Presented at the 2012 AAPM Annual Meeting « Back

Use of Observational Mechanical Gateway Connector in Spinal Cord Stimulation Trials

Mohammed A. Issa, MD, drissa80@hotmail.com, Yale School of Medicine, Morgantown, West Virginia

Introduction: Spinal Cord Stimulation (SCS) is an established treatment option for chronic intractable pain. Prior to any permanent implantation, a temporary trial is performed, which allows the patient and physician to assess the individual response and potential benefit. The Observational Mechanical Gateway (OMG) Connector (Boston Scientific) is an external accessory that enables the connection to a Medtronic or St. Jude trial system and thus provides the patient the opportunity to compare and experience another system without the need for a second trial. Design: Retrospective Cohort study. Setting: University-based Pain Management Center. Intervention: Study was approved by West Virginia University IRB. Subjects were trialed using the OMG Connector at the end of the 7-day SCS trial. Results: The average pain score at baseline was 7.3/10 overall with improvement during the SCS trial to 2.9/10 overall, 3.5/10 in Medtronic (MT), and 2.4/10 in St. Jude (SJ) SCS trials (P-value 0.04). The pain average pain score with OMG was 2.6/10 overall, 2.8/10 in MT and 2.4/10 in SJ (P-value 0.28). In terms of overall coverage of pain distribution, paresthesia, and overall satisfaction, the P-values were 0.24, 0.21, and 0.33 respectively. Overall, 12/16 patients underwent permanent implantation. One of the four failed trials was successfully retrialed after OMG connector. Conclusions: OMG connector offers patients another opportunity to better access the available treatment options during the SCS trial period. References: 1)1. Holsheimer J. Effectiveness of spinal cord stimulation in the management of chronic pain: analysis of technical drawbacks and solutions. Neurosurgery. 1997; 40:990–996. discussions 996-999 2)2. Long DM, Erickson D, Campbell J, North R. Electrical stimulation of the spinal cord and peripheral nerves for pain control. A 10-year experience. Appl Neurophysiol. 1981; 44:207–217 3)3. Shealy CN, Mortimer JT, Reswick JB. Electrical inhibition of pain by stimulation of the dorsal columns: preliminary clinical report. Anesth Analg. 1967; 46:489–491 4)4. 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. discussion 481-496 5)5. Tiede JM, Ghazi SM, Lamer TJ, Obray JB. The use of spinal cord stimulation in refractory abdominal visceral pain: case reports and literature review. Pain Pract. 2006; 6:197–202 6)6. North RB, Kidd DH, Zahurak M, James CS, Long DM. Spinal cord stimulation for chronic, intractable pain: experience over two decades. Neurosurgery. 1993; 32:384–394. discussion 394-385 7)7. Barolat G, Massaro F, He J, Zeme S, Ketcik B. Mapping of sensory responses to epidural stimulation of the intraspinal neural structures in man. J Neurosurgery. 1993; 78:233-239 8)8. Barolat G, Zeme S, Ketcik B. Multifactoral analysis of epidural spinal cord stimulation. Stereotactic Funct Neurosurgery 1991; 56:77-103 9)9. Kumar K, Taylor RS, Jacques L et al. The effects of spinal cord stimulation in neuropathic pain are sustained: a 24 month follow-up of the prospective randomized controlled multicenter trial of the effectiveness of spinal cord stimulation. Neurosurgery 10)11. Alo KM. Spinal cord stimulation for complex pain: initial experience with a dual electrode programmable, internal pulse generator. Pain Pract 2003; 2:31-38

Funding: None