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 |
KCT0006048 |
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Unique Protocol ID | CUH 2019-12-015-002 |
Public/Brief Title | Effect of sacropenia on quality of life of postherpetic neuralgia patients |
Scientific Title | Effect of sarcopenia on quality of life and activities of daily living in postherpetic neuralgia patients |
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 2019-12-015-002 |
Approval Date | 2020-01-10 |
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 | +82-63-250-1249 |
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 | +82-63-250-1249 |
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 | +82-63-250-1249 |
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 | 2020-01-13 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 | 2020-01-13 , |
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 | Postherpetic neuralgia (PHN) is associated with decreased quality of life, disabled in activities of daily living(ADL), and deteriorated psychological well-being in older patients. And sarcopenia is associated with frailty and functional disability in older patients. In this study, we will investigate the relationship between sarcopenia and PHN-related quality of life, ADL and pain intensity. |
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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 Postherpetic neuralgia patients |
Cohort/Group Description postherpetic neuralgia patients who have persistent pain for 90 days or more after zoster onset |
|
Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | patients who visited our pain clinic due to postherpetic neuralgia |
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Sampling Method | Participants will be recruited using simple random samlping method. |
Condition(s)/Problem(s) |
* (A00-B99)Certain infectious and parasitic diseases (B02.2)Zoster with other nervous system involvement postherpetic neuralgia |
Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 18Year~80Year |
|
Description PHN patients who has persistent pain for 90 days or more after zoster onset |
|
Exclusion Criteria |
patient refusal severe hepatorenal impairment cognitive dysfunction |
Healthy Volunteers |
10. Outcome Measure(s)
Type of Primary Outcome | Not applicable | |
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Primary Outcome(s) 1 | ||
Outcome | relationship between sarcopenia and quality of life of PHN patients |
|
Timepoint | at first visit to our pain clinic |
|
Secondary Outcome(s) 1 | ||
Outcome | relationship between sarcopenia and activities of daily living of PHN patients |
|
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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