Becker's Spine Review

Becker's Spine Review May/June 2017

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41 Executive Briefing For patients with low back pain only, the use of 3D neural target- ing resulted in approximately 70 percent better pain relief than the Boston Scientific previous generation system. 4 Additional- ly, the LUMINA Study showed a significant decrease in average pain scores sustained over a two-year period. 4 "Chronic pain conditions involving the low back are one of the most difficult types of pain to treat," Dr. North said. "The nerves that innervate the low back are very close to the nerves that in- nervate the rib. Older technologies were not able to precisely stimulate only those nerves. As the technology has evolved with the availability of neural targeting, I'm able to more precisely hone in on the source of my patient's pain." The whole picture — how to measure pain accurately Given the complex nature of pain, evaluating and measuring chronic pain is one of the key challenges physicians face. Many clinicians rely on the comparative pain scale to first assess a pa- tient's pain and then their response to treatment with SCS. While it helps physicians to understand how the patients are experiencing their pain, pain scores are subjective and fail to incorporate other factors that may influence how pain is impacting a patient's life. The discussion noted the importance of considering both quality of life measures along with the relief they get with SCS. "It amazes me how often my patient will begin with a pain in- tensity of 8 out of 10. Then they come back and it's 7 out of 10. I say, 'well that's not very much.' But their relief is 80 percent," said Mark Wallace , M.D., chair of the division of Pain Medicine in the Department of Anesthesiology, University of California, San Diego. "That's because pain intensity is a uni-dimensional mea- surement, whereas pain relief provides more qualitative factors that have a large impact on patients' quality of life, such as their mobility and quality of sleep." "With opioids, you might get a reduction in the pain score, but you don't get an improved health-related quality of life," noted Simon Thomson, M.D., consultant in pain medicine and neuro- modulation, Basildon and Thurrock University NHS Trust. "This is quite different from SCS, where the health-related quality of life and the pain score are maintained long term." With advancements in technology and new clinical information available, the SCS of today is a different treatment option than what existed as recently as five years ago. New data illustrates that SCS can effectively treat patients with low back pain, a com- mon pain-related diagnosis. Clinicians also now recognize that pharmacologic agents may not be effective for certain types of pain such as neuropathic pain and many patients are actively seeking treatment options that do not involve opioids. As the impact of the opioid crisis on patients, families and communities continues to increase, the need to expand the treatment para- digm is growing. The roundtable discussion concluded with a consensus among physicians that it is time for the medical com- munity to evaluate the patient pathway and reassess which pa- tients are good candidates for SCS. They believe a collaborative approach across medical specialties combined with broader awareness of advancements in SCS treatment has the poten- tial to deliver better long term relief to patients suffering from chronic pain. 1. Institute of Medicine Report from the Committee on Advancing Pain Research, Care, and Education: Relieving Pain in America, A Blueprint for Transforming Prevention, Care, Education and Research. The National Academies Press, 2011. http://books.nap.edu/openbook.php?record_id=13172&page=1 http://www.nap.edu/read/13172/chapter/2. Accessed March 25, 2016. 2. Katz Katz JN. Lumbar disc disorders and low-back pain: socioeconomic factors and consequences. J Bone Joint Surg Am, 2006, 88(suppl 2):21-24. 3. Rubin DI. Epidemiology and risk factors for spine pain. Neurol Clin, 2007, 25(2):353-371. 4. Elias Veizi, MD, PhD, et al. "Spinal Cord Stimulation (SCS) with Anatomically Guided (3D) Neural Targeting Shows Superior Chronic Axial Low Back Pain Relief Compared to Traditional SCS—LUMINA Study." Pain Medicine 2017; 0: 1-15. US Indications for Use: The Boston Scientific Neuromodulation Spinal Cord Stimulator (SCS) Systems are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain, and leg pain. Contraindications, warnings, precautions, side effects. The SCS Systems are contraindicated for patients who: are unable to operate the SCS System, have failed trial stimulation by failing to receive effective pain relief, are poor surgical risks, or are pregnant. Refer to the Instructions for Use provided with the SCS System or ControlYourPain.com for potential adverse effects, warnings, and precautions prior to using this product. Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician. Outside of US Indications for Use: CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Information for use only in countries with applicable health authority registrations. Material not intended for use in France. Results from clinical studies are not predictive of results in other studies. Results in other stud- ies may vary. NM-428001-AA_APR2017 Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 35 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. Baseline Numerical Rating Scale (NRS) 7.17 2.96 2.94 3 10 0 Pain Score < 3 2 Years 1 Year All Patients Baseline 8.6 2.87 2.98 3 10 0 2 Years 1 Year Pain Score < 3 Severe Patients LUMINA Study 2 Year Results All Patients Pain reduction in full patient group with Spectra System using 3D Neural Targeting Severe Patients Pain reduction in severe patients with low back pain only (pain score >8) using Spectra system N=49 N=41 N=38 N=213 N=178 N=169

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