Table 4.
Aggregate Cohort Numeric Pain Score (NPS) from Baseline to 3 Years
Paired t-tests demonstrated significant improvements (p<0.0001) from baseline to 3 years for VAS/NPS for all three analyses conducted: 1) as observed, 2) last observation carried forward (LOCF), and 3) intent-to-treat (where missing data was deemed failure with a zero reduction from baseline).
| Numeric Pain Score (NPS) | Aggregate Cohort BVNA As Observed (N = 95) | Aggregate Cohort BVNA Last Observation Carried Forward (N = 113b) | Aggregate Cohort BVNA ITT (Miss = Fail) (N = 113) |
|---|---|---|---|
| Baseline VAS | |||
| Mean ± SD (range) | 6.7 ± 1.16 (4 to 9) | 6.8 ± 1.2 (4 to 10) | 6.8 ± 1.2 (4 to 10) |
| [95% CI] | [6.5, 6.9] | [6.5, 7.0] | [6.5, 7.0] |
| 3-Year NPS | |||
| Mean ± SD (range) | 2.4 ± 2.15 (0 to 8) | 2.8 ± 2.57 (0 to 10) | 5.2 ± 2.55 (0 to 10) |
| [95% CI] | [2.0, 2.8] | [2.3, 3.3] | [4.7, 5.7] |
| Improvement in NPS | |||
| Mean ± SD (range) | −4.3 ± 2.29 (-1 to 9) | −4.0 ± 2.56 (-3 to 9) | −1.6 ± 2.45 (-1 to 8) |
| [95% CI] | [3.8, 4.8] | [3.5, 4.5] | [1.1, 2.0] |
| P-Valuea | <0.0001 | <0.0001 | <0.0001 |
aP-value calculated using two-sided paired t-test.
bN = 113 at baseline, n = 112 with at least one VAS/NPS collected post BVNA; baseline value carried forward to 3-years in patients without any VAS/NPS measurements post BVNA.
Abbreviations: BVNA - basivertebral nerve ablation; N - number; VAS - visual analog scale; SD - standard deviation; CI - confidence interval; NPS - numeric pain score.