| uPOD+PT | uPOD | Between-group difference in change from baselinea | P-value | Effect size (Cohen’s d) | ||
---|---|---|---|---|---|---|---|
Mean ± SD | Within-group change from baseline | Mean ± SD | Within-group change from baseline | ||||
FAAM (0–100)b | |||||||
 ITT analysis (uPOD+PT, n = 48; uPOD, n = 47) | |||||||
  Baseline | 61.6 ± 17.5 |  | 65.3 ± 13 |  |  |  |  |
  6 wk | 79.8 ± 14.1 | 18.2 (13.4 to 23.1)d | 78.4 ± 14.9 | 13.1 (9.5 to 16.8)d | 3.5 (− 1.6 to 8.5) | 0.177 | 0.349 |
  6 mo | 87.3 ± 17.6 | 25.7 (20.3 to 31.1)d | 85.2 ± 17.5 | 20 (15.5 to 24.3)d | 4.5 (− 1.7 to 10.8) | 0.153 | 0.345 |
  1 yr | 90.8 ± 12.4 | 29.3 (23.7 to 34.9)d | 88.4 ± 16.2 | 23.2 (19.2 to 27.1)d | 4.3 (−1.0 to 9.6) | 0.113 | 0.368 |
 PP analysis (uPOD+PT, n = 38; uPOD, n = 41) | |||||||
  Baseline | 62.6 ± 16.5 |  | 65 ± 13 |  |  |  |  |
  6 wk | 81 ± 15.1 | 20.1 (14.4 to 25.7)d | 78 ± 14.9 | 13 (9.1 to 16.9)d | 5.1 (−0.7 to 11.0) | 0.084 | 0.469 |
  6 mo | 91 ± 12.4 | 30.1 (25.6 to 34.6)d | 85.1 ± 16.3 | 20.2 (15.4 to 25.0)d | 7.7 (2.1 to 13.3)e | 0.008 | 0.684 |
  1 yr | 93.5 ± 11.6 | 32.6 (27.0 to 38.2)d | 89.5 ± 14.5 | 24.6 (20.6 to 28.5)d | 5.5 (0.1 to 10.8)e | 0.045 | 0.533 |
NPRS (0–10)c | |||||||
 ITT analysis (uPOD+PT, n = 48; uPOD, n = 47) | |||||||
  Baseline | 5.2 ± 1.9 |  | 4.9 ± 1.8 |  |  |  |  |
  6 wk | 2.7 ± 1.5 | 2.5 (1.9 to 3.1)d | 3.4 ± 1.6 | 1.5 (1.0 to 1.9)d | 0.9 (0.3 to 1.4)e | 0.003 | 0.583 |
  6 mo | 1.9 ± 1.8 | 3.3 (2.5 to 4.0)d | 2.6 ± 2.1 | 2.3 (1.7 to 2.9)d | 0.7 (−0.05 to 1.5) | 0.067 | 0.412 |
  1 yr | 1.1 ± 1.3 | 4.1 (3.5 to 4.8)d | 2.1 ± 2.3 | 2.8 (2.1 to 3.5)d | 1.5 (0.6 to 2.5)d | 0.001 | 0.557 |
 PP analysis (uPOD+PT, n = 38; uPOD, n = 41) | |||||||
  Baseline | 5.2 ± 2 |  | 4.9 ± 1.8 |  |  |  |  |
  6 wk | 2.7 ± 1.6 | 2.6 (1.9 to 3.3)d | 3.5 ± 1.6 | 1.5 (1.0 to 2.0)d | 0.9 (0.2 to 1.6)e | 0.008 | 0.617 |
  6 mo | 1.3 ± 1.4 | 4 (3.2 to 4.7)d | 2.6 ± 2 | 2.4 (1.7 to 3.0)d | 1.3 (0.6 to 2.1)d | 0.001 | 0.736 |
  1 yr | 0.7 ± 0.9 | 4.6 (3.9 to 5.3)d | 2 ± 2.2 | 3 (2.2 to 3.7)d | 1.3 (0.6 to 2.1)d | 0.001 | 0.702 |