Table 3. Summary of the health-related quality of life parameters overtime (baseline and 12 months) – Intention-to-treat analysis.
| Intervention (n = 93) | Placebo (n = 99) | Mean difference(95% CI) betweentreatment groupa | |
| Mean (95% CI) | Mean (95% CI) | ||
| Physical functioning | |||
| Baseline | 74.68 (70.81 to 78.84) | 70.96 (66.13 to 75.79) | 3.718 (–2.624 to 10.06) |
| 12 months | 71.81 (66.53 to 77.09) | 71.48 (66.62 to 76.33) | 0.330 (–6.792 to 7.452) |
| Role physical | |||
| Baseline | 74.36 (69.62 to 79.09) | 72.27 (67.41 to 77.14) | 2.082 (–4.662 to 8.826) |
| 12 months | 73.45 (67.94 to 78.95) | 72.84 (67.78 to 77.90) | 0.605 (–6.820–8.029) |
| Bodily pain | |||
| Baseline | 73.13 (69.09 to 77.17) | 71.13 (67.48 to 74.78) | 1.998 (–3.416 to 7.411) |
| 12 months | 72.93 (67.76 to 77.09) | 69.31 (65.64 to 72.97) | 3.621 (–1.891 to 9.132) |
| General health | |||
| Baseline | 66.77 (63.29 to 70.25) | 66.12 (62.71 to 69.54) | 0.653 (–4.188 to 5.494) |
| 12 months | 70.42 (66.85 to 73.99) | 68.66 (65.57 to 71.75) | 1.763 (–2.924 to 6.449) |
| Vitality | |||
| Baseline | 65.27 (62.80 to 67.74) | 61.76 (58.99 to 64.53) | 3.511 (–0.173 to 7.196) |
| 12 months | 65.53 (62.45 to 68.61) | 60.49 (57.39 to 63.58) | 5.041 (0.709 to 9.374) * |
| Social functioning | |||
| Baseline | 78.77 (74.76 to 82.79) | 74.26 (69.91 to 78.62) | 4.512 (–1.377 to 10.401) |
| 12 months | 80.27 (76.24 to 84.29) | 75.11 (70.66 to 79.56) | 5.151 (–0.804 to 11.107) |
| Role emotional | |||
| Baseline | 78.93 (74.32 to 85.53) | 76.26 (71.48 to 79.62) | 2.662 (–3.938 to 9.262) |
| 12 months | 80.52 (75.45 to 85.58) | 74.52 (69.43 to 79.62) | 5.995 (–1.138 to 13.129) |
| Mental health | |||
| Baseline | 73.12 (70.63 to 75.61) | 71.06 (67.74 to 74.37) | 2.058 (–2.065 to 6.180) |
| 12 months | 75.12 (72.16 to 78.08) | 71.53 (68.25 to 74.82) | 3.586 (–0.806 to 7.979) |
| Physical component score | |||
| Baseline | 49.57 (48.17 to 50.97) | 48.80 (47.32 to 50.28) | 0.772 (–1.249 to 2.793) |
| 12 months | 48.99 (47.51 to 50.47) | 49.06 (47.79 to 50.32) | –0.069 (–1.997 to 1.860) |
| Mental component score | |||
| Baseline | 50.09 (48.71 to 51.46) | 48.65 (46.82 to 50.48) | 1.440 (–0.835 to 3.715) |
| 12 months | 51.34 (49.81 to 52.86) | 48.39 (46.54 to 50.23) | 2.951 (0.573 to 5.329) * |
*Significant at p<0.05.
a
Determined with linear mixed effect.