Table 6.
Secondary outcomes at M1 and M3: ITT population.
| Outcomes | Month 1 | Month 3 | ||||
|---|---|---|---|---|---|---|
| W-TENS group | WO group | p-value | W-TENS group | WO group | p-value | |
| Sum of pain intensity difference (SPID) | ||||||
| Mean (SD) | 54.5 (7.7) | 16.3 (7.7) | 0.0007 | 176.6 (22.7) | 83.4 (22.7) | 0.0046 |
| 95% CI | [39.2, 69.8] | [0.9, 31.6] | [131.4, 221.6] | [38.3, 128.5] | ||
| Pain relief (PAR, VAS) | ||||||
| Mean (SD) | 55.9 (4.0) | 45.5 (4.2) | 0.0749 | 55.8 (4.0) | 46.6 (4.2) | 0.1154 |
| 95% CI | [48.0, 63.8] | [3.3, 53.8] | [47.9, 63.8] | [38.2, 55.0] | ||
| Total pain relief (TOTPAR) | ||||||
| Mean (SD) | 55.9 (4.0) | 45.6 (4.2) | 0.0749 | 56.2 (3.9) | 46.2 (4.3) | 0.0861 |
| 95% CI | [48.0, 63.8] | [37.3, 53.8] | [48.3, 64.1] | [37.8, 54.6] | ||
| EQ-5D: global score | ||||||
| Mean (SD) | 7.3 (0.1) | 7.8 (0.1) | 0.0171 | 7.0 (0.2) | 7.7 (0.2) | 0.0058 |
| 95% CI | [7.0, 7.6] | [7.5, 8.0] | [6.7, 7.4] | [7.4, 8.0] | ||
| PGIC: degree of change (NRS) | ||||||
| Mean (SD) | 3.6 (1.4) | 4.2 (1.7) | 0.0584 | 3.4 (1.8) | 4.4 (2.3) | 0.0031 |
| 95% CI | [3.2, 4.0] | [3.7, 4.7] | [3.0, 3.9] | [3.7, 5.1] | ||
| PGIC: description of change (NRS) | ||||||
| Mean (SD) | 4.0 (1.7) | 3.3 (1.9) | 0.0392 | 4.4 (1.8) | 3.2 (2.0) | 0.0203 |
| 95% CI | [3.5, 4.5] | [2.7, 3.8] | [3.9, 4.9] | [2.6, 3.] | ||
ANOVA, analysis of variance; CI, confidence interval; EQ-5D, EuroQol 5 dimensions (Global score: 5–12; subscores: Mobility: 1–3, Self-care, 1–2, Usual activities: 1–2, Pain/Discomfort: 1–3; Anxiety/Depression: 1–2); NRS, Numerical Rating Scale; PAR, Pain Relief; PGIC, Patient Global impression of Change. Degree of change (NRS: 0 = much better; 10 = worst) and description of change (NRS: 1 = no change or worst; 7: much better); PID, Pain Intensity Difference; SD, standard deviation; SPID, Sum of Pain Intensity Difference; TOTPAR, Total Pain Relief; VAS, visual analogue scale (0 = no pain relief; 100 = maximal pain relief); WO, weak opioid; W-TENS, wearable transcutaneous electrical nerve stimulation.
Study group: One-way ANOVA on outcomes (rank data) at M1 and M3, Least squares means, ITT population.
Between-study group difference: One-way ANOVA on outcomes (rank data) at M1 and M3. Estimate and corresponding 95% confidence interval (CI).
Study group: p-value <0.0001 except for PID and SPID in WO group: <0.05 at M1 and <0.01 at M3.