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

Not Applicable

Completed

• Conditions: Spinal Stenosis; Lumbosacral Spondylosis; Radiculopathy
• Interventions: Drug: Triamcinolone Acetonide and normal saline solution

• Registration Number: NCT02939482
• Lead Sponsor: Navamindradhiraj University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-01
• Study First Submitted: 2016-10-15
• Study First Submitted QC: 2016-10-19
• Study First Posted: 2016-10-20
• Primary Completion: 2018-08-02
• Study Completion: 2019-01-30
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-22
• Last Update Posted: 2019-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: 40 ml/min	Triamcinolone Acetonide and normal saline solution	Triamcinolone acetonide (80 mg)/2 ml and normal saline solution 18 ml infusion in 0.5 min
Group 2: 20 ml/min	Triamcinolone Acetonide and normal saline solution	Triamcinolone acetonide (80 mg)/2 ml and normal saline solution 18 ml infusion in 1 min

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Complication of Caudal Epidural Steroid Injection	2, 6, 12 weeks

Trial Locations

Locations (1)

Navamindradhiraj University; 🇹🇭 Dusit, Bangkok, Thailand