Original article
Foot orthoses in children with juvenile idiopathic arthritis: a randomised controlled trial Andrea Coda,1 Peter W Fowlie,2 Joyce E Davidson,3 Jo Walsh,4 Tom Carline,5 Derek Santos5 1
Department of Podiatry, The University of Newcastle, New South Wales, Australia 2 Ninewells Hospital and Medical School, Dundee, UK 3 Royal Hospital for Sick Children, Edinburgh, UK 4 Royal Hospital for Sick Children (Yorkhill), Glasgow, UK 5 Department of Podiatry, Queen Margaret University, Edinburgh, UK Correspondence to Dr Andrea Coda, Podiatry Lecturer, Health Precinct Building, BE154, PO Box 127, School of Health Science, Faculty of Health Medicine, University of Newcastle, Ourimbah, NSW, 2258, Australia; [email protected]. au Received 31 August 2013 Accepted 18 February 2014 Published Online First 17 March 2014
ABSTRACT Introduction There is limited evidence supporting the podiatric treatment of children with juvenile idiopathic arthritis ( JIA). This multicentre randomised controlled trial aimed to determine whether preformed foot orthoses (FOs) impacted on pain and quality of life (QoL) in children with JIA. Methods Eligible children were randomised to receive either ‘fitted’ FOs with customised chair-side corrections or ‘control’ FOs made without corrections. Changes in pain and QoL were measured using a visual analogue scale and Paediatric Quality of Life questionnaire, respectively. JIA children were assessed at baseline, 3 months and 6 months. Results 60 children were recruited. 179 out of a possible 180 assessments (99.4%) were completed. A statistically significant greater difference in pain reduction (baseline—6 months) was seen between the two groups favouring fitted FOs ( p=0.029). The reduction in pain in the fitted FOs group was clinically important (8 mm). Significant differences in QoL favouring fitted FOs were also identified as measured by the children and independently by their parents/carers. Conclusions Fitted FOs may reduce pain and improve QoL in selected children with JIA. Trial registration number NCT02001844.
What is already known on this topic Foot orthoses appear to be effective for children with lower limb pathologies. Currently, there is limited evidence supporting the podiatric treatment of children with juvenile idiopathic arthritis.
What this study adds This research adds new evidence on the effectiveness of foot orthoses in treating lower limb issues with juvenile idiopathic arthritis children.
Hypothesis The study aimed to test the hypothesis that in children with JIA, fitted FOs are more effective at reducing pain and improving quality of life than control orthoses.
METHODS INTRODUCTION
To cite: Coda A, Fowlie PW, Davidson JE, et al. Arch Dis Child 2014;99:649–651.
Juvenile idiopathic arthritis ( JIA) is the most common chronic rheumatic disease in childhood and adolescence and may generate short-term and long-term disability.1 Gait analysis in children with JIA has shown significant difference compared with healthy children with regard to kinematics and temporal data.2 Children with arthritis have been shown to be physically less active compared with healthy children.3 In children, foot orthoses (FOs) have been found to improve parameters of gait although little research has been carried out on participants specifically with JIA.4 The use of preformed semirigid FOs may represent a cheaper option than plaster of Paris (POP) casted FOs. Previous studies with JIA reported that POP custom-made FOs were very expensive and that it took between 1 and 2 months before the fitting appointment.5 In contrast, preformed FOs can be supplied to children on the same day as the initial biomechanical assessment. Current good clinic practice in JIA management supports early active intervention in an attempt to minimise long-term deformities.6 If of proven benefit, early provision of FOs would be in line with this approach.
Coda A, et al. Arch Dis Child 2014;99:649–651. doi:10.1136/archdischild-2013-305166
This was a multicentre single-blinded randomised controlled trial (RCT). Ethical approval was obtained from Queen Margaret University, NHS Lothian and NHS Tayside (REC ref no: 09/S1101/ 21). Children were eligible if they met defined criteria (box 1). The participants were recruited from the Paediatric Rheumatology Department of the Royal Hospital for Sick Children, Edinburgh, and from the Paediatric Rheumatology Clinic in Ninewells Hospital, Dundee, in 2011 and 2012. After obtaining informed consent, children were randomised in blocks of 10 each by an online computer random number generator (http://www.randomization.com) to wear fitted FOs or control FOs. Slimflex-Plus (Slimflex-Plus: Algeos (UK), Sheridan House, Bridge Industrial Estate, Speke Hall Road, Liverpool, L24 9HB, UK) FOs were adopted as the intervention ‘fitted’ FOs. The control FOs was made with leather board (1 mm) without corrections. Both FOs had the same black-ethylene vinyl acetate (EVA) top-cover (0.75 mm) to allow for blinding and monitoring the level of adherence to wearing the FOs. The same chief researcher made the fitted FOs at the time of enrolment into the trial. Patients were advised to wear their FOs 649
Original article
Box 1 Trial inclusion and exclusion criteria
Table 1
Juvenile idiopathic arthritis ( JIA) children characteristics
Baseline characteristics
Inclusion criteria ▸ Diagnosed with juvenile idiopathic arthritis (any subtype) according to International League of Associations for Rheumatology criteria ▸ Lower extremity joint involvement with disease onset ranging from 5 to 18 years ▸ Previous failure of orthotic management in which the patient has not worn any foot orthoses (FOs) for a period of at least 3 months ▸ Ability to walk a minimum of 15 m or more without assistive devices ▸ At least 6 months after start of disease modifying antirheumatic drug therapy Exclusion criteria ▸ Inability to walk barefoot or shod ▸ Concomitant musculoskeletal disease, central or peripheral nerve disease and endocrine disorders ▸ Previous foot surgery ▸ Currently using FOs ▸ Where supply of FOs is contraindicated
Male (%) Female (%) Age (years) at baseline—mean (SD) Height (cm) at baseline- mean (SD) Weight (kg) at baseline—mean (SD) CHAQ at baseline (p=0.247)—median (IQR) DMARDs at baseline (p=0.935) Steroids injection at baseline (p=0.648) JIA subtype Systemic onset Oligoarthritis Rheumatoid factor negative polyarthritis Rheumatoid factor positive polyarthritis Enthesitis related arthritis Psoriatic arthritis Undifferentiated arthritis
Control foot orthoses (FOs)
Fitted FOs
n=6 (20.7%) n=23 (79.3%) 11.17 (SD 3.51) 142.07 (17.94) 38.97 (18.04) 0.125 (1.31) n=19 (66%) n=23 (79%)
n=9 (29%) n=22 (71%) 10.64 (SD 3.84) 140.39 (22.17) 42.07 (23.41) 0.375 (0.625) n=20 (65%) n=26 (84%)
n=2 (6.9%) n=13 (44.8%) n=9 (31%) n=2 (6.9%) n=1 (3.5%) n=0 n=2 (6.9%)
n=2 (6.5%) n=20 (64.5%) n=6 (19.3%) n=1 (3.2%) n=2 (6.5%) n=0 n=0
CHAQ, Child Health Assessment Questionnaire; DMARDS, disease-modifying anti rheumatic drug.
RESULTS gradually for the first few days and then to use them in all footwear at all times including during exercise. The primary outcome was pain reduction as measured by a visual analogue scale (VAS). The VAS for pain is a horizontal line, 100 mm in length. The parents/carers of the participating children were asked to mark on the line the point representative of the current pain level experienced by their children.7 A clinically important change in pain is said to have occurred if there is more than 8 mm difference in recorded VAS between different intervals.8 Change in quality of life as measured by questionnaire was also considered using Paediatric Quality of Life questionnaire (PedsQL), a validated tool for use in children with arthritis and their parents/carers. The children and their parents/ carers completed questionnaires independently. Scores closer to 100 reflect a better quality of life. A clinically important change in quality of life is said to have occurred if the PedsQL changes by more than 5 points between different intervals.9 Outcomes were assessed at baseline, 3 months and 6 months. For a 5% two-sided t test with α=0.05 and power 80% for a RCT design with baseline and two postintervention observations, and a moderate effect size, it was estimated that a total of 46 JIA children would be required (23 controls and 23 trial).10 11 The study was overpowered to an estimated 30 participants per group to allow for potential dropouts during the 6-month data collection period. Given uncertainty around the potential for recruiting to the trial, block randomisation was used to limit the risk of biased allocation in light of either poor recruitment or the study finishing early.
Data analysis Statistical differences between the control and trial groups were compared at three time points (baseline, 3 and 6 months). All data showed a non-parametric distribution and hence a Mann– Whitney U test was used for the pairwise comparisons. χ2 Test was undertaken only for nominal drugs data. 650
Funding allowed recruitment to take place over 1 year. In all, 60 children were recruited in that time: 31 were randomised into the fitted FOs group and 29 into the control FOs group. At baseline, there was no statistical difference between the two groups (table 1). Overall, 179 out of a possible 180 assessments were completed (99.4%) and accounted for statistical analysis. A statistically significant greater difference in pain reduction between control FOs and fitted FOs favouring the fitted FOs group was achieved between all three intervals. A clinically important reduction in pain was seen between baseline and 6 months in the fitted FOs group of children (tables 2 and 3). A statistically significant greater improvement in quality of
Table 2 Comparison of the change in scores for pain and QoL between the two groups Control FOs median (IQR) Pain VAS score Baseline 6.5 (50.5) Baseline—3 months 0.0 (0.5) 3 months—6 months 0.0 (5) Baseline—6 months 0.0 (0.25) PedsQL paediatric rheumatology score Baseline 78.63 (18.65) Baseline—3 months 0.00 (0.50) 3 months—6 months 0.18 (12.77) Baseline—6 months 1.50 (7.92) PedsQL parent rheumatology score Baseline 78.04 (40.57) Baseline—3 months 2.08 (13.98) 3 months—6 months 0.00 (7.52) Baseline—6 months 1.48 (16.47)
Fitted FOs median (IQR)
p Value
14.0 5.0 1.0 8.0
(31.0) (8.0) (6.0) (19.0)
p=0.221 p=0.030* p=0.002** p=0.029*
72.60 5.00 2.86 9.05
(29.45) (8.00) (11.56) (24.62)
p=0.101 p=0.001** p=0.167 p=0.001**
62.52 7.60 1.51 11.37
(33.89) (17.74) (9.57) (14.50)
p=0.371 p=0.124 p=0.137 p=0.020*
Mann–Whitney U test was used for all comparisons. *means p
Foot orthoses in children with juvenile idiopathic arthritis: a randomised controlled trial Andrea Coda,1 Peter W Fowlie,2 Joyce E Davidson,3 Jo Walsh,4 Tom Carline,5 Derek Santos5 1
Department of Podiatry, The University of Newcastle, New South Wales, Australia 2 Ninewells Hospital and Medical School, Dundee, UK 3 Royal Hospital for Sick Children, Edinburgh, UK 4 Royal Hospital for Sick Children (Yorkhill), Glasgow, UK 5 Department of Podiatry, Queen Margaret University, Edinburgh, UK Correspondence to Dr Andrea Coda, Podiatry Lecturer, Health Precinct Building, BE154, PO Box 127, School of Health Science, Faculty of Health Medicine, University of Newcastle, Ourimbah, NSW, 2258, Australia; [email protected]. au Received 31 August 2013 Accepted 18 February 2014 Published Online First 17 March 2014
ABSTRACT Introduction There is limited evidence supporting the podiatric treatment of children with juvenile idiopathic arthritis ( JIA). This multicentre randomised controlled trial aimed to determine whether preformed foot orthoses (FOs) impacted on pain and quality of life (QoL) in children with JIA. Methods Eligible children were randomised to receive either ‘fitted’ FOs with customised chair-side corrections or ‘control’ FOs made without corrections. Changes in pain and QoL were measured using a visual analogue scale and Paediatric Quality of Life questionnaire, respectively. JIA children were assessed at baseline, 3 months and 6 months. Results 60 children were recruited. 179 out of a possible 180 assessments (99.4%) were completed. A statistically significant greater difference in pain reduction (baseline—6 months) was seen between the two groups favouring fitted FOs ( p=0.029). The reduction in pain in the fitted FOs group was clinically important (8 mm). Significant differences in QoL favouring fitted FOs were also identified as measured by the children and independently by their parents/carers. Conclusions Fitted FOs may reduce pain and improve QoL in selected children with JIA. Trial registration number NCT02001844.
What is already known on this topic Foot orthoses appear to be effective for children with lower limb pathologies. Currently, there is limited evidence supporting the podiatric treatment of children with juvenile idiopathic arthritis.
What this study adds This research adds new evidence on the effectiveness of foot orthoses in treating lower limb issues with juvenile idiopathic arthritis children.
Hypothesis The study aimed to test the hypothesis that in children with JIA, fitted FOs are more effective at reducing pain and improving quality of life than control orthoses.
METHODS INTRODUCTION
To cite: Coda A, Fowlie PW, Davidson JE, et al. Arch Dis Child 2014;99:649–651.
Juvenile idiopathic arthritis ( JIA) is the most common chronic rheumatic disease in childhood and adolescence and may generate short-term and long-term disability.1 Gait analysis in children with JIA has shown significant difference compared with healthy children with regard to kinematics and temporal data.2 Children with arthritis have been shown to be physically less active compared with healthy children.3 In children, foot orthoses (FOs) have been found to improve parameters of gait although little research has been carried out on participants specifically with JIA.4 The use of preformed semirigid FOs may represent a cheaper option than plaster of Paris (POP) casted FOs. Previous studies with JIA reported that POP custom-made FOs were very expensive and that it took between 1 and 2 months before the fitting appointment.5 In contrast, preformed FOs can be supplied to children on the same day as the initial biomechanical assessment. Current good clinic practice in JIA management supports early active intervention in an attempt to minimise long-term deformities.6 If of proven benefit, early provision of FOs would be in line with this approach.
Coda A, et al. Arch Dis Child 2014;99:649–651. doi:10.1136/archdischild-2013-305166
This was a multicentre single-blinded randomised controlled trial (RCT). Ethical approval was obtained from Queen Margaret University, NHS Lothian and NHS Tayside (REC ref no: 09/S1101/ 21). Children were eligible if they met defined criteria (box 1). The participants were recruited from the Paediatric Rheumatology Department of the Royal Hospital for Sick Children, Edinburgh, and from the Paediatric Rheumatology Clinic in Ninewells Hospital, Dundee, in 2011 and 2012. After obtaining informed consent, children were randomised in blocks of 10 each by an online computer random number generator (http://www.randomization.com) to wear fitted FOs or control FOs. Slimflex-Plus (Slimflex-Plus: Algeos (UK), Sheridan House, Bridge Industrial Estate, Speke Hall Road, Liverpool, L24 9HB, UK) FOs were adopted as the intervention ‘fitted’ FOs. The control FOs was made with leather board (1 mm) without corrections. Both FOs had the same black-ethylene vinyl acetate (EVA) top-cover (0.75 mm) to allow for blinding and monitoring the level of adherence to wearing the FOs. The same chief researcher made the fitted FOs at the time of enrolment into the trial. Patients were advised to wear their FOs 649
Original article
Box 1 Trial inclusion and exclusion criteria
Table 1
Juvenile idiopathic arthritis ( JIA) children characteristics
Baseline characteristics
Inclusion criteria ▸ Diagnosed with juvenile idiopathic arthritis (any subtype) according to International League of Associations for Rheumatology criteria ▸ Lower extremity joint involvement with disease onset ranging from 5 to 18 years ▸ Previous failure of orthotic management in which the patient has not worn any foot orthoses (FOs) for a period of at least 3 months ▸ Ability to walk a minimum of 15 m or more without assistive devices ▸ At least 6 months after start of disease modifying antirheumatic drug therapy Exclusion criteria ▸ Inability to walk barefoot or shod ▸ Concomitant musculoskeletal disease, central or peripheral nerve disease and endocrine disorders ▸ Previous foot surgery ▸ Currently using FOs ▸ Where supply of FOs is contraindicated
Male (%) Female (%) Age (years) at baseline—mean (SD) Height (cm) at baseline- mean (SD) Weight (kg) at baseline—mean (SD) CHAQ at baseline (p=0.247)—median (IQR) DMARDs at baseline (p=0.935) Steroids injection at baseline (p=0.648) JIA subtype Systemic onset Oligoarthritis Rheumatoid factor negative polyarthritis Rheumatoid factor positive polyarthritis Enthesitis related arthritis Psoriatic arthritis Undifferentiated arthritis
Control foot orthoses (FOs)
Fitted FOs
n=6 (20.7%) n=23 (79.3%) 11.17 (SD 3.51) 142.07 (17.94) 38.97 (18.04) 0.125 (1.31) n=19 (66%) n=23 (79%)
n=9 (29%) n=22 (71%) 10.64 (SD 3.84) 140.39 (22.17) 42.07 (23.41) 0.375 (0.625) n=20 (65%) n=26 (84%)
n=2 (6.9%) n=13 (44.8%) n=9 (31%) n=2 (6.9%) n=1 (3.5%) n=0 n=2 (6.9%)
n=2 (6.5%) n=20 (64.5%) n=6 (19.3%) n=1 (3.2%) n=2 (6.5%) n=0 n=0
CHAQ, Child Health Assessment Questionnaire; DMARDS, disease-modifying anti rheumatic drug.
RESULTS gradually for the first few days and then to use them in all footwear at all times including during exercise. The primary outcome was pain reduction as measured by a visual analogue scale (VAS). The VAS for pain is a horizontal line, 100 mm in length. The parents/carers of the participating children were asked to mark on the line the point representative of the current pain level experienced by their children.7 A clinically important change in pain is said to have occurred if there is more than 8 mm difference in recorded VAS between different intervals.8 Change in quality of life as measured by questionnaire was also considered using Paediatric Quality of Life questionnaire (PedsQL), a validated tool for use in children with arthritis and their parents/carers. The children and their parents/ carers completed questionnaires independently. Scores closer to 100 reflect a better quality of life. A clinically important change in quality of life is said to have occurred if the PedsQL changes by more than 5 points between different intervals.9 Outcomes were assessed at baseline, 3 months and 6 months. For a 5% two-sided t test with α=0.05 and power 80% for a RCT design with baseline and two postintervention observations, and a moderate effect size, it was estimated that a total of 46 JIA children would be required (23 controls and 23 trial).10 11 The study was overpowered to an estimated 30 participants per group to allow for potential dropouts during the 6-month data collection period. Given uncertainty around the potential for recruiting to the trial, block randomisation was used to limit the risk of biased allocation in light of either poor recruitment or the study finishing early.
Data analysis Statistical differences between the control and trial groups were compared at three time points (baseline, 3 and 6 months). All data showed a non-parametric distribution and hence a Mann– Whitney U test was used for the pairwise comparisons. χ2 Test was undertaken only for nominal drugs data. 650
Funding allowed recruitment to take place over 1 year. In all, 60 children were recruited in that time: 31 were randomised into the fitted FOs group and 29 into the control FOs group. At baseline, there was no statistical difference between the two groups (table 1). Overall, 179 out of a possible 180 assessments were completed (99.4%) and accounted for statistical analysis. A statistically significant greater difference in pain reduction between control FOs and fitted FOs favouring the fitted FOs group was achieved between all three intervals. A clinically important reduction in pain was seen between baseline and 6 months in the fitted FOs group of children (tables 2 and 3). A statistically significant greater improvement in quality of
Table 2 Comparison of the change in scores for pain and QoL between the two groups Control FOs median (IQR) Pain VAS score Baseline 6.5 (50.5) Baseline—3 months 0.0 (0.5) 3 months—6 months 0.0 (5) Baseline—6 months 0.0 (0.25) PedsQL paediatric rheumatology score Baseline 78.63 (18.65) Baseline—3 months 0.00 (0.50) 3 months—6 months 0.18 (12.77) Baseline—6 months 1.50 (7.92) PedsQL parent rheumatology score Baseline 78.04 (40.57) Baseline—3 months 2.08 (13.98) 3 months—6 months 0.00 (7.52) Baseline—6 months 1.48 (16.47)
Fitted FOs median (IQR)
p Value
14.0 5.0 1.0 8.0
(31.0) (8.0) (6.0) (19.0)
p=0.221 p=0.030* p=0.002** p=0.029*
72.60 5.00 2.86 9.05
(29.45) (8.00) (11.56) (24.62)
p=0.101 p=0.001** p=0.167 p=0.001**
62.52 7.60 1.51 11.37
(33.89) (17.74) (9.57) (14.50)
p=0.371 p=0.124 p=0.137 p=0.020*
Mann–Whitney U test was used for all comparisons. *means p
