Table 4 Assessment of functional outcome according to the EuroQoL-5D
Variable | Group A (Active) | Group B (Placebo) | p-value |
|---|---|---|---|
Mobility* (mean rank**) | |||
- Baseline | 49.35 | 43.52 | 0.052 |
- 6 weeks | 43.28 | 39.54 | 0.115 |
- 9 weeks | 39.19 | 38.76 | 0.848 |
- 12 weeks | 38.00 | 37.00 | 0.646 |
- 24 weeks | 37.54 | 36.54 | 0.597 |
- 52 weeks | 36.34 | 34.50 | 0.191 |
Self-Care* (mean rank**) | |||
- Baseline | 51.34 | 41.44 | 0.039 |
- 6 weeks | 44.51 | 37.22 | 0.111 |
- 9 weeks | 37.24 | 41.22 | 0.340 |
- 12 weeks | 37.42 | 37.58 | 0.960 |
- 24 weeks | 37.00 | 37.00 | 1.00 |
- 52 weeks | 35.29 | 35.00 | 0.359 |
Usual activities* (mean rank**) | |||
- Baseline | 48.6 | 44.3 | 0.373 |
- 6 weeks | 42.3 | 40.6 | 0.704 |
- 9 weeks | 38.9 | 39.2 | 0.945 |
- 12 weeks | 35.9 | 39.1 | 0.441 |
- 24 weeks | 38.4 | 35.5 | 0.309 |
- 52 weeks | 37.0 | 33.7 | 0.215 |
Pain/discomfort* (mean rank**) | |||
- Baseline | 49.3 | 43.6 | 0.250 |
- 6 weeks | 44.3 | 38.4 | 0.195 |
- 9 weeks | 39.1 | 37.8 | 0.769 |
- 12 weeks | 39.4 | 35.7 | 0.379 |
- 24 weeks | 40.7 | 33.2 | 0.051 |
- 52 weeks | 37.3 | 33.4 | 0.234 |
Anxiety/depression* (mean rank**) | |||
- Baseline | 47.8 | 45.1 | 0.339 |
- 6 weeks | 40.9 | 42.2 | 0.625 |
- 9 weeks | 37.8 | 40.5 | 0.251 |
- 12 weeks | 35.5 | 39.5 | 0.091 |
- 24 weeks | 35.0 | 39.1 | 0.038 |
- 52 weeks | 34.4 | 36.8 | 0.229 |
VAS-score† (mean, [95% CI‡]) | |||
- Baseline | 72.5 [65.9; 79.0] | 78.7 [73.9; 83.4] | 0.126 |
- 6 weeks | 78.0 [73.8; 82.3] | 82.6 [78.4; 86.8] | 0.127 |
- 9 weeks | 82.2 [78.3; 86.1] | 82.2 [77.2; 87.3] | 0.987 |
- 12 weeks | 84.8 [80.7; 89.0] | 82.9 [77.6; 88.3] | 0.576 |
- 24 weeks | 88.1 [83.9; 92.2] | 88.7 [85.0; 92.4] | 0.818 |
- 52 weeks | 87.9 [84.1; 91.8] | 90.8 [87.0; 94.7] | 0.282 |