Table 2.
Non-inferiority analyses on PI at M3 (main criterion): ITT and PP populations.
| Group population | Pain intensity at Month
3 p within-group change |
Between-group difference | ||||
|---|---|---|---|---|---|---|
| W-TENS | WO | W-TENS-WO | ||||
| PP Population (n) | 52 | 47 | ||||
| Mean (SD) | 3.87 (2.12) | <0.001 | 4.65 (2.37) | <0.001 | –0.79 (0.44) | Non-inferiority
a
demonstrated 95% CI <0.825 |
| 95% CI | [3.28, 4.46] | [4.03, 5.28] | [–1.65, 0.08] | |||
| ITT Population (n) | 55 | 55 | ||||
| Mean (SD) | 3.84 (2.08) | <0.001 | 4.73 (2.28) | <0.001 | –0.92 (0.40) | Non-inferiority
a
demonstrated 95% CI <0.825 |
| 95% CI | [3.27, 4.40] | [4.18, 5.30] | [–1.71, –0.12] | |||
CI, confidence interval; ITT, intent to treat; PI, pain intensity; PP, per protocol; SD, standard deviation; WO, weak opioid; W-TENS, wearable transcutaneous electrical nerve stimulation.
Least squares means for each study group and study group difference estimate. Corresponding 95% CI.
a
Non-inferiority margin was 0.825 for pain intensity on numerical rating scale and non-inferiority was demonstrated when 95% CI <0.825.