Skip to main content

Table 2 Characteristics of included studies and overview of FOs characteristics

From: Systematic review on the comparative effectiveness of foot orthoses in patients with rheumatoid arthritis

Author (year) Study design Participant description Intervention Time Outcome
Region of interest - forefoot
Chalmers et al. 2000 [31] randomized controlled clinical trial with a repeated measures design number
 - n = 28
setting
 - occupational therapy department of hospital
diagnoses
 - definitive diagnosis of RA
age (years)
 - women: 60 (10)
 - men: 63 (2)
mean (SD)
clinical characteristics
 - subluxed MTP joints
 - bilaterally MTP joint pain
Custom-made, semi-rigid (total-contact) FOs
 - based on casts taken in a non-weight bearing position
 - constructed of semi-rigid material
 - addition of forefoot cushioning, and forefoot and hindfoot nickleplast posts
target of treatment
 - support, stabilisation or correction of foot structures
 - cushioning (forefoot)
12 weeks for each intervention, separated by 2 week washouts foot pain
 - VAS pain
(primary outcome)
physical functioning
 - 50 ft walking time, s*
 - RB*
 - TADL
patient satisfaction
 - VAS treatment effectiveness
 - Nomination of the FOs of preference
Custom-made, soft (impression) FOs
 - based on an impression in preheated plastazote during weight-bearing
 - constructed of soft materials
 - addition of metatarsal lifts
target of treatment
 - support, stabilisation or correction of foot structures
 - cushioning (full length)
Control intervention
 - shoe-only
Chang et al. 2011 [35] controlled clinical trial with a repeated measures design (single session) number
 - n = 19
setting
 - podiatric outpatient clinic of a hospital
diagnoses
 - definitive diagnosis of RA
age (years)
 - 58.6 (10.1)
mean (range)
clinical characteristics
 - forefoot pain
 - toe-deformities and/or hallux valgus
Custom-made, semi-rigid (total-contact) FOs
 - based on a foot impression (made in a foot impression box) while holding the subtalar joint at a neutral position
 - constructed of semi-rigid materials (cork)
 - addition of metatarsal support (cork) and cushioning material (full-length)
target of treatment
 - support, stabilisation or correction of foot structures
 - cushioning, full length
 - forefoot plantar pressure reduction
1 month foot function
 - In-shoe plantar foot pressure (peak pressure, pressure-time integral, mean force contact area)
(primary outcome)
foot pain
 - VAS pain
patient satisfaction
 - Nomination of the FOs of preference
Custom-made, soft (impression) FOs
 - based on impression in plastazote during weight-bearing (ADL 2–3 weeks)
 - constructed of soft materials
 - addition of metatarsal pad and arch support of EVA
target of treatment
 - support, stabilisation or correction of foot structures
 - cushioning, full length
 - forefoot plantar pressure reduction
Control intervention
 - 7-mm flat EVA (40 Shore A hardness) FOs
Gibson et al. 2014 [11] controlled clinical trial with a repeated measures design (single session) number
 - n = 16
setting
 - early arthritis clinic of a hospital
diagnoses
 - definitive diagnosis of RA, > 2 years previously
age (years)
 - 50.7 (8.4)
  mean (range)
clinical characteristics
 - acquired and passively correctable pes plano valgus
 - with or without forefoot pain at MTP joints
 - orthotic naive
Custom-made, semi-rigid (total-contact) FOs
 - based on a plaster cast model of the foot using the subtalar joint neutral technique.
 - constructed of semi-rigid material (polypropylene)
 - optional adaptations (external rearfoot wedge control, arch height, forefoot cushioning) based on an algorithm of design rules.
target of treatment
 - support, stabilisation or correction of foot structures
 - cushioning (forefoot)
 - forefoot plantar pressure reduction
7 days per intervention (without washout- periods) foot function
 - Gait characteristics (rearfoot eversion, ankle internal moment, forefoot dorsiflexion, navicular height)
(primary outcome)
 - In-shoe plantar foot pressure (forefoot peak pressure, midfoot contact area pressure-time integral, mean force contact area) (primary outcome)
patient satisfaction
 - Likert scale (orthotic device comfort, orthotic device fit, self-reported efficacy, symptoms, activity levels)
  adverse events
 - minor and major
Custom-made, rigid (total-contact) FOs; CAD design using selective laser sintering
 - the CAD design is based on a digitized plaster cast model of the foot using the subtalar joint neutral technique and an algorithm of design rules
 - manufactured using selective laser sintering using nylon-12 powder
target of treatment
 - support, stabilisation or correction of foot structures
 - forefoot plantar pressure reduction
Custom-made, semi-rigid (total-contact) FOs; CAD design using fused-deposition method
 - the CAD design is based on a digitized plaster cast model of the foot using the subtalar joint neutral technique and an algorithm of design rules
 - manufactured using fused-deposition method using polylactide
target of treatment
 - support, stabilisation or correction of foot structures
 - forefoot plantar pressure reduction
Control intervention
 - shoe-only
Hodge et al. 1999 [36] controlled clinical trial with a repeated measures design (single session) number
 - n = 11
setting
 - University faculty of Health Science
diagnoses
 - history of RA
age (years)
 - 65 (49–82)
mean (range)
clinical characteristics
 - forefoot pain on shod weightbearing
Custom-made, semi-rigid (total-contact) FOs
 - based on the semi-weight bearing technique described by McPoil et al. (1989) using a latex rubber foot moulding board during moulding the EVA-material directly to the foot.
 - constructed of soft density, semi-rigid EVA
 - half-length FOs
target of treatment
 - support, stabilisation or correction of foot structures
 - forefoot plantar pressure reduction
foot function
 - In-shoe plantar foot pressure (peak pressure, pressure-time integral, average pressure, time in mask)
(primary outcome)
 - Gait characteristics (cadence)
foot pain
 - VAS pain during standing
 - VAS pain during walking
patient satisfaction
 - Nomination of the FOs of preference
Custom-made, semi-rigid (total-contact) FOs with additional metatarsal bars
 - based on the semi-weight bearing technique described by McPoil et al. (1989) using a latex rubber foot moulding board during moulding the EVA-material directly to the foot.
 - constructed of soft density, semi-rigid EVA
 - addition of metatarsal bar (latex rubber, boomerang shape)
 - half-length FOs
target of treatment
 - support, stabilisation or correction of foot structures
 - forefoot plantar pressure reduction
Custom-made, semi-rigid (total-contact) FOs with additional metatarsal domes
 - based on the semi-weight bearing technique described by McPoil et al. (1989) using a latex rubber foot moulding board during moulding the EVA-material directly to the foot.
 - constructed of soft density, semi-rigid EVA
 - addition of metatarsal dome (latex rubber, teardrop shape)
 - half-length FOs
target of treatment
 - support, stabilisation or correction of foot structures
 - forefoot plantar pressure reduction
Ready-made, soft FOs
 - contoured soft density EVA FOs
 - half-length FOs
target of treatment
 - support, stabilisation or correction of foot structures
 - forefoot plantar pressure reduction
Control intervention
 - shoe-only
Jackson et al. 2004 [32] randomized controlled trial with a repeated measures design (single session) number
 - n = 10
setting
 - podiatry centre
diagnoses
 - definitive diagnosis of RA
age (years)
61 (32–79)
mean (range)
clinical characteristics
 - forefoot pain on shod weightbearing
Ready-made, soft FOs with additional metatarsal bars
 - manufactured of expanded urethane foam with a hardness of 25 Shore A
 - addition of metatarsal square bar (latex foam, 29 Shore A)
 - full-length, contoured FOs
target of treatment
 - support, stabilisation or correction of foot structures
 - forefoot plantar pressure reduction
foot function
 - In-shoe plantar forefoot pressure (peak pressure, pressure-time integral, stance time, contact area)
(primary outcome)
 - Gait characteristics (cadence)
patient satisfaction
 - Nomination of the FOs of preference
Ready-made, soft FOs with additional metatarsal domes
 - manufactured of expanded urethane foam with a hardness of 25 Shore A
 - addition of metatarsal dome (latex foam, 29 Shore A)
 - full-length, contoured FOs
target of treatment
 - support, stabilisation or correction of foot structures
 - forefoot plantar pressure reduction
Control intervention
 - shoe-only
Tenten-Diepenmaat et al. 2016 [39] quasi-experimental clinical trial with a repeated measures design (single session) number
 - n = 45
setting
 - outpatient centre for rehabilitation and rheumatology
Diagnoses
 - definitive diagnosis of RA
age (years)
53 (13.5)
mean (range)
clinical characteristics
 - RA related foot
 - indication for treatment with FOs
Custom-made, semi-rigid (total-contact) FOs
 - constructed of prefabricated orthotic devices, custom-moulded to the patient’s foot while using the functional suspension subtalar joint neutral position technique.
 - optional addition of varus-, valgus corrections, metatarsal bars, metatarsal domes, and/or cushioning material
target of treatment
 - support, stabilisation or correction of foot structures
 - forefoot plantar pressure reduction
foot function
 - In-shoe plantar forefoot pressure (peak pressure, pressure-time integral)
(primary outcome)
Custom-made, semi-rigid (total-contact) FOs, with adaptations using the feedback of in-shoe plantar pressure measurements
 - custom-made, semi-rigid, total-contact FOs were adapted based on the feedback of in-shoe plantar pressure measurements
 - optional change or addition of
  varus-, valgus corrections, metatarsal bars, metatarsal domes, and/or cushioning material
target of treatment
 - support, stabilisation or correction of foot structures
- forefoot plantar pressure reduction
Region of interest - hindfoot
Gatt et al. 2016 [37] controlled cross-over trial number
 - n = 10
setting
 - rheumatology outpatient clinic at a general hospital
diagnoses
 - definitive diagnosis of RA
age (years)
 - 52.2 (9.1)
mean (SD)
clinical characteristics
 - subtalar and/or ankle joint pain ≥6 months
 - need of orthoses for biomechanical mal-alignment of the feet as per clinical practice
Custom-made, semi-rigid (total-contact) FOs
 - based on a cast (the positive casts were modified as outlined by Philips et al.)
 - constructed of semi-rigid material (subortolene)
target of treatment
 - support, stabilisation or correction of foot structures
3 months per intervention, with a 2 week washout period in between foot pain
 - FFI pain
 - RAI
physical functioning
 - FFI disability
 - FFI limitation
Custom-made, soft (total-contact) FOs
 - based on a cast (the positive casts were modified as outlined by Philips et al.)
 - constructed of low density EVA
target of treatment
 - support, stabilisation or correction of foot structures
Region of interest - non-specified
Cho et al. 2008 [33] randomized controlled trial number
 - n = 42
  (22 intervention-group, 20 control-group)
Setting
 - university hospital
Diagnoses
 - definitive diagnosis of RA
age (years)
 - 48.7 (11.7)
mean (SD)
clinical characteristics
 - stable disease activity
 - foot pathology (forefoot or hindfoot)
Custom-made, semi-rigid FOs
 - consisting of a medial longitudinal arch support, medial heel post and metatarsal pad.
target of treatment
 - support, stabilisation or correction of foot structures
6 months foot pain
 - VAS pain
(primary outcome)
Ready-made, soft FOs
 - simple FOs
 - 6 mm plastazote
target of treatment
 - cushioning, full length
Pallari et al. 2010 [38] quasi-experimental clinical trial with a repeated measures design (single session) number
 - n = 7
setting
 - rheumatology outpatient clinic of a hospital
Diagnoses
 - definitive diagnosis of RA
age (years)
53.4 (29–68)
mean (range)
clinical characteristics
 - current history of foot impairments
Custom-made, semi-rigid (total-contact) FOs
 - based on casts
 - mainly constructed of semi-rigid material
 - optional addition of cushioning material
target of treatment
 - support, stabilisation or correction of foot structures
foot function
 - Gait characteristics (velocity, cadence, cycle-time, stride length)
(primary outcome)
patient satisfaction
 - VAS orthotic comfort
 - VAS orthotic fit
Custom-made, semi-rigid (total-contact) FOs; CAD design using selective laser sintering
 - the CAD design is based on a weight or nonweight-bearing scan of the foot (in a subtalar joint neutral alignment) and on design rules
 - manufactured using selective laser sintering using nylon-12 powder
target of treatment
 - support, stabilisation or correction of foot structures
Rome et al. 2017 [34] randomized controlled trial number
 - n = 47
setting
 - rheumatology outpatient department
Diagnoses
 - definitive diagnosis of RA
age (years)
65 (49–82)
mean (range)
clinical characteristics
 - history of foot pain
Custom-made, semi-rigid (total-contact) FOs
 - based on a cast taken of a neutral suspension plaster
 - constructed of semi-rigid material (50 Shore A)
 - optional addition of external medial posting correction
 - addition of cushioning material (full-length)
target of treatment
 - support, stabilisation or correction of foot structures
 - cushioning
16 weeks foot pain
 - FFI foot pain
physical functioning
 - FFI disability
 - FFI functional limitation
Costs of FOs
 - EQ 5D utility index (QUALYs)
 - mean cost of resource use
Custom-made, soft FOs
 - constructed of a 6-mm breathable foam on a rubber-silicone-ethylene compound.
 - full-length FOs
target of treatment
 - support, stabilisation or correction of foot structures
 - cushioning
  1. VAS visual analogue scale, RB Robinson Bashall Functional Assessment, TADL Toronto Activities of Daily Living Measure, FFI foot function index, NRS numeric rating scale, EVA Etylene Vinyl Acetate, RAI Ritchie Articular Index, QUALYs quality-adjusted life years, * performance based