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.

Keywords

percutaneous implantation technique - paddle lead - cylindrical lead - spinal cord stimulation - intractable pain

• References

• 1 Shealy CN, Mortimer JT, Reswick JB. Electrical inhibition of pain by stimulation of the dorsal columns: preliminary clinical report. Anesth Analg 1967; 46 (4) 489-491
• 2 Zumpano BJ, Saunders RL. Percutaneous epidural dorsal column stimulation. Technical note. J Neurosurg 1976; 45 (4) 459-460
• 3 Andréll P, Yu W, Gersbach P , et al. Long-term effects of spinal cord stimulation on angina symptoms and quality of life in patients with refractory angina pectoris—results from the European Angina Registry Link Study (EARL). Heart 2010; 96 (14) 1132-1136
• 4 Atkinson L, Sundaraj SR, Brooker C , et al. Recommendations for patient selection in spinal cord stimulation. J Clin Neurosci 2011; 18 (10) 1295-1302
• 5 Kumar K, Rizvi S, Bnurs SB. Spinal cord stimulation is effective in management of complex regional pain syndrome I: fact or fiction. Neurosurgery 2011; 69 (3) 566-578 ; discussion 5578–5580
• 6 Nicholson CL, Korfias S, Jenkins A. Spinal cord stimulation for failed back surgery syndrome and other disorders. Acta Neurochir Suppl (Wien) 2007; 97 (Pt 1) 71-77
• 7 Wolter T, Kiemen A, Kaube H. High cervical spinal cord stimulation for chronic cluster headache. Cephalalgia 2011; 31 (11) 1170-1180
• 8 Yakovlev AE, Resch BE. Spinal cord stimulation for cancer-related low back pain. Am J Hosp Palliat Care 2012; 29 (2) 93-97
• 9 Fanciullo GJ, Rose RJ, Lunt PG, Whalen PK, Ross E. The state of implantable pain therapies in the United States: a nationwide survey of academic teaching programs. Anesth Analg 1999; 88 (6) 1311-1316
• 10 Mironer YE, Satterthwaite JR, Lewis EM , et al. Efficacy of a single, percutaneous, across midline, Octrode® lead using a “midline anchoring” technique in the treatment of chronic low back and/or lower extremity pain: a retrospective study. Neuromodulation 2008; 11 (4) 286-295
• 11 North RB, Kidd DH, Olin JC, Sieracki JM. Spinal cord stimulation electrode design: prospective, randomized, controlled trial comparing percutaneous and laminectomy electrodes-part I: technical outcomes. Neurosurgery 2002; 51 (2) 381-389 ; discussion 389–390
• 12 North RB, Kidd DH, Petrucci L, Dorsi MJ. Spinal cord stimulation electrode design: a prospective, randomized, controlled trial comparing percutaneous with laminectomy electrodes: part II-clinical outcomes. Neurosurgery 2005; 57 (5) 990-996 ; discussion 990–996
• 13 Vonhögen LH, Vancamp T, Vanneste S , et al. Percutaneously implanted plates in failed back surgery syndrome (FBSS). Neuromodulation 2011; 14 (4) 319-324 ; discussion 324–325
• 14 Beems T, van Dongen RT. Minimally invasive placement of epidural plate electrodes under local anaesthesia in spinal cord stimulation. Acta Neurochir Suppl (Wien) 2007; 97 (Pt 1) 105-109
• 15 Mekhail NA, Mathews M, Nageeb F, Guirguis M, Mekhail MN, Cheng J. Retrospective review of 707 cases of spinal cord stimulation: indications and complications. Pain Pract 2011; 11 (2) 148-153
• 16 Villavicencio AT, Leveque JC, Rubin L, Bulsara K, Gorecki JP. Laminectomy versus percutaneous electrode placement for spinal cord stimulation. Neurosurgery 2000; 46 (2) 399-405 ; discussion 405–406
• 17 Zhu J, Falco F, Onyewu CO, Joesphson Y, Vesga R, Jari R. Alternative approach to needle placement in spinal cord stimulator trial/implantation. Pain Physician 2011; 14 (1) 45-53
• 18 Zhu J, Falco FJ, Onyewu CO , et al. Alternative approach to needle placement in cervical spinal cord stimulator insertion. Pain Physician 2011; 14 (2) 195-210
• 19 Sears NC, Machado AG, Nagel SJ , et al. Long-term outcomes of spinal cord stimulation with paddle leads in the treatment of complex regional pain syndrome and failed back surgery syndrome. Neuromodulation 2011; 14 (4) 312-318 ; discussion 318
• 20 Levy R, Henderson J, Slavin K , et al. Incidence and avoidance of neurologic complications with paddle type spinal cord stimulation leads. Neuromodulation 2011; 14 (5) 412-422 ; discussion 422
• 21 Deer T, Bowman R, Schocket SM , et al. The prospective evaluation of safety and success of a new method of introducing percutaneous paddle leads and complex arrays with an epidural access system. Neuromodulation 2012; 15 (1) 21-29 ; discussion 29–30
• 22 Kinfe TM, Schu S, Quack FJ, Wille C, Vesper J. Percutaneous implanted paddle lead for spinal cord stimulation: technical considerations and long-term follow-up. Neuromodulation 2012; 15 (4) 402-407
• 23 Kumar K, Taylor RS, Jacques L , et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome. Pain 2007; 132 (1–2) 179-188
• 24 Turner JA, Loeser JD, Deyo RA, Sanders SB. Spinal cord stimulation for patients with failed back surgery syndrome or complex regional pain syndrome: a systematic review of effectiveness and complications. Pain 2004; 108 (1–2) 137-147
• 25 North RB, Kumar K, Wallace MS , et al. Spinal cord stimulation versus re-operation in patients with failed back surgery syndrome: an international multicenter randomized controlled trial (EVIDENCE study). Neuromodulation 2011; 14 (4) 330-335 ; discussion 335–336
• 26 Ackroyd R, Bush DJ, Graves J, McVey J, Horton S. Survey of assessment criteria prior to implantation of spinal cord stimulators in United Kingdom pain management centres. Eur J Pain 2005; 9 (1) 57-60
• 27 Aló KM, Redko V, Charnov J. Four year follow-up of dual electrode spinal cord stimulation for chronic pain. Neuromodulation 2002; 5 (2) 79-88
• 28 Burton CV. Safety and clinical efficacy. Neurosurgery 1977; 1 (2) 214-215
• 29 Erickson DL, Long DM. Ten-year follow-up of dorsal column stimulation. In: Bonica JJ, , ed. Advances in pain research and therapy. Vol 5. New York: Raven Press; 1983: 583-589
• 30 Colini Baldeschi G, De Carolis G. The Italian Experience with Octopolar Perc-Paddle Leads. Neuromodulation 2013; ; August 6 (Epub ahead of print)
• 31 Renard VM, North RB. Prevention of percutaneous electrode migration in spinal cord stimulation by a modification of the standard implantation technique. J Neurosurg Spine 2006; 4 (4) 300-303