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A Study Comparison of Clinical Outcome After Different Rate of Infusion in Caudal Epidural Steroid Injection

Primary Purpose

Spinal Stenosis, Lumbosacral Spondylosis, Radiculopathy

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Triamcinolone Acetonide and normal saline solution
Sponsored by
Navamindradhiraj University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Stenosis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • lumbosacral spinal stenosis with radiculopathy
  • no improvement after conservative treatment for 6 weeks

Exclusion Criteria:

  • previous CESI or spinal surgery
  • skin infection at injection site
  • uncontrolled diabetes mellitus
  • abnormal coagulogram
  • vertebral fracture
  • previous history of allergy to steroid or anesthetic agent

Sites / Locations

  • Navamindradhiraj University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group 1: 40 ml/min

Group 2: 20 ml/min

Arm Description

Triamcinolone acetonide (80 mg)/2 ml and normal saline solution 18 ml infusion in 0.5 min

Triamcinolone acetonide (80 mg)/2 ml and normal saline solution 18 ml infusion in 1 min

Outcomes

Primary Outcome Measures

Change from baseline Visual Analogue Scale at 2, 6, 12 weeks
Change from baseline Roland 5-point pain scale at 2, 6, 12 weeks
Change from baseline Standing tolerance test at 2, 6, 12 weeks
Change from baseline Walking tolerance test at 2, 6, 12 weeks
Change from baseline Patient satisfaction scale at 2, 6, 12 weeks

Secondary Outcome Measures

Complication of Caudal Epidural Steroid Injection

Full Information

First Posted
October 15, 2016
Last Updated
June 22, 2019
Sponsor
Navamindradhiraj University
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1. Study Identification

Unique Protocol Identification Number
NCT02939482
Brief Title
A Study Comparison of Clinical Outcome After Different Rate of Infusion in Caudal Epidural Steroid Injection
Official Title
A Prospective Study Comparison of Clinical Outcome After Different Rate Infusion in Caudal Epidural Steroid Injection
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
August 2, 2018 (Actual)
Study Completion Date
January 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Navamindradhiraj University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the effects of different rates of Caudal Epidural Steroid Injection (CESI) on clinical outcomes of the patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Stenosis, Lumbosacral Spondylosis, Radiculopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: 40 ml/min
Arm Type
Active Comparator
Arm Description
Triamcinolone acetonide (80 mg)/2 ml and normal saline solution 18 ml infusion in 0.5 min
Arm Title
Group 2: 20 ml/min
Arm Type
Experimental
Arm Description
Triamcinolone acetonide (80 mg)/2 ml and normal saline solution 18 ml infusion in 1 min
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide and normal saline solution
Intervention Description
80 mg/2 ml Triamcinolone Acetonide and 18 ml normal saline solution
Primary Outcome Measure Information:
Title
Change from baseline Visual Analogue Scale at 2, 6, 12 weeks
Time Frame
2, 6, 12 weeks
Title
Change from baseline Roland 5-point pain scale at 2, 6, 12 weeks
Time Frame
2, 6, 12 weeks
Title
Change from baseline Standing tolerance test at 2, 6, 12 weeks
Time Frame
2, 6, 12 weeks
Title
Change from baseline Walking tolerance test at 2, 6, 12 weeks
Time Frame
2, 6, 12 weeks
Title
Change from baseline Patient satisfaction scale at 2, 6, 12 weeks
Time Frame
2, 6, 12 weeks
Secondary Outcome Measure Information:
Title
Complication of Caudal Epidural Steroid Injection
Time Frame
2, 6, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: lumbosacral spinal stenosis with radiculopathy no improvement after conservative treatment for 6 weeks Exclusion Criteria: previous CESI or spinal surgery skin infection at injection site uncontrolled diabetes mellitus abnormal coagulogram vertebral fracture previous history of allergy to steroid or anesthetic agent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Satit Thiengwittayaporn, M.D.
Organizational Affiliation
Navamindradhiraj University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Navamindradhiraj University
City
Dusit
State/Province
Bangkok
ZIP/Postal Code
10300
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
8787255
Citation
Watts RW, Silagy CA. A meta-analysis on the efficacy of epidural corticosteroids in the treatment of sciatica. Anaesth Intensive Care. 1995 Oct;23(5):564-9. doi: 10.1177/0310057X9502300506.
Results Reference
result
PubMed Identifier
12447088
Citation
Botwin KP, Gruber RD, Bouchlas CG, Torres-Ramos FM, Sanelli JT, Freeman ED, Slaten WK, Rao S. Fluoroscopically guided lumbar transformational epidural steroid injections in degenerative lumbar stenosis: an outcome study. Am J Phys Med Rehabil. 2002 Dec;81(12):898-905. doi: 10.1097/00002060-200212000-00003.
Results Reference
result
PubMed Identifier
24761192
Citation
Kraiwattanapong C, Wechmongkolgorn S, Chatriyanuyok B, Woratanarat P, Udomsubpayakul U, Chanplakorn P, Keorochana G, Wajanavisit W. Outcomes of fluoroscopically guided lumbar transforaminal epidural steroid injections in degenerative lumbar spondylolisthesis patients. Asian Spine J. 2014 Apr;8(2):119-28. doi: 10.4184/asj.2014.8.2.119. Epub 2014 Apr 8.
Results Reference
result

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A Study Comparison of Clinical Outcome After Different Rate of Infusion in Caudal Epidural Steroid Injection

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