연구정보 영문

Comparison of Concordance between Chuna Manual Therapy Diagnosis Methods (palpation, X-ray, artificial intelligence program) in Lumbar Spine: An Exploratory, Cross-sectional, Prospective Observational Study

Status Approved

  • First Submitted Date

    2021/10/14

  • Registered Date

    2021/11/08

  • Last Updated Date

    2021/11/02

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0006707
    Unique Protocol ID WUKMH-HRM-21
    Public/Brief Title Comparison of Concordance between Chuna Manual Therapy Diagnosis Methods in Lumbar Spine
    Scientific Title Comparison of Concordance between Chuna Manual Therapy Diagnosis Methods (palpation, X-ray, artificial intelligence program) in Lumbar Spine: An Exploratory, Cross-sectional, Prospective Observational Study
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number IRB 2021-08
    Approval Date 2021-10-06
    Institutional Review Board Name Institutional Review Board Wonkwang Univ. Korean Medicine Hospital
    Institutional Review Board Address Institutional Review Board Wonkwang Univ. Korean Medicine Hospital, 895, Muwang-ro, Iksan-si, Jeollabuk-do, Republic of Korea
    Institutional Review Board Telephone 063-859-2841
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Jung-Han Lee
    Title Professor
    Telephone +82-63-859-2807
    Affiliation Wonkwang University. Iksan Korean Medicine Hospital
    Address 895, Muwang-ro, Iksan-si, Jeollabuk-do, Republic of Korea
    Contact Person for Public Queries
    Name Jung-Han Lee
    Title Professor
    Telephone +82-63-859-2807
    Affiliation Wonkwang University. Iksan Korean Medicine Hospital
    Address 895, Muwang-ro, Iksan-si, Jeollabuk-do, Republic of Korea
    Contact Person for Updating Information
    Name Jin-Hyun Lee
    Title A​ssistant Professor
    Telephone +82-32-290-3320
    Affiliation Catholic Kwandong University International St.Mary's Hospital
    Address 25, Simgok-ro 100beon-gil, Seo-gu, Incheon, Republic of Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Not yet recruiting
    Date of First Enrollment 2021-10-25 Anticipated
    Target Number of Participant 100
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Wonkwang University. Iksan Korean Medicine Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2021-10-25 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Ministry of Health & Welfare
    Organization Type Government
    Project ID HF20C0070
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Catholic Kwandong University
    Organization Type University
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Chuna manual therapy (CMT) is a type of manual medicine practiced by Korean medical doctors (KMDs) in South Korea. 
    Spinal diagnosis in CMT uses a system that applies manual diagnostic and X-ray tests to detect specific vertebral malpositions, based on the relative alignment across vertebral bodies. Recently, artificial intelligence (AI) programs have been developed to assist in the radiological diagnosis of CMT using X-ray images. Nevertheless, a few clinical studies have reported on the concordance between diagnosticians, diagnostics methodologies, and the use of AI programs for diagnosing CMT. At present, the evidence to support CMT diagnosis is insufficient. This study thus aims to overcome such limitations by collecting and comparing CMT diagnostic data from experts and non-experts through manual diagnosis, X-ray test, and images obtained using an AI program. The study aims to search for CMT diagnosis methods with more outstanding rationality and consistency and to explore the potential use of AI-based CMT diagnosis programs. 
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Others
    Time Perspective Cross-sectional  
    Target Number of Participant 100
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    Normal Adult Group

    Cohort/Group Description

    From 100 clinical trial subjects, the following diagnostic data will be collected to be used to evaluate the diagnostic consistency.
    
    1. Manual diagnoses by the Chuna manual therapy (CMT) expert group(n=3) 
    2. Radiological diagnoses by the CMT expert group (n=3) 
    3. Radiological diagnoses by the CMT non-expert group  (n=3) 
    4. Artificial intelligence -based diagnosis by the CMT non-expert group(n=3) 
    
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    Adult male or female aged 20–60 years
    Sampling Method
    This study is an exploratory clinical study targeting the normal condition group and does not go through a sampling method process except for the selection/exclusion criteria.
    Condition(s)/Problem(s) * (M00-M99)Diseases of the musculoskeletal system and connective tissue 
       (M99.0)Segmental and somatic dysfunction 

    Normal condition
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    20Year~60Year

    Description

    1. Adult male or female aged 20–60 years
    2. Ability to understand the study protocol and agrees to participation, and who voluntarily signs the IRB-approved consent form
    3. No communication problems during the physical examination and X-ray test 
    
    Exclusion Criteria
    1. Past trauma or surgery that may induce a structural problem in the lumbar spine (e.g., osteoporosis, fracture, and lumbar spine surgery)
    2. A history of disease that may induce a structural change in the lumbar spine (e.g., congenital spinal deformity, ankylosing spondylitis, idiopathic scoliosis, and tumor)
    3. An obesity factor of mid to high severity based on BMI (>30 kg/m2) that prevents manual spinal diagnosis
    4. A history of psychotic disorder, alcohol addiction, or drug addiction
    5. Pregnant mothers or women planning pregnancy
    6. Other individuals deemed unsuitable for the study by the principal investigator
    
    Healthy Volunteers Yes
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Not applicable
    Primary Outcome(s) 1
    Outcome
    Within-group concordance between diagnosticians per diagnosis method
    Timepoint
    After collecting diagnostic data
    Secondary Outcome(s) 1
    Outcome
    Between-group concordance per diagnosis method
    Timepoint
    After collecting diagnostic data
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Yes
    Time of Sharing 2023. 12
    Way of Sharing To be made available at a later date
    (doolyjinhyun@empal.com)
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