Results of primary and secondary outcomes (questionnaire variables) and comparisons between the active intervention groups and the control group (BB) at the 2-year follow-up
| Outcome variable | Time point | PMU (n=43) | DBC (n=43) | BB (n=40) | PMU vs BB | DBC vs BB | ||
| MD (95% CI) | p Value | MD (95% CI) | p Value | |||||
| Primary outcome | ||||||||
| VAS | 3 months | 29 (27) | 31 (20) | 35 (28) | −10 (−19 to −1) | 0.04 | −6 (−16 to 3) | 0.19 |
| 6 months | 29 (26) | 33 (22) | 35 (26) | −10 (−20 to −1) | 0.04 | −4 (−14 to 5) | 0.39 | |
| 12 months | 35 (27) | 29 (21) | 39 (26) | −7 (−21 to 2) | 0.14 | −12 (−21 to −2) | 0.02 | |
| 24 months | 27 (22) | 27 (19) | 30 (21) | −5 (−13 to 4) | 0.27 | −5 (−13 to 4) | 0.27 | |
| RM–18 | 3 months | 5 (5) | 4 (5) | 4 (4) | −1 (−2 to 1) | 0.39 | 0 (−1 to 2) | 0.97 |
| 6 months | 4 (5) | 4 (5) | 4 (5) | −1 (−3 to 1) | 0.27 | 0 (−2 to 2) | 0.88 | |
| 12 months | 6 (6) | 4 (5) | 5 (5) | 0 (−2 to 3) | 0.86 | 0 (−2 to 1) | 0.61 | |
| 24 months | 4 (5) | 4 (4) | 5 (5) | −1 (−3 to 0) | 0.15 | −1 (−3 to 1) | 0.23 | |
| 15D* | 3 months | 0.89 (0.09) | 0.90 (0.07) | 0.89 (0.07) | 0.01 (−0.01 to 0.04) | 0.26 | 0.01 (−0.01 to 0.04) | 0.26 |
| 6 months | 0.87 (0.10) | 0.90 (0.07) | 0.90 (0.08) | 0.00 (−0.03 to 0.02) | 0.78 | 0.01 (−0.02 to 0.03) | 0.57 | |
| 12 months | 0.87 (0.09) | 0.90 (0.08) | 0.88 (0.08) | 0.01 (−0.01 to 0.03) | 0.43 | 0.03 (0.00 to 0.05) | 0.02 | |
| 24 months | 0.87 (0.10) | 0.90 (0.07) | 0.87 (0.08) | 0.02 (−0.01 to 0.04) | 0.18 | 0.03 (0.00 to 0.05) | 0.03 | |
| Secondary outcomes | ||||||||
| ODI | 3 months | 15 (14) | 14 (11) | 16 (10) | −4 (−8 to 0) | 0.03 | −3 (−7 to 1) | 0.11 |
| 6 months | 14 (14) | 13 (12) | 14 (12) | −3 (−8 to 1) | 0.15 | −2 (−6 to 3) | 0.40 | |
| 12 months | 15 (14) | 12 (10) | 14 (13) | −2 (−6 to 3) | 0.43 | −3 (−8 to 1) | 0.13 | |
| 24 months | 13 (12) | 12 (11) | 15 (13) | −5 (−10 to −1) | 0.01 | −4 (−8 to 0) | 0.06 | |
| FABQ | 3 months | 32 (16) | 31 (12) | 32 (12) | −3 (−7 to 0) | 0.08 | −3 (−7 to 0) | 0.08 |
| 6 months | 31 (14) | 32 (12) | 32 (14) | −5 (−8 to −1) | 0.02 | −2 (−6 to 2) | 0.28 | |
| 12 months | 33 (14) | 31 (12) | 33 (13) | −4 (−8 to −1) | 0.02 | −4 (−8 to −1) | 0.02 | |
| 24 months | 31 (15) | 31 (11) | 35 (15) | −8 (−12 to −3) | 0.00 | −6 (−11 to −2) | 0.01 | |
| DEPS | 3 months | 5 (5) | 4 (5) | 4 (4) | 0 (−2 to 1) | 0.56 | 0 (−1 to 2) | 0.85 |
| 6 months | 5 (6) | 4 (5) | 4 (4) | 0 (−2 to 2) | 0.94 | 0 (−2 to 2) | 0.79 | |
| 12 months | 6 (5) | 3 (4) | 5 (6) | 0 (−2 to 1) | 0.65 | −2 (−3 to 0) | 0.09 | |
| 24 months | 6 (5) | 4 (4) | 6 (6) | −1 (−3 to 1) | 0.22 | −2 (−4 to 0) | 0.03 | |
Mean (SD), mean difference (MD) and 95% CI, and p value for the MD.
↵* HRQoL, Range 0–1; higher values indicate better quality of life.
DEPS, Depression Scale; FABQ, Fear-Avoidance Beliefs Questionnaire; ODI, Oswestry Disability Index; RM-18, Roland–Morris Disability Scale; VAS, visual analogue scale; 15D, 15 Dimensional Quality of Life.