Evaluation of the Effectiveness of Percutaneous Octapolar Leads in Pain Treatment with Spinal Cord Stimulation of Patients with Failed Back Surgery Syndrome During a 1‐Year Follow‐Up: A Prospective Multicenter International Study

Gatzinsky, Kliment; Baardsen, Roald; Buschman, H.P.J.

doi:10.1111/papr.12478

Cited by 18 publications

(15 citation statements)

References 37 publications

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“…These rates are similar to those reported in other registries (Gatzinsky et al., ; Rosenberg et al., ), although the follow‐up in this study was longer (2 years vs. 1 year). Multi‐focal pain was also treated, and pain reduction of ≥50% was reported for primo‐implant patients with non‐predominant pain in lower limbs, back and upper limbs, with responder rates of 56%, 44% and 75% at 2 years, respectively.…”

Section: Discussionsupporting

confidence: 92%

“…This observational study aimed to assess the effectiveness of SCS therapy and collect long‐term safety information in patients with chronic refractory lower limb, back or upper limb pain from a representative sample of implanting sites in France. Patient demographics were very similar to those reported in the literature in terms of age and pain location (Gatzinsky et al., ; Kumar et al., ; Rosenberg et al., ). The median pain duration of 3.5 years at study entry for patients in the primo‐implant group was shorter than the 10 years reported in the multicentre, observational EMP3OWER ™ study (Rosenberg et al., ), but comparable with the “time since last surgery” reported in the PROCESS trial (Kumar et al., ).…”

Section: Discussionsupporting

confidence: 73%

“…The French Authority for Health (HAS—see Supporting Information Introduction ) requested a post‐market observational study to assess the long‐term effectiveness and safety of SCS therapy in a real‐life setting in the country. While many studies have reported the efficacy of SCS (Grider et al., ; Kriek, Groeneweg, Stronks, de Ridder, & Huygen, ; Kumar et al., ; North, Kidd, Farrokhi, & Piantadosi, ; North, Kidd, Petrucci, & Dorsi, ), few have focused on the long‐term efficacy and safety of this technique and few multicentre prospective registries exist (Gatzinsky, Baardsen, & Buschman, ; Rosenberg et al., ; Schultz et al., ).…”

Section: Introductionmentioning

confidence: 99%

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

Brînzeu

Cuny

Fontaine

et al. 2019

European Journal of Pain

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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.

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Section: Discussionsupporting

confidence: 92%

Section: Discussionsupporting

confidence: 73%

Section: Introductionmentioning

confidence: 99%

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

Brînzeu

Cuny

Fontaine

et al. 2019

European Journal of Pain

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“… 14) SCS was more efficacy for lower extremity or lumbar pain. 17 , 31) In our study, rates of long-term effects were 100% (3/3) of facial pain and 66.7% (2/3) of upper extremity pain in MCS, and 66.7% (6/9) of lower extremity pain and 75% (3/4) of both lower extremity and lumbar pain in SCS. However, there were no statistical difference between site of pain and efficacy of MCS/SCS.…”

Section: Discussionsupporting

confidence: 46%

“… 29 , 30) Percentages found for long-term effects in patients who have been subjected to more than 12 months of FBSS and CRPS type I were reported to be 60–70% and 63–72%, respectively. 17 , 31 , 32) In our current series, the total rate for the long-term effect of SCS was 57.1%, with this rate affected by the proportion of the number of FBSS and CRPS type I in the patient groups. In our study, 23% of the total patients were FBSS and CRPS type I, while 63% had central neuropathic pain.…”

Section: Discussionmentioning

confidence: 46%

Long-term Effect and Predictive Factors of Motor Cortex and Spinal Cord Stimulation for Chronic Neuropathic Pain

Tanei

Kajita

Maesawa

et al. 2018

Neurol. Med. Chir.(Tokyo)

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The long-term effects of motor cortex stimulation (MCS) and spinal cord stimulation (SCS) remain unknown. To identify the long-term effects after MCS or SCS and determine any associated predictive factors for the outcomes. Fifty patients underwent MCS (n = 15) or SCS (n = 35) for chronic neuropathic pain. The degree of pain was assessed preoperatively, at 1, 6, and 12 months after surgery, and during the time of the last follow-up using Visual Analog Scale (VAS). Percentage of pain relief (PPR) was calculated, with “long-term effect” defined as PPR ≥ 30% and the presence of continued pain relief over 12 months. Outcomes were classified into excellent (PPR ≥ 70%) and good (PPR 30–69%) sub-categories. Long-term effects of MCS and SCS were observed in 53.3% and 57.1% of the patients, respectively. There were no predictive factors of long-term effects identified for any of the various preoperative conditions. However, the VAS at 1 month after surgery was significantly associated with the long-term effects in both MCS and SCS. All patients with an excellent outcome at 1 month after the surgery continued to exhibit these effects. In contrast, patients with the good outcome at 1 month exhibited a significant decrease in the effects at 6 months after surgery. The long-term effects of MCS and SCS were approximately 50% during the more than 8.5 and 3.5 years of follow-up, respectively. The VAS at 1 month after surgery may be a postoperative predictor of the long-term effects for both MCS and SCS.

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Clinical Effectiveness and Mechanism of Action of Spinal Cord Stimulation for Treating Chronic Low Back and Lower Extremity Pain: a Systematic Review

Vallejo

Gupta²,

Cedeño

et al. 2020

Curr Pain Headache Rep

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Evaluation of the Effectiveness of Percutaneous Octapolar Leads in Pain Treatment with Spinal Cord Stimulation of Patients with Failed Back Surgery Syndrome During a 1‐Year Follow‐Up: A Prospective Multicenter International Study

Cited by 18 publications

References 37 publications

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

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

Long-term Effect and Predictive Factors of Motor Cortex and Spinal Cord Stimulation for Chronic Neuropathic Pain

Clinical Effectiveness and Mechanism of Action of Spinal Cord Stimulation for Treating Chronic Low Back and Lower Extremity Pain: a Systematic Review

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