A Prospective Study Comparison of Clinical Outcome After Different Rate Infusion in Caudal Epidural Steroid Injection
Overview
- Phase
- Not Applicable
- Intervention
- Triamcinolone Acetonide and normal saline solution
- Conditions
- Spinal Stenosis
- Sponsor
- Navamindradhiraj University
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- Change from baseline Visual Analogue Scale at 2, 6, 12 weeks
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Satit Thiengwittayaporn
Associate Professor
Navamindradhiraj University
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
Arms & Interventions
Group 1: 40 ml/min
Triamcinolone acetonide (80 mg)/2 ml and normal saline solution 18 ml infusion in 0.5 min
Intervention: Triamcinolone Acetonide and normal saline solution
Group 2: 20 ml/min
Triamcinolone acetonide (80 mg)/2 ml and normal saline solution 18 ml infusion in 1 min
Intervention: Triamcinolone Acetonide and normal saline solution
Outcomes
Primary Outcomes
Change from baseline Visual Analogue Scale at 2, 6, 12 weeks
Time Frame: 2, 6, 12 weeks
Change from baseline Roland 5-point pain scale at 2, 6, 12 weeks
Time Frame: 2, 6, 12 weeks
Change from baseline Standing tolerance test at 2, 6, 12 weeks
Time Frame: 2, 6, 12 weeks
Change from baseline Walking tolerance test at 2, 6, 12 weeks
Time Frame: 2, 6, 12 weeks
Change from baseline Patient satisfaction scale at 2, 6, 12 weeks
Time Frame: 2, 6, 12 weeks
Secondary Outcomes
- Complication of Caudal Epidural Steroid Injection(2, 6, 12 weeks)