임상연구정보서비스

Value of phase angle for analgesic measurement in lumbosacral transforaminal block

Status Approved

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	KCT0005642
Unique Protocol ID	SMC 2020-09-170-001
Public/Brief Title	Value of phase angle for analgesic measurement in lumbosacral transforaminal block
Scientific Title	Value of phase angle for analgesic measurement in lumbosacral transforaminal block
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	SMC 2020-09-170-001
Approval Date	2020-10-08
Institutional Review Board Name	Samsung Medical Center Institutional Review Board
Institutional Review Board Address	81, Irwon-ro, Gangnam-gu, Seoul
Institutional Review Board Telephone	02-3410-2973
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	Jin Young Lee
Title	MD, PhD
Telephone	+82-2-3410-1929
Affiliation	Samsung Medical Center
Address	Ilwon ro 81, Gangnam gu, Seoul, Korea
Contact Person for Public Queries
Name	Jin Young Lee
Title	MD, PhD
Telephone	+82-2-3410-1929
Affiliation	Samsung Medical Center
Address	Ilwon ro 81, Gangnam gu, Seoul, Korea
Contact Person for Updating Information
Name	Jin Young Lee
Title	MD, PhD
Telephone	+82-2-3410-1929
Affiliation	Samsung Medical Center
Address	Ilwon ro 81, Gangnam gu, Seoul, Korea

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
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2020-10-09 Actual
Target Number of Participant	100
Primary Completion Date	2020-11-30 , Anticipated
Study Completion Date	2020-12-31 , Anticipated
Name of Study	Samsung Medical Center
Recruitment Status	Recruiting
Date of First Enrollment	2020-10-09 ,

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	Samsung Medical Center
Organization Type	Medical Institute
Project ID	SMC 2020-09-170-001

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Samsung Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	This study evaluates the value of phase angle for analgesic measurement after transforaminal block in lumbosacral radicular pain

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	Retrospective
Target Number of Participant	100
Cohort/Group Number	2
Cohort/ Group 1	Cohort/Group Label patient who showed a reduction over 50% on pain score following block
Cohort/ Group 1	Cohort/Group Description phase angle and temperature of patient who showed a reduction over 50% on pain score following block
Cohort/ Group 2	Cohort/Group Label patient who showed a reduction below 50% on pain score following block
Cohort/ Group 2	Cohort/Group Description phase angle and temperature of patient who showed a reduction below 50% on pain score following block
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	patient who underwent transforaminal block with lumbosacral radicular pain in Samsung Medical Center
Sampling Method	We retrospectively reviewed the electronic medical records of patients with lumbosacral radicular pain, who underwent a transforaminal block from February to September 2020 at Samsung Medical Center
Condition(s)/Problem(s)	* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M51.2)Other specified intervertebral disc displacement lumbosacral radicular pain by herniated nucleus pulposus or spinal stenosis
Rare Disease	No
Inclusion Criteria	Gender Both
	Age No Limit~No Limit
	Description patients with lumbosacral radicular pain, who underwent a transforaminal block from February to September 2020 at Samsung Medical Center
Exclusion Criteria	lumbosacral surgery, neoplastic disease, peripheral vascular disease, cardiovascular medication
Healthy Volunteers	No

10. Outcome Measure(s)

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