Baseline characteristics
| All randomized (N=140) | Basivertebral nerve ablation arm (N=66) | Standard care arm (N=74) | BVN ablation in former standard care arm (N=61) | P value | |
| Mean age in years (range) | 49.7 (26–70) | 49.4 (30–68) | 50.0 (26–70) | 49.5 (26–70) | 0.73* |
| Male, n (%) | 71 (50.7%) | 34 (51.5%) | 37 (50.0%) | 31 (50.8%) | 0.87† |
| Duration LBP symptoms ≥5 years, n (%) | 100 (71.4%) | 42 (63.6%) | 58 (78.4%) | 49 (80.3%) | 0.06† |
| Mean days per week with LBP | 6.9 (4–7) | 6.8 (4–7) | 6.9 (4–7) | 6.9 (4–7) | 0.98* |
| Mean ODI (range) | 45.9 (30–88) | 44.7 (30–76) | 46.9 (30–88) | 46.2 (26–76) | 0.30* |
| Mean VAS (range) | 6.79 (4.0–10.0) | 6.73 (4.0–10.0) | 6.85 (4.0–10.0) | 6.78 (3.0–100) | 0.61* |
| Mean SF-36 PCS2 (range) | 32.1 (17.2–47.6) | 32.1 (18.4–46.9) | 32.1 (17.2–47.6) | 33.1 (20.9–45.2) | 0.95* |
| Mean SF-36 MCS3 (range) | 52.9 (22.2–69.8) | 53.4 (22.2–69.8) | 52.4 (29.4–69.4) | 49.2 (21.6–66.3) | 0.54* |
| Mean EQ-5D-5L4 (range) | 0.61 (.25-.83) | 0.61 (.27-.83) | 0.61 (.25-.83) | 0.61 (.28-.86) | 0.89* |
| Mean BDI5 (range) | 6.3 (0–20) | 6.2 (0–20) | 6.4 (0–20) | 6.7 (0–20) | 0.89* |
| Treatment history, n (%) | |||||
| Opioid use at baseline | 40 (28.6%) | 22 (33.3%) | 18 (24.3%) | 14 (23.0%) | 0.27† |
| Injections | 95 (67.9%) | 42 (63.6%) | 53 (71.6%) | 44 (72.1%) | 0.37† |
| Past lower back surgeries | 14 (10.0%) | 7 (10.6%) | 7 (9.5%) | 5 (8.2%) | 1.00† |
| Type of Modic by subject, n (%) | 0.86‡ | ||||
| Type 1 | 52 (37.1%) | 23 (34.8%) | 29 (39.2%) | 26 (42.6%) | |
| Type 2 | 70 (50.0%) | 34 (51.5%) | 36 (48.6%) | 29 (47.5%) | |
| Mixed (type 1 and type 2) | 18 (12.9%) | 9 (13.6%) | 9 (12.2 %) | 6 (9.8 %) |
Demographic and baseline characteristics for randomized patients demonstrated no statistically significant differences between arms.
*P value from a two-sample t-test with a factor of treatment group.
†P value from a Fisher’s exact test with a factor of treatment group.
‡P value from a χ2 test with a factor of treatment group.
BDI, Beck Depression Index; BVN, basivertebral nerve; BVNA, basivertebral nerve ablation; EQ-5D-5L, EuroQual Group 5 Dimension 5-Level Quality of Life; LBP, low back pain; MCS, Mental Component Summary; ODI, Oswestry Disability Index; PCS, Physical Component Summary; SF-36, Short Form 36; VAS, Visual Analog Scale.