Foot Orthoses- Custom v Off-the-shelf in Rheumatoid Arthritis
Research type
Research Study
Full title
A randomised controlled trial of prefabricated versus customised foot orthoses for people with rheumatoid arthritis: FOCOS RA trial [Foot Orthoses- Custom v off-the-shelf in Rheumatoid Arthritis].
IRAS ID
179892
Contact name
Kellie Gibson
Contact email
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Summary of Research
The overall objective of the research is to evaluate the clinical and cost-effectiveness of prefabricated insoles (FOs) for people with early Rheumatoid Arthritis (RA). The project is designed to address important evidence gaps in the literature concerning the prescription of insoles for people with early RA as recent research has demonstrated that earlier intervention predicts more favourable foot pain and disability outcomes. We have developed an approach whereby comparative effectiveness of custom versus prefabricated insoles are compared in a context which is reflective of current podiatric practice in the NHS setting.Sumary of Results
Primary aim: to evaluate the effectiveness, using the pain subscale of the Foot Function Index at 12 months after prescription of prefabricated FOs in comparison with customised FOs.
The results of the primary analysis suggest that there is no statistically or clinical significant difference (superiority not observed) between customised and prefabricated FOs for management of foot pain measured using the FFI pain subscale at 12 months (multiple linear regression). Non inferiority analysis were not warranted/required.Secondary aims 1) To evaluate the effectiveness, in terms of superiority of prefabricated versus custom FOs for people with early RA achieved at 12 months’ exposure to intervention.
As above. Note that the superiority analysis superseded the planned non-inferiority analysis.Secondary aim 2) To evaluate the effectiveness, in terms of foot-related disability reduction achieved at 6 and 12 months following intervention with either custom or prefabricated FOs.
Results of secondary analyses suggest that there are no statistically or clinically significant differences in foot-related disability (FIS activity limitation, FIS participation restriction, FFI disability subscales) at 6 or 12 months between intervention groups (all p>0.05).Secondary aim 3) To evaluate the effectiveness in terms of overall patient satisfaction (as measured by a patient satisfaction questionnaire) A total of n=55 participants were asked the question “Would you class yourself as either satisfied or unsatisfied with your foot orthoses over the previous 12 months?” (somewhat equally distributed across intervention arms, i.e. 29 custom FOs group vs 26 prefab FOs group). A total of 47/55 were satisfied with their foot orthoses over the previous 12 months (24/29 [82.8%] custom FOs groups and 23/26 [88.5%] prefab FOs group. A chi-square test of independence found no association between proportions satisfied in either intervention group (p=0.549).
Secondary aim 4) To evaluate the cost-effectiveness of prefabricated FOs in comparison with customised FOs This aim remains outstanding as outlined above.
Secondary aim 5) To explore and compare the effects of prefabricated versus custom FOs on self-reported foot-disease activity (using the newly developed Rheumatoid Arthritis Foot Disease Activity Index) Results of secondary analysis suggest that there was no statistically or clinically significant difference in inflammatory foot disease (measured using the RADAI-F5) at 6 or 12 months between intervention groups (p>0.05).
Secondary aim 6) To explore patient opinions, perceptions, and experiences of benefit following orthotic therapy (prospective serial interviews) The findings indicated the following themes, 1) Decreased foot pain with orthotic use 2) orthotic ease-of-use with increased fit, comfort and appropriate footwear and 3) overall satisfaction and orthotic reliance. Five of the seven participants indicated decreased foot pain with orthotic wear. This coincided with the participants who indicated they found the orthoses comfortable and easy to use when appropriate footwear was selected (theme 2). All participants indicated the need to adapt footwear to accommodate the orthoses. Five of the seven participants also indicated their satisfaction with the orthoses in relation to comfort, reliance and increased walking time.
What are the key overall outcomes from the project?
This is the largest RCT of foot orthoses in early RA to date. The results of this study suggest that neither customised FOs nor prefab FOs are superior to one another for outcomes of interest including foot pain, foot related disability, or inflammatory foot disease over 6 or 12 months. The final remaining health economics component will be important to formally establish the relative cost-effectiveness of these interventions.REC name
East of England - Essex Research Ethics Committee
REC reference
15/EE/0410
Date of REC Opinion
24 Dec 2015
REC opinion
Further Information Favourable Opinion