<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/NCT03236753</url>
  </required_header>
  <id_info>
    <org_study_id>KHNMCOH 2016-09-006</org_study_id>
    <nct_id>NCT03236753</nct_id>
  </id_info>
  <brief_title>Clinical Research on the Efficacy of Thread-embedding Acupuncture on Herniated Intervertebral Disc of Lumbar Spine</brief_title>
  <official_title>Clinical Research on the Efficacy and Safety of Thread-embedding Acupuncture for Treatment of Herniated Intervertebral Disc of Lumbar Spine; A Multicenter, Randomized, Patient-assessor Blinded, Controlled, Parallel Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kyunghee University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kyung Hee University Hospital at Gangdong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>DongGuk University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Daegu Korean Medicine Hospital of Daegu Haany University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kyunghee University Medical Center</source>
  <oversight_info>
    <has_dmc>No</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>
      This clinical trial is designed to evaluate the efficacy and safety of thread-embedding&#xD;
      acupuncture for treatment of lumbar herniated intervertebral disc (L-HIVD) by assessing pain,&#xD;
      function, and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Seventy patient between the ages of 19 and 70 with L-HIVD will be recruited by eligibility&#xD;
      criteria and randomly allocated to the thread-embedding acupuncture (TEA) group and sham&#xD;
      thread-embedding acupuncture (STEA) group. Both groups will receive treatment on predefined&#xD;
      23 acupoints once a week for 8 weeks, and needle with thread removed will be used in STEA&#xD;
      group instead of normal TEA. 100 mm visual analogue scale (VAS) for low back pain will be&#xD;
      assessed as a primary outcome. Also, 100mm VAS for radiating pain, Oswestry disability index&#xD;
      (ODI), Rolland Morris disability questionnaire (RMDQ), EQ-5D-5L and global perceived effect&#xD;
      (GPE) will be measured as secondary outcomes. All the outcomes will be assessed at baseline,&#xD;
      4 weeks after screening, treatment end (8 weeks, primary end point) and follow-up sessions&#xD;
      (12 and 16 weeks).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 11, 2017</start_date>
  <completion_date type="Actual">July 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 4, 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>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline 100mm Pain Visual Analogue Scale (VAS) for low back pain at Week 8</measure>
    <time_frame>Week 1 (Baseline), Week 4, Week 8 (Primary end point, Treatment end), Week 12, Week 16 (F/U)</time_frame>
    <description>Measurement instrument for subjective pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>100mm Pain Visual Analogue Scale (VAS) for radiating pain</measure>
    <time_frame>Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U)</time_frame>
    <description>Measurement instrument for subjective pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oswestry Disability Index (ODI)</measure>
    <time_frame>Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U)</time_frame>
    <description>Validated questionnaire for disability of low back pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQol-5 dimensions-5 level (EQ-5D-5L)</measure>
    <time_frame>Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U)</time_frame>
    <description>Standardized instrument for generic health status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Roland-Morris Disability Questionnaire (RMDQ)</measure>
    <time_frame>Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U)</time_frame>
    <description>Health status measure for low back pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Perceived Effect (GPE)</measure>
    <time_frame>Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U)</time_frame>
    <description>Assessment of change in the patient's chief complaint</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Lumbar Disc Herniation</condition>
  <arm_group>
    <arm_group_label>Thread-Embedding Acupuncture (TEA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The TEA group will be treated once a week for 8 weeks, using 29G x 40mm or 29G x 60mm TEA on predefined 23 acupoints selected by expert group according to STRICTA. All other treatment affecting the outcomes will be prohibited during the trial period. All therapeutic procedure will be performed by acupuncture specialists who have received training for the consensus of multicenter.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Thread-Embedding Acupuncture (STEA)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The STEA group will be treated once a week for 8 weeks, using 29G x 40mm or 29G x 60mm sham TEA on predefined 23 acupoints selected by expert group according to STRICTA.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Thread-embedding Acupuncture (TEA)</intervention_name>
    <description>The acupoints and size of TEA are as follows:&#xD;
Both EX-B2 of herniated intervertebral disc level, its upper level and its lower level (6 acupoints): perpendicular insertion, 4cm&#xD;
Both BL24: transverse insertion toward L1 level along the erector muscle of spine, 6cm&#xD;
Both BL25: transverse insertion toward iliac crest, 4cm&#xD;
Both BL26: transverse insertion toward L1 level along the erector muscle of spine, 6cm&#xD;
Both BL26: oblique insertion toward iliolumbar ligament, 6cm&#xD;
Both EX-B7: oblique insertion toward gluteus medius muscle, 6cm&#xD;
Both BL28: oblique insertion toward sacroiliac ligament, 6cm&#xD;
Both GB30: perpendicular insertion, 6cm&#xD;
Symptomatic side GB34, BL57 and ST36: oblique insertion toward foot, 4cm</description>
    <arm_group_label>Thread-Embedding Acupuncture (TEA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sham Thread-embedding Acupuncture (STEA)</intervention_name>
    <description>All procedure of STEA group, including acupoints and size of TEA will be same as that of TEA group. However, thread-removed TEA will be used for STEA group instead of normal TEA, and removing procedure of thread will be performed aseptic and secretly for patient-blinding and prevention of infection.</description>
    <arm_group_label>Sham Thread-Embedding Acupuncture (STEA)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female adults aged 19-70&#xD;
&#xD;
          2. Radiating pain matched with severer abnormality than bulging shown by CT or MRI on&#xD;
             lumbar spine&#xD;
&#xD;
          3. 40 or higher low back pain on 100mm pain VAS&#xD;
&#xD;
          4. Volunteers who agree to participate and sign the Informed Consent Form, following a&#xD;
             detailed explanation of clinical trials&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Congenital abnormalities or surgical history on lumbar regions&#xD;
&#xD;
          2. Red flag signs that may be suspected of cauda equina syndrome, such as bladder and&#xD;
             bowel dysfunction or saddle anesthesia&#xD;
&#xD;
          3. Tumor, fracture or infection in lumbar regions&#xD;
&#xD;
          4. Injection treatment on lumbar regions within 1 week&#xD;
&#xD;
          5. Psychiatric disorder currently undergoing treatment such as depression or&#xD;
             schizophrenia&#xD;
&#xD;
          6. Inappropriate condition for thread-embedding acupuncture due to skin disease or&#xD;
             hemostatic disorder (PT INR &gt; 2.0 or taking anticoagulant)&#xD;
&#xD;
          7. Other diseases that could affect or interfere with therapeutic outcomes, including&#xD;
             severe gastrointestinal disease, cardiovascular disease, hypertension, diabetes, renal&#xD;
             disease, liver disease or thyroid disorder&#xD;
&#xD;
          8. Contraindication of acetaminophen including intercurrent disease, hypersensitivity&#xD;
             reaction or other medication&#xD;
&#xD;
          9. Pregnant women or other inappropriate condition for thread-embedding acupuncture&#xD;
&#xD;
         10. Heavy drinking (more than 3 cups per day) that could cause hepatotoxicity with&#xD;
             acetaminophen&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Byung-Kwan Seo, PhD., KMD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kyunghee University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dongguk University Bundang Oriental Hospital</name>
      <address>
        <city>Seongnam</city>
        <state>Gyeonggi</state>
        <zip>13601</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Daegu Korean Medicine Hospital of Daegu Haany University</name>
      <address>
        <city>Daegu</city>
        <zip>42158</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyunghee University Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>02447</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyung Hee University Hospital at Gangdong</name>
      <address>
        <city>Seoul</city>
        <zip>05278</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>February 5, 2020</last_update_submitted>
  <last_update_submitted_qc>February 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kyunghee University Medical Center</investigator_affiliation>
    <investigator_full_name>Byung-Kwan Seo</investigator_full_name>
    <investigator_title>PhD., KMD</investigator_title>
  </responsible_party>
  <keyword>Thread-Embedding Acupuncture</keyword>
  <keyword>Herniated Intervertebral Disc of Lumbar Spine</keyword>
  <keyword>Low Back Pain</keyword>
  <keyword>Radiculopathy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intervertebral Disc Displacement</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03236753
org study id: KHNMCOH 2016-09-006
nct id: NCT03236753
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This clinical trial is designed to evaluate the efficacy and safety of thread-embedding
      acupuncture for treatment of lumbar herniated intervertebral disc (L-HIVD) by assessing pain,
      function, and quality of life.
Seventy patient between the ages of 19 and 70 with L-HIVD will be recruited by eligibility
      criteria and randomly allocated to the thread-embedding acupuncture (TEA) group and sham
      thread-embedding acupuncture (STEA) group. Both groups will receive treatment on predefined
      23 acupoints once a week for 8 weeks, and needle with thread removed will be used in STEA
      group instead of normal TEA. 100 mm visual analogue scale (VAS) for low back pain will be
      assessed as a primary outcome. Also, 100mm VAS for radiating pain, Oswestry disability index
      (ODI), Rolland Morris disability questionnaire (RMDQ), EQ-5D-5L and global perceived effect
      (GPE) will be measured as secondary outcomes. All the outcomes will be assessed at baseline,
      4 weeks after screening, treatment end (8 weeks, primary end point) and follow-up sessions
      (12 and 16 weeks).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change from Baseline 100mm Pain Visual Analogue Scale (VAS) for low back pain at Week 8
time frame: Week 1 (Baseline), Week 4, Week 8 (Primary end point, Treatment end), Week 12, Week 16 (F/U)
description: Measurement instrument for subjective pain
measure: 100mm Pain Visual Analogue Scale (VAS) for radiating pain
time frame: Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U)
description: Measurement instrument for subjective pain
measure: Oswestry Disability Index (ODI)
time frame: Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U)
description: Validated questionnaire for disability of low back pain.
measure: EuroQol-5 dimensions-5 level (EQ-5D-5L)
time frame: Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U)
description: Standardized instrument for generic health status
measure: Roland-Morris Disability Questionnaire (RMDQ)
time frame: Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U)
description: Health status measure for low back pain
measure: Global Perceived Effect (GPE)
time frame: Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U)
description: Assessment of change in the patient's chief complaint
arm group label: Thread-Embedding Acupuncture (TEA)
arm group type: Experimental
description: The TEA group will be treated once a week for 8 weeks, using 29G x 40mm or 29G x 60mm TEA on predefined 23 acupoints selected by expert group according to STRICTA. All other treatment affecting the outcomes will be prohibited during the trial period. All therapeutic procedure will be performed by acupuncture specialists who have received training for the consensus of multicenter.
arm group label: Sham Thread-Embedding Acupuncture (STEA)
arm group type: Sham Comparator
description: The STEA group will be treated once a week for 8 weeks, using 29G x 40mm or 29G x 60mm sham TEA on predefined 23 acupoints selected by expert group according to STRICTA.
intervention type: Procedure
intervention name: Thread-embedding Acupuncture (TEA)
description: The acupoints and size of TEA are as follows:
Both EX-B2 of herniated intervertebral disc level, its upper level and its lower level (6 acupoints): perpendicular insertion, 4cm
Both BL24: transverse insertion toward L1 level along the erector muscle of spine, 6cm
Both BL25: transverse insertion toward iliac crest, 4cm
Both BL26: transverse insertion toward L1 level along the erector muscle of spine, 6cm
Both BL26: oblique insertion toward iliolumbar ligament, 6cm
Both EX-B7: oblique insertion toward gluteus medius muscle, 6cm
Both BL28: oblique insertion toward sacroiliac ligament, 6cm
Both GB30: perpendicular insertion, 6cm
Symptomatic side GB34, BL57 and ST36: oblique insertion toward foot, 4cm
arm group label: Thread-Embedding Acupuncture (TEA)
intervention type: Procedure
intervention name: Sham Thread-embedding Acupuncture (STEA)
description: All procedure of STEA group, including acupoints and size of TEA will be same as that of TEA group. However, thread-removed TEA will be used for STEA group instead of normal TEA, and removing procedure of thread will be performed aseptic and secretly for patient-blinding and prevention of infection.
arm group label: Sham Thread-Embedding Acupuncture (STEA)
criteria: 
gender: All
minimum age: 19 Years
maximum age: 70 Years
healthy volunteers: No
last name: Byung-Kwan Seo, PhD., KMD
role: Principal Investigator
affiliation: Kyunghee University Medical Center
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Kyunghee University Medical Center
investigator full name: Byung-Kwan Seo
investigator title: PhD., KMD
mesh term: Intervertebral Disc Displacement
sharing ipd: No