Introduction
Materials and methods
Study design
Participants
Intervention
Intervention blinding
Data capture and outcome measures
Patient-reported outcome measures
Treatment adherence
Examination of intervention blinding
Biomechanical outcome measures
Statistical analysis
Results
Feasibility outcome measures
Recruitment
Participant demographics and clinical characteristics
Total group (n = 37) | Functional foot orthoses (n = 19) | Sham intervention (n = 18) | |
---|---|---|---|
Age (years) | 58.4 (11.6) | 60.5 (10.4) | 56.2 (12.6) |
Gender (female) | 26 (70.3 %) | 15 (78.9 %) | 11 (61.1 %) |
Body mass index (kg/m2) | 29.5 (4.5) | 31.2 (4.5) | 27.7 (3.9) |
Right foot affected (proportion) | 20 (54.1 %) | 11 (57.9 %) | 9 (50.0 %) |
Adherence with treatment
Outcome measures | ||||||||
---|---|---|---|---|---|---|---|---|
Functional foot orthoses group (FFO) | Sham intervention group (sham) | Mean difference FFO-sham (95 % CI) | ||||||
Type of outcome measure | Baseline (n = 19) | 12 weeks (n = 18) | Difference (12 weeks − baseline)c
| Baseline (n = 19) | 12 weeks (n = 18) | Difference (12 weeks − baseline)c
| ||
Patient reported | Pain in last 24 h (NRS) | 5.6 (2.0) | 4.5 (2.0) | −1.1 (2.5) | 4.7 (2.4) | 4.6 (2.8) | 0.3 (3.4) | −1.4 (−3.5 to 0.7) |
MFPDI function | 10.5 (4.1) | 6.5 (4.7) | −3.6 (3.8) | 9.8 (5.3) | 8.4 (5.2) | −2.2 (4.1) | −1.4 (−4.1 to 1.4) | |
PGIC (%) | 83.4 | 46.6 | 36.8 (6.1 to 67.2) | |||||
Biomechanical | Max Midfoot Force (% BW)b
| 10.7 (6.6) | 4.4 (6.3) | 6.3 (1.7 to 10.9) | ||||
Peak hindfoot angle (SD)a
| 0.7° (1.6°) | −0.3° (2.5°) | 1.04° (−0.5° to 2.6°) | |||||
Feasibility | Mean adherence (hours/week) | 30.9 | 48.9 | |||||
Participant adherence ≥21 h/week | 14/18 (78 %) | 14/15 (93 %) | ||||||
Blinding maintained | 14/18 (78 %) | 11/15 (73 %) |
Treatment blinding
Clinical outcome measures
Clinical outcome measures | |||||||
---|---|---|---|---|---|---|---|
Functional foot orthoses group (FFO) | Sham intervention group (sham) | Mean difference of FFO-sham (95 % CI) | |||||
Baseline (n = 19) | 12 weeks (n = 18) | Difference (12 weeks − baseline)a
| Baseline (n = 19) | 12 weeks (n = 18) | Difference (12 weeks − baseline)a
| ||
Pain at its worst in last 24 h | 5.6 (2.0) | 4.5 (2.0) | −1.1 (2.5) | 4.7 (2.4) | 4.6 (2.8) | 0.3 (3.4) | −1.4 (−3.5 to 0.7) |
Pain on average in last 24 h | 6.6 (2.0) | 3.7 (1.8) | −2.8 (2.5) | 5.9 (2.4) | 3.7 (2.3) | −2.1 (3.1) | −0.7 (−2.7 to 1.3) |
Pain on average in last week | 5.9 (1.7) | 4.2 (2.0) | −1.6 (2.5) | 5.8 (1.9) | 3.9 (2.0) | −1.6 (2.3) | 0.0 (−1.7 to 1.8) |
Pain on average in last month | 6.0 (1.6) | 4.3 (1.9) | −1.6 (2.0) | 6.0 (1.9) | 4.5 (1.9) | −1.2 (1.1) | −0.4 (−1.6 to 0.8) |
Pain while walking in last week | 6.5 (1.4) | 4.3 (2.1) | −2.1 (2.4) | 6.1 (2.1) | 4.1 (2.1) | −1.7 (2.2) | −0.3 (−2.0 to 1.3) |