Table 2 Efficacy endpoint results at the 12-and 24-week visits
Baseline | 12-week visit | Mean absolute difference | p * | 24-week visit | Mean absolute difference | p * | |
|---|---|---|---|---|---|---|---|
N | 166 | 166 | 150 | ||||
WOMAC questionnaire | |||||||
Pain subscale | |||||||
Median score (IQR) | 9 (7–11) | 4 (2–6) | 5 (2–7) | < 0.001 | 3 (1–5) | 5 (2–8) | < 0.001 |
Mean score (SD) | 9.0 (3.5) | 4.3 (3.4) | 4.8 (4.3) | 4.0 (3.8) | 5.0 (4.6) | ||
95%CI | 8.5–9.6 | 3.7–4.8 | 4.1–5.4 | 3.4–4.6 | 4.3–5.8 | ||
Pain on walking | |||||||
Median score (IQR) | 2 (1–2) | 1 (0–1) | 1 (0–2) | < 0.001 | 1 (0–1) | 1 (0–2) | < 0.001 |
Mean score (SD) | 1.7 (1.0) | 0.8 (0.8) | 0.9 (1.1) | 0.8 (0.9) | 0.9 (1.1) | ||
95%CI | 1.5–1.8 | 0.7–1.0 | 0.7–1.0 | 0.7–0.9 | 0.7–1.0 | ||
Stiffness subscale | |||||||
Median score (IQR) | 4 (3–5) | 2 (1–3) | 2 (0–3) | < 0.001 | 1 (0–2) | 2 (1–3) | < 0.001 |
Mean score (SD) | 3.7 (1.7) | 1.9 (1.4) | 1.8 (2.0) | 1.7 (1.7) | 2.0 (2.2) | ||
95%CI | 3.4–4.0 | 1.7–2.1 | 1.5–2.1 | 1.4–2.0 | 1.6–2.3 | ||
Functional capacity subscale | |||||||
Median score (IQR) | 31 (24–37) | 15 (7–22) | 14 (4–25) | < 0.001 ** | 13 (5–23) | 14 (5–29) | < 0.001 ** |
Mean score (SD) | 31.0 (12.7) | 16.3 (11.8) | 14.7 (14.5) | 15.1 (12.5) | 16.1 (15.4) | ||
95%CI | 29.1–33.0 | 14.5–18.1 | 12.4–16.9 | 13.0–17.1 | 13.6–18.6 | ||
EQ-5D-5L | |||||||
Mobility | |||||||
Median score (IQR) | 3 (2–3) | 2 (1–3) | 1 (0–1) | < 0.001 | NA | NA | NA |
Mean score (SD) | 2.8 (0.9) | 2.1 (0.8) | 0.8 (0.9) | NA | NA | ||
95%CI | 2.7–2.9 | 1.9–2.2 | 0.6–0.9 | NA | NA | ||
Self-care | |||||||
Median score (IQR) | 2 (1–3) | 1 (1–2) | 0 (0–1) | < 0.001 | NA | NA | NA |
Mean score (SD) | 2.2 (1.1) | 1.6 (0.8) | 0.6 (0.9) | NA | NA | ||
95%CI | 2.1–2.4 | 1.5–1.8 | 0.5–0.7 | NA | NA | ||
Usual activities | |||||||
Median score (IQR) | 3 (2–3) | 2 (1–2) | 1 (0–1) | < 0.001 | NA | NA | NA |
Mean score (SD) | 2.7 (0.9) | 2.0 (0.9) | 0.8 (1.0) | NA | NA | ||
95%CI | 2.6–2.8 | 1.8–2.1 | 0.6–0.9 | NA | 0.6–0.9 | ||
Pain/discomfort | |||||||
Median score (IQR) | 3 (3–4) | 2 (2–3) | 1 (0–2) | < 0.001 | NA | NA | NA |
Mean score (SD) | 3.0 (0.8) | 2.2(0.8) | 0.9 (1.0) | NA | NA | ||
95%CI | 2.9–3.2 | 2.0–2.3 | 0.7–1.0 | NA | NA | ||
Anxiety/depression | |||||||
Median score (IQR) | 2 (1–3) | 1 (1–2) | 0 (0–1) | < 0.001 | NA | NA | NA |
Mean score (SD) | 2.1 (1.1) | 1.5 (0.8) | 0.6 (1.1) | NA | NA | ||
95%CI | 1.9–2.3 | 1.4–1.6 | 0.5–0.8 | NA | NA | ||
EQ VAS | |||||||
Median score (IQR) | 60 (40–75) | 70 (60–85) | 10 (0–30) | < 0.001 | NA | NA | NA |
Mean score (SD) | 55.4 (22.4) | 69.2 (19.7) | 13.8 (23.6) | NA | NA | ||
95%CI | 52.0–59.0 | 66.2–72.2 | 10.1–17.4 | NA | NA | ||
Consumption of analgesics/NSAIDs as rescue medication, n (%) patients | 120 (72.3) | 63 (38.0) | NA | < 0.001*** | 58 (38.7) | NA | < 0.001*** |