NCT01053273

A Randomized, Equivalence Trial of Percutaneous Lumbar Adhesiolysis and Caudal Epidural Steroid Injections

Comparative Effectiveness of Percutaneous Adhesiolysis and Caudal Epidural Steroid Injections in Low Back and/or Lower Extremity Pain: A Randomized, Equivalence Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Pain Management Center of Paducah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to: * evaluate the effectiveness of percutaneous epidural adhesiolysis in managing chronic low back and/or lower extremity pain in patients without post lumbar surgery syndrome or spinal stenosis and compare with fluoroscopically directed caudal epidural steroid injections. * evaluate and compare the adverse event profile in all groups.

Detailed description

Recruitment is indicated in patients with chronic low back pain and/or lower extremity pain without post lumbar laminectomy syndrome or spinal stenosis, non-responsive to conservative therapy with physical therapy, chiropractic, medical therapy, and fluoroscopically directed epidural injections. This is a single-center study performed in an interventional pain management referral center in the United States. The study involves 120 patients assigned to one of 2 groups with 60 patients in each group. Data management analysis includes sample size justification of 40 patients in each group with a power of 80% and a 0.05% 2-sided significance level. Statistical methodology includes chi-squared statistics, Fisher's exact test, t-test, and paired t-test with significance evaluated at P value \< 0.05.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
PROCEDURE	Caudal Epidural Injection	Group I will receive caudal epidural injections with catheterization up to S3 with local anesthetic, steroids, and 0.9% sodium chloride solution
PROCEDURE	percutaneous adhesiolysis	Group II will receive percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate betamethasone.

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-01-01
• Completion: 2014-01-27
• First posted: 2010-01-21
• Last updated: 2017-04-25

Locations

1 site across 1 country: United States