Follow-up parameters | Total group (n = 41) | Group A: placebo (n = 15) | Group B: 500 μg icatibant (n = 12) | Group C: 2000 μg icatibant (n = 14) | ||||
Difference mean baseline–mean follow-up (SD) | p Value (baseline vs follow-up) | Difference mean baseline–mean follow-up (SD) | p Value (baseline vs follow-up) | Difference mean baseline–mean follow-up (SD) | p Value (baseline vs follow-up) | Difference mean baseline–mean follow-up (SD) | p Value (baseline vs follow-up) | |
Pain (VAS): | ||||||||
VAS rest (0–100 mm) | 22.78 (SD 24.41) | <0.001 | 16.71 (SD 18.96) | 0.004 | 26.54 (SD 28.12) | 0.007 | 26.32 (SD 26.95) | 0.003 |
VAS activity (0–100 mm) | 21.71 (SD 24.61) | <0.001 | 14.72 (SD19.60) | 0.011 | 26.09 (SD 31.43) | 0.007 | 25.77 (SD 23.73) | 0.001 |
US | ||||||||
Effusion superior recess in mm (SD) | −0.19 (SD 2.02) | 0.550 | −0.31 (SD 2.21) | 0.570 | −0.02 (1.56) | 0.957 | −0.18 (SD2.28) | 0.740 |
Effusion lateral recess in mm (SD) | −0.21 (SD 2.26) | 0.771 | 0.38 (SD 2.28) | 0.570 | −0.13 (SD 1.57) | 0.788 | −0.69 (SD 2.81) | 0.479 |
Synovial hypertrophy superior recess in mm (SD) | 0.13 (SD 2.03) | 0.697 | 0.99 (SD 1.65) | 0.036 | −0.10 (SD 1.72) | 0.844 | −1.29 (SD 2.4) | 0.362 |
Synovial hypertrophy lateral recess in mm (SD) | −0.58 (SD 19.3) | 0.064 | −0.05 (SD 1.74) | 0.504 | −0.54 (SD 1.19) | 0.155 | −1.2 (SD 2.53) | 0.169 |
Contrast medium slope value | −2.60 (SD 14.02) | 0.197 | −3.64 (SD 14.78) | 0.317 | 12.04 (SD 13.76) | 0.285: | 1.97 (SD 13.27) | 0.826 |
MRI: | ||||||||
Effusion superior recess in mm (SD) | 0.17 (SD 2.85) | 0.860 | −0.46 (SD 2.63) | 0.444 | 3.09 (SD 1.59) | 0.863 | 0.69 (SD 3.56) | 0.479 |
Effusion lateral recess in mm (SD) | −0.01 (SD 2.15) | 0.026 | 0.74 (SD 2.83) | 0.410 | 0.29 (SD 1.20) | 0.518 | 1.3 (SD 1.75) | 0.016 |
Contrast medium slope value (SD) | −0.22 (SD 1.02) | 0.218 | 0.41 (SD 0.80) | 0.123 | −0.51 (SD 0.97) | 0.214 | −0.56 (SD 1.05) | 0.077 |
Follow-up data: pain at rest and during activity improved in all subgroups. A statistically significant improvement could also be observed for synovial hypertrophy in the superior recess on US in the placebo group and for effusion in the lateral recess on MRI in the 2000 μg icatibant group. No statistically significant differrences were found for any of the other US and MRI parameters including power Doppler (PD)-US, contrast-enhanced (CE)-US and CE-MRI.