Presented at the 2013 AAPM Annual Meeting « Back

A Prospective Comparison of Specify 565 Versus 2 (1x8) Octapolar Leads in Treatment of Chronic Low Axial Back Pain

Krishna Kumar, MD, krishna.kumar902@gmail.com¹, Syed A. Rizvi, MD², (1) Regina General Hospital, Regina, Saskatchewan, Canada, (2) Regina General Hospital, Regina, Saskatchewan, Canada

Introduction: Chronic low back pain (CLBP) is a major source of morbidity. Traditionally, CLBP has defied harnessing by spinal cord stimulation (SCS) because of the difficulty in achieving paresthesia coverage. Methods: A controlled trial comparing dual-percutaneous (Octapolar, Medtronic Inc.) and a single surgical lead (Specify 565, Medtronic Inc.) for the treatment of CLBP. 20 patients who passed screening with trial leads were randomly assigned to receive either permanent dual 8-contact or a surgical lead. Patient outcomes were quantified prospectively on a visual analogue scale (VAS), EuroQoL-5Dimension (EQ-5D), and Oswestry Disability Index (ODI) at baseline, 3 months, and 6 months post-implantation. Results: At baseline, 3 months, and 6 months post-implantation, in the 565 group EQ-5D scores improved from 0.40, to 0.59, and 0.66, respectively; ODI scores declined from 71, to 55, to 51; while VAS scores dropped from 7.95, to 5.33, and 5.21 cm. In the dual Octapolar group EQ-5D scores improved from 0.42, to 0.68, and 0.77, respectively; ODI scores declined from 70, to 55, to 51; while VAS scores dropped from 7.55 cm, to 4.96, and 4.69. Statistical analysis indicated that changes in scores were significantly different post-implantation compared with baseline (p<0.05). Conclusions: Patients in both arms registered comparable, durable improvement in pain, quality of life, and disability over 6 months. SCS with Specify or a dual Octapolar lead array offers effective treatment for CLBP. References: 1) Kumar K, Taylor RS, Jacques L, Eldabe S, Meglio M, Molet J, Thomson S, O'Callaghan J, Eisenberg E, Milbouw G, Buchser E, Fortini G, Richardson J, North RB. The effects of spinal cord stimulation in neuropathic pain are sustained: a 24-month follow-up 2) Kumar K, Hunter G, Demeria D. Spinal cord stimulation in treatment of chronic benign pain: challenges in treatment planning and present status, a 22-year experience. Neurosurgery 2006; 58: 481–496. 3) North RB, Kidd DH, Olin J, Sieracki JM, Farrokhi F, Petrucci L, Cutchis PN. Spinal cord stimulation for axial low back pain: a prospective, controlled trial comparing dual with single percutaneous electrodes. Spine 2005; 30:1412- 1418.

Funding: A research grant of CAN$10,000 was received for this project by Medtronic Inc.