Table 1.

Selected characteristics of studies included in analysis (nine unique studies)

Authors(s)/country	Reference no.	Study aim	Method/device	Number of patients with HV	Age (mean±SD)	Orthosis	Orthosis material/wearing duration	Result
Chadchavalpa nichaya et al 2018/Thailand	36	To investigate the effect of custom-moulded RTV silicone toe separator to reduce HVA.	Randomised controlled trial/ radiographic measurement and clinical assessment	45	HV group: 60.3±9.4 Control group: 60.8±10.8	Custom-moulded RTV toe separator	Silicone/12 months	Both groups have significant differences in mean HVA with a decrease of 3.3°±2.4° for the study group and increase of 1.9°±1.9° for the control group. Hallux pain of study group is reduced.
Doty et al 2015/USA	37	To compare the plantar pressure distribution in standard footwear and in the same footwear with orthoses of three different lengths.	Randomised controlled trial/Tactilus Free Form Sensor System	25	Mean: 57	Full-length orthosis	Not Reported/immediate	No significant changes in medial pressure with the addition of any orthosis compared with standard footwear alone.
						Sulcus-length orthosis
						3/4-length orthosis
Farzadi et al 2015/Iran	22	To investigate the effect of orthosis with medial arch support on plantar pressure distribution.	Quasi-experimental/Pedar-X in-shoe system	16	26.1±5.7	Prefabricated arch support foot orthosis	5 mm thick polypropylene/1 month	The use of the foot orthosis leads to a decrease in peak pressure and maximum force.
Moulodi et al 2019/Iran	38	To compare the HVA, ROM, FAOS, pain and function in daily activities after the use of orthosis.	Randomised controlled trial/clinical assessment	24	22.79±1.44	Static orthosis with toe separator	A bar and a single strap/1 month	Both orthoses can reduce HVA up to 3°; significant difference in ROM by using dynamic orthosis.
						Dynamic orthosis	Firm plastic, straps & a free joint/ 1 month
Plaass et al 2020/Germany	39	To analyse the effect of a dynamic orthosis on IMA and HVA.	Randomised controlled trial/radiographic measurement and clinical assessment	36	HV group: 53.2±14.0 Control group: 48.5±12.9	Dynamic orthosis	Not Reported/3 months	Dynamic orthosis can provide pain relief in patients but showed no effect on HVA.
Reina et al 2013/ Spain	40	To determine if the use of custom-made foot orthotics prevents the advancement of IMA and HVA.	Randomised controlled trial/radiographic measurement	23	HV group: 30.31±9.27 Control group: 30.94±14.06	Custom-made foot orthoses	3 mm thick polypropylene sheet and 3 mm thick polyethylene foam sheet/12 months	Custom-made orthoses appear to have no effect.
Tang et al 2002/Taiwan	43	To assess the effects of a new foot–toe orthosis on HVA.	Uncontrolled intervention study/radiographic measurement and clinical assessment	17	42.59±16.52	Total contact orthosis with toe separator	Plastazote poron, microcell pull, plastazote and mineral oil-based polymer gel toe separator/3 months	The new total contact orthosis with fixed toe separator reduces HVA.
Tehraninasr et al 2008/Iran	41	To compare the effects of wearing an orthosis with toe separator and night-time orthosis on IMA, HVA and foot pain.	Randomised controlled trial/radiographic measurement	30	27±8.91	Orthosis with toe separator	Polyfoam, polyethylene, plastazote toe separator/3 months	IMA and HVA are reduced in both groups; however, the reduction is not significant; the orthosis with toe separator significantly reduces the pain intensity.
						Nighttime orthosis	Polyfoam and a rigid polyethylene bar/3 months
Torkki et al 2003/Finland	42	To compare the effectiveness of surgical and orthotic treatment with patients on VAS.	Randomised controlled trial/Not Reported	69	HV group: 49±10 Control group: 47±9	Not Reported	Not Reported/12 months	Orthoses provide short-term symptomatic relief.

FAOS, Foot and Ankle Outcome Score; HV, hallux valgus; HVA, hallux valgus angle; IMA, intermetatarsal angle; ROM, range of motion; RTV, room temperature vulcanising; VAS, Visual Analogue Scale.