Placebo v active for SPADI, (total scores, pain, and disability subscales) and pain (rest, night, and on movement) scores
| Week 1 Active (n=55), placebo (n=50) | Week 4 Active (n=55), placebo (n=51) | Week 12 Active (n=53), placebo (n=48) | ||||
|---|---|---|---|---|---|---|
| Outcome measure (max score) | Mean change (SD) | Difference in mean change between groups (95% CI) | Mean change (SD) | Difference in mean change between groups (95% CI) | Mean change (SD) | Difference in mean change between groups (95% CI) |
| When corrected using the Bonferroni adjustment all results are statistically significant with the exception of pain at rest in week 4. | ||||||
| SPADI (100) | ||||||
| Active | 16.5 (15.3) | 15.8 (9.9 to 21.8) | 13.6 (18.5) | 12.9 (6.6 to 19.1) | 13.5 (19.3) | 10.9 (3.6 to 18.2) |
| Placebo | 0.66 (15.1) | 0.8 (13.2) | 2.6 (17.4) | |||
| SPADI – pain subscale (100) | ||||||
| Active | 22.5 (18.1) | 22.2 (14.9 to 29.4) | 17.0 (20.9) | 14.2 (21.9 to 6.5) | 16.6 (21.7) | 11.0 (2.7 to 19.3) |
| Placebo | 0.3 (19.3) | 2.8 (19.0) | 5.6 (20.3) | |||
| SPADI – disability subscale (100) | ||||||
| Active | 10.6 (16.6) | 9.5 (3.4 to 15.7) | 10.25 (20.1) | 11.5 (4.9 to 18.2) | 10.5 (20.2) | 10.9 (3.2 to 18.4) |
| Placebo | 1.04 (15.1) | −1.27 (13.3) | −0.4 (18.2) | |||
| Pain at rest (100) | ||||||
| Active | 14.8 (19.4) | 10.8 (3.3 to 18.4) | 14.5 (22.6) | 7.9 (−1.5 to 17.4) | 12. 9 (23.9) | 14.6 (23.5 to 5.7) |
| Placebo | 4 (19.7) | 6.5 (26.3) | −1.6 (21.4) | |||
| Pain at night (100) | ||||||
| Active | 21.6 (25.3) | 14.8 (5.8 to 23.8) | 22.4 (28.0) | 11.8 (1.0 to 22.6) | 16.3 (30.5) | 13.9 (2.6 to 25.2) |
| Placebo | 6.8 (20.6) | 10.6 (28.0) | 2.4 (26.8) | |||
| Pain on movement (100) | ||||||
| Active | 21.3 (22.6) | 11.3 (3.3 to 19.3) | 16.9 (24.4) | 10.2 (0.8 to 19.7) | 19.2 (24.5) | 15.4 (25.1 to 5.7) |
| Placebo | 9.9 (18.1) | 6.7 (24.5) | 3.8 (24.9) | |||