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.