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

June 22, 2019 updated by: Satit Thiengwittayaporn, Navamindradhiraj University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Dusit, Bangkok, Thailand, 10300
        • Navamindradhiraj University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1: 40 ml/min
Triamcinolone acetonide (80 mg)/2 ml and normal saline solution 18 ml infusion in 0.5 min
Drug: Triamcinolone Acetonide and normal saline solution
80 mg/2 ml Triamcinolone Acetonide and 18 ml normal saline solution
Experimental: Group 2: 20 ml/min
Triamcinolone acetonide (80 mg)/2 ml and normal saline solution 18 ml infusion in 1 min
Drug: Triamcinolone Acetonide and normal saline solution
80 mg/2 ml Triamcinolone Acetonide and 18 ml normal saline solution

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Complication of Caudal Epidural Steroid Injection
Time Frame: 2, 6, 12 weeks
2, 6, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Navamindradhiraj University

Investigators

  • Principal Investigator: Satit Thiengwittayaporn, M.D., Navamindradhiraj University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

August 2, 2018

Study Completion (Actual)

January 30, 2019

Study Registration Dates

First Submitted

October 15, 2016

First Submitted That Met QC Criteria

October 19, 2016

First Posted (Estimate)

October 20, 2016

Study Record Updates

Last Update Posted (Actual)

June 25, 2019

Last Update Submitted That Met QC Criteria

June 22, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COA 74/2559

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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