Oswestry Disability Index (ODI) between arm results
| Oswestry disability index (ODI) | Basivertebral nerve ablation arm (N=66) | Standard care arm (N=74) | LS mean difference between arms | P value |
| Baseline ODI Mean, SD (Range) | 44.7, 11.3 (30–76) | 46.9, 11.7 (30 to 88) | 0.30* | |
| 3-Month ODI | n=66b† | n=74† | ||
| Mean, SD (Range) | 21.0, 15.9 (0–62) | 42.3, 15.8 (7–75) | ||
| Mean change from baseline, SD | −23.7, 18.0 | −4.6, 15.0 | ||
| LS Mean change (95% CI) | −24.3, (−28.0 to −20.7) | −4.0, (−8.2 to 0.1) | −20.3, (−25.9 to −14.7) | <0.001‡ |
| 6-Month ODI | n=61§ | n=72¶ | ||
| Mean, SD (Range) | 19.1, 15.4 (0–56) | 44.8, 14.3 (6–76) | ||
| Mean change from baseline, SD | −25.1, 17.4 | −2.4, 14.3 | ||
| LS Mean change (95% CI) | −26.1 (−29.7 to −22.5) | −1.6 (−4.9 to 1.7) | −24.5 (−29.4 to −19.6) | <0.0001c |
| 3 Month ODI Responder Rates | n=65§ | n=53¶ | ||
| ≥15-point reduction n(%) | 45 (69.2%) | 11 (20.8%) | <0.001f | |
| ≥20-point reduction n(%) | 40 (61.5%) | 7 (13.2%) | <0.001** | |
| 6 Month ODI Responder Rates | n=61§ | n=61¶ | ||
| ≥15-point reduction n(%) | 41 (67.2%) | 9 (12.5%) | <0.001** | |
| ≥20-point reduction n(%) | 38 (62.3%) | 8 (11.1%) | <0.001** |
The primary outcome measure for this study is the difference in least squares (LS) mean change in ODI between the basivertebral nerve (BVN) ablation arm and the standard care arm at 3 months of follow-up. Significant differences in LS mean reduction in ODI and responder rates were observed at both 3 and 6 months between the arms.
*P value from a two-sample t-test with a factor of treatment group. Testing between randomized arms.
†Multiple imputations were used to impute missing values for 3-month primary endpoint change in ODI.
‡Estimates and p value from an ANCOVA with a factor of treatment group and a covariate of baseline ODI score. Values have been adjusted for multiple imputations.
§As observed. No imputations for missing values.
¶Standard care control arm 6-month last attended visit (median of 176.5 days). No imputations for missing data.
**P value from a Fisher’s exact test.
ANCOVA, analysis of covariance; LS, least squares; ODI, Oswestry Disability Index.;