Status Approved
First Submitted Date
2021/10/14
Registered Date
2021/11/08
Last Updated Date
2021/11/02
1. Background
CRIS Registration Number |
KCT0006707 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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 | Assistant 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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Ministry of Health & Welfare |
Organization Type | Government |
Project ID | HF20C0070 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Catholic Kwandong University |
Organization Type | University |
7. Study Summary
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. |
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8. Study Design
Study Type | Observational Study |
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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
Study Population Description | Adult male or female aged 20–60 years |
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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)
Type of Primary Outcome | Not applicable | |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Yes |
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Time of Sharing | 2023. 12 |
Way of Sharing | To be made available at a later date
(doolyjinhyun@empal.com) |
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