<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/NCT03750591</url>
  </required_header>
  <id_info>
    <org_study_id>JS-CT-2017-05-1</org_study_id>
    <nct_id>NCT03750591</nct_id>
  </id_info>
  <brief_title>Observational Study on Effectiveness and Safety of Integrative Korean Medicine Treatment for Inpatients With Sciatica Due to Lumbar Intervertebral Disc Herniation</brief_title>
  <official_title>Observational Study on Effectiveness and Safety of Integrative Korean Medicine Treatment for Inpatients With Sciatica Due to Lumbar Intervertebral Disc Herniation</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Observational study on the effectiveness and safety of integrative Korean medicine treatment&#xD;
      for inpatients with sciatica due to lumbar intervertebral disc herniation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Establishment of a Korean medicine inpatient treatment registry of inpatients with sciatica&#xD;
      due to lumbar intervertebral disc herniation with or without spinal stenosis, in conjunction&#xD;
      with an observational study to the aim of evaluating the effectiveness and safety of Korean&#xD;
      medicine treatment for inpatients&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 31, 2018</start_date>
  <completion_date type="Actual">November 8, 2019</completion_date>
  <primary_completion_date type="Actual">May 10, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>NRS change from Baseline NRS at discharge</measure>
    <time_frame>Baseline (admission), discharge (up to 14 weeks after baseline)</time_frame>
    <description>Numeric rating scale (NRS) of low back pain, and radiating leg pain In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ODI change from Baseline ODI at discharge</measure>
    <time_frame>Baseline (admission), discharge (up to 14 weeks after baseline)</time_frame>
    <description>Oswestry Disability Index(ODI) The ODI evaluates functional impairment and is a 10-item questionnaire developed to assess the level of disability due to back pain. Each item is graded into 6 levels, each representing a score of 0-5. Higher scores indicate greater limitation relating to back pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PGIC</measure>
    <time_frame>6 months after baseline</time_frame>
    <description>Patient global impression of change (PGIC) PGIC grades the level of subjective improvement into 7 levels (1, very much improved; 2, much improved; 3, slightly improved; 4, no change; 5, slightly worse; 6, much worse; and 7, very much worse).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EQ-5D change from Baseline EQ-5D at each time point</measure>
    <time_frame>Baseline (admission), 2 weeks after baseline, discharge (up to 14 weeks after baseline), 6 months after baseline</time_frame>
    <description>EuroQol-5 Dimension(EQ-5D) EQ-5D is a tool developed for health-related quality of life (HRQoL) assessment, and is widely used in the health care sector. Scores range from -1, 'health worse than death' to 1, 'perfect health'. EQ-5D-5L has 5 dimensions covering current health status and functionality: mobility (M), self care (SC), usual activities (UA), pain/discomfort (PD), and anxiety/depression (AD), to be rated out of 5 grades (1, no problem; 2, slight problem; 3, some/moderate problem; 4, severe problem; 5, extreme problem).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lumbar ROM from Baseline Lumbar ROM at each time point</measure>
    <time_frame>Baseline (admission), 2 weeks after baseline, discharge (up to 14 weeks after baseline)</time_frame>
    <description>Lumbar Range of Motion(ROM) (Flexion/Extension/Lateral flexion/Rotation) Pain upon movement in lumbar range of motion (ROM) will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SLR from Baseline SLR at each time point</measure>
    <time_frame>Baseline (admission), 2 weeks after baseline, discharge (up to 14 weeks after baseline)</time_frame>
    <description>Straight Leg Raise test(SLR) The straight leg raise(SLR)is a test done during a physical examination to determine whether a patient with low back pain has an underlying herniated disc, often located at L5 (fifth lumbar spinal nerve).&#xD;
If the patient experiences sciatic pain when the straight leg is at an angle of between 30 and 70 degrees, then the test is positive and a herniated disk is a possible cause of the pain.[3] A negative test suggests a likely different cause for back pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AE</measure>
    <time_frame>up to 14 weeks after baseline</time_frame>
    <description>Adverse events(AE) Physicians will monitor and record any unexpected or unintended patient reaction to integrative korean medicine at each visit. Adverse events (AEs) associated with integrative korean medicine will include, but not be limited to, AEs anticipated from previous reports of korean medicine, and will stay open to all possibilities taking into consideration other potential, unknown AEs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS change from Baseline NRS at each timepoint</measure>
    <time_frame>Baseline (admission), 2 weeks after baseline, 6 months after baseline</time_frame>
    <description>Numeric rating scale (NRS) of low back pain, and radiating leg pain In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ODI change from Baseline ODI at each timepoint</measure>
    <time_frame>Baseline (admission), 2 weeks after baseline, 6 months after baseline</time_frame>
    <description>Oswestry Disability Index(ODI) The ODI evaluates functional impairment and is a 10-item questionnaire developed to assess the level of disability due to back pain. Each item is graded into 6 levels, each representing a score of 0-5. Higher scores indicate greater limitation relating to back pain.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1000</enrollment>
  <condition>Sciatica Due to Intervertebral Disc Disorder</condition>
  <condition>Intervertebral Disc Displacement</condition>
  <condition>Sciatica</condition>
  <condition>Sciatic Radiculopathy</condition>
  <arm_group>
    <arm_group_label>Integrative Korean medicine treatment group</arm_group_label>
    <description>Observation of pain, function, quality of life, satisfaction, and adverse events in inpatients with lumbar intervertebral disc herniation hospitalized at 4 Korean medicine hospitals&#xD;
Interventions:&#xD;
Drug: Herbal medicine Procedure/Surgery: Chuna manual therapy Procedure/Surgery: Bee venom pharmacopuncture Procedure/Surgery: Pharmacopuncture Procedure/Surgery: Acupuncture Procedure/Surgery: Electroacupuncture Procedure/Surgery: Cupping Other intervention(s)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Herbal medicine</intervention_name>
    <description>Herbal medicine will be mainly administered in water-based decoction (120ml) and dried powder (2g) form (the ingredients are mainly, but not restricted to: 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>Integrative Korean medicine treatment group</arm_group_label>
    <other_name>Traditional herbal medicine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Chuna manual therapy</intervention_name>
    <description>Chuna is a Korean spinal manipulation that incorporates spinal manipulation techniques for joint mobilization involving highvelocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement.&#xD;
Chuna manipulation will be administered at the physician's discretion.</description>
    <arm_group_label>Integrative Korean medicine treatment group</arm_group_label>
    <other_name>Chuna manipulation</other_name>
    <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.&#xD;
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, 26gauze(G) x 1.5 syringe, Shinchang medical co., Korea).</description>
    <arm_group_label>Integrative Korean medicine treatment 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 Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26gauze(G) x 1.5 syringe, Shinchang medical co., Korea).</description>
    <arm_group_label>Integrative Korean medicine treatment 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>Integrative Korean medicine treatment 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>Integrative Korean medicine treatment 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>Integrative Korean medicine treatment 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>Integrative Korean medicine treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are admitted or scheduled to be admitted to Jaseng Hospital of Korean&#xD;
        Medicine, Bucheon Jaseng Hospital of Korean Medicine, Daejeon Jaseng Hospital of Korean&#xD;
        Medicine, or Haeundae Jaseng Hospital of Korean Medicine&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Lumbar intervertebral disc herniation as confirmed by a doctor of medicine or a doctor&#xD;
             of Korean medicine through an MRI taken within 3 years&#xD;
&#xD;
          2. Patients with radiculopathy (ipsilateral or bilateral radiculopathy)&#xD;
&#xD;
          3. Patients whose pain intensity of back pain or radiating leg pain is NRS≥5&#xD;
&#xD;
          4. Patients aged 19 to 70&#xD;
&#xD;
          5. Patients who have agreed to participate in the clinical study and given written&#xD;
             informed consent&#xD;
&#xD;
          6. Patients admitted to a Korean medicine hospital for treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who have been diagnosed with a serious disease that may cause low back pain&#xD;
             or neck pain (e.g. spinal metastasis of tumor, acute fracture, spinal dislocation)&#xD;
&#xD;
          2. Patients admitted due to pain caused by traffic accidents&#xD;
&#xD;
          3. Patients with progressive neurological deficit or severe neurological symptoms such as&#xD;
             spinal cord injury&#xD;
&#xD;
          4. Patients with severe mental illness&#xD;
&#xD;
          5. Patients with difficulty or refusal to give sign written informed consent&#xD;
&#xD;
          6. Patients for whom the researchers judge participation in the clinical study to be&#xD;
             difficult&#xD;
&#xD;
          7. Diagnosis of lumbar spondylolisthesis of Meyerding Ⅱ or higher by a doctor of medicine&#xD;
             or doctor of Korean medicine through X-ray or MRI&#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>HYUN WOO CHO, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Haeundae Jaseng Hospital of Korean Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bucheon Jaseng Hospital of Korean Medicine</name>
      <address>
        <city>Bucheon</city>
        <state>Gyeonggi Province</state>
        <zip>14598</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haeundae Jaseng Hospital of Korean Medicine</name>
      <address>
        <city>Busan</city>
        <zip>48102</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Daejeon Jaseng Hospital of Korean Medicine</name>
      <address>
        <city>Daejeon</city>
        <zip>35262</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jaseng Hospital of Korean Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>06110</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 14, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>March 11, 2020</last_update_submitted>
  <last_update_submitted_qc>March 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jaseng Medical Foundation</investigator_affiliation>
    <investigator_full_name>In-Hyuk Ha, KMD</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>Integrative Korean medicine</keyword>
  <keyword>treatment</keyword>
  <keyword>effectiveness</keyword>
  <keyword>safety</keyword>
  <keyword>Lumbar intervertebral disc herniation</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>Sciatica</mesh_term>
    <mesh_term>Hernia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03750591
org study id: JS-CT-2017-05-1
nct id: NCT03750591
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Observational study on the effectiveness and safety of integrative Korean medicine treatment
      for inpatients with sciatica due to lumbar intervertebral disc herniation
Establishment of a Korean medicine inpatient treatment registry of inpatients with sciatica
      due to lumbar intervertebral disc herniation with or without spinal stenosis, in conjunction
      with an observational study to the aim of evaluating the effectiveness and safety of Korean
      medicine treatment for inpatients
observational model: Cohort
time perspective: Prospective
measure: NRS change from Baseline NRS at discharge
time frame: Baseline (admission), discharge (up to 14 weeks after baseline)
description: Numeric rating scale (NRS) of low back pain, and radiating leg pain In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'.
measure: ODI change from Baseline ODI at discharge
time frame: Baseline (admission), discharge (up to 14 weeks after baseline)
description: Oswestry Disability Index(ODI) The ODI evaluates functional impairment and is a 10-item questionnaire developed to assess the level of disability due to back pain. Each item is graded into 6 levels, each representing a score of 0-5. Higher scores indicate greater limitation relating to back pain.
measure: PGIC
time frame: 6 months after baseline
description: Patient global impression of change (PGIC) PGIC grades the level of subjective improvement into 7 levels (1, very much improved; 2, much improved; 3, slightly improved; 4, no change; 5, slightly worse; 6, much worse; and 7, very much worse).
measure: EQ-5D change from Baseline EQ-5D at each time point
time frame: Baseline (admission), 2 weeks after baseline, discharge (up to 14 weeks after baseline), 6 months after baseline
description: EuroQol-5 Dimension(EQ-5D) EQ-5D is a tool developed for health-related quality of life (HRQoL) assessment, and is widely used in the health care sector. Scores range from -1, 'health worse than death' to 1, 'perfect health'. EQ-5D-5L has 5 dimensions covering current health status and functionality: mobility (M), self care (SC), usual activities (UA), pain/discomfort (PD), and anxiety/depression (AD), to be rated out of 5 grades (1, no problem; 2, slight problem; 3, some/moderate problem; 4, severe problem; 5, extreme problem).
measure: Lumbar ROM from Baseline Lumbar ROM at each time point
time frame: Baseline (admission), 2 weeks after baseline, discharge (up to 14 weeks after baseline)
description: Lumbar Range of Motion(ROM) (Flexion/Extension/Lateral flexion/Rotation) Pain upon movement in lumbar range of motion (ROM) will be assessed.
measure: SLR from Baseline SLR at each time point
time frame: Baseline (admission), 2 weeks after baseline, discharge (up to 14 weeks after baseline)
description: Straight Leg Raise test(SLR) The straight leg raise(SLR)is a test done during a physical examination to determine whether a patient with low back pain has an underlying herniated disc, often located at L5 (fifth lumbar spinal nerve).
If the patient experiences sciatic pain when the straight leg is at an angle of between 30 and 70 degrees, then the test is positive and a herniated disk is a possible cause of the pain.[3] A negative test suggests a likely different cause for back pain.
measure: AE
time frame: up to 14 weeks after baseline
description: Adverse events(AE) Physicians will monitor and record any unexpected or unintended patient reaction to integrative korean medicine at each visit. Adverse events (AEs) associated with integrative korean medicine will include, but not be limited to, AEs anticipated from previous reports of korean medicine, and will stay open to all possibilities taking into consideration other potential, unknown AEs.
measure: NRS change from Baseline NRS at each timepoint
time frame: Baseline (admission), 2 weeks after baseline, 6 months after baseline
description: Numeric rating scale (NRS) of low back pain, and radiating leg pain In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'.
measure: ODI change from Baseline ODI at each timepoint
time frame: Baseline (admission), 2 weeks after baseline, 6 months after baseline
description: Oswestry Disability Index(ODI) The ODI evaluates functional impairment and is a 10-item questionnaire developed to assess the level of disability due to back pain. Each item is graded into 6 levels, each representing a score of 0-5. Higher scores indicate greater limitation relating to back pain.
arm group label: Integrative Korean medicine treatment group
description: Observation of pain, function, quality of life, satisfaction, and adverse events in inpatients with lumbar intervertebral disc herniation hospitalized at 4 Korean medicine hospitals
Interventions:
Drug: Herbal medicine Procedure/Surgery: Chuna manual therapy Procedure/Surgery: Bee venom pharmacopuncture Procedure/Surgery: Pharmacopuncture Procedure/Surgery: Acupuncture Procedure/Surgery: Electroacupuncture Procedure/Surgery: Cupping Other intervention(s)
intervention type: Drug
intervention name: Herbal medicine
description: Herbal medicine will be mainly administered in water-based decoction (120ml) and dried powder (2g) form (the ingredients are mainly, but not restricted to: 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: Integrative Korean medicine treatment group
other name: Traditional herbal medicine
intervention type: Procedure
intervention name: Chuna manual therapy
description: Chuna is a Korean spinal manipulation that incorporates spinal manipulation techniques for joint mobilization involving highvelocity, 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 at the physician's discretion.
arm group label: Integrative Korean medicine treatment group
other name: Chuna manipulation
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, 26gauze(G) x 1.5 syringe, Shinchang medical co., Korea).
arm group label: Integrative Korean medicine treatment group
other name: Bee venom acupuncture
intervention type: Procedure
intervention name: Pharmacopuncture
description: Pharmacopuncture consisting of select herbal ingredients will be administered at Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26gauze(G) x 1.5 syringe, Shinchang medical co., Korea).
arm group label: Integrative Korean medicine treatment 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: Integrative Korean medicine treatment 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: Integrative Korean medicine treatment 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: Integrative Korean medicine treatment 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: Integrative Korean medicine treatment group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: 70 Years
healthy volunteers: No
last name: HYUN WOO CHO, PhD
role: Principal Investigator
affiliation: Haeundae Jaseng Hospital of Korean Medicine
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Jaseng Medical Foundation
investigator full name: In-Hyuk Ha, KMD
investigator title: Director
mesh term: Intervertebral Disc Displacement
mesh term: Radiculopathy
mesh term: Sciatica
mesh term: Hernia
sharing ipd: Undecided