<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/NCT03237208</url>
  </required_header>
  <id_info>
    <org_study_id>08.06.2017/02</org_study_id>
    <nct_id>NCT03237208</nct_id>
  </id_info>
  <brief_title>Transcutaneous Electrical Nerve Stimulation Treatment of Renal Colic</brief_title>
  <official_title>Patients Undergoing Routine Transcutaneous Electrical Nerve Stimulation Treatment in Patients With Renal Colic Who Admitted to the Emergency Department: A Randomized Double Blind Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Adiyaman University Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Adiyaman University Research Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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 present trial was to investigate the analgesic efficacy and safety of&#xD;
      Transcutaneous electrical nerve stimulation treatment in patients with renal colic within the&#xD;
      emergency department.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Renal colic, an intensely painful condition, is a common presenting complaint to the&#xD;
      emergency department. Parenteral opioids, nonsteroidal anti-inflammatory drugs and&#xD;
      acetaminophen are commonly used to provide relief from renal colic. The aim of the present&#xD;
      trial was to investigate the analgesic efficacy and safety of Transcutaneous electrical nerve&#xD;
      stimulation treatment in patients with renal colic within the emergency department.&#xD;
&#xD;
      Study Design and Setting: A prospective, randomized, double-blind, placebo controlled,&#xD;
      single-center, clinical trial will be conducted in emergency department of a tertiary care&#xD;
      university hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 12, 2017</start_date>
  <completion_date type="Actual">August 20, 2017</completion_date>
  <primary_completion_date type="Actual">August 12, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction of the intensity of pain</measure>
    <time_frame>0 minutes, 15 minutes and 30 minutes after taking Transcutaneous Electrical Nerve Stimulation application</time_frame>
    <description>Subjects will complete 100 mm visual analog scales at time zero, 15 and 30 minutes after taking Transcutaneous Electrical Nerve Stimulation application</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>30 minutes after</time_frame>
    <description>30 minutes after taking Transcutaneous Electrical Nerve Stimulation application</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Renal Colic</condition>
  <arm_group>
    <arm_group_label>TENS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receiving the real transcutaneous electrical nerve stimulation (TENS) with 100 hertz, pulse width 200 microseconds, voltage 2 milliampere</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients receiving the application of transcutaneous electrical nerve stimulation, but transcutaneous electrical nerve stimulation will not be activated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TENS</intervention_name>
    <description>Transcutaneous electrical nerve stimulation (TENS) treatment will be activated.</description>
    <arm_group_label>TENS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>placebo group</intervention_name>
    <description>Transcutaneous electrical nerve stimulation treatment will not be activated.</description>
    <arm_group_label>placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult patients with renal colic admitted to emergency department.&#xD;
&#xD;
          2. Adult patients who were definitively diagnosed with acute renal colic due to urinary&#xD;
             system stones using unenhanced computed abdominopelvic tomography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients below 18 years of age&#xD;
&#xD;
          2. Patients with haemodynamic instability, with fever (temperature=38°C [100.4°F]), with&#xD;
             evidence of peritoneal inflammation,&#xD;
&#xD;
          3. Patients using any analgesic within the previous 48 hours of emergency department&#xD;
             presentation&#xD;
&#xD;
          4. Patients who declined to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Umut Gulacti, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Adiyaman University of Medical Faculty</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Adiyaman University Research Hospital</name>
      <address>
        <city>Adıyaman</city>
        <state>Central</state>
        <zip>02000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Simpson PM, Fouche PF, Thomas RE, Bendall JC. Transcutaneous electrical nerve stimulation for relieving acute pain in the prehospital setting: a systematic review and meta-analysis of randomized-controlled trials. Eur J Emerg Med. 2014 Feb;21(1):10-7. doi: 10.1097/MEJ.0b013e328363c9c1.</citation>
    <PMID>23839103</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>September 8, 2017</last_update_submitted>
  <last_update_submitted_qc>September 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Adiyaman University Research Hospital</investigator_affiliation>
    <investigator_full_name>Umut Gulacti</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Transcutaneous electrical nerve stimulation</keyword>
  <keyword>emergency medicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colic</mesh_term>
    <mesh_term>Renal Colic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03237208
org study id: 08.06.2017/02
nct id: NCT03237208
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of the present trial was to investigate the analgesic efficacy and safety of
      Transcutaneous electrical nerve stimulation treatment in patients with renal colic within the
      emergency department.
Renal colic, an intensely painful condition, is a common presenting complaint to the
      emergency department. Parenteral opioids, nonsteroidal anti-inflammatory drugs and
      acetaminophen are commonly used to provide relief from renal colic. The aim of the present
      trial was to investigate the analgesic efficacy and safety of Transcutaneous electrical nerve
      stimulation treatment in patients with renal colic within the emergency department.

      Study Design and Setting: A prospective, randomized, double-blind, placebo controlled,
      single-center, clinical trial will be conducted in emergency department of a tertiary care
      university hospital.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Reduction of the intensity of pain
time frame: 0 minutes, 15 minutes and 30 minutes after taking Transcutaneous Electrical Nerve Stimulation application
description: Subjects will complete 100 mm visual analog scales at time zero, 15 and 30 minutes after taking Transcutaneous Electrical Nerve Stimulation application
measure: Adverse events
time frame: 30 minutes after
description: 30 minutes after taking Transcutaneous Electrical Nerve Stimulation application
arm group label: TENS
arm group type: Active Comparator
description: Patients receiving the real transcutaneous electrical nerve stimulation (TENS) with 100 hertz, pulse width 200 microseconds, voltage 2 milliampere
arm group label: placebo group
arm group type: Sham Comparator
description: Patients receiving the application of transcutaneous electrical nerve stimulation, but transcutaneous electrical nerve stimulation will not be activated.
intervention type: Device
intervention name: TENS
description: Transcutaneous electrical nerve stimulation (TENS) treatment will be activated.
arm group label: TENS
intervention type: Device
intervention name: placebo group
description: Transcutaneous electrical nerve stimulation treatment will not be activated.
arm group label: placebo group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Umut Gulacti, M.D.
role: Principal Investigator
affiliation: Adiyaman University of Medical Faculty
facility: 
country: Turkey
citation: Simpson PM, Fouche PF, Thomas RE, Bendall JC. Transcutaneous electrical nerve stimulation for relieving acute pain in the prehospital setting: a systematic review and meta-analysis of randomized-controlled trials. Eur J Emerg Med. 2014 Feb;21(1):10-7. doi: 10.1097/MEJ.0b013e328363c9c1.
PMID: 23839103
responsible party type: Principal Investigator
investigator affiliation: Adiyaman University Research Hospital
investigator full name: Umut Gulacti
investigator title: Principal Investigator
mesh term: Colic
mesh term: Renal Colic
sharing ipd: Undecided