<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/NCT03293212</url>
  </required_header>
  <id_info>
    <org_study_id>JS-CT-2017-03</org_study_id>
    <nct_id>NCT03293212</nct_id>
  </id_info>
  <brief_title>Characteristics and Medical Resource Utilization of Postoperative Patients</brief_title>
  <official_title>Characteristics and Medical Resource Utilization of Postoperative Patients: A Cross-sectional Survey of Outpatients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jaseng Medical Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Korea Institute of Oriental Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
      The objective of this study is to assess and analyze the characteristics and usage of&#xD;
      conventional and Korean medical services in postoperative patients. This study therefore&#xD;
      investigates the proportion of patients with a history of surgery out of patients visiting a&#xD;
      spine-specialty Korean medicine hospital, and the prognosis and preference for conventional&#xD;
      and Korean medicine treatment by previous treatment history in postoperative patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A considerable number of patients suffer prolonged chronic pain that does not retract or&#xD;
      diminish after surgery, and are thus unable to achieve the desired results in receiving&#xD;
      surgical treatment. Postoperative pain is gradually being perceived as a social issue as&#xD;
      opposed to a personal health condition. Meanwhile, although efforts to address chronic pain&#xD;
      with integrative medicine are continued in answer to the lack of success of pain management&#xD;
      through surgery, there is still a lack of supporting evidence.&#xD;
&#xD;
      The objective of this survey study is to assess the characteristics, usage of conventional&#xD;
      and Korean medical services, and prognosis by period before and after surgery in&#xD;
      postoperative patients visiting a Korean medicine hospital, and analyze the associations&#xD;
      between the preference for conventional and Korean medicine treatment. This study therefore&#xD;
      investigates the usage of conventional and Korean medical services in postoperative patients,&#xD;
      and is expected to provide information that will potentially aid patient decision making.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 29, 2017</start_date>
  <completion_date type="Actual">October 31, 2017</completion_date>
  <primary_completion_date type="Actual">October 31, 2017</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Numeric rating scale (NRS) of pain</measure>
    <time_frame>Within 7 days after 1st visit</time_frame>
    <description>11-point pain scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Five level version of EuroQol-5 Dimension (EQ-5D-5L)</measure>
    <time_frame>Within 7 days after 1st visit</time_frame>
    <description>Health-related quality of life questionnaire consisting of 5 descriptive items and EQ Visual Analogue Scales (EQ-VASs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional disability questionnaire (for low back pain patients as indicated by postoperative condition)</measure>
    <time_frame>Within 7 days after 1st visit</time_frame>
    <description>Oswestry Disability Index (ODI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional disability questionnaire (for neck pain patients as indicated by postoperative condition)</measure>
    <time_frame>Within 7 days after 1st visit</time_frame>
    <description>Neck Disability Index (NDI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional disability questionnaire (for knee pain patients as indicated by postoperative condition)</measure>
    <time_frame>Within 7 days after 1st visit</time_frame>
    <description>Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional disability questionnaire (for shoulder pain patients as indicated by postoperative condition)</measure>
    <time_frame>Within 7 days after 1st visit</time_frame>
    <description>Shoulder Pain and Disability Index (SPADI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH)</measure>
    <time_frame>Within 7 days after 1st visit</time_frame>
    <description>Questionnaire assessing the effect of health problems on the ability to work and to perform regular activities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory-II (BDI-II)</measure>
    <time_frame>Within 7 days after 1st visit</time_frame>
    <description>The Korean version of the BDI-II has been validated and consists of 21 multiple choice items for diagnosis of depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical service use</measure>
    <time_frame>Within 7 days after 1st visit</time_frame>
    <description>Type(s) of medical service use before and after surgery post-onset</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical costs</measure>
    <time_frame>Within 7 days after 1st visit</time_frame>
    <description>Medical costs from medical service use before and after surgery post-onset</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with and preference for conventional and Korean medicine</measure>
    <time_frame>Within 7 days after 1st visit</time_frame>
    <description>Satisfaction with and preference for conventional and Korean medicine as measured using a 9-point Likert scale</description>
  </secondary_outcome>
  <enrollment type="Actual">102</enrollment>
  <condition>Pain, Postoperative</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients newly visiting 4 sites of Jaseng Hospital of Korean Medicine due to postoperative&#xD;
        pain&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with chief complaint(s) of at least one or more of the following: low back&#xD;
             pain (or radiating leg pain), neck pain (or radiating arm pain), knee pain, or&#xD;
             shoulder pain&#xD;
&#xD;
          -  Patients with a history of musculoskeletal surgery related to the chief complaint(s)&#xD;
&#xD;
          -  Patients capable of effective communication with the researcher(s) and understanding&#xD;
             the survey items&#xD;
&#xD;
          -  Patients who have given written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients without a history of musculoskeletal surgery associated with the low back,&#xD;
             neck, shoulder, or knee region(s)&#xD;
&#xD;
          -  Patients whose current pain is mainly attributed to traffic accident injury&#xD;
&#xD;
          -  Patients incapable of answering the researcher interviews and surveys&#xD;
&#xD;
          -  Patients with other reasons rendering study participation inappropriate as judged by&#xD;
             the researcher(s)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>In-Hyuk Ha, KMD, M.Sc.</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>February 2018</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>March 27, 2019</last_update_submitted>
  <last_update_submitted_qc>March 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2019</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>Postoperative pain</keyword>
  <keyword>Failed back surgery syndrome</keyword>
  <keyword>Korean medicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</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/NCT03293212
org study id: JS-CT-2017-03
nct id: NCT03293212
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to assess and analyze the characteristics and usage of
      conventional and Korean medical services in postoperative patients. This study therefore
      investigates the proportion of patients with a history of surgery out of patients visiting a
      spine-specialty Korean medicine hospital, and the prognosis and preference for conventional
      and Korean medicine treatment by previous treatment history in postoperative patients.
A considerable number of patients suffer prolonged chronic pain that does not retract or
      diminish after surgery, and are thus unable to achieve the desired results in receiving
      surgical treatment. Postoperative pain is gradually being perceived as a social issue as
      opposed to a personal health condition. Meanwhile, although efforts to address chronic pain
      with integrative medicine are continued in answer to the lack of success of pain management
      through surgery, there is still a lack of supporting evidence.

      The objective of this survey study is to assess the characteristics, usage of conventional
      and Korean medical services, and prognosis by period before and after surgery in
      postoperative patients visiting a Korean medicine hospital, and analyze the associations
      between the preference for conventional and Korean medicine treatment. This study therefore
      investigates the usage of conventional and Korean medical services in postoperative patients,
      and is expected to provide information that will potentially aid patient decision making.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Numeric rating scale (NRS) of pain
time frame: Within 7 days after 1st visit
description: 11-point pain scale
measure: Five level version of EuroQol-5 Dimension (EQ-5D-5L)
time frame: Within 7 days after 1st visit
description: Health-related quality of life questionnaire consisting of 5 descriptive items and EQ Visual Analogue Scales (EQ-VASs)
measure: Functional disability questionnaire (for low back pain patients as indicated by postoperative condition)
time frame: Within 7 days after 1st visit
description: Oswestry Disability Index (ODI)
measure: Functional disability questionnaire (for neck pain patients as indicated by postoperative condition)
time frame: Within 7 days after 1st visit
description: Neck Disability Index (NDI)
measure: Functional disability questionnaire (for knee pain patients as indicated by postoperative condition)
time frame: Within 7 days after 1st visit
description: Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)
measure: Functional disability questionnaire (for shoulder pain patients as indicated by postoperative condition)
time frame: Within 7 days after 1st visit
description: Shoulder Pain and Disability Index (SPADI)
measure: Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH)
time frame: Within 7 days after 1st visit
description: Questionnaire assessing the effect of health problems on the ability to work and to perform regular activities
measure: Beck Depression Inventory-II (BDI-II)
time frame: Within 7 days after 1st visit
description: The Korean version of the BDI-II has been validated and consists of 21 multiple choice items for diagnosis of depression.
measure: Medical service use
time frame: Within 7 days after 1st visit
description: Type(s) of medical service use before and after surgery post-onset
measure: Medical costs
time frame: Within 7 days after 1st visit
description: Medical costs from medical service use before and after surgery post-onset
measure: Satisfaction with and preference for conventional and Korean medicine
time frame: Within 7 days after 1st visit
description: Satisfaction with and preference for conventional and Korean medicine as measured using a 9-point Likert scale
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: In-Hyuk Ha, KMD, M.Sc.
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: In-Hyuk Ha, KMD
investigator title: Director
mesh term: Pain, Postoperative
sharing ipd: No