. 2023 Apr 24;43(8):1409–1422. doi: 10.1007/s00296-023-05324-3

Table 1.

Characteristics of included trials with a control group*

Author, year [ref]	Trial design	Country, Population	Groups	Sample size	Age, years (mean ± SD)	Sex, female, n (%)	BMI, kg/m² (mean ± SD)	Unilateral/ bilateral presentation (n/%)	Outcomes measures reported in both groups	Timepoints
Halstead et al. 2016 [20]	Two-arm parallel group, randomised controlled feasibility trial	UK, adults aged ≥ 18 years with radiographically confirmed midfoot OA and symptoms of the dorsal and medial regions of the midfoot	Intervention group (prefabricated arch contouring FOs)	19	60.5 ± 10.4	15 (78.9)	31.2 ± 4.5	Right foot (11/57.9)	Pain measured using NRS (0 to 10) while walking in the last week Function measured using MFPDI function subscale	Baseline, 12 weeks (short term)
Control group (sham FOs)	18	56.2 ± 12.6	11 (61.1)	27.7 ± 3.9	Right foot (9/50.0)

Author, year [ref]

Trial design

Country, Population

Groups

Sample size

Age, years
(mean ± SD)

Sex, female, n (%)

BMI, kg/m² (mean ± SD)

Unilateral/ bilateral presentation (n/%)

Outcomes measures reported in both groups

Timepoints

Halstead et al. 2016 [20]

Two-arm parallel group, randomised controlled feasibility trial

UK, adults aged ≥ 18 years with radiographically confirmed midfoot OA and symptoms of the dorsal and medial regions of the midfoot

Intervention group (prefabricated arch contouring FOs)

60.5 ± 10.4

15 (78.9)

31.2 ± 4.5

Right foot (11/57.9)

Pain measured using NRS (0 to 10) while walking in the last week

Function measured using MFPDI function subscale

Baseline, 12 weeks (short term)

Control group (sham FOs)

56.2 ± 12.6

11 (61.1)

27.7 ± 3.9

Right foot (9/50.0)

*SD standard deviation, BMI body mass index, FOs foot orthoses, NRS numerical rating scale, MFPDI Manchester foot pain and disability index