<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/NCT02241967</url>
  </required_header>
  <id_info>
    <org_study_id>CLIN-005-13F</org_study_id>
    <secondary_id>CX001078</secondary_id>
    <nct_id>NCT02241967</nct_id>
  </id_info>
  <brief_title>Dose Dependent Effects of tDCS on Post-Operative Pain</brief_title>
  <acronym>tDCS-TKA</acronym>
  <official_title>Dose Dependent Effects of tDCS on Post-Operative Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proper control of acute and chronic pain is one of the most important areas in health&#xD;
      care. Despite the profound advances in neuroscience over the past 20 years, the investigators&#xD;
      still largely use opiate narcotics, much as was done in the Civil War. Total knee&#xD;
      arthroplasty (TKA) is one of the most common orthopedic procedures performed 1. While knee&#xD;
      pain is often a complaint that precedes TKA, the procedure itself is associated with&#xD;
      considerable post-operative pain lasting days to weeks. Adequate postoperative pain control&#xD;
      is an important factor in determining recovery time and hospital length of stay. New&#xD;
      analgesic strategies are needed that can be used adjunctively to existing strategies with the&#xD;
      potential to reduce reliance on opioid analgesia. Several novel brain stimulation&#xD;
      technologies including transcranial magnetic stimulation (TMS) and transcranial direct&#xD;
      current stimulation (tDCS) are beginning to demonstrate promise as treatments for a variety&#xD;
      of pain conditions. Electricity has no metabolite or other residue, and can be delivered with&#xD;
      minimal discomfort and without problems associated with drug-drug interactions. In two&#xD;
      independent preliminary pilot studies, the Investigators have shown that tDCS can reduce&#xD;
      post-operative PCA use by as much as 46% while simultaneously reducing subjective pain&#xD;
      ratings. The present study aims to determine the effects of transcranial direct current&#xD;
      stimulation (tDCS) on post-operative pain, patient-controlled analgesia (PCA) use, and&#xD;
      post-surgical complications during the 48-hour post-operative period following total knee&#xD;
      arthroplasty.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study employs a randomized, double-blind, sham-controlled design to evaluate the&#xD;
      effects of tDCS on pain among Veterans receiving unilateral total knee arthroplasty (TKA) and&#xD;
      unilateral total hip arthroplasty (THA). Further, this study will examine dose-dependency of&#xD;
      the tDCS analgesic effects. Each tDCS session delivered either 20 min of real or sham tDCS.&#xD;
      Real tDCS was administered at 2mA whereas sham tDCS delivered none.&#xD;
&#xD;
      120 patients undergoing TKA will be randomly assigned to one of four groups:Group 1 will have&#xD;
      4 sessions of real tDCS, Group 2 - 2 sessions of real tDCS (+ 2 sham-sessions), and Group 3 -&#xD;
      1 session of real tDCS (+ 3 sham-sessions). Group 4 is &quot;Sham&quot; tDCS, which does not involve&#xD;
      any real stimulation. The participants will receive 2 tDCS treatments on the day of their&#xD;
      surgery, and 2 tDCS treatments the day after their surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2016</start_date>
  <completion_date type="Actual">July 2, 2020</completion_date>
  <primary_completion_date type="Actual">July 2, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post-operative Opioid Pain Medication Dose</measure>
    <time_frame>2-Days</time_frame>
    <description>Patient Controlled Analgesia pump usage will be measured (mg of morphine-equivalent) during the acute post-operative period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient-reported Pain Intensity Ratings</measure>
    <time_frame>2-Days</time_frame>
    <description>Patients reported pain intensity using a visual analog scale (VAS) before and after each tDCS session during the 2 day routine postoperative hospital stay. Patients reported pain intensity by marking a line anchored with a minimum of &quot;0- no pain at all&quot; to maximum of &quot;10- worst pain imaginable.&quot; Lower values represent a more favorable outcome. This outcome data is the sum of all VAS scores collected before and after each tDCS session during the 2-day hospital stay, thus each participant had a total of 8 VAS scores during the experimental intervention during hospital stay.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient-reported Average Pain Ratings</measure>
    <time_frame>6 Months</time_frame>
    <description>Visual analogue scale pain ratings will be collected during the perioperative and post-discharge periods . Visual analogue scale ratings range from 0-10; a blank line is anchored with a 0 and 10 with the following labels: &quot;0- no pain,&quot; &quot;10-worst pain imaginable.&quot;</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">119</enrollment>
  <condition>Total Knee Arthroplasty (Postoperative Pain)</condition>
  <condition>Total Hip Arthroplasty(Postoperative Pain)</condition>
  <arm_group>
    <arm_group_label>tDCS Full Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 active treatments</description>
  </arm_group>
  <arm_group>
    <arm_group_label>tDCS Half Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 active treatments</description>
  </arm_group>
  <arm_group>
    <arm_group_label>tDCS Minimal dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 active treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham tDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>no active treatments</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>4 Real sessions of Transcranial Direct Current Stimulation</intervention_name>
    <description>Stimulation of brain areas associated with pain perception using low amplitude direct current of 2mA delivered by electrodes attached to the scalp.</description>
    <arm_group_label>tDCS Full Dose</arm_group_label>
    <other_name>tDCS Full Dose</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>2 Real Sessions of Transcranial Direct Current Stimulation</intervention_name>
    <description>Stimulation of brain areas associated with pain perception using low amplitude direct current of 2mA delivered by electrodes attached to the scalp. 2 real sessions of tDCS and 2 sham.</description>
    <arm_group_label>tDCS Half Dose</arm_group_label>
    <other_name>tDCS Half Dose</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>1 Real Session of Transcranial Direct Current Stimulation</intervention_name>
    <description>Stimulation of brain areas associated with pain perception using low amplitude direct current of 2mA delivered by electrodes attached to the scalp. 1 real sessions of tDCS and 3 sham.</description>
    <arm_group_label>tDCS Minimal dose</arm_group_label>
    <other_name>tDCS Minimal Dose</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham Transcranial Direct Current Stimulation</intervention_name>
    <description>Four sessions of sham tDCS; control intervention.</description>
    <arm_group_label>Sham tDCS</arm_group_label>
    <other_name>Sham tDCS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants will be 120 patients undergoing TKA or THA surgery at the Ralph H. Johnson&#xD;
        VAMC in Charleston SC.&#xD;
&#xD;
          -  Between the ages of 19 and 90&#xD;
&#xD;
          -  Mentally capable of reading, writing, giving consent, and following instructions&#xD;
&#xD;
          -  Cleared for and scheduled for unilateral TKA or THA surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Implanted medical devices above the waist&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  History of seizures&#xD;
&#xD;
          -  Allergic to latex rubber&#xD;
&#xD;
          -  Psychiatric conditions other than for depression and/or anxiety disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey J Borckardt, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ralph H. Johnson VA Medical Center, Charleston, SC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ralph H. Johnson VA Medical Center, Charleston, SC</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29401-5799</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <results_first_submitted>June 25, 2021</results_first_submitted>
  <results_first_submitted_qc>September 10, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 7, 2021</results_first_posted>
  <last_update_submitted>June 24, 2022</last_update_submitted>
  <last_update_submitted_qc>June 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>total knee arthroplasty</keyword>
  <keyword>pain</keyword>
  <keyword>post-surgical pain</keyword>
  <keyword>opioid</keyword>
  <keyword>transcranial direct current stimulation</keyword>
  <keyword>tDCS</keyword>
  <keyword>brain stimulation</keyword>
  <keyword>total hip arthroplasty</keyword>
  <keyword>TKA</keyword>
  <keyword>THA</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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 8, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT02241967/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>tDCS Full Dose</title>
          <description>4 active treatments administered at 2mA for 20minutes each sessions, two the day of surgery and two the day after surgery.&#xD;
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.</description>
        </group>
        <group group_id="P2">
          <title>tDCS Half Dose</title>
          <description>2 active treatments administered at 2mA for 20minutes each sessions. 2 real sessions the day of surgery and 2 sham sessions the day after surgery.&#xD;
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.</description>
        </group>
        <group group_id="P3">
          <title>tDCS Minimal Dose</title>
          <description>1 active treatment administered at 2mA for 20minutes for the first session immediately following surgery, then 1 sham session later, day of surgery, and 2 sham sessions the day after surgery.&#xD;
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.</description>
        </group>
        <group group_id="P4">
          <title>Sham tDCS</title>
          <description>no active treatments. All 4 sessions were sham tDCS. 2 delivered day of surgery, 2 delivered day after surgery.&#xD;
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="30"/>
                <participants group_id="P4" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="30"/>
                <participants group_id="P4" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>tDCS Full Dose</title>
          <description>4 active treatments&#xD;
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.</description>
        </group>
        <group group_id="B2">
          <title>tDCS Half Dose</title>
          <description>2 active treatments&#xD;
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.</description>
        </group>
        <group group_id="B3">
          <title>tDCS Minimal Dose</title>
          <description>1 active treatment&#xD;
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.</description>
        </group>
        <group group_id="B4">
          <title>Sham tDCS</title>
          <description>no active treatments&#xD;
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.</description>
        </group>
        <group group_id="B5">
          <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="30"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="30"/>
            <count group_id="B4" value="29"/>
            <count group_id="B5" value="119"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="63.9" spread="8.73"/>
                    <measurement group_id="B2" value="67.0" spread="8.95"/>
                    <measurement group_id="B3" value="63.5" spread="7.93"/>
                    <measurement group_id="B4" value="64.2" spread="8.14"/>
                    <measurement group_id="B5" value="64.7" spread="8.50"/>
                  </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="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="28"/>
                    <measurement group_id="B5" value="112"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="29"/>
                    <measurement group_id="B4" value="28"/>
                    <measurement group_id="B5" value="116"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="3"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="19"/>
                    <measurement group_id="B5" value="82"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="29"/>
                    <measurement group_id="B5" value="119"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Procedure Type</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Total Knee Arthroplasty (TKA)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="20"/>
                    <measurement group_id="B5" value="82"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Total Hip Arthroplasty (THA)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Post-operative Opioid Pain Medication Dose</title>
        <description>Patient Controlled Analgesia pump usage will be measured (mg of morphine-equivalent) during the acute post-operative period.</description>
        <time_frame>2-Days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>tDCS Full Dose</title>
            <description>4 active treatments&#xD;
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.</description>
          </group>
          <group group_id="O2">
            <title>tDCS Half Dose</title>
            <description>2 active treatments&#xD;
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.</description>
          </group>
          <group group_id="O3">
            <title>tDCS Minimal Dose</title>
            <description>1 active treatment&#xD;
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.</description>
          </group>
          <group group_id="O4">
            <title>Sham tDCS</title>
            <description>no active treatments&#xD;
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.</description>
          </group>
        </group_list>
        <measure>
          <title>Post-operative Opioid Pain Medication Dose</title>
          <description>Patient Controlled Analgesia pump usage will be measured (mg of morphine-equivalent) during the acute post-operative period.</description>
          <units>mg of morphine equivalent dose (MED)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.99" spread="2.99"/>
                    <measurement group_id="O2" value="31.12" spread="3.73"/>
                    <measurement group_id="O3" value="28.65" spread="31.12"/>
                    <measurement group_id="O4" value="33.15" spread="5.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Patient-reported Pain Intensity Ratings</title>
        <description>Patients reported pain intensity using a visual analog scale (VAS) before and after each tDCS session during the 2 day routine postoperative hospital stay. Patients reported pain intensity by marking a line anchored with a minimum of &quot;0- no pain at all&quot; to maximum of &quot;10- worst pain imaginable.&quot; Lower values represent a more favorable outcome. This outcome data is the sum of all VAS scores collected before and after each tDCS session during the 2-day hospital stay, thus each participant had a total of 8 VAS scores during the experimental intervention during hospital stay.</description>
        <time_frame>2-Days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>tDCS Full Dose</title>
            <description>4 active treatments&#xD;
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.</description>
          </group>
          <group group_id="O2">
            <title>tDCS Half Dose</title>
            <description>2 active treatments&#xD;
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.</description>
          </group>
          <group group_id="O3">
            <title>tDCS Minimal Dose</title>
            <description>1 active treatment&#xD;
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.</description>
          </group>
          <group group_id="O4">
            <title>Sham tDCS</title>
            <description>no active treatments&#xD;
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient-reported Pain Intensity Ratings</title>
          <description>Patients reported pain intensity using a visual analog scale (VAS) before and after each tDCS session during the 2 day routine postoperative hospital stay. Patients reported pain intensity by marking a line anchored with a minimum of &quot;0- no pain at all&quot; to maximum of &quot;10- worst pain imaginable.&quot; Lower values represent a more favorable outcome. This outcome data is the sum of all VAS scores collected before and after each tDCS session during the 2-day hospital stay, thus each participant had a total of 8 VAS scores during the experimental intervention during hospital stay.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="29"/>
                <count group_id="O4" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.33" spread=".44"/>
                    <measurement group_id="O2" value="5.59" spread=".43"/>
                    <measurement group_id="O3" value="5.84" spread=".48"/>
                    <measurement group_id="O4" value="5.33" spread=".56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient-reported Average Pain Ratings</title>
        <description>Visual analogue scale pain ratings will be collected during the perioperative and post-discharge periods . Visual analogue scale ratings range from 0-10; a blank line is anchored with a 0 and 10 with the following labels: &quot;0- no pain,&quot; &quot;10-worst pain imaginable.&quot;</description>
        <time_frame>6 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>tDCS Full Dose</title>
            <description>4 active treatments&#xD;
4 Real sessions of Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current of 2mA delivered by electrodes attached to the scalp.</description>
          </group>
          <group group_id="O2">
            <title>tDCS Half Dose</title>
            <description>2 active treatments&#xD;
2 Real Sessions of Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current of 2mA delivered by electrodes attached to the scalp. 2 real sessions of tDCS and 2 sham.</description>
          </group>
          <group group_id="O3">
            <title>tDCS Minimal Dose</title>
            <description>1 active treatment&#xD;
1 Real Session of Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current of 2mA delivered by electrodes attached to the scalp. 1 real sessions of tDCS and 3 sham.</description>
          </group>
          <group group_id="O4">
            <title>Sham tDCS</title>
            <description>no active treatments&#xD;
Sham Transcranial Direct Current Stimulation: Four sessions of sham tDCS; control intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient-reported Average Pain Ratings</title>
          <description>Visual analogue scale pain ratings will be collected during the perioperative and post-discharge periods . Visual analogue scale ratings range from 0-10; a blank line is anchored with a 0 and 10 with the following labels: &quot;0- no pain,&quot; &quot;10-worst pain imaginable.&quot;</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.06" spread=".46"/>
                    <measurement group_id="O2" value="3.45" spread=".72"/>
                    <measurement group_id="O3" value="3.77" spread=".74"/>
                    <measurement group_id="O4" value="4.89" spread=".59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2-Days during the routine post-operative hospital stay; the duration in which tDCS was delivered.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>tDCS Full Dose</title>
          <description>4 active treatments&#xD;
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.</description>
        </group>
        <group group_id="E2">
          <title>tDCS Half Dose</title>
          <description>2 active treatments&#xD;
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.</description>
        </group>
        <group group_id="E3">
          <title>tDCS Minimal Dose</title>
          <description>1 active treatment&#xD;
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.</description>
        </group>
        <group group_id="E4">
          <title>Sham tDCS</title>
          <description>no active treatments&#xD;
Transcranial Direct Current Stimulation: Stimulation of brain areas associated with pain perception using low amplitude direct current delivered by electrodes attached to the scalp.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="29"/>
              </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="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jeffrey Borckardt, Ph.D</name_or_title>
      <organization>Ralph H. Johnson VA Medical Center</organization>
      <phone>843-792-3295</phone>
      <email>Jeffrey.Borckardt@va.gov</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/NCT02241967
org study id: CLIN-005-13F
secondary id: CX001078
nct id: NCT02241967
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The proper control of acute and chronic pain is one of the most important areas in health
      care. Despite the profound advances in neuroscience over the past 20 years, the investigators
      still largely use opiate narcotics, much as was done in the Civil War. Total knee
      arthroplasty (TKA) is one of the most common orthopedic procedures performed 1. While knee
      pain is often a complaint that precedes TKA, the procedure itself is associated with
      considerable post-operative pain lasting days to weeks. Adequate postoperative pain control
      is an important factor in determining recovery time and hospital length of stay. New
      analgesic strategies are needed that can be used adjunctively to existing strategies with the
      potential to reduce reliance on opioid analgesia. Several novel brain stimulation
      technologies including transcranial magnetic stimulation (TMS) and transcranial direct
      current stimulation (tDCS) are beginning to demonstrate promise as treatments for a variety
      of pain conditions. Electricity has no metabolite or other residue, and can be delivered with
      minimal discomfort and without problems associated with drug-drug interactions. In two
      independent preliminary pilot studies, the Investigators have shown that tDCS can reduce
      post-operative PCA use by as much as 46% while simultaneously reducing subjective pain
      ratings. The present study aims to determine the effects of transcranial direct current
      stimulation (tDCS) on post-operative pain, patient-controlled analgesia (PCA) use, and
      post-surgical complications during the 48-hour post-operative period following total knee
      arthroplasty.
The proposed study employs a randomized, double-blind, sham-controlled design to evaluate the
      effects of tDCS on pain among Veterans receiving unilateral total knee arthroplasty (TKA) and
      unilateral total hip arthroplasty (THA). Further, this study will examine dose-dependency of
      the tDCS analgesic effects. Each tDCS session delivered either 20 min of real or sham tDCS.
      Real tDCS was administered at 2mA whereas sham tDCS delivered none.

      120 patients undergoing TKA will be randomly assigned to one of four groups:Group 1 will have
      4 sessions of real tDCS, Group 2 - 2 sessions of real tDCS (+ 2 sham-sessions), and Group 3 -
      1 session of real tDCS (+ 3 sham-sessions). Group 4 is "Sham" tDCS, which does not involve
      any real stimulation. The participants will receive 2 tDCS treatments on the day of their
      surgery, and 2 tDCS treatments the day after their surgery.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Post-operative Opioid Pain Medication Dose
time frame: 2-Days
description: Patient Controlled Analgesia pump usage will be measured (mg of morphine-equivalent) during the acute post-operative period.
measure: Patient-reported Pain Intensity Ratings
time frame: 2-Days
description: Patients reported pain intensity using a visual analog scale (VAS) before and after each tDCS session during the 2 day routine postoperative hospital stay. Patients reported pain intensity by marking a line anchored with a minimum of "0- no pain at all" to maximum of "10- worst pain imaginable." Lower values represent a more favorable outcome. This outcome data is the sum of all VAS scores collected before and after each tDCS session during the 2-day hospital stay, thus each participant had a total of 8 VAS scores during the experimental intervention during hospital stay.
measure: Patient-reported Average Pain Ratings
time frame: 6 Months
description: Visual analogue scale pain ratings will be collected during the perioperative and post-discharge periods . Visual analogue scale ratings range from 0-10; a blank line is anchored with a 0 and 10 with the following labels: "0- no pain," "10-worst pain imaginable."
arm group label: tDCS Full Dose
arm group type: Experimental
description: 4 active treatments
arm group label: tDCS Half Dose
arm group type: Experimental
description: 2 active treatments
arm group label: tDCS Minimal dose
arm group type: Experimental
description: 1 active treatment
arm group label: Sham tDCS
arm group type: Sham Comparator
description: no active treatments
intervention type: Device
intervention name: 4 Real sessions of Transcranial Direct Current Stimulation
description: Stimulation of brain areas associated with pain perception using low amplitude direct current of 2mA delivered by electrodes attached to the scalp.
arm group label: tDCS Full Dose
other name: tDCS Full Dose
intervention type: Device
intervention name: 2 Real Sessions of Transcranial Direct Current Stimulation
description: Stimulation of brain areas associated with pain perception using low amplitude direct current of 2mA delivered by electrodes attached to the scalp. 2 real sessions of tDCS and 2 sham.
arm group label: tDCS Half Dose
other name: tDCS Half Dose
intervention type: Device
intervention name: 1 Real Session of Transcranial Direct Current Stimulation
description: Stimulation of brain areas associated with pain perception using low amplitude direct current of 2mA delivered by electrodes attached to the scalp. 1 real sessions of tDCS and 3 sham.
arm group label: tDCS Minimal dose
other name: tDCS Minimal Dose
intervention type: Device
intervention name: Sham Transcranial Direct Current Stimulation
description: Four sessions of sham tDCS; control intervention.
arm group label: Sham tDCS
other name: Sham tDCS
criteria: 
gender: All
minimum age: 19 Years
maximum age: 90 Years
healthy volunteers: No
last name: Jeffrey J Borckardt, PhD
role: Principal Investigator
affiliation: Ralph H. Johnson VA Medical Center, Charleston, SC
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pain, Postoperative
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 