The Politics of Neuromodulation in the USA: Spinal Cord Stimulation and the Washington State Department of Labor and Industry

Abstract

As a medical subspecialty, neuromodulation has suffered historically from a paucity of careful studies of the safety, efficacy, and cost-effectiveness of neuromodulation procedures. The need for high-quality, peer reviewed research and publication has been emphasized by our professional societies, including the International Neuromodulation Society, which have played increasingly responsive and responsible roles in an attempt to meet this need. Thus, the last decade has seen a tremendous growth in documentation supporting the safety and efficacy of neuromodulation therapies. Of particular note are the randomized controlled trials (RCTs) in patients with failed back surgery syndrome (FBSS) and complex regional pain syndrome, which have demonstrated that spinal cord stimulation (SCS) provides a statistically significant and clinically meaningful improvement in pain when compared with conventional medical management, spinal re-operation, or physical therapy ( 1. 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; 32: 179-188 Abstract Full Text Full Text PDF Scopus (721) Google Scholar , 2. 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. 2008; 63: 762-768 Crossref PubMed Scopus (1) Google Scholar , 3. North RB Kidd DH Farrokhi F Piantadosi SA Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial. Neurosurgery. 2005; 56: 98-107 Crossref PubMed Scopus (490) Google Scholar , 4. Kemler MA Barendse GA van Kleef M et al. Spinal cord stimulation in patients with chronic reflex sympathetic dystrophy. N Engl J Med. 2000; 343: 618-624 Crossref PubMed Scopus (625) Google Scholar , 5. Kemler MA De Vet HC Barendse GA Van Den Wildenberg FA Van Kleef M The effect of spinal cord stimulation in patients with chronic reflex sympathetic dystrophy: two years’ follow-up of the randomized controlled trial. Ann Neurol. 2004; 55: 13-18 Crossref PubMed Scopus (218) Google Scholar ).