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
CRIS Registration Number |
KCT0002949 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | The Catholic University of Korea, Daejeon St. Mary's Hospital |
Organization Type | Medical Institute |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | The Catholic University of Korea, Daejeon St. Mary's Hospital |
Organization Type | Medical Institute |
7. Study Summary
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. |
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8. Study Design
Study Type | Observational Study |
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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
Study Population Description | CRPS patients and healthy volunteers |
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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)
Type of Primary Outcome | Not applicable | |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Not provided at time of Registration |
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