Protocol for Evaluation of the Comparative Effectiveness of Percutaneous Adhesiolysis and Caudal Epidural Steroid Injections in Low Back and/or Lower Extremity Pain without Post Surgery Syndrome or Spinal Stenosis

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Background: Treatment of chronic low back pain with or without lower extremity pain continues to be a challenge. Epidural steroids are commonly utilized in patients after the failure of conservative treatment. The results of epidural steroid injections have been variable based on the pathophysiology, the route of administration, injected drugs, and utilization of fluoroscopy. In patients resistant to fluoroscopically directed epidural injections, percutaneous epidural adhesiolysis and percutaneous targeted delivery of injections with or without adhesiolysis has been recommended. Percutaneous adhesiolysis has been studied in chronic pain syndromes related to post laminectomy syndrome and spinal stenosis with encouraging results. There is a paucity of literature regarding the effectiveness of the targeted delivery of medications with or without epidural adhesiolysis in patients recalcitrant to epidural steroid injections without a history of surgery and spinal stenosis. Study Design: A randomized, equivalence trial of percutaneous lumbar adhesiolysis and caudal epidural steroid injections in patients with low back and/or lower extremity pain without post surgery syndrome or spinal stenosis. Setting: An interventional pain management practice setting in the United States. Objective: The study is designed 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 it with fluoroscopically directed caudal epidural steroid injections Methods: The study design includes 120 patients randomly assigned into 2 groups. Group I (60 patients), the control group, will receive caudal epidural injections with catheterization up to S3 with local anesthetic, steroids, and 0.9% sodium chloride solution; Group II (60 patients), the intervention group, will receive percutaneous adhesiolysis with target delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-participate betamethasone. Randomization will be performed by computer-generated random allocation sequence by simple randomization. Outcome Measures: Multiple outcome measures will be utilized including numeric rating scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake with assessment at 3, 6, 12, 18 and 24 months post treatment. Significant pain relief is considered as 50% or more, whereas significant improvement in the disability score is defined as a reduction of 40% or more. Results: The results will be analyzed to show significant relief as well as improvement in functional status. Limitations: This study is limited by potentially inadequate double blinding and the lack of a placebo group.Conclusion: This protocol describes a comparative effectiveness evaluation of percutaneous adhesiolysis and epidural steroid injections in managing chronic low back and lower extremity pain in patients without post surgery syndrome or spinal stenosis utilizing a randomized, equivalence trial design. Clinical Trial Registration: NCT01053273 Key words: Chronic low back pain, disc herniation, post lumbar surgery syndrome, spinal stenosis, epidural steroid injections, percutaneous adhesiolysis, randomized trial, comparative effectiveness