Background/Objectives: Over the last 20 years, spinal cord stimulation (SCS) has seen the development of various paresthesia-free paradigms. Recently, a novel modality has emerged (Fast-Acting Sub-perception Therapy, FAST) that engages the surrounding inhibition mechanism of action. We evaluated long-term, real-world outcomes of preferential FAST-SCS use in patients with chronic pain. Methods: In this multi-center, observational, consecutive case series, medical chart data from chronic pain patients preferentially using FAST-SCS (no exclusions) were retrospectively reviewed. Results: Data from 167 patients in 13 European centers were analyzed; 74% of patients suffered from persistent spine pain syndrome type 2 and 87% presented with low back and/or leg pain. At the last follow-up (mean 1.6 years), the numerical rating scale (NRS) overall pain score decreased by 5.1 ± 2.5 points versus baseline, from 8.0 ± 1.2 to 2.9 ± 2.2 (n = 167, p < 0.0001). 87% of patients reported ≥50% pain relief, and 55% were “high responders” with overall NRS pain scores ≤2/10. At the last follow-up, functional disability improved significantly (the Oswestry Disability Index reduced by 29.2 ± 21.5 points, n = 65, p < 0.0001) and patients had a significant gain in quality of life (EQ-5D-5L visual analog scale increased by 52.0 ± 26.9 points, n = 86, p < 0.0001). Results at the 2-year follow-up showed a sustained, substantial reduction in pain; 67% of patients were high responders and the NRS overall pain score decreased by 5.6 ± 2.4 versus baseline (n = 52, p < 0.0001). Conclusions: Our real-world outcomes suggest that in patients with chronic low back and/or leg pain, FAST-SCS therapy provided durable and profound pain relief and led to significant improvements in disability and quality of life.

Spinal cord stimulation (SCS) is proven to effectively relieve chronic neuropathic pain. However, some implanted patients may face loss of efficacy (LoE) over time, and conversion to more recent devices may rescue SCS therapy. Recent SCS systems offer novel stimulation capabilities, such as temporal modulation and spatial neural targeting, and can be used to replace previous neurostimulators without changing existing leads. Our multicenter, observational, consecutive case series investigated real-world clinical outcomes in previously implanted SCS patients who were converted to a new implantable pulse generator. Data from 58 patients in seven European centers were analyzed (total follow-up 7.0 years, including 1.4 years after conversion). In the Rescue (LoE) subgroup (n = 51), the responder rate was 58.5% at the last follow-up, and overall pain scores (numerical rating scale) had decreased from 7.3 ± 1.7 with the previous SCS system to 3.5 ± 2.5 (p < 0.0001). Patients who converted for improved battery longevity (n = 7) had their pain scores sustained below 3/10 with their new neurostimulator. Waveform preferences were diverse and patient dependent (34.4% standard rate; 44.8% sub-perception modalities; 20.7% combination therapy). Our results suggest that patients who experience LoE over time may benefit from upgrading to a more versatile SCS system.

Background and Aims: Painful shoulder is one of the most frequent consultation causes. Multiple treatments have been described to relieve pain, restore range of motion and improve functionality. Methods: This randomised clinical trial was conducted in 60 patients. The treatment group received combined pulsed radiofrequency (PRF) on suprascapular nerve (SN) and axillary-circumflex nerve (ACN). The control group received PRF on SN only. The primary outcome was pain intensity measured by the Numerical Rating Scale (NRS). The secondary outcomes were the Shoulder Pain and Disability Index (SPADI), the Constant–Murley range of motion scale and Disability of the Arm, Shoulder and Hand (DASH) scale. The patients were monitored at the baseline visit and at 1, 3, 6 and 9 months. A mixed ordinal regression model was estimated to evaluate the association between the study group and pain measured with NRS. Results: A global decrease in pain at the end of the study was noted. The global baseline NRS was 8.4, and the global final NRS at 9 months of follow-up was 6.2. Combined PRF on SN and ACN was not associated with lower NRS pain scores compared to single SN PRF [odds ratio (OR) =1.04, 95% confidence interval (CI) 0.91–1.20, P = 0.507]. Secondary outcomes showed no significant differences: SPADI (OR = 1.04, 95% CI 0.92–1.18), Constant–Murley (OR = 1.01, 95% CI 0.90–1.14), DASH (OR = 1.04, 95% CI 0.92–1.17). Conclusion: Combined PRF applied to SN and ACN was not superior to PRF applied to SN alone.

Background/Objectives: Evidence on the effectiveness of spinal cord stimulation using fast-acting subperception therapy (FAST-SCS) in patients with persistent spinal pain syndrome (PSPS) remains limited. We evaluated clinical outcomes of FAST-SCS in patients with PSPS types 1 (i.e., non-surgical back pain) and 2 (i.e., failed back surgery syndrome). Methods: Our global, multicenter, retrospective, observational chart review included all consecutive adults with chronic low back and/or leg pain due to PSPS who received SCS with a multimodal device and reported using FAST-SCS at their latest follow-up. Available data from the patients’ medical files, documented by site personnel per their standard of care, were collected and analyzed. Pain intensity was assessed using the numerical rating scale (NRS); percent pain relief (PPR) was recorded where available. Main outcomes included changes in overall pain (NRS) compared to baseline, proportion of patients with ≥50% reduction in overall pain (NRS), proportion of patients with minimal pain (NRS ≤ 2), and high responder rates (PPR ≥ 80%). Data was analyzed for all PSPS patients at the last follow-up, with preliminary analysis of patients who completed 3-year assessments. Results in PSPS type 1 and 2 patients at the last follow-up are also presented. Results: In total, 424 patients (mean age 61.6 ± 13.5 years; 57% female; 61% PSPS type 2) were included. Mean baseline NRS was 8.0 ± 1.4. At the last follow-up (mean 1.6 ± 1.5 years post-implantation), NRS decreased by 5.3 points to 2.7 ± 2.3 (p < 0.0001), 77% of patients achieved ≥50% reduction in pain, 56% reported minimal pain, and 62% were high responders. Similar improvements were observed in the preliminary analysis of 104 PSPS patients who completed the 3-year follow-up, with ≥5-point reduction in the NRS, 77% responder rate, 60% patients with minimal pain, and 70% high responders. The analysis of PSPS type 1 and 2 populations, adjusted for baseline NRS and follow-up durations, showed comparable outcomes. Conclusions: In this global, observational, “as-treated” cohort, favorable real-world outcomes were observed in PSPS patients using FAST-SCS, supporting its use as an effective treatment option in chronic spinal pain management.