<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/NCT01701804</url>
  </required_header>
  <id_info>
    <org_study_id>JS-CT-2011-2</org_study_id>
    <nct_id>NCT01701804</nct_id>
  </id_info>
  <brief_title>The Effectiveness of Non-surgical Integrative Package on Failed Back Surgery Syndrome</brief_title>
  <official_title>The Effectiveness of Non-surgical Integrative Package on Failed Back Surgery Syndrome : A Multicenter, Prospective, Case Series Observational Study</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>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the effect of a non-surgical integrative package&#xD;
      consisting of Chuna herbal medicine, Chuna manual therapy, bee-venom pharmacoacupuncture,&#xD;
      acupuncture on failed back surgery syndrome through means of a prospective case series.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to investigate the effect of a non-surgical integrative package&#xD;
      on failed back surgery syndrome through means of a prospective case series.&#xD;
&#xD;
      After initial screening, treatment will be administered one session a week for 16 weeks.&#xD;
      Patients will be followed up at 4 and 8 weeks after conclusion of treatment.&#xD;
&#xD;
      The integrative package used in this study consists of 120ml of Chuna herbal&#xD;
      medicine(Ostericum koreanum, Eucommia ulmoides, Acanthopanax Sessiliflorus, Achyranthes&#xD;
      bidentata, Psoralea corylifolia, Peucedanum japonicum, Cibotium barometz, Lycium chinense,&#xD;
      Boschniakia rossica, and Cuscuta chinensis) and dried extracts in pill form(Cibotium&#xD;
      barometz, Atractylodes japonica) taken twice a day 30 minutes after meals, Chuna manual&#xD;
      therapy, intermuscular injections of bee-venom pharmacoacupuncture(Select 6 acupoints,&#xD;
      concentration 10,000:1, 0.1 cc per acupoint, total amount injected 1.0 cc/session),&#xD;
      acupuncture and allow for NSAID intake during the investigational period. The subject is&#xD;
      allowed a maximum of 3 pills/day, taken at a minimum of 8 hrs apart. The number of pills&#xD;
      taken will be measured at 4 wks after conclusion of treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2011</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>VAS of low back pain</measure>
    <time_frame>Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week, 14th week, 16th week, 24th week</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>VAS of radiating leg pain</measure>
    <time_frame>Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week, 14th week, 16th week, 24th week</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>ODI (Oswestry Disability Index)</measure>
    <time_frame>Baseline, 4th week, 8th week, 12th week, 16th week, 24th week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36 (Quality of Life)</measure>
    <time_frame>Baseline, 4th week, 8th week, 12th week, 16th week, 24th week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General assessment(patient/doctor)</measure>
    <time_frame>16th week, 24th week</time_frame>
    <description>General assessment of improvement by doctor and patient</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">120</enrollment>
  <condition>Failed Back Surgery Syndrome</condition>
  <arm_group>
    <arm_group_label>integrative treatment</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chuna herbal medicine</intervention_name>
    <description>120ml of Chuna herbal medicine(Ostericum koreanum, Eucommia ulmoides, Acanthopanax Sessiliflorus, Achyranthes bidentata, Psoralea corylifolia, Peucedanum japonicum, Cibotium barometz, Lycium chinense, Boschniakia rossica, and Cuscuta chinensis) taken twice a day 30 minutes after meals for 16 weeks</description>
    <arm_group_label>integrative treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Chuna manual therapy</intervention_name>
    <description>A type of Korean spinal manual therapy administered 5~10 minutes at physician's discretion once a week for 16 weeks. Applies mobilization using High-Velocity, Low-Amplitude thrusts to joints slightly beyond the passive ROM and manual force within the passive ROM without thrusts.</description>
    <arm_group_label>integrative treatment</arm_group_label>
    <other_name>Chuna manipulation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Acupuncture</intervention_name>
    <description>Acupuncture using sterilized disposable needles, sized 0.30X40 mm. Needles left for 15~20 minutes, selecting 6 acupoints(both BL23, BL24, BL25) and other acupoints at physician's discretion, using a total of 10~20 acupoints once a week for 16 weeks.</description>
    <arm_group_label>integrative treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bee-venom pharmacoacupuncture</intervention_name>
    <description>Bee-venom pharmacoacupuncture using 30G sterilized bee venom. Selecting 6 acupoints(both BL23, BL24, BL25) and other acupoints at physician's discretion, concentration 10,000:1, 0.1 cc per acupoint, total amount injected 1.0 cc/session once a week for 16 weeks.</description>
    <arm_group_label>integrative treatment</arm_group_label>
    <other_name>BV</other_name>
    <other_name>Bee-venom therapy</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patient sampling within Failed Back Surgery Syndrome clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients suffering from low back pain and/or leg pain that does not improve or the&#xD;
             return of the symptoms within 1 year of spinal surgery&#xD;
&#xD;
          -  Low back pain and/or leg pain with duration at least 3 weeks at baseline&#xD;
&#xD;
          -  Low back pain and/or leg pain at least 60mm on VAS scale&#xD;
&#xD;
          -  Age between 18 and 60&#xD;
&#xD;
          -  Given consent to lumbar MRI&#xD;
&#xD;
          -  Voluntary participation with written consent given to study consent form&#xD;
&#xD;
          -  Given consent to not receive other treatment concerning pain due to spinal disorders&#xD;
             during study participation period&#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, OMD, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jaseng Hospital of Korean Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jaseng Hospital of Oriental Medicine</name>
      <address>
        <city>Bucheon</city>
        <state>Gyeonggi Province</state>
        <zip>420-814</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jaseng Hospital of Oriental Medicine</name>
      <address>
        <city>Seoul</city>
        <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>October 22, 2011</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</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>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Failed Back Surgery Syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Failed Back Surgery Syndrome</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/NCT01701804
org study id: JS-CT-2011-2
nct id: NCT01701804
lead sponsor: 
The purpose of this study is to investigate the effect of a non-surgical integrative package
      consisting of Chuna herbal medicine, Chuna manual therapy, bee-venom pharmacoacupuncture,
      acupuncture on failed back surgery syndrome through means of a prospective case series.
The purpose of this study is to investigate the effect of a non-surgical integrative package
      on failed back surgery syndrome through means of a prospective case series.

      After initial screening, treatment will be administered one session a week for 16 weeks.
      Patients will be followed up at 4 and 8 weeks after conclusion of treatment.

      The integrative package used in this study consists of 120ml of Chuna herbal
      medicine(Ostericum koreanum, Eucommia ulmoides, Acanthopanax Sessiliflorus, Achyranthes
      bidentata, Psoralea corylifolia, Peucedanum japonicum, Cibotium barometz, Lycium chinense,
      Boschniakia rossica, and Cuscuta chinensis) and dried extracts in pill form(Cibotium
      barometz, Atractylodes japonica) taken twice a day 30 minutes after meals, Chuna manual
      therapy, intermuscular injections of bee-venom pharmacoacupuncture(Select 6 acupoints,
      concentration 10,000:1, 0.1 cc per acupoint, total amount injected 1.0 cc/session),
      acupuncture and allow for NSAID intake during the investigational period. The subject is
      allowed a maximum of 3 pills/day, taken at a minimum of 8 hrs apart. The number of pills
      taken will be measured at 4 wks after conclusion of treatment.
observational model: Cohort
time perspective: Prospective
measure: VAS of low back pain
time frame: Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week, 14th week, 16th week, 24th week
measure: VAS of radiating leg pain
time frame: Baseline, 2nd week, 4th week, 6th week, 8th week, 10th week, 12th week, 14th week, 16th week, 24th week
measure: ODI (Oswestry Disability Index)
time frame: Baseline, 4th week, 8th week, 12th week, 16th week, 24th week
measure: SF-36 (Quality of Life)
time frame: Baseline, 4th week, 8th week, 12th week, 16th week, 24th week
measure: General assessment(patient/doctor)
time frame: 16th week, 24th week
description: General assessment of improvement by doctor and patient
arm group label: integrative treatment
intervention type: Drug
intervention name: Chuna herbal medicine
description: 120ml of Chuna herbal medicine(Ostericum koreanum, Eucommia ulmoides, Acanthopanax Sessiliflorus, Achyranthes bidentata, Psoralea corylifolia, Peucedanum japonicum, Cibotium barometz, Lycium chinense, Boschniakia rossica, and Cuscuta chinensis) taken twice a day 30 minutes after meals for 16 weeks
arm group label: integrative treatment
intervention type: Procedure
intervention name: Chuna manual therapy
description: A type of Korean spinal manual therapy administered 5~10 minutes at physician's discretion once a week for 16 weeks. Applies mobilization using High-Velocity, Low-Amplitude thrusts to joints slightly beyond the passive ROM and manual force within the passive ROM without thrusts.
arm group label: integrative treatment
other name: Chuna manipulation
intervention type: Procedure
intervention name: Acupuncture
description: Acupuncture using sterilized disposable needles, sized 0.30X40 mm. Needles left for 15~20 minutes, selecting 6 acupoints(both BL23, BL24, BL25) and other acupoints at physician's discretion, using a total of 10~20 acupoints once a week for 16 weeks.
arm group label: integrative treatment
intervention type: Procedure
intervention name: Bee-venom pharmacoacupuncture
description: Bee-venom pharmacoacupuncture using 30G sterilized bee venom. Selecting 6 acupoints(both BL23, BL24, BL25) and other acupoints at physician's discretion, concentration 10,000:1, 0.1 cc per acupoint, total amount injected 1.0 cc/session once a week for 16 weeks.
arm group label: integrative treatment
other name: BV
other name: Bee-venom therapy
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 69 Years
healthy volunteers: No
last name: Joonshik Shin, OMD, Ph.D
role: Principal Investigator
affiliation: Jaseng Hospital of Korean Medicine
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Syndrome
mesh term: Failed Back Surgery Syndrome