<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/NCT03761862</url>
  </required_header>
  <id_info>
    <org_study_id>Neuraltherapyinbtl</org_study_id>
    <nct_id>NCT03761862</nct_id>
  </id_info>
  <brief_title>Evaluation of the Neural Therapy Effect on Long Term Postoperative Discomforts in Patients Who Undergo Bilateral Tubal Ligation</brief_title>
  <official_title>Evaluation of the Neural Therapy Effect on Long Term Postoperative Discomforts and Gynecologic Symptoms in Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kanuni Sultan Suleyman Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kanuni Sultan Suleyman Training and Research Hospital</source>
  <oversight_info>
    <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 this study was to explore the effect of neural therapy on postoperative pain and&#xD;
      discomfort such as abdominal swelling; and gynecologic symptoms such as dysmenorrhea,&#xD;
      dyspareunia, amount of menstrual bleeding and vaginitis. It also aimed to find out any&#xD;
      possible links between the clinical changes and pathophysiologic mechanisms. One hundred and&#xD;
      thirteen patients were randomly divided into two groups (neural therapy and control).&#xD;
      Postoperative first day, neural therapy was applied to the T10 to S4 dermatomes and&#xD;
      utero-vaginal ganglion in random with local anesthetic agent. All patients were recalled one&#xD;
      year after the treatment. The visual analog scale (VAS) were noted in both groups, also&#xD;
      discomfort and gynecologic symptoms are recorded.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">December 1, 2018</completion_date>
  <primary_completion_date type="Actual">December 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pain scores</measure>
    <time_frame>1 year later</time_frame>
    <description>Visual Analog Scale was used as the pain scale.1 to 10 points are given here. High score (8- 10) indicates severe pain.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">113</enrollment>
  <condition>Pain, Postoperative</condition>
  <condition>Neural Therapy of Huneke</condition>
  <condition>Dysmenorrhea</condition>
  <condition>Dyspareunia</condition>
  <condition>Sterilization, Tubal</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>The control group with bilateral tubal ligation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Neural Therapy</arm_group_label>
    <description>The treatment group</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Neural Therapy</intervention_name>
    <description>Neural therapy is a form of alternative medicine in which local anesthetic is injected into certain locations of the body in an attempt to treat chronic pain and illness.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Neural Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who undergo bilateral tubal ligation admitted to the training and research&#xD;
        hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who undergo bilateral tubal ligation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous abdominal surgery&#xD;
&#xD;
          -  Patients with diseases that could have neurologic complications (DM, SLE ...)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>November 30, 2018</last_update_submitted>
  <last_update_submitted_qc>November 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kanuni Sultan Suleyman Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Pınar Yalcin bahat</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyspareunia</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Dysmenorrhea</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/NCT03761862
org study id: Neuraltherapyinbtl
nct id: NCT03761862
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to explore the effect of neural therapy on postoperative pain and
      discomfort such as abdominal swelling; and gynecologic symptoms such as dysmenorrhea,
      dyspareunia, amount of menstrual bleeding and vaginitis. It also aimed to find out any
      possible links between the clinical changes and pathophysiologic mechanisms. One hundred and
      thirteen patients were randomly divided into two groups (neural therapy and control).
      Postoperative first day, neural therapy was applied to the T10 to S4 dermatomes and
      utero-vaginal ganglion in random with local anesthetic agent. All patients were recalled one
      year after the treatment. The visual analog scale (VAS) were noted in both groups, also
      discomfort and gynecologic symptoms are recorded.
observational model: Other
time perspective: Retrospective
measure: Pain scores
time frame: 1 year later
description: Visual Analog Scale was used as the pain scale.1 to 10 points are given here. High score (8- 10) indicates severe pain.
arm group label: Control
description: The control group with bilateral tubal ligation
arm group label: Neural Therapy
description: The treatment group
intervention type: Procedure
intervention name: Neural Therapy
description: Neural therapy is a form of alternative medicine in which local anesthetic is injected into certain locations of the body in an attempt to treat chronic pain and illness.
arm group label: Control
arm group label: Neural Therapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Kanuni Sultan Suleyman Training and Research Hospital
investigator full name: Pınar Yalcin bahat
investigator title: Principal Investigator
mesh term: Dyspareunia
mesh term: Pain, Postoperative
mesh term: Dysmenorrhea