Spinal cord stimulation (SCS) is a safe and effective treatment of a variety of chronic pain conditions. As our understanding of the mechanisms of action and potential uses of SCS has evolved, clinical and technological advancements have followed. This review provides an overview of potential mechanisms of action of SCS, evidence for its effectiveness, potential complications, and highlights of developing areas of interest.
Background: Spinal cord stimulation (SCS) is a well-established treatment for chronic intractable pain of the trunk and/or limbs; however, low back pain (LBP) is difficult to treat using traditional SCS. Differential Target Multiplexed spinal cord stimulation (DTM SCS) is an advanced approach inspired from animal studies demonstrating improved pain-related behavior and pain-relevant biological processes.
Objective:The purpose of this study was to compare the effectiveness of DTM SCS and traditional SCS in treating chronic LBP and leg pain (LP).Methods: This prospective, postmarket randomized controlled trial compared DTM SCS to traditional SCS in patients with chronic LBP and LP. Primary end point was LBP responder rate (percentage of subjects with ≥ 50% relief) at 3 months. Noninferiority and superiority were assessed. Other outcomes included mean change in back and leg pain, responder rates, disability, global health, satisfaction, and safety profile throughout the 12-month follow-up.Results: One hundred twenty-eight subjects were randomized across 12 centers (67 DTM SCS and 61 traditional SCS). Of the 94 patients implanted, 46 subjects in each group completed the 3-month assessment. LBP responder rate of 80.1% with DTM SCS was superior to 51.2% with traditional SCS (p = 0.0010). Mean LBP reduction (5.36 cm) with DTM SCS was greater than reduction (3.37 cm) with traditional SCS (p < 0.0001). These results were sustained at 6 months and 12 months. Safety profiles were similar between treatment groups.
Conclusion:Superiority of DTM SCS compared with traditional SCS for chronic LBP was demonstrated. Clinical improvements provided by DTM SCS were
M ET HOD S Study design and patient selectionThis multicenter, prospective, open-label, postmarket RCT was designed to assess DTM SCS as compared with traditional SCS in subjects with intractable LBP and LP. The study was conducted at 12 investigational sites across the United States in compliance with the US Code of Federal Regulations, Good Clinical Practice Guidelines, and the 18th World Medical Assembly of Helsinki. The study protocol and informed consent forms were approved by the Western Institutional Review Board, Puyallup, WA. The study was registered with clinicaltrials.gov (NCT03606187). Key eligibility criteria are listed in Table 1.sustained over 12 months and are expected to significantly impact the management of chronic LBP.
Deaths from opioid overdoses have increased dramatically over the past few years. Given that immediate-release (IR) opioids account for most of the U.S. market share, and that abusers generally prefer IR opioids over extended-release (ER) opioids, it is not surprising that rates of abuse are higher for IR than ER opioids. IR opioids are widely prescribed, often without consideration for risks of abuse, misuse, and diversion. Prescription opioid abuse and misuse often begins through oral administration and progresses into non-oral routes (e.g. snorting, injecting) as abusers gain more experience; non-oral routes carry heightened safety concerns. Current approaches used for reducing opioid abuse include U.S. Food and Drug Administration regulations, state legislation, insurance company policies, the use of multimodal analgesic therapy, patient risk assessment and monitoring, limiting access to opioids by reducing IR opioid prescription quantity and length, prescription drug monitoring programs, patient education on proper disposal of unused medication and risks of diversion, as well as abuse-deterrent formulations. Albeit, most abuse-deterrent formulations have focused on ways to prevent the circumvention of ER characteristics rather than placing obstacles to abuse of IR opioid formulations. Reducing opioid abuse requires the combined efforts of multiple stakeholders, including prescribing clinicians, patients, pharmacists, nurses, insurance companies, government agencies, and pharmaceutical companies.
Background and Objectives: Multiple variables play a role in spinal cord stimulation (SCS) treatment outcomes, including patient anatomy, pain pattern, lead location, stimulation parameters, and so on. A wide range of stimulation parameters are considered safe and on-label, and as a result a growing number of new frequencies and frequency-combinations are being incorporated into standard practice. A standardized approach to therapy delivery may provide more consistent outcomes for more patients. The Vectors study evaluated whether there is significant sustained improvement in pain and functional outcomes when therapy is delivered using a standardized approach.Materials and Methods: Vectors, a post-market, single-arm study evaluated the safety and efficacy of SCS with an implantable neurostimulator starting with 1 kHz stimulation, targeting the T9-T10 disc space following paresthesia mapping. Subjects with chronic intractable low back and leg pain (visual analogue scale [VAS] ≥ 50 mm) were enrolled. The primary endpoint was change in overall pain (VAS) at the three-month visit compared to baseline. Subjects were followed through 12 months.
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