Measure | Vertebroplasty | Placebo | Treatment effect difference (95% CI) | P value |
No. (%) | No. (%) | |||
NRS pain <4/10 | ||||
At 3 days | 18 (31) | 5 (9) | 22 (8 to 36) | 0.004 |
At 14 days* | 24 (44) | 12 (21) | 23 (6 to 39) | 0.01 |
1 month | 28 (51) | 10 (18) | 33 (17 to 50) | <0.001 |
3 months | 29 (55) | 17 (33) | 22 (4 to 41) | 0.02 |
6 months | 35 (69) | 24 (47) | 22 (3 to 40) | 0.03 |
Absolute reduction NRS pain | ||||
At 3 days | 3.5±2.6 | 1.8±2.3 | 1.8 (0.8 to 2.7) | <0.001 |
At 14 days | 4.2±2.7 | 3.0±3.0 | 1.2 (0.1 to 2.3) | 0.03 |
1 month | 4.6±3.0 | 3.2±2.7 | 1.4 (0.4 to 2.5) | 0.01 |
3 months | 5.4±3.5 | 4.1±3.1 | 1.3 (0.0 to 2.6) | 0.05 |
6 months | 6.1±3.3 | 4.8±3.1 | 1.3 (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.