Table 1

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

Authors(s)/countryReference no.Study aimMethod/deviceNumber of patients with
HV
Age (mean±SD)OrthosisOrthosis material/wearing durationResult
Chadchavalpa nichaya et al 2018/Thailand36To investigate the effect of custom-moulded RTV silicone toe separator to reduce HVA.Randomised controlled trial/ radiographic measurement and clinical assessment45HV group: 60.3±9.4 Control group: 60.8±10.8Custom-moulded RTV toe separatorSilicone/12 monthsBoth 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/USA37To 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 System25Mean: 57Full-length orthosisNot Reported/immediateNo 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/Iran22To investigate the effect of orthosis with medial arch support on plantar pressure distribution.Quasi-experimental/Pedar-X in-shoe system1626.1±5.7Prefabricated arch support foot orthosis5 mm thick polypropylene/1 monthThe use of the foot orthosis leads to a decrease in peak pressure and maximum force.
Moulodi et al 2019/Iran38To compare the HVA, ROM, FAOS, pain and function in daily activities after the use of orthosis.Randomised controlled trial/clinical assessment2422.79±1.44Static orthosis with toe separatorA bar and a single strap/1 monthBoth orthoses can reduce HVA up to 3°; significant difference in ROM by using dynamic orthosis.
Dynamic orthosisFirm plastic, straps & a free joint/ 1 month
Plaass et al 2020/Germany39To analyse the effect of a dynamic orthosis on IMA and HVA.Randomised controlled trial/radiographic measurement and clinical assessment36HV group: 53.2±14.0
Control group: 48.5±12.9
Dynamic orthosisNot Reported/3 monthsDynamic orthosis can provide pain relief in patients but showed no effect on HVA.
Reina et al 2013/ Spain40To determine if the use of custom-made foot orthotics prevents the advancement of IMA and HVA.Randomised controlled trial/radiographic measurement23HV group: 30.31±9.27
Control group: 30.94±14.06
Custom-made foot orthoses3 mm thick polypropylene sheet and 3 mm thick polyethylene foam sheet/12 monthsCustom-made orthoses appear to have no effect.
Tang et al 2002/Taiwan43To assess the effects of a new foot–toe orthosis on HVA.Uncontrolled intervention study/radiographic measurement and clinical assessment1742.59±16.52Total contact orthosis with toe separatorPlastazote poron, microcell pull, plastazote and mineral oil-based polymer gel toe separator/3 monthsThe new total contact orthosis with fixed toe separator reduces HVA.
Tehraninasr et al 2008/Iran41To compare the effects of wearing an orthosis with toe separator and night-time orthosis on IMA, HVA and foot pain.Randomised controlled trial/radiographic measurement3027±8.91Orthosis with toe separatorPolyfoam, polyethylene, plastazote toe separator/3 monthsIMA and HVA are reduced in both groups; however, the reduction is not significant; the orthosis with toe separator significantly reduces the pain intensity.
Nighttime orthosisPolyfoam and a rigid polyethylene bar/3 months
Torkki et al 2003/Finland42To compare the effectiveness of surgical and orthotic treatment with patients on VAS.Randomised controlled trial/Not Reported69HV group: 49±10
Control group: 47±9
Not ReportedNot Reported/12 monthsOrthoses 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.