VAS at rest, walking VAS, 6MWT, FFI, FHSQ, and SF-36 measurements of the groups during 6 months. Values are mean (SD) unless otherwise specified.
| Variable | T0 | T45 | T90 | T180 | p | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CG | SG | CG | SG | Mean Difference (95% CI) | CG | SG | Mean Difference (95% CI) | CG | SG | Mean Difference (95% CI) | ||
| VAS 1, cm | 3.2 (3.2) | 3.8 (2.8) | 1.7 (2.7) | 2.6 (3.0) | −0.91 (−2.22–0.39) | 1.8 (2.5) | 1.8 (2.5) | −0.05 (−1.22–1.11) | 1.8 (2.7) | 1.6 (2.2) | 0.18 (−0.94–1.31) | 0.346 |
| VAS 2, cm | 5.9 (2.8) | 6.6 (2.3) | 4.3 (3.0) | 4.4 (2.4) | −0.05 (−1.30–1.19) | 4.2 (3.2) | 3.5 (2.7) | 0.70 (−0.65–1.69) | 4.2 (3.2) | 2.6 (2.5) | 1.56 (0.25–2.88) | 0.008* |
| 6MWT, m | 386.3 (47.2) | 394.7 (58.2) | 379.1 (47.2) | 412.2 (49.2) | −33.09 (−55.44 – −10.74) | 380.9 (41.7) | 404.1 (43.4) | −23.10 (−42.84 – −3.37) | 402.1 (35.1) | 404.3 (50.2) | −2.13 (−22.22–17.95) | 0.010* |
| FFI | 52.0 (15.5) | 48.6 (16.4) | 37.2 (17.7) | 31.9 (17.2) | 5.27 (−2.83–13.38) | 34.7 (21.3) | 27.0 (17.3) | 7.70 (−1.40–16.81) | 28.4 (20.1) | 23.4 (17.6) | 5.04 (−3.72–13.81) | 0.823 |
| Insole use, h/day | — | — | 6.1 (2.8) | 6.6 (2.5) | 0.01 (−0.23–0.26) | 5.0 (3.3) | 6.3 (3.7) | 0.03 (−0.21–0.29) | 5.7 (3.4) | 5.9 (3.3) | 0.13 (−0.03–0.31) | 0.477 |
| Diclofenac use, tablets/day | — | — | 0.1 (0.3) | 0.1 (0.6) | −0.49 (−1.75–0.76) | 0.1 (0.4) | 0.1 (0.6) | −0.59 (−2.07–0.89) | 0.1 (0.5) | 0.02 (0.08) | −0.29 (−1.86–1.27) | 0.516 |
| FHSQ | ||||||||||||
| FP | 34.1 (23.5) | 34.4 (21.4) | 57.8 (21.3) | 59.9 (21.8) | −2.14 (−12.11–7.83) | 59.8 (27.4) | 62.0 (27.4) | −2.22 (−14.56–10.11) | 63.2 (25.3) | 67.2 (22.1) | −3.99 (−15.13–7.15) | 0.592 |
| FF | 50.8 (24.8) | 54.2 (24.3) | 70.6 (19.0) | 79.9 (15.3) | −9.29 (−17.29 – −1.28) | 73.3 (25.5) | 81.3 (18.2) | −7.94 (−18.18–2.30) | 78.5 (22.8) | 86.0 (14.9) | −7.45 (−16.37–1.45) | 0.753 |
| Footwear | 41.4 (18.4) | 38.7 (16.5) | 34.2 (17.4) | 39.2 (21.4) | −4.95 (−14.00–4.09) | 35.8 (16.4) | 40.8 (20.8) | −4.95 (−13.63–3.71) | 35.6 (19.1) | 40.5 (20.5) | −4.95 (−14.14–4.23) | 0.387 |
| GFH | 13.9 (17.4) | 16.7 (17.8) | 25.1 (18.4) | 32.6 (20.5) | −7.56 (−16.57–1.44) | 32.4 (25.6) | 37.7 (27.3) | −5.29 (−17.55–6.96) | 33.6 (25.3) | 38.6 (29.8) | −5.00 (−17.81–7.81) | 0.221 |
| GH | 45.4 (26.8) | 56.2 (24.6) | 52.7 (27.6) | 66.2 (24.3) | −13.51 (−25.55 – −1.47) | 52.4 (26.0) | 66.8 (25.7) | −14.32 (−26.30 – −1.47) | 51.6 (25.6) | 65.9 (26.2) | −14.32 (−26.31 – −2.33) | 0.016* |
| PA | 54.4 (22.6) | 61.2 (25.5) | 63.1 (22.6) | 69.4 (20.2) | −6.30 (−16.23–3.61) | 64.5 (23.9) | 73.9 (19.3) | −9.32 (−19.39–0.74) | 66.5 (21.9) | 69.4 (22.0) | −2.85 (−13.02–7.31) | 0.168 |
| SC | 67.6 (27.7) | 79.7 (23.8) | 76.7 (26.5) | 75.3 (25.8) | 1.35 (−10.77–13.47) | 74.3 (21.8) | 76.7 (23.2) | −2.36 (−12.81–8.08) | 78.0 (23.1) | 78.1 (22.3) | −0.06 (−10.58–10.44) | 0.458 |
| Vigor | 41.9 (20.5) | 56.4 (17.6) | 51.0 (18.1) | 55.7 (21.5) | −4.72 (−13.9–4.4) | 54.2 (16.0) | 57.9 (18.3) | −3.71 (−11.68–4.25) | 54.7 (20.3) | 55.1 (21.7) | −0.41 (−10.15–9.31) | 0.025* |
| SF-36 | ||||||||||||
| PF | 53.5 (26.0) | 57.4 (25.5) | 61.8 (24.5) | 67.3 (21.6) | −5.54 (−16.24–5.16) | 62.2 (25.6) | 71.8 (20.5) | −9.59 (−20.35–1.16) | 65.0 (23.3) | 68.6 (23.8) | −3.64 (−14.56–7.26) | 0.257 |
| RP | 31.8 (42.8) | 43.9 (43.5) | 45.3 (43.2) | 73.2 (34.4) | −27.97 (−46.08 – −9.86) | 52.0 (46.2) | 83.1 (30.6) | −31.08 (−49.24 – −12.92) | 52.0 (42.2) | 77.0 (34.5) | −25.00 (−42.88 – −7.11) | 0.371 |
| BP | 39.7 (16.5) | 46.9 (20.6) | 53.3 (23.7) | 53.2 (15.2) | 0.08 (−9.15–9.31) | 53.3 (23.6) | 61.9 (21.3) | −8.56 (−18.98–1.85) | 55.2 (22.9) | 56.1 (23.1) | −0.83 (−11.48–9.80) | 0.254 |
| GH | 47.3 (17.1) | 54.3 (18.5) | 49.6 (17.0) | 59.1 (16.1) | −9.48 (−17.14 – −1.83) | 49.4 (17.7) | 59.8 (16.7) | −10.37 (−18.36 – −2.38) | 50.6 (18.2) | 59.6 (16.1) | −8.97 (−16.93 – −1.00) | 0.768 |
| Vitality | 42.7 (20.5) | 51.9 (20.8) | 52.3 (18.8) | 54.8 (23.0) | −2.48 (−12.22–7.24) | 56.4 (18.3) | 60.0 (19.4) | −3.64 (−12.38–5.08) | 55.1 (21.5) | 55.8 (23.8) | −0.67 (−11.18–9.83) | 0.275 |
| SF | 65.5 (26.7) | 76.7 (26.2) | 72.3 (25.5) | 75.5 (27.8) | −3.18 (−15.56–9.18) | 71.6 (22.2) | 78.0 (22.1) | −6.41 (−16.68–3.84) | 79.4 (24.2) | 79.7 (20.9) | −0.33 (−10.80–10.13) | 0.303 |
| RE | 57.7 (47.6) | 58.6 (49.3) | 62.2 (46.6) | 65.8 (47.5) | −3.60 (−25.39–18.19) | 69.4 (44.7) | 69.4 (42.6) | 0.00 (−20.23–20.23) | 66.7 (45.8) | 70.3 (42.9) | −3.60 (−24.16–16.96) | 0.971 |
| MH | 59.0 (20.8) | 63.5 (20.0) | 64.3 (17.1) | 63.6 (20.4) | 0.70 (−8.02–9.42) | 63.5 (19.6) | 67.2 (21.1) | −3.72 (−13.15–5.69) | 63.9 (17.4) | 66.4 (21.5) | −2.48 (−11.55–6.58) | 0.470 |
↵* Significant p value between groups (ANOVA). VAS: visual analog scale; 6MWT: 6-min walk test; FFI: Foot Function Index; FHSQ: Foot Health Status Questionnaire; SF-36: Medical Outcomes Study Short Form-36; T0: baseline; T45: after 45 days of insole use; T90: 90 days; T180: 180 days; CG: control group; SG: study group; VAS 1: VAS pain during rest; VAS 2: VAS pain during walking; FP: foot pain; FF: foot function; GFH: general foot health; GH: general health; PA: physical activity; SC: social capacity; PF: physical functioning; RP: role-physical; BP: bodily pain; SF: social functioning; RE: role-emotional; MH: mental health.