Measure | Time point | n | Mean (SD) | p value | p value | |
---|---|---|---|---|---|---|
Paired t test | Non-parametric signed rank test | Mixed model analysis* | ||||
FACT/GOG-NTX †| Baseline | 19 | 20.8 (9.6) | – | – | – |
4Â weeks | 18 | 16.7 (9.4) | 0.0114 | 0.018 | 0.0263 | |
 | 9 weeks | 15 | 9.9 (5.6) | 0.0009 | <0.0001 | <0.0001 |
 | 13 weeks | 15 | 13.2 (8.5) | 0.0007 | <0.0002 | <0.0001 |
BPI-SF ‡ |  |  |  |  |  |  |
Pain | Baseline | 18 | 25.4 (18.5) | – | – | – |
severity | 4Â weeks | 18 | 18.2 (16.4) | 0.0048 | 0.0052 | 0.0056 |
 | 9 weeks | 16 | 15.1 (14.5) | 0.0004 | 0.0001 | <0.0001 |
 | 13 weeks | 16 | 17.6 (16.6) | 0.004 | 0.0007 | <0.0001 |
Pain | Baseline | 18 | 25.4 (18.5) | – | – | – |
interference | 4Â weeks | 18 | 18.2 (16.4) | 0.0048 | 0.0052 | 0.0056 |
 | 9 weeks | 16 | 15.1 (14.5) | 0.0004 | 0.0001 | <0.0001 |
 | 13 weeks | 16 | 17.6 (16.6) | 0.004 | 0.0007 | <0.0001 |
Worst pain in | Baseline | 18 | 6.2 (3.5) | – | – | – |
last 24Â hours | 4Â weeks | 18 | 3.8 (2.7) | 0.0057 | 0.0049 | 0.0004 |
 | 9 weeks | 16 | 2.9 (2.1) | <0.0001 | 0.0002 | <0.0001 |
 | 13 weeks | 15 | 3.6 (2.5) | <0.0001 | 0.0006 | <0.0001 |
FACT-G § |  |  |  |  |  |  |
Physical | Baseline | 18 | 9.2 (6.1) | – | – | – |
Well-being | 4Â weeks | 18 | 7.2 (5.6) | 0.3 | 0.4 | 0.3 |
 | 9 weeks | 14 | 5.0 (3.8) | <0.05 | 0.02 | 0.002 |
 | 13 weeks | 16 | 5.5 (4.3) | 0.01 | 0.002 | 0.0004 |
Social/family | Baseline | 19 | 20.5 (6.3) | – | – | – |
Well-being | 4Â weeks | 16 | 19.7 (6.3) | 0.7 | 0.8 | 0.4 |
 | 9 weeks | 14 | 19.4 (8.5) | 0.3 | 0.7 | 0.1 |
 | 13 weeks | 15 | 19.6 (7.0) | 0.3 | 0.6 | 0.3 |
Emotional | Baseline | 19 | 5.3 (5.5) | – | – | – |
Well-being | 4Â weeks | 18 | 4.4 (4.0) | 0.5 | 0.6 | 0.5 |
 | 9 weeks | 16 | 3.8 (4.3) | 0.4 | 0.3 | 0.2 |
 | 1 month | 16 | 4.1 (3.9) | 0.3 | 0.4 | 0.2 |
Functional | Baseline | 19 | 20.8 (6.7) | – | – | – |
Well-being | 4Â weeks | 17 | 19.7 (8.4) | 0.07 | 0.09 | <0.05 |
 | 9 weeks | 14 | 19.6 (7.0) | 0.1 | 0.1 | 0.1 |
 | 1 month | 15 | 20.4 (8.9) | 0.4 | 0.4 | 0.3 |