Table 3.
Outcome measure scores and effect estimates adjusted from baseline
| Footwear intervention group mean (SD) | Control group mean (SD) | Adjusted effect estimate | P | |
|---|---|---|---|---|
| Foot pain VAS | ||||
| Baseline | 14.8 (18.7) | 17.5 (22.4) | ||
| 2 months | 10.7 (13.0) | 16.8 (21.8) | − 5.0 (− 12.9 to 2.8) | 0.21 |
| 4 months | 13.8 (23.0) | 16.1 (22.3) | − 1.8 (− 10.1 to 6.4) | 0.66 |
| 6 months | 13.1 (20.8) | 20.5 (26.1) | − 6.7 (− 16.4 to 2.9) | 0.17 |
| Overall pain VASa | ||||
| Baseline | 18.7 (19.6) | 17.7 (23.9) | ||
| 2 months | 9.7 (13.6) | 23.3 (27.5) | − 13.2 (− 22.2 to − 4.3) | < 0.01 |
| 4 months | 16.2 (19.4) | 17.9 (22.8) | − 2.3 (− 0.5 to 0.6) | 0.65 |
| 6 months | 16.3 (19.2) | 20.7 (26.8) | − 4.0 (− 13.6 to 5.7) | 0.42 |
| Patient Global Assessment VASa | ||||
| Baseline | 22.7 (24.5) | 21.5 (25.8) | ||
| 2 months | 17.7 (24.2) | 16.4 (21.6) | 1.2 (− 7.4 to 9.9) | 0.78 |
| 4 months | 14.6 (16.6) | 16.6 (20.2) | − 2.8 (− 11.9 to 6.3) | 0.55 |
| 6 months | 15.3 (19.4) | 18.8 (21.9) | − 3.4 (− 12.6 to 5.7) | 0.46 |
| Health Assessment Questionnaire II | ||||
| Baseline | 0.5 (0.6) | 0.4 (0.5) | ||
| 2 months | 0.5 (0.6) | 0.4 (0.4) | − 0.1 (− 0.3 to 0.1) | 0.36 |
| 4 months | 0.6 (0.6) | 0.3 (0.5) | 0.0 (−0.2 to 0.2) | 0.84 |
| 6 months | 0.5 (0.5) | 0.4 (0.6) | − 0.1 (− 0.3 to 0.1) | 0.28 |
| LFIS total score | ||||
| Baseline | 15.5 (11.5) | 15.4 (12.5) | ||
| 2 months | 13.8 (13.0) | 16.4 (14.1) | − 4.7 (− 9.1 to − 0.3) | 0.04 |
| 4 months | 14.9 (14.2) | 14.2 (12.3) | − 1.3 (− 6.1 to 3.5) | 0.59 |
| 6 months | 14.4 (13.6) | 16.9 (14.2) | − 3.0 (0.2 to 1.8) | 0.21 |
| LLTQ activities of daily l | ||||
| Baseline | 32.7 (8.2) | 33.8 (6.8) | ||
| 2 months | 34.8 (7.2) | 32.9 (8.0) | 2.2 (− 0.2 to 4.6) | 0.07 |
| 4 months | 32.9 (8.1) | 35.4 (6.7) | − 0.4 (− 3.1 to 2.3) | 0.77 |
| 6 months | 34.0 (6.9) | 33.8 (7.7) | 1.1 (− 1.2 to 3.4) | 0.35 |
| LLTQ recreational activitiesb | ||||
| Baseline | 22.7 (11.8) | 21.1 (11.6) | ||
| 2 months | 23.5 (14.2) | 22.8 (11.5) | 0.8 (− 2.8 to 4.4) | 0.66 |
| 4 months | 20.8 (12.8) | 25.1 (9.9) | − 3.4 (− 7.5 to 0.8) | 0.11 |
| 6 months | 21.7 (12.6) | 22.2 (12.0) | − 0.9 (− 4.8 to 3.0) | 0.66 |
| Footwear comfort VASc | ||||
| Baseline | 24.0 (21.9) | 27.6 (28.0) | ||
| 2 months | 10.3 (13.1) | 26.2 (26.5) | − 10.4 (− 19.9 to − 0.9) | 0.03 |
| 4 months | 9.1 (9.8) | 24.0 (21.0) | − 11.3 (− 21.4 to − 1.3) | 0.03 |
| 6 months | 17.5 (23.5) | 27.9 (28.4) | − 8.0 (− 19.2 to 3.3) | 0.16 |
| Footwear fit VASd | ||||
| Baseline | 20.6 (20.1) | 24.0 (27.2) | ||
| 2 months | 9.8 (16.0) | 22.2 (21.3) | − 9.5 (− 17.2 to − 1.8) | 0.02 |
| 4 months | 10.3 (13.6) | 22.2 (20.4) | − 11.1 (− 19.9 to − 2.4) | 0.01 |
| 6 months | 11.9 (20.0) | 27.9 (28.4) | − 11.1 (− 21.1 to − 1.0) | 0.03 |
| Footwear ease VASe | ||||
| Baseline | 20.9 (23.0) | 19.3 (23.8) | ||
| 2 months | 12.7 (19.1) | 26.8 (28.2) | − 9.8 (− 19.4 to − 0.3) | 0.04 |
| 4 months | 10.2 (16.6) | 23.8 (25.2) | − 12.3 (− 23.0 to − 1.6) | 0.02 |
| 6 months | 11.3 (19.7) | 27.9 (28.4) | − 13.2 (− 23.8 to − 2.7) | 0.01 |
| Footwear weight VASd | ||||
| Baseline | 21.9 (21.9) | 22.7 (24.6) | ||
| 2 months | 12.7 (17.8) | 27.0 (26.6) | − 9.7 (− 19.5 to 0.0) | 0.05 |
| 4 months | 13.6 (20.3) | 24.6 (20.4) | − 10.8 (− 20.6 to − 0.9) | 0.03 |
| 6 months | 11.4 (19.7) | 27.9 (28.4) | − 10.3 (− 19.8 to − 0.8) | 0.03 |
VAS visual analogue scale, LFIS Leeds Foot Impact Scale, LLTQ Lower Limb Tasks Questionnaire
aBMI adjusted
bAge adjusted
cBMI and prednisone adjusted
dSex and BMI adjusted
eEthnicity and BMI adjusted
Data in italics indicates statistical significance