The Preliminary Results of a Comparative Effectiveness Evaluation of Adhesiolysis and Caudal Epidural Injections in Managing Chronic Low Back Pain Secondary to Spinal Stenosis: A Randomized, Equivalence Controlled Trial

Abstract

Background: Lumbar surgery and epidural injections for spinal stenosis are the most commonly performed interventions in the United States. However, there is only moderate evidence to the effectiveness of surgery and caudal epidural injections. The next sequential step is adhesiolysis and hypertonic neurolysis with targeted delivery. There have not been any randomized trials evaluating the effectiveness of percutaneous adhesiolysis and targeted delivery of local anesthetic, steroid and hypertonic sodium chloride solution in lumbar spinal stenosis. Study Design: A randomized, equivalence, controlled trial. Setting: An interventional pain management practice, a specialty referral center, a private practice setting in the United States. Objectives: To evaluate the effectiveness of percutaneous epidural adhesiolysis in patients with chronic low back and lower extremity pain with lumbar central spinal stenosis and compare with fluoroscopically directed caudal epidural injections. Methods: Patients were randomly assigned to one of 2 groups with 25 patients in each group. Group I patients received caudal epidural injections with catheterization up to S3 with local anesthetic, 0.9% sodium chloride solution, non-particulate betamethasone and served as the control group. Group II patients received percutaneous adhesiolysis with targeted delivery and injection of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate Betamethasone and formed the intervention group. Randomization was performed by computer-generated random allocation sequence by simple randomization. Outcomes Assessment: Multiple outcome measures were utilized including the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake with assessment at 3, 6, and 12 months post treatment. Significant pain relief was described as 50% or more, whereas significant improvement in the disability score was defined as a reduction of 40% or more. Results: This evaluation showed significant pain relief (> 50%) in 76% of the patients at one year follow-up in the adhesiolysis group compared to 4% of the patients in the control group. Limitations: The results of this study are limited by the lack of a placebo group, the fact that it is a preliminary report, and there are only 25 patients in each group. Conclusions: With significant pain relief in 76% of patients, percutaneous adhesiolysis utilizing local anesthetic, steroids and hypertonic sodium chloride solution may be effective in patients with chronic function-limiting low back and lower extremity pain with spinal stenosis. Key words: Spinal stenosis, percutaneous adhesiolysis, steroids, local anesthetics, hypertonic sodium chloride solution, randomized equivalence controlled trial, pragmatic trial