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Introduction <p>Fast-acting subperception therapy in spinal cord stimulation (FAST-SCS) uses low-frequency, subthreshold stimulation to engage the dorsal column-mediated surround inhibition mechanism and thereby relieve pain. Our study was performed to better characterize the multidimensional long-term clinical outcomes of FAST-SCS therapy in patients with chronic low back and/or leg pain.</p> Methods <p>Our prospective, multicenter, single-arm, open-label trial, conducted at 12 pain management centers across the USA, included male and female patients with chronic low back pain with/without leg pain refractory to conservative therapy. All eligible patients received an SCS implant. Outcomes evaluated included pain relief, disability, mobility, health-related quality of life, sleep quality, depression, pain catastrophizing, and global impression of change.</p> Results <p>Fifty-six patients received a permanent SCS implant and 55 were activated with FAST-SCS therapy. At 12&#xa0;months, 89% and 59% of patients achieved ≥ 50% and ≥ 80% pain relief, respectively (<i>p</i> &lt; 0.0001), and pain intensity (verbal numerical rating scale) decreased by 4.9 ± 2.2 points (<i>p</i> &lt; 0.0001). Significant improvements were observed in disability (Oswestry Disability Index − 24 ± 16 points, <i>p</i> &lt; 0.0001) and endurance (6-Minute Walk Test + 73 ± 96&#xa0;m, <i>p</i> &lt; 0.0001), while mobility and balance improved without reaching statistical significance (Timed Up-and-Go test − 7.5 ± 37.5&#xa0;s, <i>p</i> = 0.17). All psychosocial measures improved significantly at 12&#xa0;months compared to baseline, with an increase in the EQ5D-5L index (+ 0.200 ± 0.182, <i>p</i> &lt; 0.0001) and decreases in the Pittsburgh Sleep Quality index (− 3.96 ± 4.31, <i>p</i> &lt; 0.0001), Pain Catastrophizing Score (− 13.3 ± 11.4, <i>p</i> &lt; 0.0001), and Beck Depression Index (− 7.9 ± 10.0, <i>p</i> &lt; 0.0001). At 12&#xa0;months, 87% of patients reported being “much” or “very much” improved. Responses to FAST-SCS were at or above the minimal clinically important differences across all measured clinical dimensions.</p> Conclusion <p>This prospective study demonstrated that FAST-SCS provided statistically significant, multidimensional benefits across pain, disability, mobility, and psychosocial outcomes over 12&#xa0;months in patients with chronic low back and/or leg pain. These findings support the use of FAST-SCS in this patient population.</p> Trial Registration <p>ClinicalTrials.gov (NCT04618471). <a href="https://www.clinicaltrials.gov/study/NCT04618471">https://www.clinicaltrials.gov/study/NCT04618471</a>.</p>

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Pain Relief and Multidimensional Outcomes of Fast-Acting Subperception Spinal Cord Stimulation Therapy for Chronic Pain: The FAST Prospective, Multicenter Study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月10日

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  • Magdalena Anitescu,
  • Eric Loudermilk,
  • James North,
  • Sayed Wahezi,
  • Ajay Antony,
  • Tim Leier,
  • Drew Trainor,
  • John Noles,
  • Gregory Moore,
  • Jennifer Lee,
  • Julio Paez,
  • Derron Wilson,
  • Virginie Van Belleghem,
  • Edward Goldberg

摘要

Introduction

Fast-acting subperception therapy in spinal cord stimulation (FAST-SCS) uses low-frequency, subthreshold stimulation to engage the dorsal column-mediated surround inhibition mechanism and thereby relieve pain. Our study was performed to better characterize the multidimensional long-term clinical outcomes of FAST-SCS therapy in patients with chronic low back and/or leg pain.

Methods

Our prospective, multicenter, single-arm, open-label trial, conducted at 12 pain management centers across the USA, included male and female patients with chronic low back pain with/without leg pain refractory to conservative therapy. All eligible patients received an SCS implant. Outcomes evaluated included pain relief, disability, mobility, health-related quality of life, sleep quality, depression, pain catastrophizing, and global impression of change.

Results

Fifty-six patients received a permanent SCS implant and 55 were activated with FAST-SCS therapy. At 12 months, 89% and 59% of patients achieved ≥ 50% and ≥ 80% pain relief, respectively (p < 0.0001), and pain intensity (verbal numerical rating scale) decreased by 4.9 ± 2.2 points (p < 0.0001). Significant improvements were observed in disability (Oswestry Disability Index − 24 ± 16 points, p < 0.0001) and endurance (6-Minute Walk Test + 73 ± 96 m, p < 0.0001), while mobility and balance improved without reaching statistical significance (Timed Up-and-Go test − 7.5 ± 37.5 s, p = 0.17). All psychosocial measures improved significantly at 12 months compared to baseline, with an increase in the EQ5D-5L index (+ 0.200 ± 0.182, p < 0.0001) and decreases in the Pittsburgh Sleep Quality index (− 3.96 ± 4.31, p < 0.0001), Pain Catastrophizing Score (− 13.3 ± 11.4, p < 0.0001), and Beck Depression Index (− 7.9 ± 10.0, p < 0.0001). At 12 months, 87% of patients reported being “much” or “very much” improved. Responses to FAST-SCS were at or above the minimal clinically important differences across all measured clinical dimensions.

Conclusion

This prospective study demonstrated that FAST-SCS provided statistically significant, multidimensional benefits across pain, disability, mobility, and psychosocial outcomes over 12 months in patients with chronic low back and/or leg pain. These findings support the use of FAST-SCS in this patient population.

Trial Registration

ClinicalTrials.gov (NCT04618471). https://www.clinicaltrials.gov/study/NCT04618471.