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

Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02939482
• Other study ID #: COA 74/2559
• Status: Completed
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: January 30, 2019

Study information

• Verified date: June 2019
• Source: Navamindradhiraj University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: January 30, 2019
• Est. primary completion date: August 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lumbosacral Spondylosis
• Radiculopathy
• Spinal Stenosis
• Spondylosis

Intervention

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

Locations

Country	Name	City	State
Thailand	Navamindradhiraj University	Dusit	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Navamindradhiraj University

Country where clinical trial is conducted

Thailand, 

References & Publications (3)

Botwin KP, Gruber RD, Bouchlas CG, Torres-Ramos FM, Sanelli JT, Freeman ED, Slaten WK, Rao S. Fluoroscopically guided lumbar transformational epidural steroid injections in degenerative lumbar stenosis: an outcome study. Am J Phys Med Rehabil. 2002 Dec;81 — View Citation

Kraiwattanapong C, Wechmongkolgorn S, Chatriyanuyok B, Woratanarat P, Udomsubpayakul U, Chanplakorn P, Keorochana G, Wajanavisit W. Outcomes of fluoroscopically guided lumbar transforaminal epidural steroid injections in degenerative lumbar spondylolisthe — View Citation

Watts RW, Silagy CA. A meta-analysis on the efficacy of epidural corticosteroids in the treatment of sciatica. Anaesth Intensive Care. 1995 Oct;23(5):564-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Visual Analogue Scale at 2, 6, 12 weeks		2, 6, 12 weeks
Primary	Change from baseline Roland 5-point pain scale at 2, 6, 12 weeks		2, 6, 12 weeks
Primary	Change from baseline Standing tolerance test at 2, 6, 12 weeks		2, 6, 12 weeks
Primary	Change from baseline Walking tolerance test at 2, 6, 12 weeks		2, 6, 12 weeks
Primary	Change from baseline Patient satisfaction scale at 2, 6, 12 weeks		2, 6, 12 weeks
Secondary	Complication of Caudal Epidural Steroid Injection		2, 6, 12 weeks