Table 1.
Primary and secondary outcomes comparing changes from baseline to 1 and 4 months post-injection in hands injected with Botulinum toxin A vs. placebo.
| Baseline | 1 month | 4 months | |||||||
|---|---|---|---|---|---|---|---|---|---|
|
| |||||||||
| Test | Btx-A | Placebo | Btx-A | Placebo | Interaction p-value* | Btx-A | Placebo | Interaction p-value* | |
| LDI Blood flow (flux units)* | 398.24 | 395.65 | 362.06 | 389.55 | 0.024 | 359.75 | 361.33 | 0.796 | |
| QuickDASH score | 27.34 | 30.76 | 26.96 | 29.11 | 0.504 | 24.15 | 26.10 | 0.388 | |
| McCabe score | 221.79 | 221.15 | 185.31 | 187.19 | 0.938 | 182.19 | 182.5 | 0.906 | |
| VAS Pain score | 3.43 | 3.67 | 2.68 | 3.05 | 0.683 | 1.99 | 1.84 | 0.327 | |
| Oxygensaturation (%) | 90.95 | 92.2 | 94.1 | 95.21 | 0.917 | 92.49 | 95.31 | 0.489 | |
| Number of ulcers | 0.53 | 0.55 | 0.45 | 0.53 | 0.697 | 0.28 | 0.36 | 0.572 | |
LDI: Laser Doppler Imaging. VAS: Visual Assessment Scale.
*
Interaction p-values from Generalized Estimating Equations (GEE) compared change in outcome from baseline to follow-up visit between treatment arms.