Paddle versus cylindrical leads for percutaneous implantation in spinal cord stimulation for failed back surgery syndrome: a single-center trial.

ABSTRACT

OBJECTIVE: Spinal cord stimulation is an interventional treatment for chronic pain syndromes such as failed back surgery syndrome (FBSS), and it utilizes either cylindrical or paddle electrodes placed percutaneously into the epidural space. This prospective nonrandomized single-center study investigated the specific advantages and disadvantages of percutaneously implanted paddle and cylindrical leads in patients with FBSS. METHODS: Over a 2-year period, 100 patients with FBSS (43 men; 57 women; mean age 56.3 years) were included. Paddle leads were placed percutaneously under local anesthesia in 50 patients; conventional percutaneous cylindrical lead implantation was performed in the other 50 patients (one lead permitted per patient). Follow-up included the Visual Analog Scale (VAS) assessment of pain and administration of the Oswestry Disability Questionnaire. RESULTS: Similar significant pain reduction (69%) was demonstrated in both groups (VAS pre/post paddle 8.8/3.7; cylindrical 8.5/3.8). Using the same perioperative protocol for each group, we observed higher dislocation and infection rates for the cylindrical group (14% and 10%, respectively) than for the paddle group (6% and 2%, respectively). CONCLUSION: Minimally invasive percutaneous paddle and cylindrical leads are safe and effective, have low complication rates, and perform well in patients with FBSS. Both devices can be implanted using a local anesthetic, so that intraoperative and reproducible testing stimulation can be performed for sufficient paresthesia overlap prior to permanent device fixation.