Table 2.
Study outcomes.
| Verum | Sham | Comparison between groups | |
|---|---|---|---|
| n | 52 | 54 | |
| VAS scores | |||
| VAS baseline | 5.92 ± 1.68 | 6.17 ± 1.81 | |
| VAS 1 hour | 2.46 ± 2.23 | 4.39 ± 2.44 | |
| VAS 2 hours | 3.06 ± 2.30 | 4.31 ± 2.51 | |
| VAS 24 hours | 2.46 ± 2.27 | 3.79 ± 2.74 | |
| Primary outcome | |||
| Change in pain intensity (ABS) at 1 hour, compared to baseline | −3.46 ± 2.32 ***p < 0.0001 | −1.78 ± 1.89 ***p < 0.0001 | ***p < 0.0001 |
| Change in pain intensity (REL) at 1 hour, compared to baseline | −59% ± 35% | −30% ± 31% | ***p < 0.0001 |
| Secondary outcomes | |||
| Change in pain intensity (ABS) at 2 hours, compared to baseline | −2.87 ± 2.24 ***p < 0.0001 | −1.85 ± 1.96 ***p < 0.0001 | * p = 0.028 |
| Change in pain intensity (REL) at 2 hours, compared to baseline | −50% ± 36% | −32% ± 37% | * p = 0.026 |
| Change in pain intensity (ABS) at 24 hours, compared to baseline | −3.46 ± 2.65 ***p < 0.0001 | −2.38 ± 2.27 ***p < 0.0001 | p = 0.062 |
| Change in pain intensity (REL) at 24 hours, compared to baseline | −57% ± 37% | −40% ± 40% | * p = 0.037 |
| Rescue medication use | |||
| Secondary outcomes | |||
| Patients having used rescue medication at 2 hours | 3 (6) | 2 (4) | p = 0.66 |
| Patients not having used rescue medication at 2 hours | 44 (94) | 50 (96) | |
| Patients for whom medication data were not available at 2 hours | 5 (10) | 2 (4) | |
| Patients having used rescue medication within 24 hours | 18 (40) | 21 (41) | |
| Patients not having used rescue medication within 24 hours | 27 (60) | 30 (59) | p = 1 |
| Patients for whom medication data were not available within 24 hours | 7 (13) | 3 (6) | |
| Pain-free and pain relief data | |||
| Supplementary results | |||
| Patients reporting pain freedom at 1 hour | 15 (29) | 3 (6) | **p = 0.0016 |
| Patients reporting pain freedom at 2 hours | 9 (17) | 4 (7) | p = 0.15 |
| Patients reporting pain freedom at 24 hours | 15 (29) | 7 (13) | p = 0.056 |
| Sustained pain freedom for 24 hours | 3 (6) | 0 (0) | p = 0.11 |
| Patients reporting ≥30% pain relief at 1 hour | 41 (79) | 21 (39) | ***p < 0.0001 |
| Patients reporting ≥30% pain relief at 2 hours | 34 (65) | 28 (52) | p = 0.17 |
| Patients reporting ≥30% pain relief at 24 hours | 38 (73) | 33 (61) | p = 0.22 |
| Sustained ≥30% pain relief for 24 hours | 20 (38) | 11 (20) | p = 0.055 |
| Patients reporting ≥50% pain relief at 1 hour | 33 (63) | 17 (31) | **p = 0.0017 |
| Patients reporting ≥50% pain relief at 2 hours | 28 (54) | 22 (41) | p = 0.24 |
| Patients reporting ≥50% pain relief at 24 hours | 31 (60) | 26 (48) | p = 0.25 |
| Sustained ≥50% pain relief for 24 hours | 15 (29) | 8 (15) | p = 0.10 |
Data are expressed as mean ± standard deviation or n (%).
ABS: absolute value; REL: relative percentage.
*
p < 0.05; **p < 0.01; ***p < 0.0001.