Status Approved
First Submitted Date
2021/03/29
Registered Date
2021/03/31
Last Updated Date
2021/03/29
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0006046 |
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Unique Protocol ID | CUH 2018-11-037-007 |
Public/Brief Title | The relationship between skeletal muscle mass and lumbar disability |
Scientific Title | The relationship between skeletal muscle mass and lumbar disability in patients with lumbar spinal stenosis and postlaminectomy syndrome |
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 | CUH 2018-11-037-007 |
Approval Date | 2019-01-02 |
Institutional Review Board Name | Institutional Review Board of Jeonbuk National University Hospital |
Institutional Review Board Address | 20, Geonji-ro, Deokjin-gu, Jeonju-si, Jeollabuk-do |
Institutional Review Board Telephone | 063-250-2154 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | A Ram Doo |
Title | Dr. |
Telephone | +82-41-250-1249 |
Affiliation | Jeonbuk National University |
Address | Geonji-ro 20 Deokjin-gu Jeonju city Jellabukdo |
Contact Person for Public Queries | |
Name | A Ram Doo |
Title | Dr. |
Telephone | +82-41-250-1249 |
Affiliation | Jeonbuk National University |
Address | Geonji-ro 20 Deokjin-gu Jeonju city Jellabukdo |
Contact Person for Updating Information | |
Name | A Ram Doo |
Title | Dr. |
Telephone | +82-41-250-1249 |
Affiliation | Jeonbuk National University |
Address | Geonji-ro 20 Deokjin-gu Jeonju city Jellabukdo |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2019-01-08 Actual | |
Target Number of Participant | 100 | |
Primary Completion Date | ||
Study Completion Date | ||
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Jeonbuk National University Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2019-01-08 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Jeonbuk National University Hospital |
Organization Type | Medical Institute |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Jeonbuk National University Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | Paraspinal muscle is associated to maintain the dynamic stability of spine, and decreased paraspinal muscle mass may be related to the deterioration of low back pain. However, there has been no appropriate quantitative measuring tool for skeletal muscle mass. In this study, we will investigate the relationship between skeletal muscle mass or skeletal muscle index measured by bioelectrical impedance analysis and the degree of lumbar disability. |
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8. Study Design
Study Type | Observational Study |
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Observational Study Model | Cohort |
Time Perspective | Prospective |
Target Number of Participant | 100 |
Cohort/Group Number | 1 |
Cohort/ Group 1 |
Cohort/Group Label patients who visited our pain clinic due to lumbar spinal stenosis or postlaminectomy syndrome |
Cohort/Group Description low back pain patients, 18-80 years, who visited our pain clinic due to lumbar spinal stenosis or postlaminectomy syndrome |
|
Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | patients who visited our pain clinic due to lumbar spinal stenosis or postlaminectomy syndrome |
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Sampling Method | Participants will be recruited using simple random sampling method |
Condition(s)/Problem(s) |
* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M48.06)Spinal stenosis, lumbar region lumbar spinal stenosis postlaminectomy syndorme |
Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 18Year~80Year |
|
Description participants who agree to participate to the study with informed consent |
|
Exclusion Criteria |
1) patient refusal 2) implantable metal material 3) patients who have cardiac pacemaker or ICD 4) pregnant women |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Not applicable | |
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Primary Outcome(s) 1 | ||
Outcome | Correlation between skeletal muscle index and Oswestry lumbar disability index |
|
Timepoint | at first visit to our pain clinic |
|
Secondary Outcome(s) 1 | ||
Outcome | Correlation between percent body fat and Oswestry lumbar disability index |
|
Timepoint | at first visit to our pain clinic |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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