device treatment session (T0) to the time of administration of the first dose of post-T0 supplemental medication.</description>
          <units>Minutes</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89" lower_limit="70" upper_limit="99"/>
                    <measurement group_id="O2" value="87" lower_limit="70" upper_limit="101"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.9038</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Active Study Device With PRFE</title>
          <description>This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.&#xD;
Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE).</description>
        </group>
        <group group_id="E2">
          <title>Sham Study Device With no PRFE</title>
          <description>This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.&#xD;
No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="68"/>
              </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="71"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>
    <point_of_contact>
      <name_or_title>Dr. Rick Isenberg</name_or_title>
      <organization>Regenesis Biomedical, Inc.</organization>
      <phone>877-970-4970</phone>
      <email>isenberg@regenesisbio.com</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/NCT01694199
org study id: RBI.2012.003.P.2
nct id: NCT01694199
lead sponsor: 
has dmc: Yes
Multicenter, randomized, controlled, double-blind study to evaluate the use of 3 days of
      pulsed radiofrequency energy (PRFE) to treat pain after bunionectomy surgery.
The clinical study's primary objective is to compare the overall analgesic effect of the
      Provant Therapy System (test device) to an identical sham device (placebo) in subjects
      experiencing post-operative pain following first metatarsal bunion surgery. The study
      hypothesis is that, over the first 72 hours (3 days) after the initial test device treatment,
      subjects treated with an active test device will show a statistically significant difference
      (reduction) in pain intensity scores when compared with subjects treated with a sham
      (placebo) device. Treatment with the test device will continue through the 168 hour (7 day)
      timepoint. Safety will be followed through 28 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Overall Analgesic Efficacy (Via SPID 0-72 Hrs)
time frame: Treatment with the test device twice per day, over 3 days (7 total treatments)
description: Sum of time-weighted Pain Intensity Differences (SPID). Pain relief was assessed at completion of first treatment, 45min,60min,90min,2hrs,3hrs,4hrs,6hrs following T0 and every 2hrs between 6AM to 10PM. After 10 PM and before 6AM, pain relief assessments were done every 4hrs. Subjects rated pain relief relative to baseline using a categorical scale: 0=none; 1=a little; 2=some; 3= a lot; 4 = complete. SPIDt = ∑PID x (time(t) - time(t-1)) x PID(i). A more negative SPID value means less pain. Total score of SPID ranged from a min value of -1091550.00 in the active arm and -2120130.00 in the sham arm and a max value of 603060.00 in the active arm and 1077630.00 in the sham arm. No absolute min and max scores were calculated.
measure: TOTPAR-Pain Relief Experienced by Patients T0-72 Hours
time frame: Treatment with the test device twice per day, over 3 days (7 total treatments)
description: Pain relief was assessed at completion of first study device treatment, 45 minutes, 60 minutes, 90 minutes, 2 hours, 3 hours, 4 hours, 6 hours following T0 (±5 mins). Thereafter, pain relief was assessed every 2 hours (±5 mins) between 6AM to 10PM throughout the in-patient treatment period. After 10 PM and before 6AM, pain relief assessments were done every 4 hours. Subjects rated pain relief relative to baseline pain intensity using a categorical scale: 0=none; 1=a little; 2=some; 3= a lot; 4 = complete. Based on these scores, a time weighted pain relief score was calculated, Total Pain Relief (TOTPAR). TOTPAR-Pain Relief = ∑PID x (time(t) - time(t-1)) x PID(i)."
measure: Opioid Consumption Measured in Morphine Equivalents T0-72 Hours
time frame: Treatment with the test device twice per day, over 3 days (7 total treatments)
description: The total quantity of Supplemental Opioid analgesic administered throughout the study was recorded for each Subject. Opioid consumption prior to (T0) was not considered when calculating opioid consumption endpoints.
measure: Number of Participants Who Assessed Pain Control at 72 Hours as Good, Very Good, or Excellent
time frame: After 3 days of treatment (T0-72 hours)
description: Number of participants who assessed pain control at 72 hours as good, very good, or excellent.
measure: Time to First Use of Supplemental Analgesic Medication
time frame: Treatment with the test device twice per day, over 3 days (7 total treatments)
description: The time to first supplemental analgesic use was recorded. This was defined as the time from the initiation of the first study device treatment session (T0) to the time of administration of the first dose of post-T0 supplemental medication.
arm group label: Active study device with PRFE
arm group type: Active Comparator
description: This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.
arm group label: Sham study device with no PRFE
arm group type: Sham Comparator
description: This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.
intervention type: Device
intervention name: Pulsed Radiofrequency Energy (PRFE)
description: The intervention is pulsed radiofrequencyenergy (PRFE).
arm group label: Active study device with PRFE
other name: Provant Therapy System
intervention type: Device
intervention name: No Pulsed Radiofrequency Energy (PRFE)
description: Sham (placebo) with no therapeutic device activity
arm group label: Sham study device with no PRFE
other name: Sham Provant Therapy System
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Neil K. Singla, MD
role: Principal Investigator
affiliation: Lotus Clinical Research, LLC
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pain, Postoperative
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 