Award Title: Clinical and cost effectiveness of an early exercise programme on chronic pain and health-related  quality of life following blunt chest wall trauma: A parallel, randomised controlled trial (ELECT2 tri
Funder: Health and Care Research Wales (Welsh Government)

Abstract: Background Blunt chest wall trauma (BCWT) accounts for 15% of trauma admissions worldwide.[1] Chronic pain and disability have been reported in 62% and 57% at three months post injury respectively.[2] Physiotherapy is considered a first line treatment for BCWT, however there is little supporting research or universally accepted evidence-based guidance.[3] Standard physiotherapy traditionally involves breathing exercises. Further research is needed to establish best management for addressing chronic pain and health-related quality of life (HRQOL) in patients with BCWT.
Research (PICOT) question:
In adult patients presenting to hospital with BCWT(P), what is the impact of standard chest physiotherapy and an early exercise programme consisting of simple thoracic and shoulder girdle movements(I), compared with standard chest physiotherapy only(C), on chronic pain prevalence and severity and health-related quality of life(O) at three months post-injury(T).
Trial aims:
a)	Investigate chronic pain prevalence and severity and HRQOL at three months post-injury, using the Brief Pain Inventory (BPI) and EuroQual 5-dimensions, 5-Levels (EQ5D-5L) in adult patients with BCWT who present to hospital, receiving either standard care, or an early exercise programme and standard care.
b)	Conduct focus groups to investigate the experiences of patients completing the intervention.
c)	Conduct an analysis of the short-term cost-effectiveness of the exercise programme.
Study design: A feasibility study has already been successfully completed testing the methods proposed for this trial.[4] A multi-centre parallel, randomised controlled trial design will be used. Following presentation of our feasibility study results, five sites have agreed to participate in this study. Four sites in Wales and one in England, will recruit patients over a 12 month period. All adult patients with isolated BCWT (defined as any injury ranging from bruising to the chest wall to rib fractures with or without underlying injury to the lung, and no concurrent injuries that preclude completion of the exercise programme), presenting to hospital will be assessed for eligibility to participate. Following recruitment, patients will be randomised (stratified according to number of rib fractures and clinical frailty score) to either the control group receiving standard care only (chest physiotherapy treatment such as breathing exercises and early mobilisation), or the intervention group receiving standard care supplemented with a programme of four thoracic/shoulder girdle exercises (delivered by the physiotherapist who routinely delivers standard care). This programme will be continued by the patient, five repetitions per exercise, three times per day, for 7 days post recruitment. The programme was shown to be safe in our feasibility study, with no adverse events reported.[4]
Following randomisation patients will complete BPI and EQ5D-5L surveys at baseline and 3 months post-injury, as shown to be appropriate measures in our feasibility work.[4] Outcomes will include chronic pain prevalence/ severity and HRQOL. Focus groups convened at the end of the trial will assess the acceptability of the programme. Cost-effectiveness will assess whether the programme represents good value for money to the NHS. An improvement in chronic pain or HRQOL will be valuable to the NHS due to a reduction in resource use in primary care, outpatient physiotherapy and chronic pain services.

Lay Abstract: Why we are doing this: Over 1800 adult patients with rib injuries (ranging from simple bruising to broken ribs with injury to the lung) attended a Welsh hospital in 2018. We know from previous research that chronic pain (known as pain lasting more than three months) and poor health-related quality of life was reported by over one third of patients with a rib injury. Despite this high number of patients with pain, the physiotherapy treatment normally given to patients, has not been tested in a trial. What we hope to discover: Whether an exercise programme delivered by the physiotherapist, consisting of simple trunk and shoulder movements, can reduce the rate of chronic pain and improve health-related quality of life in adult patients presenting to hospital with rib injuries, when compared to no exercise programme. To achieve this, we will: a) Assess how many patients with rib injuries completing a simple exercise programme, report chronic pain, the severity of the pain and their overall self-reported quality of life. This will be compared to patients with rib injuries not completing the exercise programme. b) Explore patients’ opinions of the exercise programme, whether they think it is helpful or not and if not, how it could be improved. c) Assess the short-term cost-effectiveness of including an exercise programme as part of usual clinical practice. How we will do this: We recently completed a feasibility study in which we tested the methods of this proposal.[4] On a small number of patients, we tested a simple exercise programme consisting of four trunk and shoulder movements, that the patients completed for one week, three times per day. In this study, any adult patient with rib injuries (and no other injuries that prevent completion of the exercise programme) who attend one of four hospitals in Wales or one in England, will be put in either the control (receiving usual care only) or treatment group (receiving usual care plus the exercise programme). Both groups will complete a questionnaire booklet when they attend hospital and again three months later. This will allow us to assess whether the exercise programme helps reduce the rate and severity of chronic pain and improve health-related quality of life. We will talk to the patients to gain their opinion of the programme. We will assess whether the exercise programme is cost effective for the NHS. How the public has been involved: Our team of five diverse patient representatives has been part of this work for five years. They have been involved in all aspects of project development and management. They provide an invaluable insight into the patient's perspective in all of our research work. One of these patient representatives has been involved in the design and management of our recent feasibility study related to this proposed full trial. She has also been involved in the completion of this application. She will continue to support and advise on the running of this trial, if our funding application is successful, and will be joined by our other patient representative at that time. How we will tell people about the findings: A series of local and national webinars will be used to achieve a wide clinical audience. We will publish our results in a suitable journal and present at Trauma Conferences. The study's patient representatives will present their involvement experiences at the Involving People Annual Meeting and the bi-annual INVOLVE Conference.

Research Activity Codes: 6.7 PHYSICAL;8.2 HEALTH AND WELFARE ECONOMICS
Health Categories: INJURIES AND ACCIDENTS