Table 3.
Mean change scores (SD) from baseline and adjusted between group differences for main outcomes and for each subgroup at follow-up points
| Outcome | Mean (SD) change* at 2weeks/1 week | Adjusted between group difference† (95% CI) | Mean (SD) change* at 1 month | Adjusted between group difference† (95% CI) | ||
|---|---|---|---|---|---|---|
| Vertebroplasty | Placebo | Vertebroplasty | Placebo | |||
| Overall pain | 2.2 (2.8), n=102 | 2.5 (3.0), n=99 | −0.2 (−0.9 to 0.6) | 2.8 (3.0), n=102 | 2.2 (3.2), n=99 | 0.6 (−0.2 to 1.4) |
| RMDQ | 3.2 (5.1), n=94 | 4.4 (5.2), n=88 | −0.8 (−2.2 to 0.7) | 4.1 (5.9), n=94 | 3.9 (6.1, n=89 | 0.8 (−0.9 to 2.4) |
| EQ-5D (US value set) | — | — | — | 0.12 (0.19), n=94 | 0.11 (0.23), n=88 | 0.03 (−0.02 to 0.08) |
| Subgroups | ||||||
| Pain ≤6 weeks: | ||||||
| Overall pain | 2.4 (2.9), n=25 | 2.9 (3.7), n=31 | −0.7 (−2.1 to 0.7) | 3.1 (3.3), n=25 | 2.8 (4.0), n=31 | 0.1 (−1.4 to 1.6) |
| RMDQ | 2.3 (4.5), n=24 | 4.5 (5.4), n=28 | −1.6 (−4.3 to 1.0) | 3.8 (5.9), n=24 | 4.4 (5.4), n=28 | 0.2 (−3.0 to 3.4) |
| EQ-5D (US value set) | — | — | — | 0.15 (0.24), n=24 | 0.15 (0.30), n=28 | 0.03 (−0.06 to 0.13) |
| Pain >6 weeks: | ||||||
| Overall pain | 2.1 (2.7), n=77 | 2.3 (2.3), n=68 | 0.1 (−0.8 to 0.9) | 2.7 (2.9), n=77 | 2.0 (2.7), n=68 | 0.8 (−0.1 to 1.8) |
| RMDQ | 3.5 (5.3), n=70 | 4.4 (5.2), n=60 | −0.4 (−2.1 to 1.3) | 4.2 (6.0), n=70 | 3.7 (6.3), n=61 | 1.0 (−1.0, to 3.0) |
| EQ-5D (US value set) | — | — | — | 0.11 (0.18), n=70 | 0.09 (0.20), n=60 | 0.03 (−0.03 to 0.09) |
| Baseline pain score ≥8: | ||||||
| Overall pain | 3.0 (2.6), n=47 | 3.7 (3.0), n=48 | −0.8 (−1.8 to 0.3) | 3.9 (2.9), n=46 | 3.5 (3.2), n=47 | 0.3 (−0.8 to 1.5) |
| RMDQ | 3.0 (4.8), n=43 | 4.5 (5.5), n=40 | −1.0 (−3.2 to 1.2) | 4.1 (5.9), n=42 | 3.3 (5.6), n=40 | 1.4 (−1.2 to 3.9) |
| EQ-5D (US value set) | — | — | — | 0.16 (0.21), n=42 | 0.15 (0.25), n=40 | 0.05 (−0.03 to 0.12) |
| Baseline pain score <8: | ||||||
| Overall pain | 1.5 (2.7), n=55 | 1.3 (2.4), n=51 | 0.4 (−0.7 to 1.4) | 1.9 (2.8), n=56 | 1.1 (2.8), n=52 | 0.8 (−0.3 to 1.9) |
| RMDQ | 3.3 (5.4), n=51 | 4.3 (5.0), n=48 | −0.6 (−2.5 to 1.4) | 4.2 (6.0), n=52 | 4.4 (6.4), n=49 | 0.2 (−2.1 to 2.5) |
| EQ-5D (US value set) | — | — | — | 0.09 (0.17), n=55 | 0.07 (0.21), n=48 | 0.02 (−0.04 to 0.09) |
RMDQ=modified, 23 item Roland-Morris disability questionnaire.
*Positive values for mean change indicate improvements from baseline.
†Estimates of mean change from regression models adjusting for trial; positive values for between group differences favour vertebroplasty group, negative values favour placebo group.