| Group | Observed | Estimated | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Within groups Baseline to 6 months | Within groups Baseline to 12 months | Between groups 12 months | ||||||||
Baseline mean(SD) | 6 months mean (SD) | 12 months mean (SD) | Diff (95% CI) | p-value | Diff (95% CI) | p-value | Diff (95% CI) | p-value | ||
PAM-13 (0–100) ↑ | INTV | 63.9 (13.2) | 67.7 (14.5) | 66.7 (14.3) | 4.0 (0.4 to 7.5) | 0.027 | 3.1 (−0.4 to 6.5) | 0.084 | 4.0 (− 0.6 to 8.6) | 0.085 |
CTRL | 63.0 (12.9) | 64.9 (12.4) | 62.2 (10.0) | 1.4 (−2.2 to 5.0) | 0.445 | −1.0 (−4.5 to 2.6) | 0.587 | |||
BPI, severity (0–40) ↓ | INTV | 18.2 (6.5) | 17.4 (7.4) | 17.4 (6.8) | −0.8 (− 2.4 to 0.8) | 0.320 | − 0.5 (− 1.8 to 0.9) | 0.486 | 0.6 (− 1.3 to 2.4) | 0.526 |
CTRL | 18.8 (5.6) | 18.1 (6.6) | 17.4 (6.1) | −0.5 (−2.1 to 1.1) | 0.550 | −1.1 (−2.5 to 0.3) | 0.124 | |||
BPI, interference (0–70) ↓ | INTV | 29.2 (14.0) | 27.9 (16.0) | 25.9 (14.5) | −1.6 (−5.2 to 2.0) | 0.379 | −3.3 (−6.7 to 0.1) | 0.061 | −2.6 (−7.3 to 2.0) | 0.269 |
CTRL | 32.6 (13.1) | 30.8 (15.0) | 31.0 (15.0) | −0.5 (−4.3 to 3.2) | 0.779 | −0.6 (− 4.2 to 2.9) | 0.728 | |||
BPI, pain relief (0–10) ↑(0- | INTV | 3.4 (3.3) | 4.0 (2.8) | 6.3 (14.5) | 0.6 (−0.2 to 1.4) | 0.134 | 2.9 (0.5 to 5.2) | 0.017 | 2.9 (−0.1 to 5.8) | 0.055 |
CTRL | 3.5 (2.9) | 3.4 (2.9) | 3.4 (2.9) | −0.1 (−0.9 to 0.8) | 0.894 | −0.003 (−2.4 to 2.4) | 0.998 | |||
VAS, pain (0–100) ↓ | INTV | 62.7 (18.2) | 53.9 (21.5) | 55.5 (23.6) | −8.7 (−14.2 to −3.3) | 0.002 | −7.0 (− 12.5 to − 1.4) | 0.014 | −0.5 (− 7.6 to 6.7) | 0.901 |
CTRL | 62.8 (15.1) | 56.1 (19.3) | 56.0 (19.6) | −6.5 (−12.1 to − 1.0) | 0.021 | −6.5 (− 12.2 to −0.8) | 0.026 | |||
HADS, depression (0–21) ↓ | INTV | 4.4 (3.0) | 4.8 (3.9) | 4.8 (3.5) | 0.4 (−0.4 to 1.1) | 0.329 | 0.3 (−0.5 to 1.0) | 0.468 | 0.3 (−0.7 to 1.3) | 0.525 |
CTRL | 5.1 (3.1) | 5.1 (3.7) | 5.0 (3.6) | 0.2 (−0.6 to 1.0) | 0.672 | −0.1 (− 0.8 to 0.7) | 0.883 | |||
HADS, anxiety (0–21) ↓ | INTV | 7.8 (3.4) | 7.1 (4.5) | 7.2 (4.3) | −0.7 (−1.4 to 0.002) | 0.051 | −0.6 (− 1.3 to 0.2) | 0.132 | 0.1 (− 0.9 to 1.2) | 0.798 |
CTRL | 8.1 (3.6) | 7.8 (3.7) | 7.5 (3.1) | −0.5 (−1.3 to 0.2) | 0.163 | −0.7 (−1.5 to 0.1) | 0.072 | |||
PSEQ (0–60) ↑ | INTV | 38.1 (10.5) | 39.1 (12.8) | 39.1 (12.1) | 1.0 (−1.5 to 3.3) | 0.452 | 0.5 (−1.9 to 3.0) | 0.678 | 1.5 (−1.9 to 4.9) | 0.387 |
CTRL | 37.5 (10.4) | 37.6 (10.8) | 37.2 (11.2) | −0.7 (−3.2 to 1.7) | 0.554 | −1.0 (−3.5 to 1.6) | 0.453 | |||
SOC-13 (13–91) ↑ | INTV | 61.4 (12.4) | 62.8 (15.2) | 63.4 (15.5) | 1.1 (−1.4 to 3.5) | 0.401 | 1.1 (−1.4 to 3.5) | 0.393 | 0.5 (−2.9 to 3.9) | 0.771 |
CTRL | 61.8 (13.0) | 63.7 (12.9) | 62.1 (12.4) | 1.5 (−1.0 to 4.0) | 0.231 | 0.6 (−1.9 to 3.0) | 0.657 | |||
EQ-5D-5 L (0–1) ↑ | INTV | 0.63 (0.14) | 0.64 (0.16) | 0.63 (0.15) | 0.02 (−0.01 to 0.05) | 0.174 | 0.002 (− 0.03 to 0.03) | 0.896 | − 0.03 (− 0.1 to 0.01) | 0.206 |
CTRL | 0.61 (0.14) | 0.65 (0.14) | 0.64 (0.16) | 0.04 (0.004 to 0.07) | 0.029 | 0.03 (−0.002 to 0.06) | 0.069 | |||
AIOS (0–100) ↑ | INTV | 46.3 (21.3) | 51.8 (19.1) | 45.1 (16.6) | 6.5 (0.9 to 12.1) | 0.023 | 0.2 (−5.8 to 6.1) | 0.960 | 1.7 (−5.6 to 8.9) | 0.649 |
CTRL | 43.4 (18.5) | 45.5 (16.2) | 43.3 (16.4) | 0.8 (−5.0 to 6.5) | 0.797 | −1.5 (−7.7 to 4.6) | 0.625 | |||
Global health (1–5) ↑ | INTV | 2.1 (0.89) | 3.5 (0.9) | 3.6 (0.9) | 1.4 (1.1 to 1.6) | < 0.001 | 1.4 (1.2 to 1.7) | < 0.001 | −0.1 (−0.4 to 0.2) | 0.363 |
CTRL | 2.2 (0.69) | 3.6 (0.7) | 3.8 (0.6) | 1.4 (1.1 to 1.7) | < 0.001 | 1.6 (1.3 to 1.8) | < 0.001 | |||
Physical activity (1–5) ↑ | INTV | 4.0 (0.87) | 4.0 (1.0) | 4.0 (0.9) | −0.002 (−0.2 to 0.2) | 0.985 | 0.01 (−0.2 to 0.2) | 0.927 | 0.01 (−0.3 to 0.3) | 0.929 |
CTRL | 4.0 (1.02) | 4.1 (0.8) | 4.0 (0.8) | 0.1 (−0.1 to 0.3) | 0.356 | −0.003 (− 0.2 to 0.2) | 0.976 | |||
30 s Chair to Stand ↑ | INTV | 12.5 (4.1) | 13.3 (6.6) | 15.0 (4.7) | 0.9 (−0.4 to 2.2) | 0.161 | 2.2 (1.4 to 3.1) | < 0.001 | −0.5 (−1.7 to 0.7) | 0.383 |
CTRL | 11.5 (4.0) | 12.8 (5.6) | 14.4 (3.7) | 1.0 (−0.4 to 2.3) | 0.153 | 2.8 (1.9 to 3.6) | < 0.001 |