Table 1.
Study characteristics.
| Study | |||
|---|---|---|---|
| Characteristic | Petersen et al. [38] | Slangen et al. [39] | de Vos et al. [40] |
| Centers (Countries) |
18 (USA) |
2 (NL) |
7 (NL, DK, BE, DE) |
| SCS modality | 10 kHz SCS Paresthesia-free (Nevro) |
LF-SCS Continuous paresthesia (Medtronic) |
LF-SCS Continuous paresthesia (St. Jude Medical) |
| Comparison | 10 kHz SCS + CMM vs. CMM | LF-SCS + CMM vs. CMM | LF-SCS + CMM vs. CMM |
| Blinding | No | No | No |
| Follow-up duration | 6 mo | 6 mo | 6 mo |
| Indication, pain area | PDN, LL | PDN, LL | PDN, LE |
| Pain rating scale | VAS (0–10 cm) | NRS (0–10 points) | VAS (0–100 points) |
| Pain inclusion criteria | LL VAS ≥ 5 cm | LL NRS ≥ 5 points | LE VAS ≥ 50 points |
| Pain exclusion criteria | UL VAS ≥ 3 cm | UL NRS > 3 points | UE Pain > 20 points |
| Randomization ratio | 1:1 | 3:2 | 2:1 |
| Mean age by group | 10 kHz SCS + CMM: 60.7 ± 11.4 y CMM: 60.8 ± 9.9 y |
LF-SCS + CMM: 57.1 ± 12.4 y CMM: 56.5 ± 8.0 y |
LF-SCS + CMM: 58 ± 11 y CMM: 61 ± 12 y |
| Female/male proportion by group |
10 kHz SCS + CMM: 38%/62% CMM: 36%/64% |
LF-SCS + CMM: 32%/68% CMM: 36%/64% |
LF-SCS + CMM: 37.5%/62.5% CMM: 35%/65% |
| Diabetes Type I/II proportion by group |
10 kHz SCS + CMM: 7%/93% CMM: 3%/97% |
LF-SCS + CMM: 14%/86% CMM: 7%/93% |
LF-SCS + CMM: 25%/75% CMM: 25%/75% |
| Diabetes durationby group | 10 kHz SCS + CMM: 12.9 ± 8.5 y CMM: 12.2 ± 8.5 y |
LF-SCS + CMM: 12.7 ± 10.1 y CMM: 12.6 ± 7.2 y |
LF-SCS + CMM: 16 ± 11 y CMM: 17 ± 12 y |
| Duration of pain or peripheral neuropathyby group |
10 kHz SCS + CMM: 7.4 ± 5.7 y ‡ CMM: 7.1 ± 5.1 y ‡ |
LF-SCS + CMM: 6.0 ± 5.1 y † CMM: 4.9 ± 3.6 y † |
LF-SCS + CMM: 7 ± 6 y † CMM: 7 ± 6 y † |
| Duration of temporary stimulation trial |
5–7 d | 2 w | Up to 1 w |
| n randomized by group | 10 kHz SCS + CMM: 113 CMM: 103 |
LF-SCS + CMM: 22 CMM: 14 |
LF-SCS + CMM: 40 CMM: 20 |
| SCS group n trialed n with ≤50% pain relief n with ≥50% pain relief n implanted |
104 6 98 90 # |
22 * 4 17 17 |
40 3 37 37 |
| SCS group Proportion with a successful trial |
94% | 77% | 92.5% |
| SCS group Trial-to-permanent implant proportion |
87% | 77% | 92.5% |
† Duration of pain. ‡ Duration of peripheral neuropathy. * Trial lead could not be placed in 1 subject due to an adverse event. # 8 subjects had a successful trial but did not receive an implant due to declining the implant (n = 4), being lost-to-follow-up (n = 3), or having an adverse event (n = 1). Abbreviations: BE, Belgium; CMM, Conventional Medical Management; d, Day(s); DE, Germany; DK, Denmark; LE, Lower Extremities; LF-SCS, Traditional Low-Frequency Spinal Cord Stimulation; LL, Lower Limbs; mo, Month(s); NL, The Netherlands; NRS, Numerical Rating Scale; PDN, Painful Diabetic Neuropathy; SCS, Spinal Cord Stimulation; UE, Upper Extremities; UL, Upper Limbs; USA, United States of America; VAS, Visual Analog Scale; w, Weeks(s); y, Year(s).