Records View

Perfusion index as a useful diagnostic parameter of complex regional pain syndrome

Status Approved

  • First Submitted Date

    2018/06/07

  • Registered Date

    2018/06/23

  • Last Updated Date

    2018/06/23

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
    KCT0002949
    Unique Protocol ID DC15OISI0102
    Public/Brief Title Diagnostic validity of PI in CRPS
    Scientific Title Perfusion index as a useful diagnostic parameter of complex regional pain syndrome
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol
    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 DC15OISI0102
    Approval Date 2015-12-24
    Institutional Review Board Name Daejeon St. Mary's hospital IRB
    Institutional Review Board Address Department of Anesthesiology and Pain Medicine, Daejeon St. Mary’s Hospital 64, Daeheung-ro, Jung-gu, Republic of Korea, 34943
    Institutional Review Board Telephone 042-220-9040
    Data Monitoring Committee
  • 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 EungDon Kim
    Title Dr.
    Telephone +82-42-220-9040
    Affiliation The Catholic University of Korea, Daejeon St. Mary's Hospital
    Address 64, Daeheung-ro, Jung-gu, Republic of Korea, 34943
    Contact Person for Public Queries
    Name EungDon Kim
    Title Dr.
    Telephone +82-42-220-9040
    Affiliation The Catholic University of Korea, Daejeon St. Mary's Hospital
    Address 64, Daeheung-ro, Jung-gu, Republic of Korea, 34943
    Contact Person for Updating Information
    Name EungDon Kim
    Title Dr.
    Telephone +82-42-220-9040
    Affiliation The Catholic University of Korea, Daejeon St. Mary's Hospital
    Address 64, Daeheung-ro, Jung-gu, Republic of Korea, 34943
  • 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 Completed
    Date of First Enrollment 2016-01-02 Actual
    Target Number of Participant 46
    Primary Completion Date 2016-02-19 , Actual
    Study Completion Date 2016-02-19 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study The Catholic University of Korea, Daejeon St. Mary's Hospital
    Recruitment Status Completed
    Date of First Enrollment 2016-01-02 ,
  • 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 The Catholic University of Korea, Daejeon St. Mary's Hospital
    Organization Type Medical Institute
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name The Catholic University of Korea, Daejeon St. Mary's Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Subjective abnormal thermal sensations in the affected limb are a very common phenomenon in complex regional pain syndrome (CRPS) and temperature asymmetry between the affected and contralateral sides is an important diagnostic criterion for CRPS diagnosis. A ≥1.0°C temperature difference was considered the discriminative value in a previous study.
    However, CRPS patients often do not exhibit significant measured temperature differences (ΔT) between the affected and normal sides, although these patients complain of abnormal thermal sensations on the affected side. This discrepancy between patient subjective vasomotor disturbance such as abnormal thermal sensations and objective measured temperature is commonly observed in clinical settings. These findings cast doubt on the diagnostic utility of a single temperature measurement method. 
    The perfusion index (PI) is derived from the photoplethysmographic signal on pulse oximetry. The PI is calculated as the ratio (%) between the amplitude of the pulsatile signal and the non-pulsatile baseline signal, ranging from 0.02 to 20%. It is proportional to the degree of perfusion flow and can reflect the circulation status of the monitoring site. 
    The PI has been described in several studies as a more sensitive and early indicator of the sympatholytic effect after epidural block or sympathectomy compared to temperature.  However, previous PI studies focused on responses following procedures. PI has not been used previously for diagnostic purposes.
    This study was conducted to compare agreement between PI and temperature measurement methods and patient’s subjective abnormal thermal sensations. For this purpose, we investigated whether PI differences (ΔPI) were a more reliable parameter for reflection of vasomotor disturbance compared to ΔT between affected and contralateral sides in CRPS patients presenting with subjective sensation of coldness in the affected limb.
  • 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 Others  
    Target Number of Participant 46
    Cohort/Group Number 2
    Cohort/
    Group 1

    Cohort/Group Label

    healthy control

    Cohort/Group Description

    Temperature and PI are recorded after bed rest for 10 minutes in a room with an ambient 24-26 °C temperature. All jewelry or other measurement site confounders are removed before measurement. 
    PI measurement
    Pulse oximetry sensors (Patient monitor VM 8; Phillips Inc., Amsterdam, Netherlands) are applied the third finger tips of both hands in both groups.
    
    Temperature measurement
    Temperature is measured by touch thermometer (Patient monitor VM 8; Phillips Inc., Amsterdam, Netherlands) at the volar aspect of index finger tips of both hands in both groups.
    Cohort/
    Group 2

    Cohort/Group Label

    CRPS group

    Cohort/Group Description

    Temperature and PI are recorded after bed rest for 10 minutes in a room with an ambient 24-26 °C temperature. All jewelry or other measurement site confounders are removed before measurement. 
    PI measurement
    Pulse oximetry sensors (Patient monitor VM 8; Phillips Inc., Amsterdam, Netherlands) are applied the third finger tips of both hands in both groups.
    
    Temperature measurement
    Temperature is measured by touch thermometer (Patient monitor VM 8; Phillips Inc., Amsterdam, Netherlands) at the volar aspect of index finger tips of both hands in both groups.
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    CRPS patients and healthy volunteers
    Sampling Method
    probability sampling
    Condition(s)/Problem(s) * (G00-G99)Diseases of the nervous system 
       (G90.7)Complex regional pain syndrome, other and unspecified type 
    Rare Disease Yes
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~No Limit

    Description

    CRPS patients aged over 19 years who perceived the affected limbs as cold. 
    A healthy person without cardiovascular disease  aged over 19 years who is not taking  anticoagulant  that can affect peripheral blood circulation.
    Exclusion Criteria
    Exclusion criteria include age < 19 years, patients without subjective sensation of coldness, and conditions that influenced peripheral circulation, such as severe cardiovascular disease or anticoagulant use.
    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
    compare agreement between PI and temperature measurement methods
    Timepoint
    after measurement
    Secondary Outcome(s) 1
    Outcome
    Receiver operating characteristic (ROC) curve analysis was used to assess the accuracy of reflection of subjective abnormal thermal sensations between the two measurement methods (ΔPI and ΔT)
    Timepoint
    after measurement
  • 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 Not provided at time of Registration
화면 최상단으로 이동

TOP

BOTTOM

화면 최하단으로 이동