<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/NCT02975011</url>
  </required_header>
  <id_info>
    <org_study_id>JS-CT-2016-03</org_study_id>
    <nct_id>NCT02975011</nct_id>
  </id_info>
  <brief_title>Effectiveness and Safety of Korean Medicine for Lumbar Stenosis Patients With Sciatica</brief_title>
  <official_title>Observational Study on the Effectiveness and Safety of Integrative Korean Medicine Treatment for Patients With Sciatica Due to Lumbar Stenosis: Multicenter, Prospective, Single Group Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jaseng Medical Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jaseng Medical Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective study investigating the effectiveness and safety in lumbar stenosis patients&#xD;
      receiving integrative Korean medicine treatment at 3 locations of Jaseng Hospital of Korean&#xD;
      Medicine through assessment of pain, functional disability, and quality of life&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective study to the aim of investigating the effectiveness and safety in&#xD;
      patients with neurogenic claudication diagnosed as lumbar stenosis by lumbar MRI and&#xD;
      receiving integrative Korean medicine treatment (herbal medicine, Chuna manipulation, bee&#xD;
      venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, and cupping) at&#xD;
      3 locations of Jaseng Hospital of Korean Medicine (Bucheon, Daejeon, Busan (Haeundae))&#xD;
      through assessment of pain, functional disability, and quality of life with 1-year follow-up&#xD;
      period&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    This study was prematurely terminated due to delayed patient enrollment.&#xD;
  </why_stopped>
  <start_date type="Actual">March 4, 2017</start_date>
  <completion_date type="Actual">November 2, 2018</completion_date>
  <primary_completion_date type="Actual">November 2, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Numeric rating scale (NRS) of low back pain</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>Change in low back pain intensity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Numeric rating scale (NRS) of radiating leg pain</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>Change in radiating leg pain intensity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Numeric rating scale (NRS) of low back pain</measure>
    <time_frame>Baseline, 1, 2, 3, 6, 12 months</time_frame>
    <description>Low back pain intensity for the past 3 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numeric rating scale (NRS) of radiating leg pain</measure>
    <time_frame>Baseline, 1, 2, 3, 6, 12 months</time_frame>
    <description>Radiating leg pain intensity for the past 3 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oswestry Disability Index (ODI)</measure>
    <time_frame>Baseline, 1, 2, 3, 6, 12 months</time_frame>
    <description>Functional disability questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQol 5-dimensions 5-levels (EQ-5D-5L)</measure>
    <time_frame>Baseline, 1, 2, 3, 6, 12 months</time_frame>
    <description>Health-related quality of life questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Change (PGIC)</measure>
    <time_frame>6, 12 months</time_frame>
    <description>Global patient-reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Current medical service use</measure>
    <time_frame>Baseline, 1, 2, 3, 6, 12 months</time_frame>
    <description>Current use of medical services (type, frequency, period)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain-free walking time</measure>
    <time_frame>Baseline, 1, 2, 3, 6, 12 months</time_frame>
    <description>Average pain-free walking time for the past 3 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical examination</measure>
    <time_frame>Baseline, 1, 2, 3 months</time_frame>
    <description>Lumbar physical examination</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">38</enrollment>
  <condition>Lumbar Spinal Stenosis</condition>
  <arm_group>
    <arm_group_label>Lumbar stenosis group</arm_group_label>
    <description>Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manipulation, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Herbal medicine</intervention_name>
    <description>Herbal medicine will be administered in water-based decoction (120ml) and dried powder (2g) form (Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, Saposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycine max, Atractylodes japonica).</description>
    <arm_group_label>Lumbar stenosis group</arm_group_label>
    <other_name>Traditional herbal medicine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Chuna manipulation</intervention_name>
    <description>Chuna is a Korean spinal manipulation that incorporates spinal manipulation techniques for joint mobilization involving high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement. Chuna manipulation will be administered to pelvic, lumbar, thoracic, and cervical vertebrae at the physician's discretion.</description>
    <arm_group_label>Lumbar stenosis group</arm_group_label>
    <other_name>Chuna spinal manipulation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bee venom pharmacopuncture</intervention_name>
    <description>Bee venom pharmacopuncture will be administered only after confirming a negative response to hypersensitivity skin test. Diluted bee venom (saline:bee venom ratio, 10,000:1) filtered for allergens will be injected at 4-5 acupoints proximal to the dysfunctional site at the physician's discretion. Each acupuncture point will be injected to a total of 0.5-1 cc using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).</description>
    <arm_group_label>Lumbar stenosis group</arm_group_label>
    <other_name>Bee venom acupuncture</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pharmacopuncture</intervention_name>
    <description>Pharmacopuncture consisting of select herbal ingredients will be administered at Hyeopcheok (Huatuo Jiaji, EX B2), Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).</description>
    <arm_group_label>Lumbar stenosis group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Acupuncture</intervention_name>
    <description>Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.</description>
    <arm_group_label>Lumbar stenosis group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Electroacupuncture</intervention_name>
    <description>Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.</description>
    <arm_group_label>Lumbar stenosis group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cupping</intervention_name>
    <description>Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.</description>
    <arm_group_label>Lumbar stenosis group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Other intervention(s)</intervention_name>
    <description>Patients will be allowed any other additional intervention(s) as deemed necessary by the attending physician regardless of type or dose, and patterns of use will be investigated and recorded as an pragmatic clinical study.</description>
    <arm_group_label>Lumbar stenosis group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Lumbar stenosis patients with MRI results visiting and receiving treatment at 3 locations&#xD;
        of Jaseng Hospital of Korean Medicine between November 2016 and March 2018&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with radiating leg pain with or without low back pain (LBP) (walking pain NRS&#xD;
             ≥4)&#xD;
&#xD;
          -  Patients with dural sac cross-sectional area (DSCA) of &lt;100 mm2 or morphological&#xD;
             grading ≥B as assessed on MRI&#xD;
&#xD;
          -  Patients with clear neurogenic claudication symptoms (symptoms aggravated with&#xD;
             walking, and alleviated upon resting in lumbar flexion position)&#xD;
&#xD;
          -  Patients who have received surgery recommendation for lumbar spinal stenosis&#xD;
&#xD;
          -  Patients with plans of receiving Korean medicine treatment for lumbar spinal stenosis&#xD;
             for ≥2 months&#xD;
&#xD;
          -  Patients who have agreed to study participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with vascular claudication&#xD;
&#xD;
          -  Patients with other systemic diseases that may interfere with treatment effect or&#xD;
             outcome interpretation&#xD;
&#xD;
          -  Patients with soft tissue pathologies or pathologies of non-spinal origin that may&#xD;
             cause LBP or radiating leg pain (e.g. spinal tumor, rheumatoid arthritis)&#xD;
&#xD;
          -  Patients for whom acupuncture treatment may be inappropriate or unsafe (e.g.&#xD;
             hemorrhagic diseases, blood clotting disorders, history of anti-coagulation medicine&#xD;
             intake, serious diabetes with risk of infection, severe cardiovascular diseases, or&#xD;
             other conditions deemed unsuitable for acupuncture treatment)&#xD;
&#xD;
          -  Pregnant patients or patients planning pregnancy&#xD;
&#xD;
          -  Patients with serious psychological disorders&#xD;
&#xD;
          -  Patients unable to fill out study participation consent form&#xD;
&#xD;
          -  Subjects deemed unsuitable for study participation as assessed by the researchers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jinho Lee, KMD, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jaseng Medical Foundation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jaseng Medical Foundation</name>
      <address>
        <city>Seoul</city>
        <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>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>November 6, 2018</last_update_submitted>
  <last_update_submitted_qc>November 6, 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 Medical Foundation</investigator_affiliation>
    <investigator_full_name>Jinho Lee</investigator_full_name>
    <investigator_title>Medical management director</investigator_title>
  </responsible_party>
  <keyword>Magnetic Resonance Imaging</keyword>
  <keyword>Patient Satisfaction</keyword>
  <keyword>Numeric Rating Scale</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Stenosis</mesh_term>
    <mesh_term>Sciatica</mesh_term>
    <mesh_term>Constriction, Pathologic</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/NCT02975011
org study id: JS-CT-2016-03
nct id: NCT02975011
lead sponsor: 
has dmc: No
A prospective study investigating the effectiveness and safety in lumbar stenosis patients
      receiving integrative Korean medicine treatment at 3 locations of Jaseng Hospital of Korean
      Medicine through assessment of pain, functional disability, and quality of life
This is a prospective study to the aim of investigating the effectiveness and safety in
      patients with neurogenic claudication diagnosed as lumbar stenosis by lumbar MRI and
      receiving integrative Korean medicine treatment (herbal medicine, Chuna manipulation, bee
      venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, and cupping) at
      3 locations of Jaseng Hospital of Korean Medicine (Bucheon, Daejeon, Busan (Haeundae))
      through assessment of pain, functional disability, and quality of life with 1-year follow-up
      period
observational model: Case-Only
time perspective: Prospective
measure: Change in Numeric rating scale (NRS) of low back pain
time frame: Change from baseline to 3 months
description: Change in low back pain intensity
measure: Change in Numeric rating scale (NRS) of radiating leg pain
time frame: Change from baseline to 3 months
description: Change in radiating leg pain intensity
measure: Numeric rating scale (NRS) of low back pain
time frame: Baseline, 1, 2, 3, 6, 12 months
description: Low back pain intensity for the past 3 days
measure: Numeric rating scale (NRS) of radiating leg pain
time frame: Baseline, 1, 2, 3, 6, 12 months
description: Radiating leg pain intensity for the past 3 days
measure: Oswestry Disability Index (ODI)
time frame: Baseline, 1, 2, 3, 6, 12 months
description: Functional disability questionnaire
measure: EuroQol 5-dimensions 5-levels (EQ-5D-5L)
time frame: Baseline, 1, 2, 3, 6, 12 months
description: Health-related quality of life questionnaire
measure: Patient Global Impression of Change (PGIC)
time frame: 6, 12 months
description: Global patient-reported outcome
measure: Current medical service use
time frame: Baseline, 1, 2, 3, 6, 12 months
description: Current use of medical services (type, frequency, period)
measure: Pain-free walking time
time frame: Baseline, 1, 2, 3, 6, 12 months
description: Average pain-free walking time for the past 3 days
measure: Physical examination
time frame: Baseline, 1, 2, 3 months
description: Lumbar physical examination
arm group label: Lumbar stenosis group
description: Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manipulation, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.
intervention type: Drug
intervention name: Herbal medicine
description: Herbal medicine will be administered in water-based decoction (120ml) and dried powder (2g) form (Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, Saposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycine max, Atractylodes japonica).
arm group label: Lumbar stenosis group
other name: Traditional herbal medicine
intervention type: Procedure
intervention name: Chuna manipulation
description: Chuna is a Korean spinal manipulation that incorporates spinal manipulation techniques for joint mobilization involving high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement. Chuna manipulation will be administered to pelvic, lumbar, thoracic, and cervical vertebrae at the physician's discretion.
arm group label: Lumbar stenosis group
other name: Chuna spinal manipulation
intervention type: Procedure
intervention name: Bee venom pharmacopuncture
description: Bee venom pharmacopuncture will be administered only after confirming a negative response to hypersensitivity skin test. Diluted bee venom (saline:bee venom ratio, 10,000:1) filtered for allergens will be injected at 4-5 acupoints proximal to the dysfunctional site at the physician's discretion. Each acupuncture point will be injected to a total of 0.5-1 cc using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
arm group label: Lumbar stenosis group
other name: Bee venom acupuncture
intervention type: Procedure
intervention name: Pharmacopuncture
description: Pharmacopuncture consisting of select herbal ingredients will be administered at Hyeopcheok (Huatuo Jiaji, EX B2), Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
arm group label: Lumbar stenosis group
intervention type: Procedure
intervention name: Acupuncture
description: Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
arm group label: Lumbar stenosis group
intervention type: Procedure
intervention name: Electroacupuncture
description: Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
arm group label: Lumbar stenosis group
intervention type: Procedure
intervention name: Cupping
description: Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.
arm group label: Lumbar stenosis group
intervention type: Other
intervention name: Other intervention(s)
description: Patients will be allowed any other additional intervention(s) as deemed necessary by the attending physician regardless of type or dose, and patterns of use will be investigated and recorded as an pragmatic clinical study.
arm group label: Lumbar stenosis group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jinho Lee, KMD, Ph.D.
role: Principal Investigator
affiliation: Jaseng Medical Foundation
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Jaseng Medical Foundation
investigator full name: Jinho Lee
investigator title: Medical management director
mesh term: Spinal Stenosis
mesh term: Sciatica
mesh term: Constriction, Pathologic
sharing ipd: No