Spinal cord stimulation for chronic refractory pain: Long‐term effectiveness and safety data from a multicentre registry

Abstract

Background Spinal 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. Methods A 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%. Results At 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%, 36% and 67% for the lower limbs, back and upper limbs, respectively. Most patients acknowledged an improvement in pain relief (89%) and daily life activity (82%) were satisfied with treatment (91%) and willing to undergo the treatment again (93%). A significant decrease (p < 0.01) in the proportion of patients receiving pain treatment was observed for all drug and non‐drug treatments. Reported adverse events were in line with the literature. Pain intensity at 2 years was comparable for patients in the replacement group, supporting the long‐term stability and effectiveness of SCS. Conclusion Real‐world evaluation of the use of spinal cord stimulation under the recommendations of the French Health Authority shows that two years after the first implantation of an SCS device close to 60% of the patients retain a significant pain reduction and 74% show improvement in pain scores [of at least 30%] with significant decreases in drug and non‐drug pain treatments. Significance This observational, prospective study in a real‐life setting followed a large cohort of patients suffering from chronic pain and implanted with SCS devices in France. The study assessed the long‐term effectiveness and safety of SCS therapy in a representative sample of implanting sites in France.

Development of Machine Learning–Based Models to Predict Treatment Response to Spinal Cord Stimulation

“…Devices have been increasingly used over the past 5 years at a growth rate of 20%, in part due to the opioid epidemic. 1 Despite patients undergoing psychological assessment and a trial of SCS before implant, suboptimal outcomes after SCS implant may occur in as many as 50% of patients at 2 years, 2 explant rates hover around 10%, and failure rates are estimated to be 25% to 30%. 2,3 There remains a lack of a clear understanding of which patients benefit long term.…”

“…1 Despite patients undergoing psychological assessment and a trial of SCS before implant, suboptimal outcomes after SCS implant may occur in as many as 50% of patients at 2 years, 2 explant rates hover around 10%, and failure rates are estimated to be 25% to 30%. 2,3 There remains a lack of a clear understanding of which patients benefit long term. Thus, the ability to accurately predict patients who will not benefit from SCS would reduce the high financial burden of failed implants that plague the neuromodulation field.…”

Short‐ and long‐term effects of conventional spinal cord stimulation on chronic pain and health perceptions: A longitudinal controlled trial

“…Some T5 outcome measures exhibited slight improvement compared to baseline values, yet it was roughly equivalent to one SEM, indicating a non-clinically significant change. The long-term decline in SCS effects among the Perm group was unexpected, considering reports on ongoing effect of SCS for long durations, ranging from 3 to 48 months (e.g., Brinzeu et al, 2019;Campos et al, 2019;Eriksen et al, 2021;Hunter et al, 2018;Kumar et al, 2008;Rojo et al, 2021;Sears et al, 2011).…”

“…In recent years, conventional spinal cord stimulation (SCS), a minimally invasive and non-pharmacological treatment, has been recommended for pain management when other treatments failed to yield a satisfactory outcome (e.g., Geurts et al, 2017;Harmsen et al, 2021) particularly for patients with neuropathic pain, failed back syndrome, complex regional pain syndrome and angina pectoris (Brinzeu et al, 2019;de Vos et al, 2014;Kumar et al, 2008;Rigoard et al, 2019;Simpson et al, 2009;Taylor et al, 2014;Tsigaridas et al, 2015;Visnjevac et al, 2017). In most instances, the 'conventional' or 'paresthesiabased' SCS was evaluated, wherein permanently implanted percutaneous cylindrical leads are placed in the epidural space.…”

The Evolution of Surgical Technique in Spinal Cord Stimulation: A Scoping Review

“…20,40,42 Although largely successful, SCS treatment fails to provide significant pain relief in 25%-30% of patients; approximately 10% of implants are removed and not replaced. [43][44][45] Over 80% of patients undergoing explantation do so because of inadequate pain relief. A large database study suggests that on-going depression and opioid use are two major covariates that are modifiable risk factors.…”