Current Challenges in Spinal Cord Stimulation (original) (raw)
Related papers
Pain, 2004
Background: Failed back surgery syndrome is common in the United States. Management of post lumbar surgery syndrome with multiple modalities includes interventional techniques, resulting in moderate improvement, leaving a proportion of patients in intractable pain. The systematic reviews of long-term benefits and risks of spinal cord stimulation (SCS) for patients with failed back surgery syndrome showed limited to moderate evidence and cost effectiveness. However, with the exponential increase in surgery in the United States, spinal cord implants are also increasing. Thus, the discussion continues with claims of lack of evidence on one hand and escalating increases in utilization on the other hand.
Pain physician, 2020
BACKGROUND Therapeutic approaches to spinal cord stimulation (SCS) continue to evolve and improve patient outcomes in patients receiving SCS therapy secondary to failed back surgery syndrome. OBJECTIVES The aim of this study was to evaluate pain relief and other patient outcomes of SCS using selected high-dose programming parameters. STUDY DESIGN This was a prospective cohort study. SETTING This study took place at 11 centers in North America. METHODS Forty-four SCS-naive patients underwent trialing, starting with 1,000 Hz frequency, 90 µs pulse width followed by 300 Hz frequency, 800 µs pulse width, if pain relief was inadequate. Patients with 50% or greater pain relief were eligible for permanent implantation. Patient's pain rating, global impression of change, health-related quality of life, functional disability, satisfaction/recommendation, stimulation perception, device programming, and adverse events were assessed at 3 months postimplant. RESULTS There were significant im...
Spinal Cord stimulation: A valuable treatment for chronic failed back surgery patients
Journal of Pain and Symptom Management, 1997
Spinal cord stimulation (SCS) has been used in the treatment of "chronic failed back surgery syndrome'for many years. To evaluate long-term results and cost effectiveness of SCS, we interviewed 69 patients treated during" a period of 13 years. Twenty-six patients stopped using SCS; there was no clear explanation for this unsatisfactory result in 10. Forty-three patients continued with the therapy and obtained good pain relief Electrode breakage either spontaneous or due to a procedure to obtain better stimulation paresthesias was more frequent in the radiofrequency-coupled system group than in the battery group (mean +_ SEM 2.81 + 2.0 versus 1.42 +_ 1.51, respectively; P = 0.0018). Ten patients obtained better pain relief than during the trial procedure. Some still need opioid analgesics, but I1 of the 16 who require these drugs obtained a synergistic effect when concomitantly using the stimulator. Eleven patients have returned to work. In our cent~,, the application of SCS costs on average $3660 per patient per year. Although this seems expensive, it may be a cost-effective treatment if other therapies fail.
European Journal of Pain, 2018
BackgroundSpinal cord stimulation (SCS) is an established therapy for refractory neuropathic pain. To ascertain the balance between treatment benefits and risks, the French National Authority for Health requested a post‐market registry for real‐world evaluation of the long‐term effectiveness and safety of the therapy.MethodsA total of 402 patients undergoing implantation with a Medtronic SCS device as either a primo‐implant (n = 264) or replacement implant (n = 138) were enrolled across 28 representative sites in France. Outcome measures at 2 years included pain intensity, satisfaction with treatment, improvement of pain relief and daily life activity, willingness to undergo the treatment again and use of pain treatments. A patient was considered a responder if, compared to baseline, predominant pain reduction was ≥50%.ResultsAt the 2‐year follow‐up visit, predominant pain intensity for primo‐implant patients had decreased from baseline (p < 0.001), with responder rates of 55%, 3...
Pain, 2007
Patients with neuropathic pain secondary to failed back surgery syndrome (FBSS) typically experience persistent pain, disability, and reduced quality of life. We hypothesised that spinal cord stimulation (SCS) is an effective therapy in addition to conventional medical management (CMM) in this patient population. We randomised 100 FBSS patients with predominant leg pain of neuropathic radicular origin to receive spinal cord stimulation plus conventional medical management (SCS group) or conventional medical management alone (CMM group) for at least 6 months. The primary outcome was the proportion of patients achieving 50% or more pain relief in the legs. Secondary outcomes were improvement in back and leg pain, health-related quality of life, functional capacity, use of pain medication and non-drug pain treatment, level of patient satisfaction, and incidence of complications and adverse effects. Crossover after the 6-months visit was permitted, and all patients were followed up to 1 year. In the intention-to-treat analysis at 6 months, 24 SCS patients (48%) and 4 CMM patients (9%) (p < 0.001) achieved the primary outcome. Compared with the CMM group, the SCS group experienced improved leg and back pain relief, quality of life, and functional capacity, as well as greater treatment satisfaction (p 6 0.05 for all comparisons). Between 6 and 12 months, 5 SCS patients crossed to CMM, and 32 CMM patients crossed to SCS. At 12 months, 27 SCS patients (32%) had experienced device-related complications. In selected patients with FBSS, SCS provides better pain relief and improves health-related quality of life and functional capacity compared with CMM alone. Ó
THE EFFECTS OF SPINAL CORD STIMULATION IN NEUROPATHIC PAIN ARE SUSTAINED
Neurosurgery, 2008
OBJECTIVE: After randomizing 100 failed back surgery syndrome patients to receive spinal cord stimulation (SCS) plus conventional medical management (CMM) or CMM alone, the results of the 6-month Prospective Randomized Controlled Multicenter Trial of the Effectiveness of Spinal Cord Stimulation (i.e., PROCESS) showed that SCS offered superior pain relief, health-related quality of life, and functional capacity. Because the rate of crossover favoring SCS beyond 6 months would bias a long-term randomized group comparison, we present all outcomes in patients who continued SCS from randomization to 24 months and, for illustrative purposes, the primary outcome (Ͼ50% leg pain relief) per randomization and final treatment. METHODS: Patients provided data on pain, quality of life, function, pain medication use, treatment satisfaction, and employment status. Investigators documented adverse events. Data analysis included inferential comparisons and multivariate regression analyses. RESULTS: The 42 patients continuing SCS (of 52 randomized to SCS) reported significantly improved leg pain relief (P Ͻ 0.0001), quality of life (P Յ 0.01), and functional capacity (P ϭ 0.0002); and 13 patients (31%) required a device-related surgical revision. At 24 months, of 46 of 52 patients randomized to SCS and 41 of 48 randomized to CMM who were available, the primary outcome was achieved by 17 (37%) randomized to SCS versus 1 (2%) to CMM (P ϭ 0.003) and by 34 (47%) of 72 patients who received SCS as final treatment versus 1 (7%) of 15 for CMM (P ϭ 0.02). CONCLUSION: At 24 months of SCS treatment, selected failed back surgery syndrome patients reported sustained pain relief, clinically important improvements in functional capacity and health-related quality of life, and satisfaction with treatment.
Spinal Cord Stimulation for Chronic Low Back Pain
Neurosurgery, 1995
A SYSTEMATIC LITERATURE synthesis was performed to analyze the long-term risks and benefits of spinal cord stimulation for patients with failed back surgery syndrome. Relevant articles were identified through a MEDLINE search (January 1966-June 1994), bibliography reviews, searches of personal files, and literature supplied by a stimulator manufacturer. Two investigators independently reviewed each article to determine whether it met the following study inclusion criteria: 1) original data on return to work, pain, medication use, reoperations, functional disability, or stimulator use after permanent implantation of spinal cord stimulators in patients with chronic low back or leg pain despite previous back surgery; and 2) follow-up ≥30 days for all patients. Articles were excluded if data from patients with other diagnoses were mixed with (and could not be separated from) data from patients with chronic low back or leg pain, or if their data were redundant with those reported in an included article. Articles written in languages other than English or French were excluded. Thirty-nine studies, all case studies, were analyzed. At follow-up (mean, 16 mo; range, 1-45 mo), an average of 59% of patients had ≥50% pain relief (range, 15-100% of patients). Complications occurred in 42% of patients but were generally minor. It seems that approximately 50 to 60% of patients with failed back surgery syndrome report >50% pain relief with the use of spinal cord stimulation at follow-up; the lack of randomized trials precludes conclusions concerning the effectiveness of spinal cord stimulation relative to other treatments, placebo, or no treatment.
Treatment of chronic pain by spinal cord stimulation
Romanian Neurosurgery, 2019
Failed back surgery syndrome (FBSS) is often used to describe the condition of patients who have experienced continued pain after surgery. It is of multifactorial genesis and may be the consequence of various lumbar spinal diseases; lumbar disc herniation surgery or spinal canal stenosis laminectomy. The presented series included 13 patients affected with chronic pain related to FBSS who underwent implantation of spinal cord stimulation. The mean percentage of pain relief was 90 % for all patients. 60% of the patients were in a better psychological status and the intake of analgesic medications has been reduced of more than 70%. More than 50% of the patients could resume professional activities. Analysis of the risks and benefits comes in favour of spinal cord stimulation.
Pain Management
Aim: The availability of long-term (>2 years) safety outcomes of spinal cord stimulation (SCS) remains limited. We evaluated safety in a global SCS registry for chronic pain. Methods: Participants were prospectively enrolled globally at 79 implanting centers and followed out to 3 years after device implantation. Results: Of 1881 participants enrolled, 1289 received a permanent SCS implant (1776 completed trial). The annualized rate of device explant was 3.5% (all causes), and 1.1% due to inadequate pain relief. Total incidence of device explantation >3 years was 7.6% (n = 98). Of these, 32 subjects (2.5%) indicated inadequate pain relief as cause for removal. Implant site infection (11 events) was the most common device-related serious adverse event (<1%). Conclusion: This prospective, global, real-world study demonstrates a high-level of safety for SCS with low rate of explant/serious adverse events. Clinical Trial Registration: NCT01719055 ( ClinicalTrials.gov )