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Research for extracellular water ratio and phase angle of transforaminal epidural block and lumbar epidural steroid injection.

Status Approved

  • First Submitted Date

    2018/02/26

  • Registered Date

    2018/04/23

  • Last Updated Date

    2018/04/08

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    		 KCT0002819
    Unique Protocol ID 2017-03-003
    Public/Brief Title Study on effectiveness of body water composition after pain treatment such as transforaminal epidural block and lumbar epidural steroid injection
    Scientific Title Research for extracellular water ratio and phase angle of transforaminal epidural block and lumbar epidural steroid injection.
    Acronym REWRPA
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status

  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number GNAH 2017-03-002
    Approval Date 2017-03-22
    Institutional Review Board Name Gangneung Asan Hospital Institutional Review Board
    Institutional Review Board Address 38, Bangdong-gil, Sacheon-myeon, Gangneung-si, Gangwon-do
    Institutional Review Board Telephone 033-610-3018
    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 Young-Ki Kim
    Title Professor
    Telephone +82-33-641-3409
    Affiliation GangNeung Asan Hospital
    Address 38 Bangdong-gil, Sacheon-myeon, Gangneung-si, Gangwon-do, Korea
    Contact Person for Public Queries
    Name Sung-Min Shim
    Title resident
    Telephone +82-33-641-3409
    Affiliation GangNeung Asan Hospital
    Address 38 Bangdong-gil, Sacheon-myeon, Gangneung-si, Gangwon-do, Korea
    Contact Person for Updating Information
    Name Sung-Min Shim
    Title resident
    Telephone +82-33-641-3409
    Affiliation GangNeung Asan Hospital
    Address 38 Bangdong-gil, Sacheon-myeon, Gangneung-si, Gangwon-do, 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
    Study Site Single
    Overall Recruitment Status Active, not recruiting
    Date of First Enrollment 2017-03-23 Actual
    Target Number of Participant 100
    Primary Completion Date 2018-01-26 , Actual
    Study Completion Date 2018-04-27 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study GangNeung Asan Hospital
    Recruitment Status Active, not recruiting
    Date of First Enrollment 2017-03-23 ,

  • 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 GangNeung Asan Hospital
    Organization Type Medical Institute
    Project ID GNAH 2017-03-002

  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name GangNeung Asan Hospital
    Organization Type Medical Institute

  • 7. Study Summary

    Study Summary Information
    Lay Summary 
    The purpose of this study was to investigate the differences in the changes of water content and phase angle through the body composition analyzer (InBody) in patients undergoing transforaminal epidural block and lumbar epidural steroid injection. We investigate how the post-operative edema and post-operative improvement of the body's health status can be objectively assessed by the body composition analyzer because pain is different for each patient and it is difficult to objectively show the result. So far, the body composition analyzer (InBody) has not been applied to pain treatment. This study examines the effect of transforaminal epidural block and lumbar epidural steroid injection used for the treatment of lower back pain in patients with lower extremity edema. There is no study like us. The type of procedure is determined according to the clinical judgment of the outpatient clinic. If the back pain is addressed, lumbar epidural block is performed. If the radiating pain is addressed, transforaminal epidural block is applied. The body composition analyzer (InBody) was performed at supine position 10 minutes before the procedure. The patient takes a rest in the supine position for 30 minutes after the procedure. Then, the body composition analyzer (InBody) was performed again.

  • 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 Case-only
    Time Perspective Cross-sectional  
    Target Number of Participant 100
    Cohort/Group Number 2
    Cohort/
    Group 1

    Cohort/Group Label

    Transforaminal epidural block

    Cohort/Group Description

    - The target people is patients visiting pain clinic at the address of the back pain and sciatica.
- All patients who were admitted to the outpatient department of the pain clinic and underwent transforaminal epidural block were explained about clinical trial and got informed consents.
- Height and weight were measured by weight and height measuring system (GL-150, G-Tech international, Korea). 
- Personal profile such as age, sex, height, and weight were entered to the bioelectrical impedance analyzer. 
- Patients were lying down for 10 minutes in supine position. Then direct multi-frequency bioelectrical impedance analyzer (InBody 10, Seoul, Korea) was employed using hand and feet attachable electrode system.
- Transforaminal epidural block was performed.
- The patients were lying down for 30 minutes after procedure in supine position, direct multi-frequency bioelectrical impedance analysis method was employed again.
    Cohort/
    Group 2

    Cohort/Group Label

    Lumbar epidural steroid injection

    Cohort/Group Description

    - The target people is patients visiting pain clinic at the address of the back pain and sciatica.
- All patients who were admitted to the outpatient department of the pain clinic and underwent lumbar epidural steroid injection were explained about clinical trial and got informed consents.
- Height and weight were measured by weight and height measuring system (GL-150, G-Tech international, Korea). 
- Personal profile such as age, sex, height, and weight were entered to the bioelectrical impedance analyzer. 
- Patients were lying down for 10 minutes in supine position. Then direct multi-frequency bioelectrical impedance analyzer (InBody 10, Seoul, Korea) was employed using hand and feet attachable electrode system.
- Lumbar epidural steroid injection was performed.
- The patients were lying down for 30 minutes after procedure in supine position, direct multi-frequency bioelectrical impedance analysis method was employed again.
    Biospecimen
    Collection & Archiving    		 
    Not collect nor Archive
    Biospecimen Description 
    		
												
    
											    
										
    
									
									
								
							
    
						
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									9. Subject Eligibility
								
    
								
							
    
							
    
								
    
									Subject Eligibility Information
									
										
											
    
												Study Population Description
												
    Patients with low back pain or sciatica who visit pain clinic and an age of more than 19 years.
    		
											
    
											
    
												Sampling Method
												
    Purposive sampling
    		
											
    
										
										
    
											Condition(s)/Problem(s)
											
												
												* (M00-M99)Diseases of the musculoskeletal system and connective tissue 
    
												
												
												   (M54.56)Low back pain, lumbar region 
												
												
											    		
										
    
										
    
											Rare Disease
											
												
													
													No
												
											
										
    
										
    
											
												Inclusion Criteria
											
											
												
    Gender
    
												Both
											    		
										
    
										
    
											
												
    Age
    
												19Year~No Limit
											    		
										
    
										
    
											
												
    Description
    
												
    Patients with low back pain or sciatica who visit pain clinic and receiving one of the procedures such as transforaminal epidural block or lumbar epidural steroid injection.
    
											    		
										
    
										
    
											
												Exclusion Criteria
											
											
												
    Contraindications for the test of bioelectrical impedance analysis were the use of a pacemaker or a defibrillator, or an age of less than 19 years.
    
											    		
										
    
										
    
											
												Healthy Volunteers
											
											
												
													
													No
												
											
										
    
									    
								
    
							
    
						
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									10. Outcome Measure(s)
								
    
								
							
    
							
    
								
    
									Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
									
										
    
											
												
												Type of Primary Outcome
											
											Efficacy
										
    
										
											
    
												
													Primary Outcome(s) 1
												
											
    
											
    
												Outcome
												
    The difference of extracellular body water (ECW) ratio and phase angle before and after pain procedure.
    		
											
    
											
    
												Timepoint
												
    Difference between data 10 minutes before the procedure and 30 minutes after the procedure
    		
											
    
										
										
											
    
												
													Secondary Outcome(s) 1
												
											
    
											
    
												Outcome
												
    Tendency of body mass index and percent body fat
    		
											
    
											
    
												Timepoint
												
    Confirm with bioelectrical impedance analyzer 10 minutes before procedure.
    		
											
    
										
									    
								
    
							
    
						
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									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
											
												
													Yes
													
												
												
												
    Results Upload
											    		
										
    
										
											
    
												Final Enrollment Number
												36 
											
    
											
    
												Number of Publication
												0
											
    
											
											
    
												Results Upload
												
													
														inbody sumit_final.docx
													
												
											
    
											
    
												Date of Posting Results
												2018/03/22
											
    
											
    
												Protocol URL or File Upload
												
													
													
													
												
											
    
											
    
												Brief Summary
												
    We was able to confirm that bioelectrical impedance analysis might be a useful tool to evaluate body condition before and after pain procedure. Especially we found lumbar epidural steroid injection influenced extracellular body water ratio and phase angle on lower extremities by modulation of sympathetic system. Thus, edema on lower extremities was reduced and cellular integrity was improved. From now on, it is time for us to consider how to use BIA in pain treatment.
    		
											
    
										
									    
								
    
							
    
						
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									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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