| Active | Sham | Fisher’s exact P-value | ||
---|---|---|---|---|---|
N | n (%) | N | n (%) | ||
Primary outcomes | |||||
 ≥ 2 points OR ≥ 30%* | 31 | 9 (29%) | 34 | 6 (18%) | 0.131 |
Secondary outcomes | |||||
 EQ-VAS ≥ 11 | 31 | 12 (39%) | 34 | 7 (21%) | 0.061 |
 EQ 5D-Index ≥ 0.145 | 31 | 14 (45%) | 34 | 10 (29%) | 0.088 |
 BPI I ≥ 2 | 31 | 9 (29%) | 34 | 6 (18%) | 0.131 |
Exploratory outcomes | |||||
 BPI W ≥ 3* | 31 | 8 (26%) | 34 | 5 (15%) | 0.134 |
 HADS Anxiety ≥ 4** | 31 | 8 (26%) | 34 | 5 (15%) | 0.134 |
 HADS Depression ≥ 4 ** | 31 | 6 (19%) | 34 | 2 (6%) | 0.082 |
 PSEQ ≥ 7 ** | 31 | 9 (29%) | 34 | 6 (18%) | 0.131 |
 DMA mapped area ≥ *** | 31 | 16 (52%) | 34 | 10 (29%) | 0.039 |
Total mean | 31 | 33% (± 11) | 34 | 19% (± 7.1) | 0.005¥ |