<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/NCT03828877</url>
  </required_header>
  <id_info>
    <org_study_id>2018/13-26</org_study_id>
    <nct_id>NCT03828877</nct_id>
  </id_info>
  <brief_title>The Effect of Acupuncture on the Treatment of Endovenous Ablation on Pain, IL17 and IL 23</brief_title>
  <official_title>The Effect of Acupuncture on Pain, IL 17 and IL 23 in Endovenous Ablation; Prospective, Randomized, Controlled Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kahramanmaras Sutcu Imam University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kahramanmaras Sutcu Imam University</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>
      Acupuncture has emerged in China about 2,000 years ago and is one of the oldest medical&#xD;
      procedures in the world. Acupuncture continued to evolve and develop over the centuries, and&#xD;
      gradually became one of the standard treatments used in China. Introduced to other regions&#xD;
      such as Asia, Europe and the United States. The most extensive use of acupuncture is for pain&#xD;
      relief. The aim of this study was to prevent complications due to pain frequently seen in&#xD;
      patients who would be treated with endovenous ablation in the postoperative period. In&#xD;
      addition, the effect of acupuncture on operative hemodynamics, pain, vascular diameter,&#xD;
      postoperative, nausea, vomiting, pain and analgesic needs, IL17 and IL 23.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be divided into two groups. Control group (Group C, n: 35) and Acupuncture&#xD;
      group (Group A, n: 35). Inclusion criteria: willing to participate in the study, being in the&#xD;
      18-65 age range, a saphenous vein diameter greater than 5.5 mm and a small saphenous vein&#xD;
      diameter of less than 4 mm with reflux for greater than 0.5 s The patients with the study&#xD;
      will be taken.Exclusion criteria: patients outside the 18-65 age range, patients with deep&#xD;
      venous system obstruction, patients who have previously used another invasive treatment&#xD;
      method (thermal and chemical ablation, surgery), patients with heart and kidney failure,&#xD;
      patients with secondary varicose veins patients with hypercoagulable state, patients with&#xD;
      local or systemic infection, patients with obesity (body mass index&gt; 35), patients with&#xD;
      impaired consciousness, patients who do not want to participate in the study. Blood will be&#xD;
      taken from Group A and Group C patients for the measurement of IL 17 and IL 23 prior 24 hours&#xD;
      before the endovenous ablation procedure. Group A will be done LU 9 (Taiyuan), LU 7 (Lieque),&#xD;
      SP 6 (Sanyinjiao) , ST 36 (Suzanli), LI 4 (Hegu) and LIV 3 (Taichong) points to be&#xD;
      acupunctured. Vasculer access will be opened in the preoperative patient preparation room in&#xD;
      both patient groups.The points of the acupuncture group will be checked and recorded. The&#xD;
      falling press needle will be reapplied to replace the needles. Patients will be taken to the&#xD;
      operating room. In both patient groups, measurement of the vessel diameter by ultrasound&#xD;
      before the endovenous ablation procedure will be performed.During the endovenous ablation&#xD;
      procedure, SBP (Systolic blood pressure), DBP (Diastolic blood pressure), OAB (Mean arterial&#xD;
      pressure), HR (Heart rate), SPO2 (Oxygen) , the number of interventional procedures needed to&#xD;
      be successful and the duration of the procedure, the pain conditions during operation (VAS)&#xD;
      will be recorded in 1, 3, 5, 7, 10, 15 minutes.After completion of the procedure, ultrasound&#xD;
      vein ablation and measurement will be reassessed by the surgeon to evaluate the success of&#xD;
      the procedure.Nausea, vomiting, itching and pain conditions (VAS) will be measured again in&#xD;
      the postoperative 1, 30 and 60 minutes and a comparison will be made between the groups.After&#xD;
      the operation, the acupuncture points will be checked in the postoperative resting room and&#xD;
      if there are falling needles, the needles will be replaced again.Patients will be told that&#xD;
      acupuncture points should be stimulated from time to time and pres needle needles should be&#xD;
      protected for three days.On the 3rd postoperative day, patients will be referred to the&#xD;
      cardiovascular surgery outpatient clinic. Pain conditions (VAS) and analgesic consumption&#xD;
      will be evaluated.Preoperatively, postoperatively and on the 3rd day, the vessel diameters&#xD;
      will be measured and compared with ultrasonography.IL17 and IL 23 values will be compared&#xD;
      between both groups and before and after endovenous ablation.The effect of acupuncture on IL&#xD;
      17 and IL 23 will be investigated.Patients will also be told to return to the hospital&#xD;
      immediately in cases such as shortness of breath, edema, redness, pain in the legs and the&#xD;
      complications will be recorded.The aim of this study was to investigate the effect of&#xD;
      acupuncture on pain, IL17, IL 23 and vessel diameters in patients treated with N-Butyl&#xD;
      Cyanoacrylate, a new method in the treatment of endovenous ablation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 29, 2019</start_date>
  <completion_date type="Actual">March 7, 2019</completion_date>
  <primary_completion_date type="Actual">March 5, 2019</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>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>IL 17 and IL 23 values</measure>
    <time_frame>before operation and after the operation 3. days</time_frame>
    <description>Change From Baseline on the circulating levels of IL 17 and IL 23 ng/ L</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain (VAS Score)</measure>
    <time_frame>Change From Baseline of VAS Score in 1 minute,3 minute,5 minute,7 minute, 10 minute, 15 minute of pain level during operation.Each unit will be evaluated separately within itself</time_frame>
    <description>Change from Baseline VAS Score. from 1 to 10 , 0: No pain, 10: 10 pain that can not be tolerated</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain (VAS Score)</measure>
    <time_frame>Change From Baseline of VAS Score in1 minute,30 minute, 60 minute after operation and 3. days. Each unit will be evaluated separately within itself</time_frame>
    <description>Change from Baseline VAS Score (Visual analog scale) Score. from 1 to 10 , 0: No pain, 10: 10 pain that can not be tolerated</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>vessel measurement</measure>
    <time_frame>before the operation, after operation and after operation 3. days</time_frame>
    <description>Change from Baseline measurement (mm)with ultrasonografi</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Pain</condition>
  <condition>Interleukin</condition>
  <condition>Vessels; Varicose</condition>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Arm: Group C control group. Non-acupuncture group. Gruop C will be Control group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arm: Group A, group of acupuncture Akupunktur will be done with Pres Needle (0.22x1.5 mm) Blood will be taken for the measurement of IL 17 and IL 23 from Group A (Acupuncture) patients 24 hours prior to endovenous ablation procedure. Then, with press needle (0.22x1.5) LU 9 (Taiyuan), LU7 (Lieque), SP 6 (Sanyinjiao) , ST 36 (Zusanli), LI 4 (Hegu) and LIV 3 (Taichong) points will be applied acupuncture.On the 3rd day, patients will be called for control. Blood will also be taken from the blood to measure IL 17, IL 23 values.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group A ( Group Acupuncture)</intervention_name>
    <description>Group A; Acupunctur will be done with Pres Needle (0.22x1.5 mm).Acupuncture will be done points fo SP 6, LI 4 , ST 36 , LİV 3, LU 9 ,LU 7.</description>
    <arm_group_label>Group A</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Volunteers to participate in the study,&#xD;
&#xD;
          -  18-65 years of age,&#xD;
&#xD;
          -  patients with a saphenous vein diameter greater than 5.5 mm&#xD;
&#xD;
          -  small saphenous vein diameter of less than 4 mm with reflux for greater than 0.5 s&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients outside the 18-65 age range,&#xD;
&#xD;
          -  patients with deep venous system obstruction,&#xD;
&#xD;
          -  patients who have previously used another invasive treatment method (thermal and&#xD;
             chemical ablation, surgery),&#xD;
&#xD;
          -  patients with heart and kidney failure,&#xD;
&#xD;
          -  patients with secondary varicose veins,&#xD;
&#xD;
          -  patients with hypercoagulable state patients,&#xD;
&#xD;
          -  patients with local or systemic infections,&#xD;
&#xD;
          -  patients with obesity (body mass index&gt; 35),&#xD;
&#xD;
          -  patients with impaired consciousness,&#xD;
&#xD;
          -  patients who do not want to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>yavuz orak</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kahramanmaraş Sutcu Imam University Faculty of Medicine Kahramanmaraş</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kahramanmaras Sutcu Imam University Faculty of Medicine</name>
      <address>
        <city>Kahramanmaraş</city>
        <state>Onikişubat</state>
        <zip>251/A 46040</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>March 12, 2019</last_update_submitted>
  <last_update_submitted_qc>March 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kahramanmaras Sutcu Imam University</investigator_affiliation>
    <investigator_full_name>Yavuz Orak</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Acupuncture, Pain , IL 17, IL 23 and Vessel</keyword>
  <!-- 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/NCT03828877
org study id: 2018/13-26
nct id: NCT03828877
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Acupuncture has emerged in China about 2,000 years ago and is one of the oldest medical
      procedures in the world. Acupuncture continued to evolve and develop over the centuries, and
      gradually became one of the standard treatments used in China. Introduced to other regions
      such as Asia, Europe and the United States. The most extensive use of acupuncture is for pain
      relief. The aim of this study was to prevent complications due to pain frequently seen in
      patients who would be treated with endovenous ablation in the postoperative period. In
      addition, the effect of acupuncture on operative hemodynamics, pain, vascular diameter,
      postoperative, nausea, vomiting, pain and analgesic needs, IL17 and IL 23.
Patients will be divided into two groups. Control group (Group C, n: 35) and Acupuncture
      group (Group A, n: 35). Inclusion criteria: willing to participate in the study, being in the
      18-65 age range, a saphenous vein diameter greater than 5.5 mm and a small saphenous vein
      diameter of less than 4 mm with reflux for greater than 0.5 s The patients with the study
      will be taken.Exclusion criteria: patients outside the 18-65 age range, patients with deep
      venous system obstruction, patients who have previously used another invasive treatment
      method (thermal and chemical ablation, surgery), patients with heart and kidney failure,
      patients with secondary varicose veins patients with hypercoagulable state, patients with
      local or systemic infection, patients with obesity (body mass index> 35), patients with
      impaired consciousness, patients who do not want to participate in the study. Blood will be
      taken from Group A and Group C patients for the measurement of IL 17 and IL 23 prior 24 hours
      before the endovenous ablation procedure. Group A will be done LU 9 (Taiyuan), LU 7 (Lieque),
      SP 6 (Sanyinjiao) , ST 36 (Suzanli), LI 4 (Hegu) and LIV 3 (Taichong) points to be
      acupunctured. Vasculer access will be opened in the preoperative patient preparation room in
      both patient groups.The points of the acupuncture group will be checked and recorded. The
      falling press needle will be reapplied to replace the needles. Patients will be taken to the
      operating room. In both patient groups, measurement of the vessel diameter by ultrasound
      before the endovenous ablation procedure will be performed.During the endovenous ablation
      procedure, SBP (Systolic blood pressure), DBP (Diastolic blood pressure), OAB (Mean arterial
      pressure), HR (Heart rate), SPO2 (Oxygen) , the number of interventional procedures needed to
      be successful and the duration of the procedure, the pain conditions during operation (VAS)
      will be recorded in 1, 3, 5, 7, 10, 15 minutes.After completion of the procedure, ultrasound
      vein ablation and measurement will be reassessed by the surgeon to evaluate the success of
      the procedure.Nausea, vomiting, itching and pain conditions (VAS) will be measured again in
      the postoperative 1, 30 and 60 minutes and a comparison will be made between the groups.After
      the operation, the acupuncture points will be checked in the postoperative resting room and
      if there are falling needles, the needles will be replaced again.Patients will be told that
      acupuncture points should be stimulated from time to time and pres needle needles should be
      protected for three days.On the 3rd postoperative day, patients will be referred to the
      cardiovascular surgery outpatient clinic. Pain conditions (VAS) and analgesic consumption
      will be evaluated.Preoperatively, postoperatively and on the 3rd day, the vessel diameters
      will be measured and compared with ultrasonography.IL17 and IL 23 values will be compared
      between both groups and before and after endovenous ablation.The effect of acupuncture on IL
      17 and IL 23 will be investigated.Patients will also be told to return to the hospital
      immediately in cases such as shortness of breath, edema, redness, pain in the legs and the
      complications will be recorded.The aim of this study was to investigate the effect of
      acupuncture on pain, IL17, IL 23 and vessel diameters in patients treated with N-Butyl
      Cyanoacrylate, a new method in the treatment of endovenous ablation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: IL 17 and IL 23 values
time frame: before operation and after the operation 3. days
description: Change From Baseline on the circulating levels of IL 17 and IL 23 ng/ L
measure: Pain (VAS Score)
time frame: Change From Baseline of VAS Score in 1 minute,3 minute,5 minute,7 minute, 10 minute, 15 minute of pain level during operation.Each unit will be evaluated separately within itself
description: Change from Baseline VAS Score. from 1 to 10 , 0: No pain, 10: 10 pain that can not be tolerated
measure: Pain (VAS Score)
time frame: Change From Baseline of VAS Score in1 minute,30 minute, 60 minute after operation and 3. days. Each unit will be evaluated separately within itself
description: Change from Baseline VAS Score (Visual analog scale) Score. from 1 to 10 , 0: No pain, 10: 10 pain that can not be tolerated
measure: vessel measurement
time frame: before the operation, after operation and after operation 3. days
description: Change from Baseline measurement (mm)with ultrasonografi
arm group label: Group C
arm group type: No Intervention
description: Arm: Group C control group. Non-acupuncture group. Gruop C will be Control group.
arm group label: Group A
arm group type: Active Comparator
description: Arm: Group A, group of acupuncture Akupunktur will be done with Pres Needle (0.22x1.5 mm) Blood will be taken for the measurement of IL 17 and IL 23 from Group A (Acupuncture) patients 24 hours prior to endovenous ablation procedure. Then, with press needle (0.22x1.5) LU 9 (Taiyuan), LU7 (Lieque), SP 6 (Sanyinjiao) , ST 36 (Zusanli), LI 4 (Hegu) and LIV 3 (Taichong) points will be applied acupuncture.On the 3rd day, patients will be called for control. Blood will also be taken from the blood to measure IL 17, IL 23 values.
intervention type: Other
intervention name: Group A ( Group Acupuncture)
description: Group A; Acupunctur will be done with Pres Needle (0.22x1.5 mm).Acupuncture will be done points fo SP 6, LI 4 , ST 36 , LİV 3, LU 9 ,LU 7.
arm group label: Group A
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: yavuz orak
role: Principal Investigator
affiliation: Kahramanmaraş Sutcu Imam University Faculty of Medicine Kahramanmaraş
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Kahramanmaras Sutcu Imam University
investigator full name: Yavuz Orak
investigator title: Assistant Professor