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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2019-01-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Spinal Stenosis Lumbosacral Spondylosis Radiculopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group 1: 40 ml/min

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

Group Type ACTIVE_COMPARATOR

Triamcinolone Acetonide and normal saline solution

Intervention Type DRUG

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

Group 2: 20 ml/min

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

Group Type EXPERIMENTAL

Triamcinolone Acetonide and normal saline solution

Intervention Type DRUG

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

Interventions

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Triamcinolone Acetonide and normal saline solution

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No