Total population N=185 | Custom-made insole group n=70 | Sham insole group n=69 | Usual care group n=46 | |
Mean (SD) unless otherwise indicated | Mean (SD) unless otherwise indicated | Mean (SD) unless otherwise indicated | Mean (SD) unless otherwise indicated | |
Age, y | 47.6 (10.6) | 48.0 (11.3) | 48.2 (9.4) | 46.1 (11.4) |
Sex, female, No (%) | 128 (69.2) | 48 (68.6) | 48 (69.6) | 32 (69.6) |
Educational level, No (%) | ||||
Low | 59 (31.9) | 23 (32.9) | 20 (29.0) | 16 (34.8) |
Middle | 86 (46.5) | 29 (41.4) | 33 (47.8) | 24 (52.2) |
High | 40 (21.6) | 18 (25.7) | 16 (23.2) | 6 (13.0) |
BMI | 29.7 (5.3) | 29.2 (5.8) | 29.5 (4.8) | 30.9 (5.0) |
Pain history | ||||
Localization of complaints, bilateral, No (%) | 45 (24.3) | 16 (22.9) | 16 (23.2) | 13 (28.3) |
Duration of pain, mo | 6.2 (10.4) | 7.7 (15.5) | 5.1 (5.2) | 5.4 (5.6) |
VAS during rest (0–10) | 4.1 (2.6) | 3.8 (2.5) | 4.0 (2.7) | 4.9 (2.4) |
VAS during activity (0–10) | 6.8 (2.0) | 6.8 (2.0) | 6.7 (2.1) | 7.0 (1.8) |
VAS first step pain (0–10) | 7.2 (2.3) | 7.2 (2.4) | 7.3 (2.1) | 7.2 (2.5) |
DN4 (0–10>4indicates neuropathic pain) | 3.7 (2.1) | 3.9 (2.1) | 3.6 (1.8) | 3.7 (2.3) |
FFI total (0–100) | 48.7 (18.0) | 50.2 (18.8) | 46.1 (17.2) | 50.3 (18.0) |
FFI disability (0–100) | 39.6 (20.9) | 41.6 (23.1) | 37.3 (19.7) | 40.1 (19.3) |
FFI pain (0–100) | 58.7 (17.7) | 60.0 (16.7) | 55.6 (17.2) | 61.2 (19.6) |
FPDI function (9-27) | 17.5 (4.4) | 17.2 (4.2) | 17.6 (4.9) | 17.9 (4.2) |
Self-reported illness in the past 12 months, No (%) | 116 (62.7) | 45 (64.3) | 45 (65.2) | 26 (56.5) |
Other musculoskeletal pain at baseline, No (%) | 78 (42.2) | 29 (41.4) | 32 (46.4) | 17 (37.0) |
Quality of life | ||||
SF12 Physical health (0–100) | 38.2 (8.4) | 39.0 (8.4) | 37.9 (8.7) | 37.4 (7.8) |
SF12 Mental health (0–100)* | 49.2 (10.1) | 46.9 (11.1)* | 51.2 (8.9)* | 49.5 (9.9) |
EQ-5D Utility score (0–1) | 0.7 (0.2) | 0.7 (0.3) | 0.7 (0.2) | 0.7 (0.2) |
Activity level | ||||
SQUASH | 7716.7 (5270.0) | 6761.3 (4525.5) | 8755.3 (5747.8) | 7612.6 (5398.8) |
Self-reported interventions for PHP in the 3 months prior to inclusion | ||||
Visit to GP, No (%) | 165 (89.2) | 60 (85.7) | 62 (89.9) | 43 (93.5) |
Visit to physiotherapist, No (%) | 15 (8.1) | 6 (8.6) | 5 (7.2) | 4 (8.7) |
Use of pain medication, No (%) | 73 (39.5) | 30 (42.9) | 25 (36.2) | 18 (39.1) |
Exercises, No (%) | 73 (39.5) | 26 (37.1) | 29 (42.0) | 18 (39.1) |
Shockwave, No (%) | 2 (1.1) | 2 (2.9) | – | – |
Dry Needling, No (%) | 1 (0.5) | – | 1 (1.4) | – |
Massage/ manipulation, No (%) | 4 (2.2) | 1 (1.4) | 3 (4.3) | – |
Custom insoles, No (%) | 1 (0.5) | 1 (1.4) | – | – |
Prefabricated orthotic, No (%) | 67 (36.2) | 29 (41.4) | 25 (36.2) | 13 (28.3) |
Shoe advice, No (%) | 14 (7.6) | 4 (5.7) | 8 (11.6) | 2 (4.3) |
Corticosteroid injection, No (%) | 3 (1.6) | – | 2 (2.9) | 1 (2.2) |
*There was a mean difference of 4.28 (95% CI 0.18 to 8.38) on the mental health component of the SF12 between the sham insole group and the custom-made insole group, in favour of sham insole.
BMI, body mass index; DN4, Douleur Neuropathique 4; EQ-5D, EuroQol five dimension scale; FFI, Foot Function Index (total score and pain and disability subscales); FPDI, (Manchester) Foot Pain and Disability Index (function subscale); mo, months; No, number of participants; SF12, The 12-Item Short Form Health Survey; SQUASH, Short Questionnaire to Assess Health-enhancing Physical Activity; VAS, Visual Analogue Scale; y, years.