PROvision of braces for Patients with knee OsteoArthritis (PROP OA)
Research type
Research Study
Full title
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
IRAS ID
247370
Contact name
George Peat
Contact email
Sponsor organisation
Keele University
ISRCTN Number
ISRCTN28555470
Duration of Study in the UK
4 years, 2 months, 30 days
Research summary
Summary of Research
Knee osteoarthritis is very common and causes pain and problems with movement. Wearing a brace could help patients with knee osteoarthritis, however, there are mixed reports about whether wearing a knee brace does actually help.This trial of 434 adults aged 45 years or older with knee osteoarthritis, aims to show whether wearing a knee brace provides more relief for people with painful knee osteoarthritis than just having best primary care, and whether this is good value for money for the NHS.
Patients will be identified after they have consulted their GP with knee pain, by screening physiotherapy referrals in NHS services in Staffordshire, Cheshire, Greater Manchester, and Northumbria, and by asking people to volunteer following local advertising.
Participants in the trial will get “best primary care”. This includes a 20 minute appointment with a physiotherapist who will give them education about knee osteoarthritis, exercise, physical activity and weight loss, advice about how to relieve knee pain, and a knee exercise programme. They will also be given an information booklet. Half of the participants will also get a knee brace that will be checked by the physiotherapist 2 weeks later. The type of brace they get will be based on the physiotherapist’s assessment and X-ray findings. Participants will be supported to keep wearing the brace for at least 6 months, which includes text message support.
Participants will be asked about their pain and symptoms after 3, 6, and 12-months to see whether the knee brace was a useful addition to best primary care. We will ask participants if we can look at their medical records to see if wearing the knee brace has reduced the need for surgery. We will interview some patients to find out more about using the knee brace and the advice they had from physiotherapists.
Summary of Results
What was the problem?
Painful knee osteoarthritis affects 1 in 5 adults aged over 45. Knee braces might help but it is unclear if patients gain much lasting benefit.What did we do?
466 adults with knee osteoarthritis took part in a randomised trial. They were assessed by a physiotherapist and allocated at random to either:• Advice, written information, and exercise instruction (AIE), or
• AIE plus a knee brace chosen to match their pattern of knee osteoarthritis. Participants were shown how to fit the brace, had a follow-up appointment, and got sent short, motivational text messages over the following 6 months (AIE+B).Participants completed questionnaires 3, 6, and 12 months later to measure improvements. We looked at value for money for the NHS. We interviewed patients and physiotherapists to understand treatment acceptability and investigated how often the braces were actually worn.
What did we find?
Participants in the AIE+B group reported greater improvement in pain, function, quality of life and other outcomes than those in the AIE group. The differences on average were “small” and reduced over 12 months.We found no serious harms, although skin rubbing/irritation was common. At 6 months, 7 out of 10 people said they were still using their brace, although the true figure may be lower. Improvements were greater for people who used their brace as often as they were advised.
The bracing treatment cost the NHS more but also improved quality of life.
What does it mean?
Offering a knee brace, selected based on which area of the knee is most affected, together with advice, written information, and exercise instruction is safe and acceptable. Additional benefits to patients are typically small and fade over time but these may still be valued by patients and it is a cost-effective option for NHS adoption.REC name
North West - Preston Research Ethics Committee
REC reference
19/NW/0183
Date of REC Opinion
3 Jun 2019
REC opinion
Further Information Favourable Opinion