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EMERGING TREATMENT AND DIAGNOSIS | PRAGER NEW RECHARGEABLE SPINAL CORD STIMULATOR SYSTEMS OFFER ADVANTAGES IN CRPS TREATMENT BY JOSHUA P. PRAGER, MD, MS n April, 2004, the Food and Drug Administration (FDA) approved the first rechargeable spinal cord stimulator (SCS) system. This system, called Precision, TM produced by Advanced Bionics, is the first in a new generation of SCS systems that offers a significant improvement in stimulation to people with CRPS. In early 2005, Advanced Neuromodulation Systems received approval for its rechargeable system, the Eon Ț M and shortly thereafter Medtronic, the largest producer of neurostimulator systems, received FDA approval for its Restore TM System. This article will briefly review the use of SCS for treatment of CRPS and then describe the potential of the new systems in improving care and outcomes. Reprinted from The RSDSA Review, Fall 2005 68 | T H E PA I N P R A C T I T I O N E R | S P R I N G 2 0 0 6
SCS as Part of the CRPS Treatment Algorithm IN 1995, the International Association for the Study of Pain (IASP) brought together a group of international experts to address treatment of CRPS. This was one of four meetings the IASP has held in the last two decades regarding various aspects of CRPS. Stanton-Hicks published results of the 1995 meeting as a treatment algorithm, which indicates that the mainstay of CRPS/RSD treatment is physical therapy, and that nerve blocks or SCS as adjuvant treatment are important for patients who are not adequately progressing with physical therapy alone (1). The important point of this article is that SCS can significantly enhance CRPS treatment by facilitating physical therapy as part of the entire rehabilitation process. Stanton-Hicks suggested that the beneficial effect of SCS relates not only to pain relief, but it also inhibits or modulates the sympathetic outflow to the region where the tingling produced by the stimulation is experienced (2). SCS and CRPS THERE HAVE BEEN NUMEROUS STUDIES of SCS for the treatment of CRPS. These studies have been both retrospective and prospective randomized. In 1982, Broseta reported the use of SCS for CRPS-2 patients with 72 percent having experienced excellent results (3). Barolat (4) reported a 73 percent success rate of pain in 18 patients with CRPS-1. Kumar (5) discussed 12 patients treated with SCS for CRPS. Robaina (6) compared SCS with TENS in 35 patients with late-stage CRPS-1; 66 percent of patients reported good results with SCS, experiencing rapid relief of pain and reduction in swelling. Bennett (7) examined not only the effect of SCS on CRPS, but also looked at the effect of different lead arrays. He found that patient satisfaction was markedly improved with dual octapolar leads as opposed to traditional quadripolar leads. There have been four prospective studies published of spinal cord stimulation in CRPS. The first, Calvillo (8) in 1998, examined 31 patients with CRPS affecting the upper extremity with a significant reduction in pain scores compared to baseline. Oakley and Weiner (9) observed statistically significant reduction in pain and an 80 percent success rate with SCS for CRPS. The largest prospective study in CRPS was that of Kemler (10), in the New England Journal of Medicine in 2000; 54 patients with CRPS-1 of one extremity were randomized to SCS plus physical therapy or physical therapy alone. A significantly greater number of patients with SCS plus physical therapy had a much improved global perceived effect than the physical therapy group alone. Most recently, Kemler (11) published a two-year follow up of the randomized trial. The mean pain score in the 24 implanted SCS patients was significantly reduced compared to those receiving physical therapy alone; 63 of the SCS patients reported improvement in their global perceived effect. Thus, there is significant literature demonstrating the success with SCS in treating CRPS. This brief discussion above was not meant to thoroughly review or evaluate this literature, but merely to call attention to its presence and provide a reference list where one can review this information in greater detail. Rechargeability and its Implication Toward the Treatment of CRPS with SCS THE ADVENT OF RECHARGEABILITY, being able to recharge the SCS battery, creates new opportunities. Previously, when a battery failed, the entire pulse generator needed to be replaced, which required expensive surgery and was uncomfortable for the patient. Rechargeability may significantly reduce the need to replace internal pulse generators. Many CRPS patients with SCS systems have needed to use a lot of power to achieve the pain relief necessary to function. In order to reduce the need to replace the internal pulse generator, patients have often rationed the amount of stimulation by either reducing the power or turning the unit off some of the time. Thus, both patient and physician have attempted to manage the battery while compromising treatment. Rechargeability offers the opportunity to manage the patient instead of managing the battery. Bennett (12) notes that large arrays produce greater satisfaction than traditional quadripolar leads. Rechargeability offers the opportunity to use many contacts simultaneously, which uses a significantly greater amount of energy. Previously, this increased power consumption would have been prohibitive in some patients. Rechargeability allows the use of a greater number of electrodes at a given time to provide better coverage with stimulation. There are some reports that increased frequency improves stimulation in patients with CRPS. Although this not been well documented, it is important to note that higher frequency produces higher energy consumption. Higher frequency potentially compromises battery life. Thus, rechargeability provides an opportunity to fully utilize the potential of any system without needing to worry about battery failure. Conventional SCS four- and eight-contact leads were placed relatively far apart. Oakley and Prager (13) in their discussion of SCS, indicate that when SCS leads are placed closer together the result is deeper penetration of the spinal Rechargeability offers the opportunity to manage the patient instead of managing the battery. T H E PA I N P R A C T I T I O N E R | V O L U M E 16 , N U M B E R 1 | 69
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EDITORS’ CORNER | COMPLEX REGIONA
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COMMENTARY | GIORDANO Comprehending
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FEATURE | BROATCH RSDSA: Expanding
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Page 34 and 35: FEATURE | GALER TABLE 1 | IASP Diag
Page 36 and 37: FEATURE | GALER Although there is s
Page 38 and 39: FEATURE | GALER 10. Gammaitoni A, G
Page 40 and 41: INTERVIEW | COVINGTON LIFEBOAT mixe
Page 42 and 43: INTERVIEW | COVINGTON Q. Have any s
Page 45 and 46: Reap the Rewards of Membership Beco
Page 47 and 48: with depression. However, they foun
Page 49 and 50: It is common for patients in pain i
Page 51 and 52: There are multiple forms of amplifi
Page 53 and 54: Okay for Vegas. Not your Practice.
Page 55 and 56: especially opioids. Opioids should
Page 57 and 58: Subscribe to Currents Today! The Ac
Page 59 and 60: FEATURE | COMPLEX REGIONAL PAIN SYN
Page 61 and 62: FEATURE | COMPLEX REGIONAL PAIN SYN
Page 63 and 64: ZICONOTIDE: Promising New Treatment
Page 65 and 66: UNRIVALED INDEPENDENCE COMING SOON
Page 67: D O YO U G E T I T ? Subscribe to T
Page 72 and 73: OPINION | GETSON The Use of Thermog
Page 74 and 75: IN CONCLUSION | MOSKOVITZ A Theory
Page 76 and 77: IN CONCLUSION | MOSKOVITZ even thin
Page 78 and 79: IN CONCLUSION | MOSKOVITZ Comorbidi
Page 80 and 81: IN CONCLUSION | MOSKOVITZ empathy e
Page 82 and 83: AC ADEMY NEWS | AMERICAN ACADEMY OF
Page 84 and 85: CL ASSIFIED ADS & DIRECTORY | AMERI
Page 86 and 87: RESOURCES | CRPS RESOURCES FOR CRPS
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