<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/NCT01722253</url>
  </required_header>
  <id_info>
    <org_study_id>225</org_study_id>
    <nct_id>NCT01722253</nct_id>
  </id_info>
  <brief_title>Postoperative Analgesia After Low Frequency Electroacupuncture</brief_title>
  <acronym>LFE</acronym>
  <official_title>Postoperative Analgesia After Low Frequency Electroacupuncture as Adjunctive Therapy in Inguinal Hernia Surgery With Abdominal Wall Mesh Reconstruction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aristotle University Of Thessaloniki</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aristotle University Of Thessaloniki</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether electroacupuncture is a effective tool to&#xD;
      the postoperative analgesia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The electroacupuncture is a known therapeutic modality with particular application to pain.&#xD;
      In this study the investigators investigate the effect of electroacupuncture in condition of&#xD;
      surgery, which is a particularly painful situation. The investigators will verify the&#xD;
      postoperative analgesia, as patients will receive either electroacupuncture or placebo&#xD;
      electroacupuncture.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2008</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Monitoring of pain with the Visual Analogue scale within the first 24 hours after surgery</measure>
    <time_frame>within the first 24 hours after surgery</time_frame>
    <description>Monitoring of pain with the Visual Analogue scale performed preoperatively and at 30, 90 min, 10 hours and 24 hours after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Control of anxiety with the State-Trait Anxiety Inventory within 24 hours after surgery</measure>
    <time_frame>within the first 24 hours after surgery</time_frame>
    <description>The State-Trait Anxiety Inventory performed preoperatively and at 30, 90 min, 10 hours and 24 hours after surgery</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Monitoring of pain with the use of an algometer within the first 24 hours after surgery</measure>
    <time_frame>within the first 24 hours after surgery</time_frame>
    <description>Monitoring of pain with the use of an algometer performed preoperatively and at 30, 90 min, 10 hours and 24 hours after surgery</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">54</enrollment>
  <condition>Inguinal Hernia</condition>
  <arm_group>
    <arm_group_label>placebo, electroacupuncture</arm_group_label>
    <description>Electroacupuncture before and after surgery (40min and 60 min respectively) with frequency 2 Hz, and 'frequency scanning mode'.&#xD;
Placebo electroacupuncture, in which the needles are secured (without penetrating the skin) and connected to the electrical device, which is not functional.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Electroacupuncture</intervention_name>
    <description>Electrical stimulation device with frequency 2 Hz and 'frequency scanning mode'</description>
    <arm_group_label>placebo, electroacupuncture</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum, plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients in the Surgical Clinic with right or left inguinal hernia, residents of Thessaly,&#xD;
        Greece.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        inclusion criteria:&#xD;
&#xD;
          -  healthy male volunteers&#xD;
&#xD;
          -  18-75 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  bilateral or recurrent hernia&#xD;
&#xD;
          -  significant cardiovascular, pulmonary, renal, hepatic, neurological disease&#xD;
&#xD;
          -  psychiatric history&#xD;
&#xD;
          -  use of opioids until the last month&#xD;
&#xD;
          -  body mass index greater than 30&#xD;
&#xD;
          -  treatment with beta-blockers&#xD;
&#xD;
          -  aged over 75&#xD;
&#xD;
          -  previous experience with acupuncture&#xD;
&#xD;
          -  hypersensitivity to opioids&#xD;
&#xD;
          -  pacemaker patient&#xD;
&#xD;
          -  patients being treated with monoamine oxidase inhibitors and selective serotonin&#xD;
             reuptake inhibitors.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dimitrios G Vasilakos, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Aristotle University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maria I Dalamagka, consultant</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aristotle University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aristotle University</name>
      <address>
        <city>Thessaloniki</city>
        <zip>54124</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>November 3, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <last_update_submitted>June 4, 2015</last_update_submitted>
  <last_update_submitted_qc>June 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 8, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aristotle University Of Thessaloniki</investigator_affiliation>
    <investigator_full_name>Maria I. Dalamagka</investigator_full_name>
    <investigator_title>consultant Anaesthesiologist</investigator_title>
  </responsible_party>
  <keyword>electroacupuncture</keyword>
  <keyword>acupuncture</keyword>
  <keyword>pain management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Inguinal</mesh_term>
  </condition_browse>
  <!-- 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/NCT01722253
org study id: 225
nct id: NCT01722253
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine whether electroacupuncture is a effective tool to
      the postoperative analgesia
The electroacupuncture is a known therapeutic modality with particular application to pain.
      In this study the investigators investigate the effect of electroacupuncture in condition of
      surgery, which is a particularly painful situation. The investigators will verify the
      postoperative analgesia, as patients will receive either electroacupuncture or placebo
      electroacupuncture.
observational model: Case-Control
time perspective: Retrospective
measure: Monitoring of pain with the Visual Analogue scale within the first 24 hours after surgery
time frame: within the first 24 hours after surgery
description: Monitoring of pain with the Visual Analogue scale performed preoperatively and at 30, 90 min, 10 hours and 24 hours after surgery
measure: Control of anxiety with the State-Trait Anxiety Inventory within 24 hours after surgery
time frame: within the first 24 hours after surgery
description: The State-Trait Anxiety Inventory performed preoperatively and at 30, 90 min, 10 hours and 24 hours after surgery
measure: Monitoring of pain with the use of an algometer within the first 24 hours after surgery
time frame: within the first 24 hours after surgery
description: Monitoring of pain with the use of an algometer performed preoperatively and at 30, 90 min, 10 hours and 24 hours after surgery
arm group label: placebo, electroacupuncture
description: Electroacupuncture before and after surgery (40min and 60 min respectively) with frequency 2 Hz, and 'frequency scanning mode'.
Placebo electroacupuncture, in which the needles are secured (without penetrating the skin) and connected to the electrical device, which is not functional.
intervention type: Procedure
intervention name: Electroacupuncture
description: Electrical stimulation device with frequency 2 Hz and 'frequency scanning mode'
arm group label: placebo, electroacupuncture
serum, plasma
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dimitrios G Vasilakos, Professor
role: Study Chair
affiliation: Aristotle University
last name: Maria I Dalamagka, consultant
role: Principal Investigator
affiliation: Aristotle University
facility: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: Aristotle University Of Thessaloniki
investigator full name: Maria I. Dalamagka
investigator title: consultant Anaesthesiologist
mesh term: Hernia
mesh term: Hernia, Inguinal