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A new spinal cord stimulation system effectively relieves chronic, intractable pain: A multicenter prospective clinical study NEUROMODULATION Oakley, J. C., Krames, E. S., Prager, J. P., Stamatos, J., Foster, A. M., Weiner, R., Rashbaum, R. R., Henderson, J. 2007; 10 (3): 262-278

Abstract

Objectives. A prospective, open label, multicenter clinical trial confirmed the functionality of a new spinal cord stimulation (SCS) system for the treatment of chronic, intractable pain of the trunk and/or limbs. Materials and Methods. Sixty-five subjects tested a rechargeable 16-channel SCS system with individual current control of each contact on one or two percutaneous eight-contact epidural leads. After baseline measurements, subjects were tracked on pain ratings and complication rates for up to 18 months. Results. After a trial period, 75% of subjects underwent permanent implantation of the entire SCS system. More than one-half the implanted subjects experienced 50% or greater relief of pain after permanent implantation; some subjects reported relief of 90% or more of their pain. The most common complications after permanent implantation were lead migration, uncomfortable stimulation, and component failure; most resolved after reprogramming or device replacement. Conclusions. The new SCS system provided good pain relief to a majority of subjects, and the results confirm a favorable safety and efficacy profile for the SCS system.

View details for Web of Science ID 000247477400007

View details for PubMedID 22150839