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

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.

Inclusion criteria:

- Patients with history of lumbar surgery of at least 6 months duration in the past

- Patients over the 18 years of age

- Patients with a history of chronic function-limiting low back pain with or without
lower extremity pain of at least 6 months duration

- Patients who are competent to understand the study protocol and provide voluntary,
written informed consent and participate in outcome measurements

Exclusion criteria:

- Post surgery, central spinal stenosis, and facet joints as sole pain generators

- Unstable or heavy opioid use

- Uncontrolled psychiatric disorders

- Uncontrolled medical illness

- Any conditions that could interfere with the interpretation of the outcome
assessments

- Pregnant or lactating women

- Patients with a history or potential for adverse reaction(s) to local anesthetics or
steroid.