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