Table 2.
Baseline characteristics of participants by subgroup and each treatment group. Values are numbers (percentages) unless stated otherwise
| Characteristics | Baseline pain score | Duration of pain | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Mild to moderate (<8) | Severe (≥8) | ≤6 weeks | >6 weeks | ||||||
| Vertebroplasty (n=56) | Placebo (n=54) | Vertebroplasty (n=50) | Placebo (n=49) | Vertebroplasty (n=25) | Placebo (n=32) | Vertebroplasty (n=81) | Placebo (n=71) | ||
| Women | 45 (80.4) | 46 (85.2) | 39 (78.0) | 31 (63.3) | 17 (68.0) | 21 (65.6) | 67 (82.7) | 56 (78.9) | |
| Pain duration or baseline pain score | 9 (16.1)* | 15 (27.8)* | 16 (32.0)* | 17 (34.7)* | 16 (64.0)† | 17 (53.1)† | 34 (42.0)† | 42 (59.2)† | |
| Self reported opioid use | 33 (58.9) | 32 (59.3) | 39 (78.0) | 38 (77.6) | 23 (92.0) | 28 (87.5) | 49 (60.5) | 42 (59.2) | |
| Mean (SD) age at baseline (years) | 72.7 (12.7) | 75.9 (9.7) | 74.8 (9.3) | 76.3 (10.0) | 79.6 (4.9) | 78.0 (9.2) | 71.8 (12.0) | 75.2 (10.0) | |
| Mean (SD) duration of pain (weeks) | 18.8 (14.9) | 19.1 (15.2) | 16.8 (15.4) | 19.1 (16.7) | 3.4 (1.7) | 3.4 (1.8) | 22.3 (14.6) | 26.2 (14.2) | |
| Mean (SD) pain‡ | 5.5 (1.3) | 5.5 (1.3) | 8.8 (0.9) | 8.9 (0.9) | 7.7 (2.2) | 7.4 (2.2) | 6.9 (1.9) | 7.0 (1.9) | |
| Mean (SD) RMDQ score§ | 16.4 (4.0), n=52 | 16.7 (3.7), n=51 | 17.3 (2.8), n=46 | 18.4 (3.6), n=41 | 17.3 (2.5), n=24 | 18.0 (3.5), n=29 | 16.7 (3.8), n=74 | 17.2 (3.9), n=63 | |
| Mean (SD) EQ-5D score (US value set)§ | 0.60 (0.16), n=52 | 0.60 (0.19), n=50 | 0.48 (0.20), n=46 | 0.43 (0.23), n=41 | 0.49 (0.23), n=24 | 0.46 (0.26), n=29 | 0.57 (0.17), n=74 | 0.55 (0.20), n=62 | |
RMDQ=modified, 23 item Roland-Morris disability questionnaire.
*Pain duration ≤6 weeks.
†Baseline pain score ≥8.
‡In Australian trial pain was average overall pain during past week; in US trial pain was average pain intensity during past 24 hours.
§RMDQ and EQ-5D outcomes were added to Australian trial several months after enrolment began.