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Effect of sarcopenia on quality of life and activities of daily living in postherpetic neuralgia patients

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

    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
    KCT0006048
    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

    Institutional Review Board Information
    Board Approval Status Submitted approval
    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 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 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

    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 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

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Jeonbuk National University Hospital
    Organization Type Medical Institute
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Jeonbuk National University Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    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.
  • 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 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

    Subject Eligibility Information
    Study Population Description
    patients who visited our pain clinic due to postherpetic neuralgia
    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)

    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
    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

    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 No
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