Table 5.
Predicted Average Values and Differences in Functional Capacity for ITT Analysis
| Endpoint | Predicted Average Values [95% CI] | Predicted Difference over Time [95% CI] | Time # Group [95% CI] | P Value | ||
|---|---|---|---|---|---|---|
| Cryo | Sham | Cryo | Sham | |||
| Sit to stand | ||||||
| Baseline | 10.7 [9.9 to 11.5] | 10.6 [9.8 to 11.5] | ||||
| 14 days | 12.0 [11.1 to 12.8 | 12.5 [11.6 to 13.4] | 1.3 [0.4 to 2.3] | 1.8 [0.8 to 2.9] | 0.5 [−0.9 to 1.9] | 0.446 |
| Post GLA:D | 13.6 [12.5 to 14.6] | 13.9 [12.7 to 15.0] | 2.9 [1.7 to 4.1] | 3.2 [2.0 to 4.5] | 0.3 [−1.4 to 2.0] | 0.697 |
| 6 months | 14.1 [13.1 to 15.1] | 13.4 [12.4 to 14.5] | 3.4 [2.3 to 4.5] | 2.8 [1.7 to 4.0] | −0.6 [−2.2 to 1.0] | 0.447 |
| 12 months | 14.3 [13.4 to 15.3] | 14.0 [12.9 to 15.1] | 3.7 [2.6 to 4.7] | 3.4 [2.2 to 4.6] | −0.3 [−1.9 to 1.3] | 0.723 |
| Walk 40 m | ||||||
| Baseline | 26.6 [25.7 to 27.4] | 26.0 [25.2 to 26.9] | ||||
| 14 days | 25.0 [24.1 to 25.8] | 26.1 [25.1 to 27.0] | −1.6 [−2.6 to −0.6] | 0.0 [−1.0 to 1.1] | 1.6 [0.2 to 3.0] | 0.025 |
| Post GLA:D | 23.7 [22.6 to 24.8] | 25.0 [23.9 to 26.2] | −2.8 [−4.0 to −1.6] | −1.0 [−2.2 to 0.2] | 1.8 [0.1 to 3.5] | 0.040 |
| 6 months | 24.3 [23.3 to 25.3] | 25.7 [24.7 to 26.8] | −2.3 [−3.4 to −1.2] | −0.3 [−1.4 to 0.9] | 2.0 [0.4 to 3.6] | 0.015 |
| 12 months | 25.2 [24.3 to 26.2] | 25.7 [24.6 to 26.8] | −1.3 [−2.4 to −0.2] | −0.4 [−1.6 to 0.8] | 0.9 [−0.7 to 2.5] | 0.260 |
| MVC | ||||||
| Baseline | 285.6 [267.4 to 303.7] | 284.6 [265.9 to 303.2] | ||||
| 14 days | 285.8 [267.3 to 304.4] | 289.1 [269.1 to 309.2] | 0.3 [−20.7 to 21.2] | 4.6 [−17.9 to 27.0] | 4.3 [−26.5 to 35.0] | 0.784 |
| Post GLA:D | 318.0 [294.0 to 342.0] | 335.9 [311.3 to 360.5] | 32.4 [6.5 to 58.4] | 51.3 [24.7 to 77.9] | 18.9 [−18.3 to 56.0] | 0.319 |
| 6 months | 318.5 [296.4 to 340.6] | 318.1 [295.5 to 340.8] | 32.9 [8.7 to 57.2] | 33.6 [8.7 to 58.4] | 0.6 [−34.1 to 35.3] | 0.972 |
| 12 months | 301.7 [279.9 to 323.4] | 335.2 [312.1 to 358.4] | 16.1 [−7.8 to 40.0] | 50.7 [25.4 to 75.9] | 34.6 [−0.2 to 69.3] | 0.051 |
The values represent the estimated outcomes for each group, accounting for the random effects and covariates included in the mixed effects model, i.e., baseline pain level, time, group. The interaction “Time # Group” signifies the difference between groups across time. 95% CIs are displayed in brackets and statistically significant P values (P < 0.05) are italicized.
Cryo, cryoneurolysis; GLA:D, Godt Liv med Artrose I Danmark (Good Life with osteoArthritis in Denmark); ITT, intention to treat; MVC, maximum voluntary contraction.