Table 2

NRS pain outcomes VAPOUR trial

MeasureVertebroplastyPlaceboTreatment effect difference (95% CI)P value
No. (%)No. (%)
NRS pain <4/10
 At 3 days18 (31)5 (9)22 (8 to 36)0.004
 At 14 days*24 (44)12 (21)23 (6 to 39)0.01
 1 month28 (51)10 (18)33 (17 to 50)<0.001
 3 months29 (55)17 (33)22 (4 to 41)0.02
 6 months35 (69)24 (47)22 (3 to 40)0.03
Absolute reduction NRS pain
 At 3 days3.5±2.61.8±2.31.8 (0.8 to 2.7)<0.001
 At 14 days4.2±2.73.0±3.01.2 (0.1 to 2.3)0.03
 1 month4.6±3.03.2±2.71.4 (0.4 to 2.5)0.01
 3 months5.4±3.54.1±3.11.3 (0.0 to 2.6)0.05
 6 months6.1±3.34.8±3.11.3 (0.0 to 2.6)0.04
  • *Primary endpoint was the proportion of patients with an NRS pain score <4 at 14 days. Mean absolute reduction in NRS pain was a secondary pain outcome. CVR describes these changes as clinically meaningless.

  • CVR, Cochrane vertebroplasty review; NRS, numeric rated score.