<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/NCT03037684</url>
  </required_header>
  <id_info>
    <org_study_id>2016-15</org_study_id>
    <nct_id>NCT03037684</nct_id>
  </id_info>
  <brief_title>Depolarising Electrical Skin Stimulation in Neuropathic and Postoperative Pain</brief_title>
  <official_title>Selective Activation of Unmyelinated Skin Nerve Fibres Using Slow Depolarising Transcutaneous Electrical Stimulation in Patients With Neuropathic Pain or Chronic Postoperative Pain</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>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to evaluate voltage gated sodium channel (NaV1.7) dependent pain&#xD;
      phenomena in neuropathic pain and chronic postoperative pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sinus-like electrical stimulation may depolarize unmyelinated skin nociceptors involving&#xD;
      NaV1.7 channels. In this case electrical stimulation may provoke pain already with very low&#xD;
      currency intensity which normally not provoke pain in healthy subjects. This may be&#xD;
      predictive for pain relief due to the sodium channel blocker lidocaine 5% patch.&#xD;
&#xD;
      The study will characterize pain states in peripheral neuropathic pain as well as within the&#xD;
      painful scar in chronic postoperative pain with regard to the involvement of NaV1.7 channels.&#xD;
&#xD;
      In addition, the pain site in chronic postoperative pain (scar) will be characterized by&#xD;
      laser-evoked potentials (LEP) and quantitative sensory testing (QST).&#xD;
&#xD;
      Pain related questionnaires will be obtained.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 27, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>change in pain intensity</measure>
    <time_frame>at baseline and during electric nerve stimulation</time_frame>
    <description>numeric rating scale (NRS), rating from 0-10, 0=no pain, 10=maximum pain imaginable</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>heat pain threshold</measure>
    <time_frame>baseline</time_frame>
    <description>Ramped stimuli (+1 degree Celsius / sec) that are terminated when the subject presses a button.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cold pain threshold</measure>
    <time_frame>baseline</time_frame>
    <description>Ramped stimuli (-1 degree Celsius / sec) that are terminated when the subject presses a button.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mechanical detection threshold</measure>
    <time_frame>baseline</time_frame>
    <description>Fine plastic hairs with different bending forces are applied to the skin to determine the mechanical detection threshold.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mechanical pain threshold</measure>
    <time_frame>baseline</time_frame>
    <description>Differently weighted pinprick stimuli are applied at a rate of 2sec on and 2sec off in an ascending order until the first percept of sharpness is reached.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mechanical pain sensitivity</measure>
    <time_frame>baseline</time_frame>
    <description>Differently weighted pinprick stimuli are applied to obtain a stimulus- response function for pinprick-evoked pain. Subjects were asked to give a pain rating for each stimulus (rating from 0-10, 0=no pain, 10=maximum pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>dynamic mechanical allodynia</measure>
    <time_frame>baseline</time_frame>
    <description>Different stimuli, tactile and pinprick are applied with the subject giving numerical pain ratings for each stimulus (rating from 0-10, 0=no pain, maximum pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>vibration detection threshold</measure>
    <time_frame>baseline</time_frame>
    <description>Tuning fork is placed over a bony prominence until the subject cannot not feel vibration any more.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pressure pain threshold</measure>
    <time_frame>baseline</time_frame>
    <description>A pressure gauge that exerts forces of ascending stimulus intensities is applied as a slowly increasing ramp over a muscle.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LEP latency</measure>
    <time_frame>baseline</time_frame>
    <description>latency of N2 and P2 components of laser evoked potential signal curve</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LEP amplitude</measure>
    <time_frame>baseline</time_frame>
    <description>amplitude of laser evoked potential signal curve</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stadium of pain chronification</measure>
    <time_frame>baseline</time_frame>
    <description>assessment of the stadium of pain chronification (stadium 1-3) using standardized questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain severity</measure>
    <time_frame>baseline</time_frame>
    <description>assessment of pain severity (grade 1-4) using the Chronic Pain Grading Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>physical health status</measure>
    <time_frame>baseline</time_frame>
    <description>assessing the physical health status using the Short Form-12 questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mental health status</measure>
    <time_frame>baseline</time_frame>
    <description>assessing the mental health status using the Short Form-12 questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>anxiety</measure>
    <time_frame>baseline</time_frame>
    <description>assessing anxiety using the Hospital Anxiety and Depression Scale questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>depression</measure>
    <time_frame>baseline</time_frame>
    <description>assessing Depression using the Hospital Anxiety and Depression Scale questionnaire</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Neuropathy;Peripheral</condition>
  <arm_group>
    <arm_group_label>chronic pain</arm_group_label>
    <description>individuals suffering from chronic pain</description>
  </arm_group>
  <arm_group>
    <arm_group_label>neuropathic pain</arm_group_label>
    <description>individuals suffering from neuropathic pain</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>neurophysiology</intervention_name>
    <description>electrophysiologic measurements of peripheral nerves</description>
    <arm_group_label>chronic pain</arm_group_label>
    <arm_group_label>neuropathic pain</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with neuropathic pain or with chronic postoperative pain&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Group (1) patients with neuropathic pain&#xD;
&#xD;
          -  Group (2) patients with chronic postoperative pain&#xD;
&#xD;
        Exclusion Criteria (both Groups):&#xD;
&#xD;
          -  severe psychiatric disorder requiring hospitalisation in the past&#xD;
&#xD;
          -  any neurological disease other than the pain diagnosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Gunther Landmann, MD</last_name>
    <phone>+4141939</phone>
    <phone_ext>4925</phone_ext>
    <email>gunther.landmann@paraplegie.ch</email>
  </overall_contact>
  <location>
    <facility>
      <name>Centre for Pain Medicine</name>
      <address>
        <city>Nottwil</city>
        <zip>6207</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gunther Landmann, MD</last_name>
      <phone>+4141939</phone>
      <phone_ext>4925</phone_ext>
      <email>gunther.landmann@paraplegie.ch</email>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Rolke R, Baron R, Maier C, Tolle TR, Treede -DR, Beyer A, Binder A, Birbaumer N, Birklein F, Botefur IC, Braune S, Flor H, Huge V, Klug R, Landwehrmeyer GB, Magerl W, Maihofner C, Rolko C, Schaub C, Scherens A, Sprenger T, Valet M, Wasserka B. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain. 2006 Aug;123(3):231-243. doi: 10.1016/j.pain.2006.01.041. Epub 2006 May 11. Erratum In: Pain. 2006 Nov;125(1-2):197.</citation>
    <PMID>16697110</PMID>
  </reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>October 31, 2022</last_update_submitted>
  <last_update_submitted_qc>October 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Swiss Paraplegic Centre Nottwil</investigator_affiliation>
    <investigator_full_name>Landmann Gunther</investigator_full_name>
    <investigator_title>Head of Neurology</investigator_title>
  </responsible_party>
  <keyword>neuropathic pain</keyword>
  <keyword>chronic postoperative pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Nervous System Diseases</mesh_term>
    <mesh_term>Pain, Postoperative</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/NCT03037684
org study id: 2016-15
nct id: NCT03037684
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to evaluate voltage gated sodium channel (NaV1.7) dependent pain
      phenomena in neuropathic pain and chronic postoperative pain.
Sinus-like electrical stimulation may depolarize unmyelinated skin nociceptors involving
      NaV1.7 channels. In this case electrical stimulation may provoke pain already with very low
      currency intensity which normally not provoke pain in healthy subjects. This may be
      predictive for pain relief due to the sodium channel blocker lidocaine 5% patch.

      The study will characterize pain states in peripheral neuropathic pain as well as within the
      painful scar in chronic postoperative pain with regard to the involvement of NaV1.7 channels.

      In addition, the pain site in chronic postoperative pain (scar) will be characterized by
      laser-evoked potentials (LEP) and quantitative sensory testing (QST).

      Pain related questionnaires will be obtained.
observational model: Cohort
time perspective: Prospective
measure: change in pain intensity
time frame: at baseline and during electric nerve stimulation
description: numeric rating scale (NRS), rating from 0-10, 0=no pain, 10=maximum pain imaginable
measure: heat pain threshold
time frame: baseline
description: Ramped stimuli (+1 degree Celsius / sec) that are terminated when the subject presses a button.
measure: cold pain threshold
time frame: baseline
description: Ramped stimuli (-1 degree Celsius / sec) that are terminated when the subject presses a button.
measure: mechanical detection threshold
time frame: baseline
description: Fine plastic hairs with different bending forces are applied to the skin to determine the mechanical detection threshold.
measure: mechanical pain threshold
time frame: baseline
description: Differently weighted pinprick stimuli are applied at a rate of 2sec on and 2sec off in an ascending order until the first percept of sharpness is reached.
measure: mechanical pain sensitivity
time frame: baseline
description: Differently weighted pinprick stimuli are applied to obtain a stimulus- response function for pinprick-evoked pain. Subjects were asked to give a pain rating for each stimulus (rating from 0-10, 0=no pain, 10=maximum pain)
measure: dynamic mechanical allodynia
time frame: baseline
description: Different stimuli, tactile and pinprick are applied with the subject giving numerical pain ratings for each stimulus (rating from 0-10, 0=no pain, maximum pain).
measure: vibration detection threshold
time frame: baseline
description: Tuning fork is placed over a bony prominence until the subject cannot not feel vibration any more.
measure: pressure pain threshold
time frame: baseline
description: A pressure gauge that exerts forces of ascending stimulus intensities is applied as a slowly increasing ramp over a muscle.
measure: LEP latency
time frame: baseline
description: latency of N2 and P2 components of laser evoked potential signal curve
measure: LEP amplitude
time frame: baseline
description: amplitude of laser evoked potential signal curve
measure: stadium of pain chronification
time frame: baseline
description: assessment of the stadium of pain chronification (stadium 1-3) using standardized questionnaire
measure: pain severity
time frame: baseline
description: assessment of pain severity (grade 1-4) using the Chronic Pain Grading Questionnaire
measure: physical health status
time frame: baseline
description: assessing the physical health status using the Short Form-12 questionnaire
measure: mental health status
time frame: baseline
description: assessing the mental health status using the Short Form-12 questionnaire
measure: anxiety
time frame: baseline
description: assessing anxiety using the Hospital Anxiety and Depression Scale questionnaire
measure: depression
time frame: baseline
description: assessing Depression using the Hospital Anxiety and Depression Scale questionnaire
arm group label: chronic pain
description: individuals suffering from chronic pain
arm group label: neuropathic pain
description: individuals suffering from neuropathic pain
intervention type: Diagnostic Test
intervention name: neurophysiology
description: electrophysiologic measurements of peripheral nerves
arm group label: chronic pain
arm group label: neuropathic pain
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Gunther Landmann, MD
phone: +4141939
phone ext: 4925
email: gunther.landmann@paraplegie.ch
facility: 
status: Recruiting
contact: 
country: Switzerland
citation: Rolke R, Baron R, Maier C, Tolle TR, Treede -DR, Beyer A, Binder A, Birbaumer N, Birklein F, Botefur IC, Braune S, Flor H, Huge V, Klug R, Landwehrmeyer GB, Magerl W, Maihofner C, Rolko C, Schaub C, Scherens A, Sprenger T, Valet M, Wasserka B. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain. 2006 Aug;123(3):231-243. doi: 10.1016/j.pain.2006.01.041. Epub 2006 May 11. Erratum In: Pain. 2006 Nov;125(1-2):197.
PMID: 16697110
responsible party type: Principal Investigator
investigator affiliation: Swiss Paraplegic Centre Nottwil
investigator full name: Landmann Gunther
investigator title: Head of Neurology
mesh term: Peripheral Nervous System Diseases
mesh term: Pain, Postoperative
sharing ipd: No