Table 2 Mean and percentage change in clinical outcomes.
Clinical measure | Time point | Active (Mean ± SD) | Placebo (Mean ± SD) |
|---|---|---|---|
RFIQ | T0 | 65.4 ± 9.6 | 59.7 ± 19.0 |
T1 | 46.9 ± 19.6 | 50.1 ± 21.5 | |
T2 | 40.7 ± 24.0 | 48.0 ± 23.0 | |
T3 | 46.2 ± 19.9 | 46.5 ± 25.0 | |
T1-T0 (% Change) | -28.1 ± 27.1 | -16.6 ± 18.9 | |
T2-T0 (% Change) | -38.1 ± 33.7 | -20.3 ± 22.2 | |
T3-T0 (% Change) | -28.5 ± 30.8 | -23.0 ± 27.1 | |
BPI Pain Severity | T0 | 5.6 ± 1.1 | 5.4 ± 2.1 |
T1 | 4.5 ± 2.2 | 4.5 ± 2.4 | |
T2 | 4.2 ± 2.4 | 4.4 ± 2.2 | |
T3 | 4.6 ± 2.3 | 4.3 ± 2.2 | |
T1-T0 (% Change) | -23.5 ± 30.4 | -18.1 ± 24.5 | |
T2-T0 (% Change) | -27.6 ± 35.5 | -17.0 ± 24.3 | |
T3-T0 (% Change) | -19.6 ± 34.4 | -20.7 ± 24.6 | |
BPI Pain Interference | T0 | 6.4 ± 1.9 | 6.1 ± 2.2 |
T1 | 5.4 ± 2.4 | 4.7 ± 2.7 | |
T2 | 5.3 ± 2.5 | 4.8 ± 2.7 | |
T3 | 5.0 ± 2.4 | 4.8 ± 3.0 | |
T1-T0 (% Change) | -15.7 ± 38.6 | -23.7 ± 27.7 | |
T2-T0 (% Change) | -16.5 ± 40.9 | -21.7 ± 31.0 | |
T3-T0 (% Change) | -23.8 ± 31.8 | -23.1 ± 34.5 | |
PVAQ | T0 | 50.3 ± 10.3 | 47.6 ± 11.8 |
T1 | 42.1 ± 12.0 | 43.9 ± 13.0 | |
T2 | 41.5 ± 10.0 | 37.7 ± 14.5 | |
T3 | 39.6 ± 14.4 | 37.2 ± 15.4 | |
T1-T0 (% Change) | -15.3 ± 21.7 | -8.2 ± 12.1 | |
T2-T0 (% Change) | -16.3 ± 17.4 | -21.8 ± 18.9 | |
T3-T0 (% Change) | -20.7 ± 24.1 | -23.7 ± 20.2 | |
PCS | T0 | 24.9 ± 14.2 | 22.9 ± 16.3 |
T1 | 18.7 ± 12.7 | 14.8 ± 12.3 | |
T2 | 17.9 ± 13.3 | 15.2 ± 15.7 | |
T3 | 17.2 ± 14.3 | 13.8 ± 14.0 | |
T1-T0 (% Change) | -23.6 ± 24.5 | -30.2 ± 28.0 | |
T2-T0 (% Change) | -30.5 ± 30.4 | -37.3 ± 33.0 | |
T3-T0 (% Change) | -34.8 ± 36.4 | -39.9 ± 32.9 | |
DASS Stress | T0 | 21.1 ± 8.6 | 19.2 ± 10.1 |
T1 | 16.3 ± 11.0 | 17.2 ± 9.2 | |
T2 | 17.5 ± 10.0 | 16.9 ± 9.3 | |
T3 | 17.3 ± 9.3 | 16.3 ± 9.7 | |
T1-T0 (% Change) | -27.7 ± 38.1 | -4.2 ± 33.7 | |
T2-T0 (% Change) | -18.9 ± 34.1 | -5.6 ± 32.1 | |
T3-T0 (% Change) | -16.9 ± 33.2 | -4.7 ± 50.9 | |
DASS Anxiety | T0 | 15.1 ± 9.1 | 17.1 ± 11.3 |
T1 | 8.9 ± 7.6 | 13.1 ± 11.4 | |
T2 | 9.7 ± 8.0 | 12.3 ± 11.5 | |
T3 | 9.6 ± 6.9 | 13.3 ± 11.8 | |
T1-T0 (% Change) | -39.6 ± 35.8 | -5.6 ± 91.0 | |
T2-T0 (% Change) | -28.8 ± 51.0 | -22.1 ± 39.4 | |
T3-T0 (% Change) | -30.2 ± 45.4 | -6.3 ± 94.1 | |
DASS Depression | T0 | 14.1 ± 10.0 | 15.7 ± 10.8 |
T1 | 13.1 ± 10.4 | 11.9 ± 9.6 | |
T2 | 13.6 ± 10.3 | 12.3 ± 10.6 | |
T3 | 12.9 ± 9.7 | 12.7 ± 11.8 | |
T1-T0 (% Change) | -16.9 ± 44.9 | -21.2 ± 31.0 | |
T2-T0 (% Change) | -10.9 ± 48.2 | -18.1 ± 43.7 | |
T3-T0 (% Change) | -12.7 ± 57.4 | -20.8 ± 53.9 | |
WHO-5 Wellbeing | T0 | 27.2 ± 16.9 | 34.4 ± 12.4 |
T1 | 39.5 ± 18.3 | 39.2 ± 11.4 | |
T2 | 37.1 ± 19.3 | 38.9 ± 13.0 | |
T3 | 35.7 ± 24.6 | 40.3 ± 17.4 | |
T1-T0 (% Change) | 41.0 ± 50.6 | 22.8 ± 46.2 | |
T2-T0 (% Change) | 24.3 ± 35.9 | 19.4 ± 45.7 | |
T3-T0 (% Change) | 18.7 ± 71.0 | 16.7 ± 35.0 | |
EQ5D Health Status | T0 | 33.1 ± 27.0 | 40.6 ± 22.8 |
T1 | 42.8 ± 29.8 | 41.8 ± 23.0 | |
T2 | 40.5 ± 29.8 | 43.3 ± 23.7 | |
T3 | 37.2 ± 28.6 | 44.2 ± 25.3 | |
T1-T0 (% Change) | 70.4 ± 118.8 | 7.3 ± 20.2 | |
T2-T0 (% Change) | 55.9 ± 109.1 | 12.5 ± 28.5 | |
T3-T0 (% Change) | 47.0 ± 110.7 | 12.8 ± 30.9 | |
EQ5D Index | T0 | 15.0 ± 27.8 | 7.0 ± 18.8 |
T1 | 16.1 ± 29.1 | 9.0 ± 22.2 | |
T2 | 15.8 ± 28.2 | 11.9 ± 29.9 | |
T3 | 15.9 ± 29.1 | 9.2 ± 23.0 | |
T1-T0 (% Change) | 10.5 ± 28.5 | 7.3 ± 20.2 | |
T2-T0 (% Change) | 3.4 ± 33.5 | 12.5 ± 28.5 | |
T3-T0 (% Change) | 12.4 ± 32.0 | 12.8 ± 30.9 | |
MOS Sleep Scale | T0 | 56.3 ± 13.3 | 57.6 ± 14.1 |
T1 | 52.7 ± 12.4 | 54.1 ± 18.6 | |
T2 | 52.5 ± 12.7 | 50.1 ± 16.5 | |
T3 | 51.2 ± 16.3 | 50.9 ± 19.2 | |
T1-T0 (% Change) | -5.3 ± 14.3 | -6.9 ± 17.4 | |
T2-T0 (% Change) | -5.9 ± 13.3 | -12.6 ± 19.6 | |
T3-T0 (% Change) | -9.1 ± 20.1 | -12.0 ± 22.0 | |
MTS | T0 | 17.5 ± 19.6 | 17.1 ± 21.9 |
T1 | 17.3 ± 14.3 | 17.8 ± 14.4 | |
T2 | 17.9 ± 15.2 | 15.8 ± 17.1 | |
T3 | 19.5 ± 18.9 | 14.3 ± 14.8 | |
T1-T0 (% Change) | -37.0 ± 206.3 | 56.8 ± 223.3 | |
T2-T0 (% Change) | -17.3 ± 155.9 | -27.0 ± 62.5 | |
T3-T0 (% Change) | -20.4 ± 284.2 | -37.7 ± 64.0 | |
PPT | T0 | 161.8 ± 76.7 | 206.3 ± 120.5 |
T1 | 178.3 ± 82.9 | 188.7 ± 103.7 | |
T2 | 183.5 ± 85.8 | 198.9 ± 110.1 | |
T3 | 174.6 ± 85.3 | 210.1 ± 109.3 | |
T1-T0 (% Change) | 17.9 ± 56.7 | -4.9 ± 30.2 | |
T2-T0 (% Change) | 19.9 ± 49.6 | 4.5 ± 44.7 | |
T3-T0 (% Change) | 14.4 ± 49.3 | 10.1 ± 45.1 |