<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/NCT02972099</url>
  </required_header>
  <id_info>
    <org_study_id>2015-12</org_study_id>
    <nct_id>NCT02972099</nct_id>
  </id_info>
  <brief_title>Pulsed Radiofrequency for Emotional Stress</brief_title>
  <acronym>TcPRF</acronym>
  <official_title>The Psychological Effects of Transcutaneous Pulsed Radiofrequency (TcPRF) in Patients With Emotional Stress</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Swiss Paraplegic Centre Nottwil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Swiss Paraplegic Centre Nottwil</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to assess the short-term and long-term effects of&#xD;
      transcutaneous pulsed radio frequency treatment on the physiological status, subjective&#xD;
      well-being, and on the intensity of pain. Category A Transcutaneous Pulsed Radiofrequency is&#xD;
      a method that is widely used for control of pain. There are no known complications. In this&#xD;
      study a Radiofrequency generator will be used that has a separate outlet for transcutaneous&#xD;
      use. Patients will be recruited within the clinic population of patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Data will be assessed in at three times, the baseline testing, the first and the second&#xD;
      follow-up meeting (+2-4 days of intervention; as well as + 40 days via post/email)&#xD;
&#xD;
      The inclusion criteria are: Inclusion:&#xD;
&#xD;
        -  age 18 - 65&#xD;
&#xD;
        -  chronic pain (Duration of three Months or more) patients of the Pain Center Nottwil,&#xD;
           Swiss Paraplegic Center&#xD;
&#xD;
      The following criteria will lead to an exclusion of the study:&#xD;
&#xD;
        -  severe medical issues, such as cancer or comparable diseases&#xD;
&#xD;
        -  severe mental disorders such as severe depression or schizophrenia&#xD;
&#xD;
        -  patients with pacemakers or with atrial fibrillation&#xD;
&#xD;
        -  Women who are pregnant or breast-feeding The primary outcome assessed is the&#xD;
           physiological status, assessed by the heart rate variability (HRV). Secondary outcomes&#xD;
           are the subjective well-being, as assessed by the &quot;Marburger questionnaire regarding&#xD;
           habitual well-being&quot; (FW-7) questionnaire as well as the intensity of pain, as assessed&#xD;
           by the numeric rating scale for pain intensity (NRS) score and by a 7-point Likert&#xD;
           scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">July 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 2017</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>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Physiological status - Change between Baseline and Follow-up 1</measure>
    <time_frame>Baseline; Follow-up 1 (+2-4 days)</time_frame>
    <description>physiological status, assessed by the heart rate variability (HRV)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective Wellbeing - Change between Baseline and Follow-up 1 &amp; 2</measure>
    <time_frame>Baseline; Follow-up 1 (+2-4 days); Follow-up 2 (+40 days by post)</time_frame>
    <description>Secondary outcome is the subjective well-being, as assessed by the FW-7 questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensity of pain - Change between Baseline and Follow-up 1 &amp; 2</measure>
    <time_frame>Baseline; Follow-up 1 (+2-4 days); Follow-up 2 (+40 days by post)</time_frame>
    <description>the intensity of pain is assessed by the Numeric Rating Scale for pain (NRS) score by a 7-point Likert scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>TcPRF Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>According to the standard application of the device, for the PRF procedure one 5 x 13 cm skin electrode will be placed over the forehead, the other one over the posterior aspect of the neck. PRF with a duty load of 14.8 msec/sec and an average pulse frequency of 5.11 Hz will be applied for 25min. The voltage will be set to generate a current of 1 A.&#xD;
Voltage and impedance will be monitored continuously during treatment and if necessary the voltage will be corrected to ensure the proper current.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The setup will be made as for active treatment but no current will be delivered. The patients will not be able to feel any difference to the real treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TcPRF</intervention_name>
    <description>Transcutaneous Pulsed Radiofrequency is a method that is widely used for control of pain. There are no known complications. In this study a Radiofrequency generator will be used that has a separate outlet for transcutaneous use. It is used in the daily clinical practice in the Pain Center of the Swiss Paraplegic Center.</description>
    <arm_group_label>TcPRF Group</arm_group_label>
    <other_name>TOP Lesion Generator TLG-10 (TOP Corporation - Tokyo, Japan)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>In the Placebo Treatment, no current will be delivered. Since no sensations are produced by TcPRF treatment the patients won't recognize the difference.</description>
    <arm_group_label>Placebo Group</arm_group_label>
    <other_name>TOP Lesion Generator TLG-10 (TOP Corporation - Tokyo, Japan)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 18 - 65&#xD;
&#xD;
          -  chronic pain (Duration of three Months or more) patients of the Pain Center, Swiss&#xD;
             Paraplegic Center, Nottwil&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe medical issues, such as cancer or comparable diseases&#xD;
&#xD;
          -  severe mental disorders such as severe depression or schizophrenia&#xD;
&#xD;
          -  patients with pacemakers or with atrial fibrillation&#xD;
&#xD;
          -  Women who are pregnant or breast-feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Lacher, Dr. phil.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pain Center, Swiss Paraplegic Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pain Center, Swiss Paraplegic Center</name>
      <address>
        <city>Nottwil</city>
        <state>Luzern</state>
        <zip>6207</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>August 2, 2018</last_update_submitted>
  <last_update_submitted_qc>August 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02972099
org study id: 2015-12
nct id: NCT02972099
lead sponsor: 
has dmc: Yes
The objective of the study is to assess the short-term and long-term effects of
      transcutaneous pulsed radio frequency treatment on the physiological status, subjective
      well-being, and on the intensity of pain. Category A Transcutaneous Pulsed Radiofrequency is
      a method that is widely used for control of pain. There are no known complications. In this
      study a Radiofrequency generator will be used that has a separate outlet for transcutaneous
      use. Patients will be recruited within the clinic population of patients.
Data will be assessed in at three times, the baseline testing, the first and the second
      follow-up meeting (+2-4 days of intervention; as well as + 40 days via post/email)

      The inclusion criteria are: Inclusion:

        -  age 18 - 65

        -  chronic pain (Duration of three Months or more) patients of the Pain Center Nottwil,
           Swiss Paraplegic Center

      The following criteria will lead to an exclusion of the study:

        -  severe medical issues, such as cancer or comparable diseases

        -  severe mental disorders such as severe depression or schizophrenia

        -  patients with pacemakers or with atrial fibrillation

        -  Women who are pregnant or breast-feeding The primary outcome assessed is the
           physiological status, assessed by the heart rate variability (HRV). Secondary outcomes
           are the subjective well-being, as assessed by the "Marburger questionnaire regarding
           habitual well-being" (FW-7) questionnaire as well as the intensity of pain, as assessed
           by the numeric rating scale for pain intensity (NRS) score and by a 7-point Likert
           scale.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: Physiological status - Change between Baseline and Follow-up 1
time frame: Baseline; Follow-up 1 (+2-4 days)
description: physiological status, assessed by the heart rate variability (HRV)
measure: Subjective Wellbeing - Change between Baseline and Follow-up 1 & 2
time frame: Baseline; Follow-up 1 (+2-4 days); Follow-up 2 (+40 days by post)
description: Secondary outcome is the subjective well-being, as assessed by the FW-7 questionnaire
measure: Intensity of pain - Change between Baseline and Follow-up 1 & 2
time frame: Baseline; Follow-up 1 (+2-4 days); Follow-up 2 (+40 days by post)
description: the intensity of pain is assessed by the Numeric Rating Scale for pain (NRS) score by a 7-point Likert scale
arm group label: TcPRF Group
arm group type: Experimental
description: According to the standard application of the device, for the PRF procedure one 5 x 13 cm skin electrode will be placed over the forehead, the other one over the posterior aspect of the neck. PRF with a duty load of 14.8 msec/sec and an average pulse frequency of 5.11 Hz will be applied for 25min. The voltage will be set to generate a current of 1 A.
Voltage and impedance will be monitored continuously during treatment and if necessary the voltage will be corrected to ensure the proper current.
arm group label: Placebo Group
arm group type: Placebo Comparator
description: The setup will be made as for active treatment but no current will be delivered. The patients will not be able to feel any difference to the real treatment.
intervention type: Device
intervention name: TcPRF
description: Transcutaneous Pulsed Radiofrequency is a method that is widely used for control of pain. There are no known complications. In this study a Radiofrequency generator will be used that has a separate outlet for transcutaneous use. It is used in the daily clinical practice in the Pain Center of the Swiss Paraplegic Center.
arm group label: TcPRF Group
other name: TOP Lesion Generator TLG-10 (TOP Corporation - Tokyo, Japan)
intervention type: Device
intervention name: Placebo
description: In the Placebo Treatment, no current will be delivered. Since no sensations are produced by TcPRF treatment the patients won't recognize the difference.
arm group label: Placebo Group
other name: TOP Lesion Generator TLG-10 (TOP Corporation - Tokyo, Japan)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel Lacher, Dr. phil.
role: Principal Investigator
affiliation: Pain Center, Swiss Paraplegic Center
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Chronic Pain
sharing ipd: No