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
|
- *Mann Whitney U test; p < 0.05.
- **Scores are presented as mean rank. The higher the score, the more problems experienced with activities of daily living.
- †All variables are denoted as a score between 0-100, with 100 being the best possible outcome.
- ‡CI, confidence interval.