Table 2.
Pivotal studies documenting the efficacy of 10 kHz SCS.
| Study (First Author et al., Year of Publication) | Pain Type/Area | Study Design, n, Follow-Up | Pain Relief and Responder (≥50% Pain Relief) Rate at Last Follow-Up |
|---|---|---|---|
| Al-Kaisy et al., 2014 [49] | Chronic back and leg pain | Single arm, prospective n = 65 Follow-up, 24 months |
Average pain relief at 24 months: back pain, 61%; leg pain, 57%. Responder rate at 24 months: back pain, 60%; leg pain 71% |
| Kapural et al., 2016 [52] | Chronic back and leg pain (predominant back pain) | Prospective, RCT n = 85 in 10 kHz SCS group Follow-up, 24 months |
Average pain relief baseline to 24 months: back pain 68%; leg pain 66% Responder rate at 24 months: back pain 77%; leg pain 73% |
| Stauss et al., 2019 [56] | Chronic pain in trunk and limbs | Single-arm, retrospective n = 1661 Mean follow-up time, 8.9 months (range: 0.1 to 33.2 months) |
Median pain relief (VRS) at last visit: 62% Responder rate at last visit: 74%. |
| Kallewaard et al., 2020 [61] | FBSS (predominant leg pain) | Single arm, prospective n = 50 Follow-up, 12 months |
Average pain relief baseline to 12 months: back pain, 63%; leg pain, 75%. Responder rate at 12 months: back pain, 76%; leg pain, 80%. |
| Amirdelfan et al., 2020 [57] | Chronic upper limb and neck pain | Single arm, prospective n= 45 Follow-up, 12 months |
Average pain relief baseline to 12 months: upper limb pain, 86%; neck pain, 79%. Responder rate at 12 months: upper limb pain, 95%; neck pain by 89%. |
| Sayed et al., 2020 [62] | Chronic upper limb and neck pain | Single arm, retrospective n = 47 Median follow-up time, 19.4 months |
Average pain relief baseline to last follow up: 58% Responder rate at last follow up: 76% |
| Sayed et al., 2020 [67] | Thoracic back pain | Single arm, retrospective n= 19 Follow-up, 12 months |
Average pain relief baseline to 12 months: 70% Responder rate at 12 months: 89% |
| Tate et al., 2021 [63] | Chronic pelvic pain | Single arm, prospective n = 13 Follow-up, 12 months |
Average pain relief baseline to 12 months: 72% reduction. Responder rate at 12 months: 77% |
| Gupta et al., 2020 [66] | Chronic post-surgical pain | Single arm, prospective n= 25 Follow-up, 12 months |
Average pain relief baseline to 12 months: 82% reduction Responder rate at 12 months: 88% |
| Peterson et al., 2021 [65] | Painful diabetic neuropathy | RCT n = 87 in 10 kHz SCS group Follow-up, 6 month assessment reported |
>Average pain relief baseline to 6 months: Lower limb: 78% Responder rate at 6 months: 85% |