Off-the-shelf versus customised foot orthoses for people with rheumatoid arthritis (RA).

INTERVENTION: For the purposes of this study, participants will be randomised to receive prefabricated (experimental) or customised (control) foot orthoses. Prefabricated orthoses are off‐the‐shelf insoles with adaptable elements such as clip on wedges, the addition of a cushioning forefoot cover which come in a range of sizes. Customised orthoses are based on the individuals foot shape, in this case collected using a foam box impression. This is manufactured based on the Podiatrists prescription from a biomechanical assessment and manufactured in a commercial lab. For this study, we have developed a protocol‐driven intervention prescription plan for both arms of the study to ensure fair comparison between the two devices. For both intervention arms, each participant will receive a minimum of 2 one‐to‐one sessions with the podiatrist pertaining to the foot orthoses interventions:‐ Session 1. All participants will be assessed in order to inform their foot orthoses prescription. During this session participants will receive standard podiatry co‐interventions. In the prefab foot orthoses arm only, participants will receive their foot orthoses at this session following the assessment by the podiatrist (this is in line with routine clinical practice for prefab foot orthoses – which can be provided ‘off‐the‐shelf’ on the same day). The podiatrist will check fit‐to‐feet, and fit‐to‐shoe or the orthotic, and will seek subjective information from the participant concerning initial comfort and fit. This appointment will take approximately 45 minutes. Session 2 [custom arm only]. Participants in the custom foot orthoses arm a will return for the fitting of either their customised foot orthoses within 2‐3 weeks of their session 1 appointment (this is in line with routine clinical practice where there is a gap between initial assessment and fitting to allow for manufacture of the custom device). At fitting stage, the podiatrist will check fit‐to‐feet, and fit‐to‐shoe or the ortho CONDITION: Early rheumatoid arthritis ; Musculoskeletal Diseases ; Rheumatoid arthritis PRIMARY OUTCOME: Foot function. It will be calculated at 12 months using the Foot Function Index pain subscale (FFIpain), which is a composite score for foot pain. The FFI is a widely used, valid and reliable self‐administered questionnaire consisting of 23 items grouped into 3 domains: foot pain (9 items), disability (9 items), and activity limitation (5 items). For each subscale, items are rated using a 100mm visual analogue scale (VAS), and a composite score is calculated by summing item and dividing by the total number of items in that subscale. A higher score is indicative of more severe foot pain and disability. SECONDARY OUTCOME: 1. Foot related disability (Foot Functional Index‐ FFI and Leeds Foot Impact Scale‐ LFIS subscales); 2. Localised foot disease activity (RADAIF5); 3. Global disability (Health Assessment questionnaire‐ HAQ); 4. Health related quality of life (HRQoL) (EQ5D 5L); ; All measured at baseline, 6 and 12 months following intervention with either custom or prefabricated FOs.; ; 5. A satisfaction questionnaire used to measure orthotic device comfort, fit, and self‐reported efficacy symptoms and activity levels, at baseline, 6 and 12 months; 6. A small random sample of participants will be invited to take part in an interview to explore experiences of the interventions and perceptions of improved/deteriorated outcomes; 7. Global disability will be measured using the Stanford Health Assessment questionnaire, collected at baseline, 6 and 12 months; 8. Global disease activity will be measured using the Disease activity Score using 28 joints (DAS28), collected at baseline, 6 and 12 months; 9. Disease duration will be recorded as the time in months from onset of symptoms and time in months from disease diagnosis as self‐reported by the patient. Collected at baseline, 6 and 12 months.; 10. Reproducibility of the Rheumatoid Arthritis Foot Disease Activity Index (RADAI‐F5), collected at baseline and 1 week later INCLUSION CRITERIA: Current Inclusion Criteria (06/03/2018): 1. Are aged over 18 years old, male/female 2. Have been diagnosed with RA <2 years previously based on the 2010 ACR/EULAR classification criteria 3. Meet the minimum threshold score of =20mm on a visual analogue scale for foot pain which is localised to any one of the following: MTP joints, midfoot, rearfoot, and/or periarticular tendons surrounding the ankle/subtalar joints. 4. If any rearfoot or forefoot bony deformity or malalignment is present, this must be passively correctable as tested through a range of motion assessment. 5. Must not have worn foot orthoses in the previous 6 weeks if provided prior to RA diagnosis or anytime post diagnoses. Previous INCLUSION CRITERIA: 1. Are aged 18‐65 , male/ female 2. Have been diagnosed with RA <2 years previously based on the 2010 ACR/EULAR classification criteria. 3. Meet the minimum threshold score of =20mm on a visual analogue scale for foot pai