None listed
Conditions
Brief summary
Background: Foot orthoses are commonly prescribed by health care professionals as an intervention for people with rheumatoid arthritis. The aim of the study was to evaluate the clinical and cost effectiveness of foot orthoses in people with established rheumatoid arthritis. Methodology: A single-blind randomised controlled trial was undertaken to compare a customised foot orthoses and a simple insole in 41 people with established rheumatoid arthritis. The Foot Function Index measured foot pain, disability and functional limitation. Costs were estimated from the perspective of the NHS and from the societal (patient and family) perspective to include costs from outside the NHS. Effects were assessed in terms of health gain expressed as quality adjusted life years (QALYS). Results: At baseline, 20 participants received the customised foot orthoses and 21 participants received a simple insole. At 16 weeks, (n = 15) 75% participants in the customised foot orthoses group and (n= 14) 66% participants in the simple insole group completed the study. Pain scores improved significantly in both groups (p<0.05). Custom-made foot orthoses significantly improved disability scores (p<0.000) but not for the SI group (p=0.40). The cost effectiveness results demonstrated no difference in cost between the groups (custom-made foot orthoses: £159.10; simple insole: £79.10 p=0.35), with the customised foot orthoses being less effective in terms of cost per QALY gain (p<0.001). Conclusion: In people with established RA, semi-rigid customised foot orthoses can improve pain and disability scores in comparison to simple insoles. From a cost effectiveness analysis perspective the customised foot orthoses were far more expensive to manufacture, with no significant cost per QALY gain.
Interventions
Two foot orthoses were prescribed over 16 weeks and included: (1) Custom-made foot orthoses and (2) simple insoles. The custom-made foot orthoses were manufactured from high density ethyl vinyl acetate, with a thickness of 20mm and a shore density of 50, a contoured medial arch, high heel cup and external medial posting correction customised to each patient according to the amount of valgus rearfoot deformity present and maximum forefoot balancing technique, determined by the external manufactur
Two foot orthoses were prescribed over 16 weeks and included: (1) Custom-made foot orthoses and (2) simple insoles. The custom-made foot orthoses were manufactured from high density ethyl vinyl acetate, with a thickness of 20mm and a shore density of 50, a contoured medial arch, high heel cup and external medial posting correction customised to each patient according to the amount of valgus rearfoot deformity present and maximum forefoot balancing technique, determined by the external manufacturer providing the interventions (Langer Biomechanics Group, Cheadle, UK). All foot orthoses were covered with 1.6mm cushioning material extending the length of the foot. The simple insoles were a simple 6mm cushioning insole made from a breathable foam core on a rubber-silicone-ethylene compound, cut to fit the exact shape of the participants’ footwear. Both interventions were the same top colour. Each participant was asked to wear the foot orthoses or simple insole as frequently as possible. Each participant completed a diary with the number of hours worn during the week and any adverse events.
Sponsors
University of Teesside
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants were eligible if they were over 18 years old, history of foot pain, ability to walk a required distance of 5 metres for measurement of foot function and had a diagnosis of RA according to the American Rheumatism Association revised criteria.
Exclusion criteria
Participants with a history of previous foot surgery or ulceration, those with an unstable medical regime or in a state of flare, currently using foot orthoses or unwilling to change their footwear to accommodate an orthotic, or with poor language ability or inability to understand the research protocol were excluded
Outcome results
None listed