Table 1.
Baseline patient characteristics at randomization.
| W-TENS group n = 55 |
WO group n = 55 |
|
|---|---|---|
| Age (years) | ||
| Mean (SD) | 66.9 ± 8.1 | 66.0 ± 7.8 |
| 95% CI ⩾75 years, n (%) |
[64.7–69.1] 8 (14.5) |
[63.9–68.2] 6 (10.9) |
| Min–Max | 55–89 | 55–89 |
| Sex (female) | ||
| N (%) | 37 (67.3) | 34 (61.8) |
| 95% CI | [54.9–79.7] | [49.0–74.7] |
| Weight (kg) (W-TENS group, n = 54) | ||
| Mean (SD) | 77.4 (14.4) | 83.0 (18.3) |
| 95% CI | [73.5–81.3] | [78.1–87.9] |
| Min–Max | 45–106 | 57–147 |
| Height (cm) (W-TENS group, n = 54) | ||
| Mean (SD) | 166.4 (8.5) | 166.9 (10.2) |
| 95% CI | [164.1–168.7] | [164.1–169.6] |
| Min–Max | 150–188 | 150–193 |
| BMI (kg/m2) (W-TENS group, n = 54) | ||
| Mean (SD) | 28.0 (5.0) | 29.8 (5.8) |
| 95% CI | [26.6–29.3] | [28.2–31.4] |
| Min–Max | 19.2–40.9 | 20.4–45.4 |
| Studied knee (right) | ||
| N (%) | 28 (50.9) | 30 (55.6) |
| 95% CI | [37.7–64.1] | [42.3–68.8] |
| DN4 global score (0–10) | ||
| Mean (SD) | 1.0 (1.2) | 1.0 (1.0) |
| 95% CI | [0.65–1.28] | [0.76–1.32] |
| Min–Max | 0.0–5.0 | 0.0–4.0 |
| PI (NRS: 0–10) | ||
| Mean (SD) | 5.9 (1.3) | 5.8 (1.3) |
| 95% CI | [5.5–6.2] | [5.5–6.2] |
| Range | 4.0–9.0 | 4.0–8.0 |
| WOMAC (global score 0–96) (WO group, n = 53) | ||
| Mean (SD) | 47.2 (15.5) | 46.7 (13.5) |
| 95% CI | [43.0–51.4] | [42.9–50.4] |
| Range | 17–74 | 13–80 |
| WOMAC (pain sub-score 0–20) (WO group, n = 53) | ||
| Mean (SD) | 10.9 (2.5) | 10.6 (2.8) |
| 95% CI | [10.2–11.6] | [9.9–11.4] |
| Range | 6–17 | 3–16 |
| WOMAC (function sub-score 0–68) (WO group, n = 54) | ||
| Mean (SD) | 32.0 (12.1) | 31.9 (10.5) |
| 95% CI | [28.7–35.2] | [29.1–34.8] |
| Range | 7–53 | 3–58 |
| WOMAC (stiffness sub-score 0–8) (WO group, n = 54) | ||
| Mean (SD) | 4.3 (2.0) | 4.3 (1.8) |
| 95% CI | [3.8–4.9] | [3.8–4.8] |
| Range | 0–8 | 0–8 |
| EQ-5D (global score 5–12) (WO group, n = 54) | ||
| Mean (SD) | 8.2 (1.4) | 7.7 (1.5) |
| 95% CI | [7.8–8.5] | [7.4–8.1] |
| Range | 6.0–11.0 | 6.0–12.0 |
BMI, body mass index; CI, confidence interval; DN4, Neuropathic Pain Diagnostic Questionnaire–4 questions; EQ-5D, EuroQol 5 Dimensions; NRS, Numerical Rating Scale (0 = non-pain; 10 = Maximal pain as you can imagine); PI, pain intensity; SD, standard deviation; WOMAC, Western Ontario and McMaster University Osteoarthritis Index; WO, weak opioid; W-TENS, wearable transcutaneous electrical nerve stimulation.
Global score: 0–96 (24 items, 0–4), Pain subscore: 0–20 (5 items, 0–4), Function subscore: 0–68 (17 items, 0–4), and Stiffness subscore: 0–8 (2 items, 0–4); EQ-5D = EuroQol 5 dimensions (Global score: 5–12, Mobility: 1–3, Self-care, 1–2, Usual activities: 1–2, Pain/Discomfort: 1–3; Anxiety/Depression: 1–2).