Table 2.
Difference in symptomatic and structural changes within and between insole groups from baseline to 12 months’ follow-up in participants with medial knee osteoarthritis
| Outcome | Mean (SD) week 0 | Mean (SD) week 52 | Mean (SD) difference within groups (week 0−week 52) | Mean (95% CI) difference between groups (week 0−week 52)* | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Wedge insoles (n=103) | Control insoles (n=97) | Wedge insoles (n=89) | Control insoles (n=90) | Wedge insoles | Control insoles | Wedge insoles−control insoles | ||||
| Secondary measures | ||||||||||
| Primary outcomes | ||||||||||
| Average pain† (0-10) | 4.0 (2.1) | 4.3 (1.9) | 3.1 (2.1) | 3.1 (2.3) | 0.9 (2.1) | 1.3 (2.4) | −0.3 (−1.0 to 0.3) | |||
| Medial tibial cartilage volume (mm3) | 1550 (452) | 1520 (439) | 1513 (480) | 1483 (432) | 43 (45) | 43 (53) | −0.4 (−15.4 to 14.6) | |||
| Pain on walking† (0-10) | 4.2 (2.2) | 4.3 (1.9) | 3.2 (2.1) | 3.0 (2.5) | 0.9 (2.2) | 1.4 (2.6) | −0.3 (−1.0 to 0.4) | |||
| WOMAC‡: | ||||||||||
| Pain (0-20) | 7.1 (3.0) | 7.2 (2.9) | 6.4 (3.3) | 6.2 (3.2) | 0.7 (2.7) | 1.2 (3.1) | −0.4 (−1.2 to 0.4) | |||
| Function (0-68) | 23.7 (12.2) | 23.6 (10.9) | 20.8 (12.2) | 20.1 (11.6) | 3.1 (9.0) | 4.0 (11.2) | −0.7 (−3.6 to 2.2) | |||
| Stiffness (0-8) | 4 (2) | 4 (1) | 3 (2) | 3 (2) | 0.4 (1.4) | 0.6 (1.7) | −0.3 (−0.7 to 0.2) | |||
| Health related quality of life (−0.04-1.00)§ | 0.7 (0.2) | 0.7 (0.2) | 0.7 (0.2) | 0.7 (0.2) | −0.02 (0.11) | −0.01 (0.13) | −0.01 (−0.05 to 0.02) | |||
| Physical activity scale for elderly (0-400) | 182 (81) | 162 (68) | 167 (83) | 167 (88) | 16 (77) | 1 (83) | 7.8 (−15.4 to 30.9) | |||
| No of daily steps | 7908 (3712) | 7562 (3593) | 8059 (4946) | 6688 (4106) | −14 (3189) | 673 (3217) | −797.9 (−1966 to 370.2) | |||
WOMAC=Western Ontario and McMaster Universities osteoarthritis index.
Differences within and between groups concern only participants with baseline and follow-up data.
*Adjusted for baseline value of variable.
†Assessed using numerical rating scale, with higher scores indicating worse pain.
‡Higher scores indicating worse pain, function, and stiffness.
§Assessed using assessment of quality of life instrument, with higher scores indicating better quality of life.