본문바로가기



검색

CRIS문의

  • Status : Approved
    • First Submitted Date : 2019/06/26
    • Registered Date : 2019/07/11
    • Last Updated Date : 2019/07/10
  • 페이스북공유하기
  • 트위터공유하기
  • 구글플러스공유하기
  • 카카오스토리공유하기
  • 네이버밴드공유하기
  • 출력

1. Background

Background Information
CRIS
Registration Number
KCT0004134 
Unique Protocol ID CR-19-009 
Public/Brief Title Necessity of steroid in Selective Nerve Root Block 
Scientific Title The effectiveness of Steroid in the Selective Nerve Root Block of Lumbar Radiculopathy: A Double Blind, Randomized Controlled Clinical Trial  
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 CR-19-009-L 
Approval Date 2019-06-05 
Institutional Review Board  
Name Daegu Catholic University Medical Center Institutional Review Board 
Address 33, Duryugongwon-ro 17-gil, Nam-gu, Daegu 
Telephone 053-650-4423 
Data Monitoring Committee  

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Sangbong Ko 
Title Professor 
Telephone +82-53-650-4283 
Affiliation The Catholic University of Daegu 
Address 13, Hayang-ro, Hayang-eup, Gyeongsan-si, Gyeongsangbuk-do, Republic of Korea 
Contact Person for Public Queries
Name Sangbong Ko 
Title Professor 
Telephone +82-53-650-4283 
Affiliation The Catholic University of Daegu 
Address 13, Hayang-ro, Hayang-eup, Gyeongsan-si, Gyeongsangbuk-do, Republic of Korea 
Contact Person for Updating Information
Name Sangbong Ko 
Title Professor 
Telephone +82-53-650-4283 
Affiliation The Catholic University of Daegu 
Address 13, Hayang-ro, Hayang-eup, Gyeongsan-si, Gyeongsangbuk-do, Republic of Korea 

4. Status

Status Information
Study Site Single
Overall Recruitment Status Not yet recruiting  
Date of First Enrollment 2019-08-02 , Anticipated
Target Number of Participant 40
Primary Completion Date 2019-12-02 , Anticipated
Study Completion Date 2020-07-31 , Anticipated
Recruitment Status by Participating Study Site 1
Name of Study Site Daegu Catholic University Medical Center 
Recruitment Status Not yet recruiting  
Date of First Enrollment 2019-08-02 , Anticipated

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Daegu Catholic University Medical Center 
Organization Type Medical Institute  
Project ID  

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
Organization Name Daegu Catholic University Medical Center 
Organization Type Medical Institute  

7. Study Summary

Study Summary Information
Lay Summary 1. Purpose <br />To confirm that the addition of hyaluronic acid is effective in eliminating steroid hormone in patients with selective nerve root block for lumbar radiculopathy. <br />2. Background <br />Lower leg radiculopathy usually occurs in the buttocks or in the lumbar spine. Such pain is the pain that radiates to the thighs, calves, ankle joints, and sles, and is usually is felt like knife stabbing, dulling, burning, electrical tingling, dull senstation, insect crawling pain. It is a very sensitive symptom that occurs in 95&#37; of symptoms. <br />Many therpies have been proposed for the relief of these radiating pain, and physical therapy, massage and various medications have been proposed. Many of these drugs have been studied for the use of gabapentin, pregablin as well as anti-inflammatory agents and muscle relaxants. Recently epidural injection and selective nerve root block(SNRB) have been performed as minimally invasive treatment. SNRB is a method of reliieving pain by injecting steroid and local anesthetics in the pressured nerve roots that cause radiating pain. Although there is disabreement about the ultimate therapeutic effect of SNRB, many researchers believe that it is an effective tereatment method. Drugs used for SNRB include corticosteroids that inhibit the production and release of inflammatory precursors and local anethetics that inhibit the delivery of nociceptive receptors. The detailed mechanism of SNRB is not celar. The duration of an improvement varies but is generally know to be too short. Prirmann et al. asserted that SNRB was effective initially but not lasted for 2 weeks. <br />Although hyaluronic acid injections are a rare risk of injecting into the blood vessels or epidural space of the spine, there is also an effect of reducing swelling, fibrosis, and edema. The authors reported that the use of this hyaluronic acid in the treatment of SNRB prolongs the treatemnt effect by 2-4weeks. <br />3. Methods <br />Based on the CONSORT guideline, the random assignment method used Permuted Block Randomization. <br />In the test group, 1ml of steroid, 1ml of hyaluronic acid, 1ml of lidocaine, 1ml of bupivacaine cocktail was used, and 1ml of hyaluronic acid, 1ml of lidocaine, 1ml of bupivacaine, and 1ml of normal saline were used as control group. 1ml of dexamethasone 5mg/1ml(dexamethasone disodium phosphate 5mg, Cheil Pharmaceutical Co., Ltd.) is used as the steroid hormone. The evaluation was made on the basis of the pre-injection demographic data and on the LANSS Scale, SF-36, Revised Roland Morris Disability Questionnaire(RMDQ), and Oswestry Disability Index(ODI). Visual Analogue Scale of Pain(VAS) were assessed at 2 weeks after injection, VAS, RMDQ, ODI were assessed at 6 weeks after injection, and VAS, SF-36, RMDQ, ODI were assessed at 12 weeks after injection.  

8. Study Design

Study Design Information
Study Type Interventional Study 
Study Purpose Treatment    
Phase Not applicable 
Intervention Model Parallel  
Blinding/Masking Double 
Blinded Subject Subject, Investigator 
Allocation RCT 
Intervention Type /Procedure/Surgery  
Intervention Description In the test group, mixed injection of 1ml of corticosteroid hormone, 1ml of hyaluronic acid, 1ml of lidocaine, 1ml of bupivacaine, and 1ml of normal saline were used. 1ml of dexamethasone 5mg/1ml( Dexamethasone disodium phosphate 5ml, Cheil Pharmaceutical Co., Ltd) is used as the corticosteroid hormone.  
Number of Arms
Arm 1 Arm Label Mixture of 1ml of corticosteroid hormone, 1ml of hyaluronic acid, 1ml of lidocaine, 1ml of bupivacaine, and 1ml of normal saline 
Target Number of Participant 20 
Arm Type Experimental 
Arm Description Mixture of 1ml of corticosteroid hormone, 1ml of hyaluronic acid, 1ml of lidocaine, 1ml of bupivacaine, and 1ml of normal saline 
Arm 2 Arm Label Mixture of 1ml of hyaluronic acid, 1ml of lidocaine, 1ml of bupivacaine, and 1ml of normal saline 
Target Number of Participant 20 
Arm Type Active comparator 
Arm Description Mixture of 1ml of hyaluronic acid, 1ml of lidocaine, 1ml of bupivacaine, and 1ml of normal saline 

9. Subject Eligibility

Subject Eligibility Information
Condition(s) / Problem(s) * Diseases of the musculo-skeletal system and connective tissue
 Lumbar vertebra, Herniated disc, Spinal Stenosis, Radiculopathy, Spinal Injections
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 20 Year ~ No Limit
Description 1. Patients visiting out orthopaedic outpatient clinic unitl the registration of 20 pateints on IRB approval date <br />2. LANSS &gt; 7 <br />3. Patients who require SNRB with a VAS score of 3 or more <br />4. Patients who voluntarily agreed to the informed consent  
Exclusion Criteria 1. Pregant patients <br />2. Patient who have secondary gain such as worker&#39;s compensation. <br />3. Patient who have severe cor-morbidity <br />4. Patient who lost during follow up period due to other cuase such movings. <br />5. Patient who have contraindication to medications. <br />6. Patient who were participating in itnerventional studies during the study period. <br />7. Patient with cancer of the spinie due to primary or metastatic cancer <br />8. Patinet who cannot communicate  
Healthy Volunteers No

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome Efficacy 
Primary Outcome(s) 1 
Outcome Improving rate of lower leg radiating pain( Visual Analogue Scale ) 
Timepoint Pre-injection, 2weeks, 6 weeks, 12 weeks after injection 
Secondary Outcome(s) 1 
Outcome Functional Outcome using Oswestry Disability Index, Rolland Morris Disability Questionnaire 
Timepoint Pre-injection, 6 weeks, 12 weeks after injection 
Secondary Outcome(s) 2 
Outcome Quality of Life using Short Form 36 Questionnaire(SF-36) 
Timepoint Pre-injection, 12 weeks after injection 

11. Study Results and Publication

Study Results and Publication Information
Result Registered No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information
Sharing Statement Yes 
Time of Sharing 2020.06
Way of Sharing Available on Request
(bong@cu.ac.kr)
  • 출력
Quick Link
자주하시는 질문
Q&A
등록절차
입력항목설명집