Table A5:
Pain Intensity, SENZA-RCT Study
| Outcome | 10-kHz High-Frequency SCS | Conventional SCS | Differencea | Relative Risk (95% CI) |
|---|---|---|---|---|
| Back Pain Intensity, VAS, Mean ± SD | ||||
| Baseline | 7.4 ± 1.2 | 7.8 ± 1.2 | 0.33 | — |
| 3 months | NR | NR | — | — |
| 6 months | NR | NR | — | — |
| 24 months | 2.4 ± 2.3 | 4.5 ± 2.9 | 5.0 ± 2.5 | — |
| Back Pain Responder, %b | ||||
| 3 months | 84.3 | 43.8 | 40.5 | 1.9 (1.4–2.5) |
| 6 months | 76.4 | 51.9 | 24.5 | 1.5 (1.2–1.9) |
| 12 months | 78.7 | 51.3 | 27.4 | 1.5 (1.2–1.9) |
| 24 months | 76.5 | 49.3 | 27.2 | — |
| Back Pain Remitter, %c | ||||
| 3 months | 65.2 | 31.3 | 33.9 | 2.1 (1.4–3.0) |
| 6 months | 59.6 | 36.7 | 22.9 | 1.6 (1.1–2.3) |
| 12 months | 68.5 | 36.3 | 32.2 | 1.9 (1.3–2.7) |
| 24 months | 65.9 | 31.0 | 27.2 | — |
| Leg Pain Intensity, VAS, Mean ± SD | ||||
| Baseline | 7.1 ± 1.5 | 7.6 ± 1.4 | 0.34 | — |
| 3 months | NR | NR | — | — |
| 6 months | NR | NR | — | — |
| 12 months | 2.1 | 3.8 | 1.7 | — |
| 24 months | 2.4 ± 2.5 | 3.9 ± 2.8 | 1.5 | — |
| Leg Pain Responder, %b | ||||
| 3 months | 83.1 | 55.0 | 28.1 | 1.5 (1.2–1.9) |
| 6 months | 80.9 | 54.4 | 26.5 | 1.5 (1.2–1.9) |
| 12 months | 78.7 | 51.3 | 27.4 | 1.5 (1.2–2.0) |
| 24 months | 72.9 | 49.3 | 23.6 | — |
| Leg Pain Remitter, %c | ||||
| 3 months | 76.4 | 37.5 | 38.9 | 2.0 (1.5–2.8) |
| 6 months | 68.6 | 44.3 | 24.3 | 1.5 (1.2–2.0) |
| 12 months | 67.4 | 42.5 | 24.9 | 1.6 (1.2–2.1) |
| 24 months | 65.9 | 30.4 | 35.5 | — |
Abbreviations: SCS, spinal cord stimulation; VAS, visual analogue scale.
a
Crude differences calculated for this health technology assessment.
b
Pain responder when pain intensity decreases ≥50% over baseline.
b
Pain remitter when pain intensity score ≤ 2.5.
Source: Kapural et al, 2015.30