Study protocol: is online patient education feasible in people with patellofemoral pain whilst they wait for physiotherapy: a randomised controlled feasibility trial (OPEN)
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Background: Long-term persistent musculoskeletal conditions affect many adults in the United Kingdom (UK) and patellofemoral pain (PFP) is one of the most common. PFP negatively affects important facets of health, including quality of life and physical activity level, and carries a very poor prognosis. People with PFP typically wait for up to 18-weeks to see a physiotherapist in the UK National Health Service (NHS) and their symptoms are unlikely to improve without care. Education interventions have demonstrated the ability to provide reassurance and reduce care visits in people with low back pain and it is plausible that people with PFP may respond similarly. Our primary aim is to determine if online patient education is a feasible intervention for people with PFP whilst they wait for NHS physiotherapy. Methods: This is a randomised, controlled, single-blind feasibility trial with an embedded qualitative study, where a subset of participants will be invited to a follow-up online semi-structured interview or focus group. The trial will have a primary end point of six-weeks; sufficient to allow us to determine feasibility (primary aim) and provide data to inform a subsequent substantiative trial (secondary aim). Participants will be eligible if they are aged > 18 and describe symptoms consistent with PFP. We will aim to recruit 20 participants per group based on guidance for feasibility studies. Participants will take part whilst they are on the waiting list for physiotherapy to avoid disrupting their routine care. Participants will be randomised to either online education or continued waiting list control. Outcome measures include recruitment and eligibility, randomisation and blinding, adherence and acceptability, data collection, global rating of change, worst pain in the past week, and health-related quality of life. Discussion: This trial will test the feasibility of online patient education, designed using learning theory and user involvement, compared with a waiting list control in people with PFP. The results of this trial will be submitted for publication when available and if feasibility is established and there is indication of a meaningful clinical effect then a substantiative trial should follow. Trial registration: NCT06744257
