<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/NCT02196129</url>
  </required_header>
  <id_info>
    <org_study_id>JS-CT-2014-02</org_study_id>
    <nct_id>NCT02196129</nct_id>
  </id_info>
  <brief_title>Immediate Pain Relieving Effects of Sinbaro-3 for Low Back Pain</brief_title>
  <official_title>Immediate Pain Relieving Effects of Sinbaro-3 Pharmaco-acupuncture in Low Back Pain Patients; A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jaseng Hospital of Korean Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jaseng Hospital of Korean Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the immediate pain relieving effects of sinbaro-3&#xD;
      pharmaco-acupuncture in patients with low back pain admitted for inpatient care&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      60 patients with LBP with moderate to severe pain(NRS&gt;6) were randomly allocated to 2 groups.&#xD;
      The experimental group was treated with sinbaro-3 pharmacoacupuncture and the control group&#xD;
      was treated with Hwangryun pharmacoacupuncture. All administrations were limited to 1&#xD;
      session, and comparisons of measurements were made before and after treatment. Primary&#xD;
      outcomes were measured using the VAS scale. Post-treatment follow-up will be performed to&#xD;
      measure primary outcomes at 30 minutes, 2hours, 4hours, and 6 hours after treatment. Before&#xD;
      and after each measurement, the patients are asked to stand up and rotate their torso. At&#xD;
      termination of the study, satisfaction levels of the patient's current status will also be&#xD;
      collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>Phase 3</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analogue Scale</measure>
    <time_frame>At baseline</time_frame>
    <description>The patient is asked to stand up and roatate the torso to the left and right, then asked to mark on the visual analogue scale the intensity of the pain they are experiencing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analogue Scale</measure>
    <time_frame>30 minutes following treatment</time_frame>
    <description>The patient is asked to stand up and roatate the torso to the left and right, then asked to mark on the visual analogue scale the intensity of the pain they are experiencing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analogue Scale</measure>
    <time_frame>2 hours following treatment</time_frame>
    <description>The patient is asked to stand up and roatate the torso to the left and right, then asked to mark on the visual analogue scale the intensity of the pain they are experiencing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analogue Scale</measure>
    <time_frame>4 hours following treatment</time_frame>
    <description>The patient is asked to stand up and roatate the torso to the left and right, then asked to mark on the visual analogue scale the intensity of the pain they are experiencing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analogue Scale</measure>
    <time_frame>6 hours following treatment</time_frame>
    <description>The patient is asked to stand up and roatate the torso to the left and right, then asked to mark on the visual analogue scale the intensity of the pain they are experiencing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Satisfaction levels</measure>
    <time_frame>6hrs following treatment</time_frame>
    <description>7-point Likert scale</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Expected treatment effects</measure>
    <time_frame>At baseline</time_frame>
    <description>The patients are asked to reply how effective they think the treatment is going to be on a 6-point Likert-scale</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Low Back Pain With Radiculopathy</condition>
  <condition>Low Back Pain Without Radiculopathy</condition>
  <condition>Herniated Intervertebral Disc</condition>
  <arm_group>
    <arm_group_label>Sinbaro-3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1cc Harpagophytum Procumbens(freeze drying) pharmacoacupuncture adminstered to 6 acupoints at the site of pain Administered once and once only before any interventions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hwangryun(distillation)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>1cc Hwangryun(distillation) pharmaco-acupuncture administered to 6 acupoints at the site of pain Administered once and once only before any other intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sinbaro-3</intervention_name>
    <description>1cc administered to site of pain(ashi acupoints), once and once only before any other intervention/if pain in both low back and extermities, the site of most pain</description>
    <arm_group_label>Sinbaro-3</arm_group_label>
    <other_name>Harpagophytum Procumbens</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hwangryun</intervention_name>
    <description>1cc administered to site of pain(ashi acupoints), once and once only before any other intervention/if pain in both low back and extermities, the site of most pain</description>
    <arm_group_label>Hwangryun(distillation)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients admitted to a Korean Medicine hospital for low back pain with or without&#xD;
             radiculopathy&#xD;
&#xD;
          -  Age between 18 and 69&#xD;
&#xD;
          -  NRS score of &gt;6 on the day of the intervention&#xD;
&#xD;
          -  Voluntary participation with written consent given to study consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of serious disease(s) which are possible causes of back pain such as&#xD;
             malignancy, vertebral fracture, spinal infection, inflammatory spondylitis, cauda&#xD;
             equina compression, etc.&#xD;
&#xD;
          -  Prior diagnosis of other chronic disease(s) which could affect effectiveness or&#xD;
             interpretation of treatment results such as cardiovascular disease, diabetic&#xD;
             neuropathy, fibromyalgia, rheumatoid arthritis, Alzheimer's disease, epilepsy, etc.&#xD;
&#xD;
          -  Progressive neurologic deficit(s) or concurrent severe neurological symptoms&#xD;
&#xD;
          -  Unsuitable for or at risk of complications from acupuncture treatment such as patients&#xD;
             with clotting disorders, severe diabetes with risk of infection, serious&#xD;
             cardiovascular disease, or undergoing anticoagulant treatment, etc.&#xD;
&#xD;
          -  Under prescription of corticosteroids, immuno-suppressant drugs, psychiatric medicine,&#xD;
             or other medication considered unsuitable for subjects by the researcher&#xD;
&#xD;
          -  Experience of gastroenteric complications after taking NSAIDs or currently undergoing&#xD;
             treatment for digestive disorders&#xD;
&#xD;
          -  During pregnancy or suspected pregnancy&#xD;
&#xD;
          -  Subjects considered unsuitable for clinical trial by the researcher&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joonshik Shin</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jaseng Hospital of Korean Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jaseng Hospital of Korean Medicine</name>
      <address>
        <city>Seoul</city>
        <state>Gangnam-Gu</state>
        <zip>135-896</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>November 5, 2018</last_update_submitted>
  <last_update_submitted_qc>November 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jaseng Hospital of Korean Medicine</investigator_affiliation>
    <investigator_full_name>In-Hyuk Ha</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>low back pain</keyword>
  <keyword>pharmacoacupuncture</keyword>
  <keyword>sinbaro-3</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intervertebral Disc Displacement</mesh_term>
    <mesh_term>Radiculopathy</mesh_term>
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</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/NCT02196129
org study id: JS-CT-2014-02
nct id: NCT02196129
lead sponsor: 
has dmc: Yes
The purpose of this study is to investigate the immediate pain relieving effects of sinbaro-3
      pharmaco-acupuncture in patients with low back pain admitted for inpatient care
60 patients with LBP with moderate to severe pain(NRS>6) were randomly allocated to 2 groups.
      The experimental group was treated with sinbaro-3 pharmacoacupuncture and the control group
      was treated with Hwangryun pharmacoacupuncture. All administrations were limited to 1
      session, and comparisons of measurements were made before and after treatment. Primary
      outcomes were measured using the VAS scale. Post-treatment follow-up will be performed to
      measure primary outcomes at 30 minutes, 2hours, 4hours, and 6 hours after treatment. Before
      and after each measurement, the patients are asked to stand up and rotate their torso. At
      termination of the study, satisfaction levels of the patient's current status will also be
      collected.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Visual Analogue Scale
time frame: At baseline
description: The patient is asked to stand up and roatate the torso to the left and right, then asked to mark on the visual analogue scale the intensity of the pain they are experiencing
measure: Visual Analogue Scale
time frame: 30 minutes following treatment
description: The patient is asked to stand up and roatate the torso to the left and right, then asked to mark on the visual analogue scale the intensity of the pain they are experiencing
measure: Visual Analogue Scale
time frame: 2 hours following treatment
description: The patient is asked to stand up and roatate the torso to the left and right, then asked to mark on the visual analogue scale the intensity of the pain they are experiencing
measure: Visual Analogue Scale
time frame: 4 hours following treatment
description: The patient is asked to stand up and roatate the torso to the left and right, then asked to mark on the visual analogue scale the intensity of the pain they are experiencing
measure: Visual Analogue Scale
time frame: 6 hours following treatment
description: The patient is asked to stand up and roatate the torso to the left and right, then asked to mark on the visual analogue scale the intensity of the pain they are experiencing
measure: Satisfaction levels
time frame: 6hrs following treatment
description: 7-point Likert scale
measure: Expected treatment effects
time frame: At baseline
description: The patients are asked to reply how effective they think the treatment is going to be on a 6-point Likert-scale
arm group label: Sinbaro-3
arm group type: Experimental
description: 1cc Harpagophytum Procumbens(freeze drying) pharmacoacupuncture adminstered to 6 acupoints at the site of pain Administered once and once only before any interventions
arm group label: Hwangryun(distillation)
arm group type: Placebo Comparator
description: 1cc Hwangryun(distillation) pharmaco-acupuncture administered to 6 acupoints at the site of pain Administered once and once only before any other intervention
intervention type: Drug
intervention name: Sinbaro-3
description: 1cc administered to site of pain(ashi acupoints), once and once only before any other intervention/if pain in both low back and extermities, the site of most pain
arm group label: Sinbaro-3
other name: Harpagophytum Procumbens
intervention type: Drug
intervention name: Hwangryun
description: 1cc administered to site of pain(ashi acupoints), once and once only before any other intervention/if pain in both low back and extermities, the site of most pain
arm group label: Hwangryun(distillation)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 69 Years
healthy volunteers: No
last name: Joonshik Shin
role: Principal Investigator
affiliation: Jaseng Hospital of Korean Medicine
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Jaseng Hospital of Korean Medicine
investigator full name: In-Hyuk Ha
investigator title: Dr
mesh term: Intervertebral Disc Displacement
mesh term: Radiculopathy
mesh term: Back Pain
mesh term: Low Back Pain