Knee osteoarthritis (symptomatic) Musculoskeletal Diseases Gonarthrosis [arthrosis of knee]
Conditions
Interventions
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 (interven
Sponsors
Keele University
Eligibility
Sex/Gender
All
Age
45 Years to 100 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS-5) - composite score of patient-reported pain, other symptoms, activities of daily living, function in sport and recreation and knee-related quality of life at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 05/10/2023: Secondary outcomes are captured using participant self-report questionnaires at 3, 6 and 12 months post-randomisation: 1. Pain is measured using the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscale, Numeric Rating Scale of knee pain on activity, measure of Intermittent and Constant Osteoarthritis Pain (ICOAP); Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [items for which are included within the KOOS] 2. Arthritis self-efficacy is measured using the Arthritis Self-Efficacy Scale (ASES) 3. Function is measured using the Knee injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS ADL), Function in Sport and Recreation (KOOS Sport/Rec) subscales and WOMAC 4. Physical activity is measured using the International Physical Activity Questionnaire - Elderly (IPAQ-E) 5. Symptoms are captured using the Knee injury and Osteoarthritis Outcome Score (KOOS) 6. Social participation is measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) 8. Patient global rating of change is measured using a Numeric Rating Scale 9. Treatment response is measured using the OMERACT-OARSI responder criteria (this combines data on pain and function from the WOMAC with patient’s global assessment of change) 10. Instability (buckling) is measured by self-report questions 11. Treatment acceptability is measured by self-report questions 12. Adverse events are captured through case report forms (CRF), and direct contact between the CTU and the participant, their PROP OA physiotherapist, GP or the Site PI 13. Adherence to brace use is captured in part through SMS text messages (tapering schedule over the first 6 months of follow-up, with a text message also at 12 months) 14. Cost effectiveness is evaluated using EuroQol EQ-5D-5L, Healthcare resource use (NHS/private), out-of-pocket expenses, Time Off Work. Unit costs from standard UK sources will be sought for all | — |
Countries
England, United Kingdom
Contacts
Public ContactNicola Halliday
Outcome results
None listed