Table 2.
Primary and secondary continuous outcomesa in placebo (n = 103) and intervention (n = 102) groups
| Placebo, mean (SD) | Nortriptyline, mean (SD) | Baseline-adjusted difference at 14 weeks | |||||||
|---|---|---|---|---|---|---|---|---|---|
|
| |||||||||
| Baseline | 14 weeks | Change | Baseline | 14 weeks | Change | Difference | 95% CI | P-value | |
| Primary outcome | |||||||||
| Pain (WOMAC)b | 61.2 (12.5) | 42.5 (24.0) | −18.7 (25.8) | 60.2 (13.5) | 36.0 (23.2) | −24.3 (22.5) | −6.2 | −0.26 to 12.56 | 0.06 |
|
| |||||||||
| Secondary outcomes | |||||||||
| Function (WOMAC)b | 59.9 (14.8) | 41.9 (24.2) | −18.0 (23.2) | 62.8 (15.0) | 39.6 (24.4) | −23.2 (21.5) | −4.4 | −10.48 to 1.79 | 0.16 |
| Stiffness (WOMAC)b | 61.2 (20.1) | 47.2 (27.9) | −14.0 (29.5) | 65.2 (20.3) | 45.4 (27.4) | −19.9 (27.4) | −3.6 | −10.94 to 3.72 | 0.33 |
| Global assessment VASb | 72.6 (21.1) | 53.6 (28.6) | −19.0 (33.0) | 74.3 (20.2) | 49.3 (30.8) | −25.0 (33.5) | −4.7 | −12.91 to 3.46 | 0.26 |
|
| |||||||||
| Quality of lifec | |||||||||
| Physical function | 31.6 (9.9) | 31.0 (10.1) | −0.6 (8.8) | 29.9 (10.6) | 31.9 (11.5) | 2.0 (10.0) | 2.0 | −0.39 to 4.43 | 0.10 |
| Role limitations due to physical health | 39.7 (11.1) | 39.7 (12.1) | −0.1 (11.5) | 39.9 (11.0) | 41.7 (11.9) | 1.8 (11.9) | 2.0 | −0.95 to 4.88 | 0.19 |
| Bodily pain | 35.5 (7.5) | 38.6 (8.8) | 3.1 (9.4) | 35.7 (8.1) | 41.4 (10.0) | 5.8 (8.8) | 2.8 | 0.42 to 5.08 | 0.02 |
| General health | 46.1 (8.6) | 46.7 (10.1) | 0.6 (7.8) | 47.4 (8.4) | 47.4 (8.7) | 0.1 (7.3) | −0.1 | −2.15 to 1.88 | 0.90 |
| Energy and vitality | 47.1 (10.0) | 47.1 (10.8) | 0.0 (9.9) | 46.2 (8.8) | 46.8 (10.9) | 0.6 (8.5) | 0.3 | −2.15 to 2.72 | 0.82 |
| Social function | 44.8 (11.4) | 43.2 (13.5) | −1.6 (12.8) | 44.7 (11.5) | 45.0 (12.7) | 0.4 (13.2) | 1.9 | −1.40 to 5.14 | 0.26 |
| Role limitations due to emotional health | 47.8 (11.4) | 44.7 (12.9) | −3.1 (13.9) | 47.3 (11.8) | 46.0 (12.9) | −1.3 (11.8) | 1.6 | −1.63 to 4.79 | 0.33 |
| Emotional wellbeing | 52.1 (8.8) | 51.7 (10.0) | −0.4 (8.9) | 51.9 (9.1) | 51.4 (10.9) | −0.6 (9.7) | −0.2 | −2.66 to 2.21 | 0.86 |
a
All outcomes have been standardised to a range of 0–100.
b
0 = best-possible outcome.
c
100 = best-possible outcome. SD = standard deviation. VAS = visual analogue scale. WOMAC = McMaster Universities Osteoarthritis Index.