nominally significantp = 0.022
In the ITT population, the active group was relatively stable or showed a slight improvement (37.45 ± 11.31 to 37.96 ± 10.78; mean Δ +0.51), whereas the sham group exhibited a decline (35.23 ± 13.15 to 32.91 ± 14.00; mean Δ −2.32), yielding a nominally significant between-group difference in change ( p = 0.022; Table 2 ).