Table 5

Quality of life (QOL) between arm results

Quality of life measurementsBasivertebral nerve ablation arm (n=66)Standard CareArm (n=74)LS mean difference between armsP-Value
Baseline SF-36 (PCS)n=66n=74
 Mean, SD (Range)32.1, 6.8 (18.4–46.9)32.1, 7.4 (17.2–47.6)0.95*
3 Month SF-36 (PCS)N=64†N=51†
 Mean, SD (Range)45.6, 9.7 (22.3–60.8)33.6, 7.2 (14.9–50.8)
 Mean change from baseline, SD13.5, 9.02.2, 6.2
 LS Mean change (95% CI)13.6 (11.8 to 15.5)2.1 (0.0 to 4.1)11.6 (8.8 to 14.4)<0.001‡
6 Month SF-36 (PCS)n=61†n=70§
 Mean, SD (Range)45.8, 9.7 (26.4–59.9)33.9, 7.1 (20. 9–54.9)
 Mean change from baseline, SD13.3, 9.81.9, 7.1
 LS Mean change (95% CI)13.4 (11.5, 15.4)1.8 (0.0, 3.6)11.7 (9.0, 14.3)<0.001‡
Baseline SF-36 (MCS)n=66n=74
 Mean, SD (Range)53.4, 9.5 (22.2–69.8)52.4, 9.4 (29.4–69.4)0.54*
3 Month SF-36 (MCS)N=64†N=51†
 Mean, SD (Range)56.2, 7.3 (31.9 to 67.6)50.3, 11.4 (17.6 to 66.2)
 Mean change from baseline, SD2.3, 6.8−2.4, 9.6
 LS Mean change (95% CI)2.5 (0.7 to 4.4)−2.7 (-4.7 to –0.6)5.2 (2.4 to 8.0)<0.001‡
6 Month SF-36 (MCS)N=61†N=70§
 Mean, SD (Range)55.1, 8.4 (23.3–69.8)49.0, 11.6 (21.6–66.3)
 Mean change from baseline, SD1.4, 9.5−3.7, 9.4
 LS Mean change (95% CI)1.6 (-0.7 to 3.8)−3.9 (-6.0 to –1.8)5.5 (2.4 to 8.5)<0.001‡
Baseline EQ-5D-5Ln=66n=74
 Mean, SD (Range)0.61, 0.13 (0.27–0.83)0.61, 0.13 (0.25–0.83)0.89*
3 Month EQ-5D-5LN=65†N=51†
 Mean, SD (Range)0.79, 0.13 (0.46–1.00)0.63, 0.13 (0.35–0.83)
 Mean change from baseline, SD0.18, 0.150.02, 0.13
 LS Mean change (95% CI)0.18 (0.15 to 0.21)0.02 (-0.02 to 0.05)0.16, (0.12 to 0.21)<0.001‡
6 Month EQ-5D-5LN=61†N=70§
 Mean, SD (Range)0.81, 0.14 (0.50–1.00)0.61, 0.14 (0.28–0.86)
 Mean change from baseline, SD0.19 0.16−0.00, 0.13
 LS Mean change (95% CI)0.19 (0.16 to 0.22)−0.01 (-0.04 to 0.02)0.20, (0.15 to 0.24)<0.001‡
  • Secondary outcome measures for this study included the difference in LS mean change in quality of life (QOL) measures of Short Form-36 (physical and mental component summaries) and the EuroQual Group 5 Dimension 5-Level Quality of Life (EQ-5D-5L) between the basivertebral nerve (BVN) ablation arm and the standard care arm. Significant differences were observed in all QOL measurements between the study arms at 3 and 6 months.

  • *P value from a two-sample t-test with a factor of treatment group. Testing between randomized arms.

  • †As observed, with no imputation for missing data.

  • ‡Estimates and p value from an ANCOVA with a factor of treatment group and a covariate of baseline score.

  • §Standard care control arm 6 months as last attended (median follow-up of 176.5 days).

  • EQ-5D-5L, EuroQual Group 5 Dimension 5-Level Quality of Life; LS, least squares; MCS, Mental Component Summary; PCS, Physical Component Summary; QOL, quality of life; SF, Short Form.