Early rheumatoid arthritis Musculoskeletal Diseases Rheumatoid arthritis
Conditions
Interventions
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 ada
Sponsors
University of East London
Eligibility
Sex/Gender
All
Inclusion criteria
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 pain which is localised to any one of the following: MTP joints, midfoot, rearfoot, and/or periarticular tendons surrounding the ankle/subtalar joints 4. Have any rearfoot or forefoot bony deformity or malalignment is present, this must be passively correctable as tested through a range of motion assessment 5. Are foot orthotic treatment naïve
Exclusion criteria
Exclusion criteria: 1. They have been diagnosed with any neurological or endocrine diseases such as diabetes which could potentially affect peripheral nerves, foot structure, function and pain perception 2. They have any trauma or injury affecting the musculoskeletal systems of the lower limb of foot. 3. They do not have early RA 4. They do not meet the minimum threshold for foot pain 5. They are not orthotic-treatment naïve
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactKellie Gibson
Outcome results
None listed