A Randomized, Multicenter, Double-Blind, Parallel Pilot Study Assessing the Effect of Mechanical Adhesiolysis vs Adhesiolysis with Corticosteroid and Hyaluronidase Administration into the Epidural Space During Epiduroscopy

Abstract Objective Epiduroscopy is a proven method of diagnosis and treatment for chronic radicular pain after spinal surgery, which is known as failed back surgery syndrome (FBSS). The aim of the study was to compare the efficacy of drugs (the enzyme hyaluronidase and corticosteroid DEPO-Medrol) administrated into the epidural space during epiduroscopy, performed within the ventral and ventro-lateral epidural space with a focus on releasing foraminal adhesions. Methods Forty-eight patients with diagnosed FBBS were randomized into two groups before epiduroscopy. Group A received the standard treatment—mechanical lysis of fibrotic tissue in the epidural space. Group B received hyaluronidase and corticosteroid methylprednisolone acetate during the procedure. Subjects were followed for six and 12 months via scheduled double-blinded examinations by pain physicians. Leg and back pain intensity was assessed by an 11-point numerical rating scale, and patients’ functional disability was assessed by the Oswestry Disability Index (ODI). Results Study subjects showed a significant decrease in ODI score in both groups (P