Spinal Stenosis Clinical Trial
Official title:
A Prospective Study Comparison of Clinical Outcome After Different Rate Infusion in Caudal Epidural Steroid Injection
Verified date | June 2019 |
Source | Navamindradhiraj University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Thailand | Navamindradhiraj University | Dusit | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Navamindradhiraj University |
Thailand,
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
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 |
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