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

Navamindradhiraj University112 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

112

Conditions

Spinal Stenosis Lumbosacral Spondylosis Radiculopathy

Interventions

Triamcinolone Acetonide and normal saline solutionDRUG

80 mg/2 ml Triamcinolone Acetonide and 18 ml normal saline solution

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Navamindradhiraj University

Dusit, Bangkok, Thailand

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

Time frame: 2, 6, 12 weeks

Data from ClinicalTrials.gov

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