<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/NCT04446221</url>
  </required_header>
  <id_info>
    <org_study_id>JS-CT-2020-05</org_study_id>
    <nct_id>NCT04446221</nct_id>
  </id_info>
  <brief_title>Long Term Follow-Up of Post Neck Pain Patients Accompanying Ossification of Posterior Longitudinal Ligament Treated With Integrated Complementary and Alternative Medicine: Observational Study</brief_title>
  <official_title>Long Term Follow-Up of Post Neck Pain Patients Accompanying Ossification of Posterior Longitudinal Ligament Treated With Integrated Complementary and Alternative Medicine: 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to reveal the effectiveness and safety of integrative Korean&#xD;
      medicine for Ossification of Posterior Longitudinal Ligament(OPLL) by observation inpatients&#xD;
      treated with integrative Korean medicine.&#xD;
&#xD;
      This study is a prospective observational study. The subjects for study are patients&#xD;
      diagnosed with OPLL and who have been admitted to four Jaseng Hospital of Korean medicine&#xD;
      (Gangnam, Bucheon, Daejeon, and Haeundae) for 2016.04.01-2019.12.31.&#xD;
&#xD;
      Medical records of selected patients will be analyzed, and telephone surveys will be&#xD;
      conducted for each patient. The survey questions are Numeric ratinc scale (NRS), Vernon-Mior&#xD;
      Neck Disability Index (NDI), quality of life, and Patient Global Impression of Change (PGIC),&#xD;
      etc.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 12, 2020</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">August 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Numeric rating scale (NRS)</measure>
    <time_frame>Finish survey by September 2020</time_frame>
    <description>NRS uses an 11-point scale to evaluate current neck pain and radiating pain where no pain is indicated by '0', and the worst pain imaginable by '10'. NRS was assessed at admission, 2 weeks after admission, discharge, and long term follow up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vernon-Mior Neck Disability Index (NDI)</measure>
    <time_frame>Finish survey by September 2020</time_frame>
    <description>NDI is a 10-item questionnaire developed to evaluate the degree of disability for neck back pain. Each item is divided into 6 levels, and 0 to 5 points are awarded. The higher the score, the greater the degree of disability. We will conduct an validated Korean NDI questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The five level version of EuroQol-5 Dimension (EQ-5D)</measure>
    <time_frame>Finish survey by September 2020</time_frame>
    <description>EQ-5D is most widely used as a method of indirectly calculating the quality of life from various aspects. The EQ-5D-5L consists of 5 questions (mobility, self-care, usual activities, pain, anxiety/depression) that ask about the current state of health, and answers each question with 5 likert. (1=I have no problems about, 2=I have slight problems about, 3=I have moderate problems about, 4=I have severe problems about, 5=I am unable to about) In this study, the validated Korean version questionnaire will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Change (PGIC)</measure>
    <time_frame>Finish survey by September 2020</time_frame>
    <description>PGIC is an indicator that evaluates the improvement of patients in 7 steps, and the subject responds with improvement of functional limitation after treatment with 7 likert. (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spine surgery</measure>
    <time_frame>Finish survey by September 2020</time_frame>
    <description>The number of spinal surgery after discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Current symptoms survey</measure>
    <time_frame>Finish survey by September 2020</time_frame>
    <description>Pain, neurological problems, etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment after discharge survey</measure>
    <time_frame>Finish survey by September 2020</time_frame>
    <description>Treatment history in the last 3 month</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with integrative Korean medicine survey</measure>
    <time_frame>Finish survey by September 2020</time_frame>
    <description>Preference for integrative Korean medicine, satisfaction with integrative Korean medicine, How helpful hospitalization has been for returning to work and adjusting to daily life.</description>
  </secondary_outcome>
  <enrollment type="Actual">78</enrollment>
  <condition>OPLL</condition>
  <condition>Medicine, Korean Traditional</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>phone survey</intervention_name>
    <description>A questionnaire about the current symptoms and satisfaction for received treatment will be conducted over the phone for patients.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The subjects for study are patients diagnosed with OPLL and who have been admitted to four&#xD;
        Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, and Haeundae) for&#xD;
        2016.04.01-2019.12.31&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with OPLL by C spine X-ray or MRI or CT&#xD;
&#xD;
          -  Paithents who was admitted to Jaseng hospital of Korean medicien.&#xD;
&#xD;
          -  Patients have agreed to participate the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient hospitalized under 3 days&#xD;
&#xD;
          -  Patients who have been diagnosed with certain serious diseases that may cause&#xD;
             disturbance to interpretation of conclusion (cardiovascular problems, kidney disease,&#xD;
             diabetic neuropathy, dementia, epilepsy, and so on)&#xD;
&#xD;
          -  Patients who have been diagnosed with certain serious diseases that may cause back&#xD;
             pain or neck pain (tumor metastases to the spine, fibromyalgia, rheumatoid arthritis,&#xD;
             gout, and so on)&#xD;
&#xD;
          -  Patients had cervical spinal surgery within 3 months&#xD;
&#xD;
          -  Patients diagnosed with C spine fracture by C spine X-ray or MRI or CT&#xD;
&#xD;
          -  Patients deemed unable to participate in the clinical research by other researchers&#xD;
&#xD;
          -  Patients haven't agreed to participate the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <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>January 2022</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>January 25, 2022</last_update_submitted>
  <last_update_submitted_qc>January 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2022</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>acupuncture therapy</keyword>
  <keyword>herbal medicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ossification of Posterior Longitudinal Ligament</mesh_term>
    <mesh_term>Neck Pain</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/NCT04446221
org study id: JS-CT-2020-05
nct id: NCT04446221
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to reveal the effectiveness and safety of integrative Korean
      medicine for Ossification of Posterior Longitudinal Ligament(OPLL) by observation inpatients
      treated with integrative Korean medicine.

      This study is a prospective observational study. The subjects for study are patients
      diagnosed with OPLL and who have been admitted to four Jaseng Hospital of Korean medicine
      (Gangnam, Bucheon, Daejeon, and Haeundae) for 2016.04.01-2019.12.31.

      Medical records of selected patients will be analyzed, and telephone surveys will be
      conducted for each patient. The survey questions are Numeric ratinc scale (NRS), Vernon-Mior
      Neck Disability Index (NDI), quality of life, and Patient Global Impression of Change (PGIC),
      etc.
observational model: Other
time perspective: Retrospective
measure: Numeric rating scale (NRS)
time frame: Finish survey by September 2020
description: NRS uses an 11-point scale to evaluate current neck pain and radiating pain where no pain is indicated by '0', and the worst pain imaginable by '10'. NRS was assessed at admission, 2 weeks after admission, discharge, and long term follow up.
measure: Vernon-Mior Neck Disability Index (NDI)
time frame: Finish survey by September 2020
description: NDI is a 10-item questionnaire developed to evaluate the degree of disability for neck back pain. Each item is divided into 6 levels, and 0 to 5 points are awarded. The higher the score, the greater the degree of disability. We will conduct an validated Korean NDI questionnaire
measure: The five level version of EuroQol-5 Dimension (EQ-5D)
time frame: Finish survey by September 2020
description: EQ-5D is most widely used as a method of indirectly calculating the quality of life from various aspects. The EQ-5D-5L consists of 5 questions (mobility, self-care, usual activities, pain, anxiety/depression) that ask about the current state of health, and answers each question with 5 likert. (1=I have no problems about, 2=I have slight problems about, 3=I have moderate problems about, 4=I have severe problems about, 5=I am unable to about) In this study, the validated Korean version questionnaire will be used.
measure: Patient Global Impression of Change (PGIC)
time frame: Finish survey by September 2020
description: PGIC is an indicator that evaluates the improvement of patients in 7 steps, and the subject responds with improvement of functional limitation after treatment with 7 likert. (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).
measure: Spine surgery
time frame: Finish survey by September 2020
description: The number of spinal surgery after discharge
measure: Current symptoms survey
time frame: Finish survey by September 2020
description: Pain, neurological problems, etc.
measure: Treatment after discharge survey
time frame: Finish survey by September 2020
description: Treatment history in the last 3 month
measure: Satisfaction with integrative Korean medicine survey
time frame: Finish survey by September 2020
description: Preference for integrative Korean medicine, satisfaction with integrative Korean medicine, How helpful hospitalization has been for returning to work and adjusting to daily life.
intervention type: Other
intervention name: phone survey
description: A questionnaire about the current symptoms and satisfaction for received treatment will be conducted over the phone for patients.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
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: Ossification of Posterior Longitudinal Ligament
mesh term: Neck Pain
sharing ipd: No