Osteoarthritis Musculoskeletal Diseases
Conditions
Interventions
This study aims to take advantage of the incentive for behavioural change in patients with osteoarthritis (OA) who have been placed on the waiting list for orthopaedic surgery, to obtain a durable alt
Sponsors
NHS Lothian
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For participants: 1. Undergoing total knee arthroplasty for OA 2. Participant meets at least 1 of the following threshold criteria: 2.1. BMI =30 kg/m2 2.2. Inability to perform straight leg raise (no extensor lag) or patient-reported ‘giving way’ 2.3. Not taking appropriate analgesics unless analgesics are not tolerated/contra-indicated 2.4. Not using shock-absorbing footwear 3. Participants are able to consent and willing to comply with the study protocol 4. Sufficient time for the intervention to be delivered before planned date of surgery and for the follow up appointment to be conducted 3 months after planned date of surgery For staff: Staff members to be interviewed should be members of the research team involved in delivering the intervention to participants or members of the clinical care team/associated personnel at the site where the intervention is being delivered. The age range was omitted in V1 of the protocol but has been included in V2 (amendment currently being processed). The age range for the study is 18-85 years (inclusive).
Exclusion criteria
Exclusion criteria: For participants: 1. Patients undergoing revision knee arthroplasty or fully constrained knee arthroplasty 2. Knee replacement for a diagnosis other than OA 3. Patients with a second contralateral procedure planned within the study timeframe 4. Procedures done purely for pain relief (such as for patients with no walking capacity) 5. Patients involved in another research study containing elements of behaviour change related to diet, physical activity and other study elements 6. Participants that cannot understand verbal explanations or written information given in English 7. Pregnant until >4 months postpartum; breastfeeding Additional exclusion criteria applicable to participants eligible for weight loss aspect of the intervention: 1. Patients who have recently lost a significant amount of weight (>5kg in the preceding 3 months) or who are already on a specialised diet 2. Patients with: 2.1. Insulin dependent diabetes 2.2. Brittle type 2 diabetes which is managed in secondary care (confirmed by recent HbA1c measurement if available) 2.3. Patients with moderate or severe retinopathy 3. Patients taking 4 or more antihypertensive agents 4. Patients with active mental illness: severe depression, bipolar disorders, schizophrenia or other psychotic disorders 5. Myocardial infarctions or stroke within the previous 3 months 6. Heart failure of grade III New York Heart Association or more severe 7. Porphyria 8. Substance abuse e.g., drugs, alcohol 9. Eating disorder accompanied by purging (through laxative abuse or induced vomiting) 10. Previous bariatric surgery or scheduled bariatric surgery 11. Angina, arrhythmia, including atrial fibrillation or prolonged QT syndrome 12. Taking monoamine- oxidase inhibitor (MAOI) medication 13. Taking anticoagulant medication (e.g., warfarin) 14. Taking varenicline (smoking cessation medication) 15. Chronic renal failure of stage 4 or 5 (as indicated by a recent eGFR reading of <30mls/min/1.73) 16. Patients: 16.1. With active liver disease (except non-alcoholic fatty liver disease (NAFLD) 16.2. With a history of hepatoma 16.3. Within 6 months of onset of acute hepatitis 17. People having active treatment for cancer other than skin cancer treated with curative intent by local treatment only, or people taking hormonal or other long-term secondary prevention treatment after initial cancer treatment 18. Active treatment or investigation for possible or confirmed gastric or duodenal ulcer; maintenance treatment with acid suppression is not a contraindication 19. Displaying symptoms associated with gallstones in the last 3 months 20. Not taking a proton-pump inhibitor if taking oral ibuprofen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is whether the intervention and study protocol is feasible and acceptable and whether a full-scale effectiveness trial is warranted. The following will be measured and used to inform study feasibility: 1. Rate of recruitment 2. Rate of retention at follow up review after planned surgery date 3. Adherence to the intervention estimated through review questionnaires and weight change (for those receiving weight loss aspect of intervention) In addition the following information will be assessed qualitatively: 1. Qualitative interviews (with participants, researchers and clinical staff) exploring acceptability, feasibility, adherence and possible barriers to implementing the intervention 2. Acceptability of the different outcome measures | — |
Secondary
| Measure | Time frame |
|---|---|
| Change will be monitored a minimum of 90 days after the planned surgery date in the outcomes the trialists are interested in evaluating in the effectiveness trial. These are: 1. Pain, function, and stiffness, measured using WOMAC sub scores 2. Change, measured using OKS (function and pain), EQ5D score (health status), timed get-up-and-go test (time a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down) and self-efficacy (proficiency to do various tasks) questionnaire scores 3. Clinical outcomes following surgery, measured using a review questionnaire completed 90 days after surgery 4. Management of patient comorbidities, measured using a review questionnaire completed 90 days after surgery 5. Patient satisfaction with knee pain and function, measured using a satisfaction questionnaire 6. Identification of key cost drivers, measured using through consultations with local experts to discuss the types of NHS services expected to be major and minor drivers differences in costs in patients undertaking the intervention or standard care | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed