Title: COmbining brief interventions for Modifiable health Behaviours withIN a physiotherapy consultation for pEople with a rotator cuff Disorder: intervention development and testing in a single arm feasibility study (COMBINED)
Funder: Health Education England

Abstract: Background Shoulder pain is a common and burdensome problem. The rotator cuff muscles and tendons are the most common cause. Current research suggests that structured, progressed exercise provides comparable clinical outcomes to surgery and corticosteroid injections, without the associated costs and risk. But, approximately 50% of patients still have persistent problems six months after onset, despite treatment. Evidence suggests an association between health behaviours, including smoking, overweight/obesity, low physical activity, and rotator cuff disorders. Recognising this, and that many patients continue to have pain and disability over the longer term, provides an opportunity to think differently about the management of this problem. By identifying and addressing these modifiable health behaviours, combined with a physiotherapist-led exercise programme, patient outcomes could be improved.Research Question In adult patients diagnosed with a rotator cuff disorder, is it feasible to develop a combined intervention and conduct a future substantive, multi-centre randomised controlled trial (RCT) to test the hypothesis that combining brief interventions for modifiable health behaviours with a structured progressive physiotherapist-led exercise programme will be more clinically effective than the exercise programme alone?Objectives To identify and develop theory- and evidence-based brief interventions to target the key modifiable health behaviours (smoking, overweight/obesity, low physical activity); To conduct a pilot and feasibility RCT to determine recruitment, retention and intervention fidelity.Methods Stage One: Intervention development, using an intervention mapping approach, to identify and develop existing brief interventions for the identified health behaviours.Stage Two: A parallel, two-arm, randomised pilot and feasibility RCT with process evaluation. Participants: Adult patients referred to physiotherapy in two NHS Trusts, diagnosed with a rotator cuff disorder. Control/intervention: Participants will be randomised on a 1:1 ratio to: 1) A structured, progressive physiotherapist-led exercise programme; 2) The same exercise programme combined with a brief intervention targeting one of the modifiable health behaviours. Feasibility/process outcomes: 1) Numbers/proportions of patients identified and recruited; 2) Number/proportions of patients who decline participation; 3) Rate of retention at three months; 4) Intervention fidelity and adherence; 5) Intervention acceptability. Clinical outcomes: 1)Patient Activation Measure; 2) Self-efficacy (health behaviour specific) 3) Self-reported behaviour change: (i) smoking, (ii) weight, (iii) physical activity; 4) Objective measures of behaviour change: (i) saliva cotinine test, (ii) weight, (iii) accelerometer (step count); 5) Shoulder Pain and Disability Index. Sample size: 60 participants. Analysis: Analysis will focus on process outcomes, e.g. recruitment, retention, intervention fidelity; alongside descriptive analysis of key modifiable behaviours and clinical outcomes in order to inform the sample size of the future main trial. Interviews will explore intervention acceptability (participants and clinicians) and will be analysed using the Framework method. Anticipated impact and dissemination Patients and the public have been involved in the development of this work and will continue to be so throughout. Findings will be published, presented at conferences, disseminated locally and more widely via social media channels. The main anticipated impact of this pilot and feasibility RCT will be to fully inform the future main RCT that will test whether patients' clinical outcomes of pain and function are improved.

Lay abstract: Shoulder pain is a common problem. The rotator cuff muscles and tendons, which move and stabilise the shoulder joint, are the most likely cause. Rotator cuff problems can result in pain and difficulty with everyday tasks. Routine treatments for this condition include physiotherapy, injections and surgery. However, data from studies testing these treatments suggest they offer, on average, small to moderate benefits. Also when different treatments are compared, for example, exercise versus surgery it is unclear which treatments are best. Exercise therapy appears to be the most promising treatment, particularly given the lower risks and costs associated with this. But, in the long term, patients' outcomes (such as pain and function) are still poor, with 41% of patients still reporting shoulder pain 12 months later.Research suggests a link between certain lifestyle factors (or health behaviours) and rotator cuff problems. These are smoking, being overweight, and low physical activity levels. These are called 'modifiable health behaviours' because these health behaviours can be changed.Given this link between rotator cuff problems and health behaviours, and that many patients with shoulder problems have persistent pain, there is a need to think differently about how we best treat these patients.This study aims to find out if it is possible to improve patients' outcomes by combining exercise therapy (shown to be the most promising treatment for this condition), with interventions that target the modifiable health behaviours, for example, to help patients stop smoking or lose weight. This will be through a 'brief intervention', which includes advice, encouragement and support to help patients change the health behaviour. This typically takes 5-10 minutes to deliver as part of routine physiotherapy care. Before a large study can be conducted to see if this works, two stages of research are planned: Stage 1: First, the brief interventions for each of the modifiable health behaviours (smoking, overweight, low physical activity) need to be identified and developed further for use with these patients. This will be done together with experts in health interventions, researchers, patients and healthcare professionals. Stage 2: To work out if a future large study is feasible, a smaller pilot study will be carried out first in two NHS Hospitals. This will find out, for example, if patients are willing to take part in the study, how well the brief lifestyle intervention is delivered, whether it can be combined successfully with exercise therapy and what patients and physiotherapists think about the new intervention.Patients referred to physiotherapy with a rotator cuff problem will be asked to take part in the study. They will be allocated to either receive a physiotherapist-led exercise programme only or the same exercise programme combined with a brief intervention targeted at one of the modifiable health behaviours. Information about shoulder pain and function will be collected, as well as information related to the three key health behaviours. These include patient's weight, smoking status and physical activity levels. Interviews will explore patients' and staff views on acceptability of the intervention.This information will determine if it is possible to carry out a future large study; which will test if combining the treatments in this way (a brief intervention for the modifiable health behaviour combined with an exercise programme) could improve patient outcomes. Patients and clinicians have been involved so far by shaping the research question and design of the study, and will be involved throughout the research process. The results of this research will be shared locally with patients and healthcare professionals, and more widely by presenting at conferences, publishing in journals and use of social media channels, such as Twitter.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL;6.7 PHYSICAL
Health categories: MUSCULOSKELETAL