Table 3 ITT estimates of clinical effectiveness at 3, 6 and 12 months
All | Advice plus cognitive behavioural intervention | |||||
|---|---|---|---|---|---|---|
Control | Advice plus cognitive behavioural intervention | Non-complier | Complier | Mean compliance difference (95% CI)* | p value | |
Mean change from baseline (95% CI)* | Mean change from baseline (95% CI)* | |||||
Roland Morris Questionnaire (points) † | ||||||
3 months | 0.9 (0.32, 1.53) | 2.0 (1.55, 2.46) | 0.9 (-0.06, 1.83) | 2.3 (1.82, 2.85) | 1.5 (0.44, 2.47) | 0.005 |
6 months | 1.0 (0.38, 1.64) | 2.5 (1.98, 2.92) | 1.6 (0.68, 2.58) | 2.7 (2.18, 3.21) | 1.0 (-0.00, 2.07) | 0.05 |
12 months | 1.0 (0.36, 1.70) | 2.3 (1.86, 2.82) | 2.1 (1.12, 3.07) | 2.5 (1.99, 3.09) | 0.4 (-0.62, 1.52) | 0.41 |
Modified Von Korff disability (%) † | ||||||
3 months | 8.8 (5.42, 12.14) | 13.4 (10.81, 16.03) | 6.5 (1.27, 11.65) | 14.6 (11.56, 17.71) | 8.2 (2.51, 13.82) | 0.005 |
6 months | 5.7 (2.17, 9.19) | 14.0 (11.43, 16.60) | 9.0 (4.30, 13.67) | 15.2 (12.07, 18.42) | 6.3 (0.99, 11.53) | 0.02 |
12 months | 5.3 (1.82, 8.78) | 13.9 (11.32, 16.50) | 10.0 (5.48, 14.60) | 16.0 (12.88, 19.12) | 6.0 (0.78, 11.14) | 0.024 |
Modified Von Korff pain (%) † | ||||||
3 months | 5.4 (2.41, 8.30) | 12.3 (10.02, 14.51) | 7.4 (2.85, 11.87) | 13.6 (10.94, 16.22) | 6.2 (1.31, 11.12) | 0.013 |
6 months | 5.6 (2.27, 8.85) | 13.8 (11.38, 16.18) | 8.8 (4.44, 13.24) | 15.5 (12.51, 18.41) | 6.6 (1.67, 11.58) | 0.009 |
12 months | 6.4 (3.12, 9.62) | 13.4 (10.98, 15.76) | 11.6 (7.28, 15.85) | 14.4 (11.52, 17.21) | 2.8 (-2.05, 7.65) | 0.257 |
EQ-5D | ||||||
3 months | 0.5 (0.51, 0.58) | 0.6 (0.59, 0.65) | 0.6 (0.50, 0.61) | 0.6 (0.59, 0.66) | 0.1 (0.01, 0.13) | 0.014 |
6 months | 0.6 (0.54, 0.62) | 0.6 (0.59, 0.65) | 0.6 (0.55, 0.64) | 0.6 (0.60, 0.66) | 0.03 (-0.03, 0.09) | 0.293 |
12 months | 0.6 (0.54, 0.61) | 0.6 (0.60, 0.66) | 0.6 (0.56, 0.66) | 0.6 (0.59, 0.66) | 0.01 (-0.04, 0.07) | 0.616 |