Summary
EarLy Exercise in blunt Chest wall Trauma: a mixed methods, multi-centre, parallel randomised controlled trial (ELECT2 Trial)
Funder: HCRW
Background and study aims
Injuries to the chest lead to a large number of admission to hospital every year in the UK and globally. It is now well-known that at least two thirds of patients with injuries to their chest, will go on to develop chronic pain and disability. Chronic pain is pain that lasts longer than 3 months after the original injury. Very little is yet known about how to reduce the risk of this chronic pain and disability, including the effectiveness of physiotherapy. The overall aim of this trial is to look at the impact of an early exercise programme, which includes simple upper back/chest and shoulder girdle movements, on the number of people experiencing chronic pain and physical disability, and the severity of the pain.
Who can participate?
The trial will run in five hospitals in Wales and England, where all adult patients who can complete the exercise programme, presenting to the Emergency Department with an injury to their chest, will be invited to participate.
What does the study involve?
The exercise programme consists of four simple exercises, which will be completed three times a day, for one week in total. Half of the patients taking part will complete the exercise programme and the other half will not. All patients will receive normal routine physiotherapy care and will be asked to complete questionnaires when they first come to hospital, and again at three months after their injury. The whole trial will take 2 years to complete, with patients being invited to participate over a one year period.
What are the possible benefits and risks of participating?
There are no known risks involved with participation in this trial. There were no adverse events reported by patients completing the intervention in the feasibility study. Patients will be asked to complete a number of chest and shoulder girdle exercises, which will be supervised by one of the physiotherapy team responsible for the patient’s overall care. The potential benefit of the study is that the trial will demonstrate that the rate of chronic pain and disability is improved with the exercise programme, improving resource use in this patient group.
Where is the study run from?
Swansea Trials Unit, based at Swansea University Medical School (UK)
When is the study starting and how long is it expected to run for?
The study will start at the end of January 2022 and will run for one year.
Results
We know from previous research that chronic pain (pain persisting over 3 months after an injury) and poor health-related quality of life is reported by over one third of adult patients with a rib injury. Despite this, there is no evidence supporting the physiotherapy treatment given to these patients in hospital. We tested whether an exercise programme consisting of simple trunk and shoulder movements, could reduce the rate of chronic pain and improve health-related quality of life in these patients. In six hospitals, 360 patients with rib injuries were split into two groups; one that completed the exercise programme and one that didn’t. Both groups still received other routine physiotherapy treatment. All patients filled out questionnaires on admission to hospital and again three months later, to tell us about their pain and health related quality of life. We also looked at whether the programme was cost effective, and if patients and physiotherapists liked it or not.
71% patients told us how much of the exercise programme they had completed. Only 23% of these patients completed the entire programme.
By three months, the levels of chronic pain and poor quality of life reported by patients was very low. This suggest that most patients made a full recovery.
We found that for some patients, the exercise programme may not have helped their recovery. Chronic pain was reported by 28.3% of those patients completing the exercise programme, and 16.9% of those not completing it.
The exercise programme was safe. There were no reported differences in the rate of problems (related to the trial) between the two groups.
Patients felt the exercise programme was helpful and easy to follow, although was possibly started too early after their injury.
The physiotherapists reported that the programme was straightforward. They also felt that for some patients, it was started too early after their injury.
The exercise programme is not cost-effective for patients with blunt chest wall trauma.
Contact Details
Trial Manager / Lead Contact: Prof Ceri Battle
Email: Ceri.Battle@wales.nhs.uk
ISCRTN Number: 65829737; IRAS ID: 304751;