A multi-centre, primary care, randomised, parallel-group, superiority trial (with internal pilot) to evaluate the effectiveness of bracing in the management of symptomatic knee osteoarthritis: the PROP OA trial
Knee osteoarthritis (symptomatic)
Participants will be randomised (1:1 allocation, random permuted blocks) to receive either Best Primary Care (comparator) or Best Primary Care plus Bracing with Adherence Enhancing Component (intervention) using a web-based randomisation service. Randomisation will be stratified by clinic site, predominant compartmental distribution of knee osteoarthritis and by presence/absence of self-reported knee buckling. Comparator: Best Primary Care Participants randomised to receive Best Primary Care will receive a single, face-to-face consultation with a physiotherapist that will include education, self-help advice on pain management and a lower limb exercise program to be completed at home. Participants will also be provided with high quality written material, and a print out of their exercise program to facilitate their exercise practice at home. Intervention: Best Primary Care plus Bracing with Adherence Enhancing Component Participants randomised to receive the intervention will receive an initial face-to-face treatment session with a physiotherapist that will include best primary care (as described above) and prescribing of either a patellofemoral, tibiofemoral unloading, or neutral stabilising knee brace according to their pattern of knee osteoarthritis (based on clinical assessment and plain X-ray findings). Braces will be fitted to ensure maximum comfort and dose of brace use will be individually tailored. Participants will be advised to wear the brace on painful weight-bearing activity, with a starting minimum usage of 1 hour on two or more days per week, gradually increased based on tolerance to wearing the brace on all painful weight-bearing activity up to a maximum of 8 hours per day. Individuals will be advised to wear the brace for 6 months, and continue to wear it beyond this time if they find it beneficial. Two weeks after the initial treatment session participants will return for a follow-up consultation. During this time the physiotherapist will chec
Current inclusion criteria as of 14/05/2021: 1. Aged 45 years and over 2. Residing in England 3. Clinically significant knee pain on weight bearing (NRS >=4) 4. With or without knee instability or buckling 5. Able to have knee x-ray 6. Able to read and write English 7. Access to a mobile phone that can receive SMS text messages 8. Able to give full informed consent 9. Willing to participate _____ Previous inclusion criteria: 1. Aged 45 years and over 2. Residing in England 3. Clinically significant knee pain on weight bearing (NRS >=4) 4. With or without knee instability or buckling 5. No morning joint-related stiffness or morning stiffness that lasts no longer than 30 minutes 6. Able to have knee x-ray 7. Able to read and write English 8. Access to a mobile phone that can receive SMS text messages 9. Able to give full informed consent 10. Willing to participate
Current inclusion criteria as of 14/05/2021: 1. Red flags in the history or clinical examination that may indicate further investigation or referral for possible serious underlying pathology 2. Vulnerable individuals (e.g. in palliative phase of care for cancer, unstable mental health disorders) 3. Inflammatory arthritis (e.g. rheumatoid arthritis, psoriatic arthritis) 4. Symptoms not attributable to knee osteoarthritis 5. Previous total knee replacement, high tibial osteotomy, or autologous cartilage implantation 6. On the waiting list for TKR/THR within the next 6 months 7. Unwilling to wear a knee brace 8. Brace size unavailable for leg circumference 9. Knee brace contraindicated (superficial wounds where the knee brace would reside, psoriasis, eczema or poor circulation, arterial insufficiency, or severe varicosities that could result in skin at risk with regular brace wear, a history of thrombophlebitis in either leg) 10. Recent/routine knee brace wear within the last 3 months 11. Nursing home resident 12. Unable to attend clinic 13. Close family member already a trial participant 14. Knee injection in the last 3 months 15. Course of physiotherapy in the last 3 months 16. Significant neurological disorder (e.g. stroke, Parkinson’s disease, multiple sclerosis, dementia) 17. Fibromyalgia 18. Autologous cartilage implantation in last 12 months in the knee to be treated 19. Significant fixed flexion deformity that prevents fitting of brace _____ Previous exclusion criteria: 1. Red flags in the history or clinical examination that may indicate further investigation or referral for possible serious underlying pathology 2. Vulnerable individuals (e.g. in palliative phase of care for cancer, unstable mental health disorders) 3. Inflammatory arthritis (e.g. rheumatoid arthritis, psoriatic arthritis) 4. Symptoms not attributable to knee osteoarthritis 5. Previous total knee replacement, high tibial osteotomy, or autologous cartilage implantation 6. On the waiting list