<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/NCT03030079</url>
  </required_header>
  <id_info>
    <org_study_id>16-1063</org_study_id>
    <nct_id>NCT03030079</nct_id>
  </id_info>
  <brief_title>Electrical Stimulus Therapy for Chronic Phantom Limb Pain</brief_title>
  <official_title>Exploratory Study of Electrical Stimulus as a Treatment Option for Chronic Phantom Limb Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hanger Clinic: Prosthetics &amp; Orthotics</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this pilot study is to assess the effectiveness of an electrical stimulation&#xD;
      therapy option for the treatment of chronic phantom limb pain in upper or lower limb&#xD;
      amputees. This therapy has been previously used for sports and joint injuries and is marketed&#xD;
      for relaxation of muscle spasms, re-education of muscle action, prevention of disuse atrophy,&#xD;
      increased local blood circulation, and maintaining or increasing range of motion. The&#xD;
      investigators would like to explore the idea that physically exercising the muscles of the&#xD;
      residual limb and increasing blood flow to the site of amputation through the promotion of&#xD;
      motor contraction using electrical stimulation decreases chronic phantom limb pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are a large number of people living with an amputation due mainly to cardiovascular&#xD;
      disease, diabetes, and trauma; and of these there is evidence to show that up to 80% of&#xD;
      amputees experience phantom limb pain (PLP). PLP is classified as cramping, burning,&#xD;
      shooting, or stabbing pain in the missing limb following an amputation. Current treatments&#xD;
      include pharmacological drugs, anesthesia, additional surgery, mirror therapy, transcutaneous&#xD;
      electrical nerve stimulation (TENS) and others. TENS, as usually implemented, has been used&#xD;
      to effectively reduce pain in multiple spots of the body, but has shown little effect in&#xD;
      reducing phantom limb pain especially long term even with varying the frequency and intensity&#xD;
      of the electrical stimulation. These current treatments can be invasive, costly, and have&#xD;
      shown only to offer immediate relief. Using an electrical stimulator at a higher intensity&#xD;
      has proven to to reduce pain and increase healing in numerous sports and joint related&#xD;
      injuries. Anecdotally, the investigators have learned that a similar treatment protocol when&#xD;
      applied to persons with phantom limb pain can mitigate their pain. The goal of this pilot&#xD;
      study is to assess the effectiveness of higher intensity electrical stimulation in the&#xD;
      management of PLP and also to acquire data to inform the investigators to the most&#xD;
      appropriate study design and power for a future more formal clinical trial. To accomplish&#xD;
      this the investigators will utilize the ACP Omnistim FX2 Pro electrical stimulator, that has&#xD;
      been provided to us by Accelerated Care Plus (ACP) Corporation, to physically exercise the&#xD;
      muscles of the residual limb and hence increase the local blood flow and explore it's&#xD;
      potential for treatment of PLP both short and long term. The self-identified subject will be&#xD;
      hooked up to the ACP electrical stimulator using surface electrodes that will pass a current&#xD;
      through the skin first at a low intensity for 5 minutes to allow the subject to adjust to the&#xD;
      tingling sensation. The current will then be gradually increased to a level sufficient to&#xD;
      elicit a non-painful motor contraction for 15 minutes. Using a numerical pain scale and short&#xD;
      answer questions about the characteristics of the pain the investigators will track both&#xD;
      short term and long term changes in pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">June 28, 2023</completion_date>
  <primary_completion_date type="Actual">June 27, 2023</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>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Use of electrical stimulus medium frequency alternating current for short term decreased Phantom Limb Pan</measure>
    <time_frame>After each 20 minute treatment session up to 5 weeks</time_frame>
    <description>Pain level data will be taken before and after each session to analyze any short term decreases in pain using a self-reported numeric 10-point pain scale. T- tests will be used for within subject testing looking at pre and post treatment measures to quantify a decrease in pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess the effectiveness of reducing chronic phantom limb pain long term.</measure>
    <time_frame>Weekly for 5 weeks</time_frame>
    <description>An overall sustained decrease in phantom limb pain will be assessed weekly using a self-reported numeric 10-point pain scale. ANOVAs will be used to look at trends in post treatment measures over time.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Phantom Limb Pain</condition>
  <arm_group>
    <arm_group_label>Experimental Electrical stimulation Regimen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Explore the efficacy of an electrical stimulus regimen on the treatment of chronic phantom limb pain using a standard-of-care electrical stimulation system</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Experimental Electrical Stimulation Regimen</intervention_name>
    <description>The electrodes will pass an electrical current through the skin and into the muscle first at a low intensity for 5 minutes to allow the subject to adjust to the sensation. The current will then be gradually increased to a level sufficient to elicit a non-painful motor contraction. The subject will sit in a relaxed position as the electrical stimulator contracts the muscles for a duration of 15 minutes.</description>
    <arm_group_label>Experimental Electrical stimulation Regimen</arm_group_label>
    <other_name>Device: Omnistim FX2 Pro</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Self-identified adult volunteers with a limb deficiency with a well-healed site of&#xD;
             amputation&#xD;
&#xD;
          -  Subjects experiencing at least a 4 out of 10 of chronic phantom limb pain based on a&#xD;
             numeric 10-point pain scale.&#xD;
&#xD;
          -  Any ethnicity and gender&#xD;
&#xD;
          -  Age (18-85 years)&#xD;
&#xD;
          -  Able to understand and follow directions in English, assessed by their ability to&#xD;
             respond during the recruitment and consent processes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects that are not able to understand the procedures and who are unable to come to&#xD;
             the facility.&#xD;
&#xD;
          -  Any individual whose amputation site is not completely healed&#xD;
&#xD;
          -  Anyone with cardiac demand pacemakers and/or implanted defibrillator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Weir, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital Colorado Research Institute</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>June 30, 2023</last_update_submitted>
  <last_update_submitted_qc>June 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</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>Phantom Limb</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/NCT03030079
org study id: 16-1063
nct id: NCT03030079
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The goal of this pilot study is to assess the effectiveness of an electrical stimulation
      therapy option for the treatment of chronic phantom limb pain in upper or lower limb
      amputees. This therapy has been previously used for sports and joint injuries and is marketed
      for relaxation of muscle spasms, re-education of muscle action, prevention of disuse atrophy,
      increased local blood circulation, and maintaining or increasing range of motion. The
      investigators would like to explore the idea that physically exercising the muscles of the
      residual limb and increasing blood flow to the site of amputation through the promotion of
      motor contraction using electrical stimulation decreases chronic phantom limb pain.
There are a large number of people living with an amputation due mainly to cardiovascular
      disease, diabetes, and trauma; and of these there is evidence to show that up to 80% of
      amputees experience phantom limb pain (PLP). PLP is classified as cramping, burning,
      shooting, or stabbing pain in the missing limb following an amputation. Current treatments
      include pharmacological drugs, anesthesia, additional surgery, mirror therapy, transcutaneous
      electrical nerve stimulation (TENS) and others. TENS, as usually implemented, has been used
      to effectively reduce pain in multiple spots of the body, but has shown little effect in
      reducing phantom limb pain especially long term even with varying the frequency and intensity
      of the electrical stimulation. These current treatments can be invasive, costly, and have
      shown only to offer immediate relief. Using an electrical stimulator at a higher intensity
      has proven to to reduce pain and increase healing in numerous sports and joint related
      injuries. Anecdotally, the investigators have learned that a similar treatment protocol when
      applied to persons with phantom limb pain can mitigate their pain. The goal of this pilot
      study is to assess the effectiveness of higher intensity electrical stimulation in the
      management of PLP and also to acquire data to inform the investigators to the most
      appropriate study design and power for a future more formal clinical trial. To accomplish
      this the investigators will utilize the ACP Omnistim FX2 Pro electrical stimulator, that has
      been provided to us by Accelerated Care Plus (ACP) Corporation, to physically exercise the
      muscles of the residual limb and hence increase the local blood flow and explore it's
      potential for treatment of PLP both short and long term. The self-identified subject will be
      hooked up to the ACP electrical stimulator using surface electrodes that will pass a current
      through the skin first at a low intensity for 5 minutes to allow the subject to adjust to the
      tingling sensation. The current will then be gradually increased to a level sufficient to
      elicit a non-painful motor contraction for 15 minutes. Using a numerical pain scale and short
      answer questions about the characteristics of the pain the investigators will track both
      short term and long term changes in pain.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Use of electrical stimulus medium frequency alternating current for short term decreased Phantom Limb Pan
time frame: After each 20 minute treatment session up to 5 weeks
description: Pain level data will be taken before and after each session to analyze any short term decreases in pain using a self-reported numeric 10-point pain scale. T- tests will be used for within subject testing looking at pre and post treatment measures to quantify a decrease in pain.
measure: Assess the effectiveness of reducing chronic phantom limb pain long term.
time frame: Weekly for 5 weeks
description: An overall sustained decrease in phantom limb pain will be assessed weekly using a self-reported numeric 10-point pain scale. ANOVAs will be used to look at trends in post treatment measures over time.
arm group label: Experimental Electrical stimulation Regimen
arm group type: Experimental
description: Explore the efficacy of an electrical stimulus regimen on the treatment of chronic phantom limb pain using a standard-of-care electrical stimulation system
intervention type: Device
intervention name: Experimental Electrical Stimulation Regimen
description: The electrodes will pass an electrical current through the skin and into the muscle first at a low intensity for 5 minutes to allow the subject to adjust to the sensation. The current will then be gradually increased to a level sufficient to elicit a non-painful motor contraction. The subject will sit in a relaxed position as the electrical stimulator contracts the muscles for a duration of 15 minutes.
arm group label: Experimental Electrical stimulation Regimen
other name: Device: Omnistim FX2 Pro
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Richard Weir, PhD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
mesh term: Phantom Limb
sharing ipd: No