Oswestry Disability Index (ODI) | Basivertebral nerve ablation in the former standard care arm(n=61) | P value |
Re-baseline ODI | ||
Mean, SD (Range) | 46.2, 11.7 (26 to 76) | |
3 Month ODI | n=60* | |
Mean, SD (Range) | 21.5, 16.2 (0 to 66) | |
Change from baseline Mean, SD | −24.7, 18.5 | <0.001† |
6 Month ODI | n=58* | |
Mean, SD (Range) | 20.4, 16.8 (0 to 62) | |
Change from baseline | ||
Mean, SD | −25.9, 17.1 | <0.001† |
3 Month Responder Rate | n=60* | |
≥15-point ODI reduction n(%) | 38 (63.3%) | 0.04‡ |
≥20-point reduction from baseline n(%) | 33 (55.0%) | 0.44‡ |
6 Month Responder Rate | n=58* | |
≥15-point ODI reduction n(%) | 42 (72.4%) | <0.001‡ |
≥20-point reduction from baseline n(%) | 35 (60.3%) | 0.12‡ |
Visual Analog Scale (VAS) | Basivertebral nerve ablation in the former standard care arm(n=61) | P Value |
Re-baseline VAS | ||
Mean, SD (Range) | 6.8, 1.3 (3 to 10) | |
3 Month VAS | n=60* | |
Mean, SD (Range) | 3.3, 2.5 (0 to 8) | |
Change from baseline Mean, SD | −3.5, 2.6 | <0.001† |
6 Month VAS | n=58* | |
Mean, SD (Range) | 2.9, 2.6 (0 to 8) | |
Change from baseline | ||
Mean, SD | −3.8, 2.9 | <0.001† |
3 Month Responder Rate | n=60* | |
≥2 cm reduction n(%) | 47 (78.3%) | <0.001‡ |
6 Month Responder Rate | n=58* | |
≥2 cm reduction n(%) | 43 (74.1%) | <0.001‡ |
At 3 and 6 months following basivertebral nerve ablation, reductions from re-baseline were significant for both pain and function in former standard care arm patients.
*As observed. No imputations for missing values.
†P value from a paired t-test (baseline to 9 and 12 months) for the BNV ablation arm.
‡P value from a Binomial test.
ODI, Oswestry Disability Index; VAS, Visual Analog Scale.