Early exercise in blunt chest wall trauma: a feasibility trial

Plain English summary of protocol

Background and study aims
Blunt chest wall trauma, such as bruising or broken ribs, makes up 15% of all trauma admissions to Emergency Departments (ED) worldwide, with reported mortality ranging between 4 and 60%. The most common injury mechanisms include low velocity falls (>2m), high velocity falls (>2m), road traffic accidents, assaults and sporting injuries. Over 1800 patients presented to the Emergency Department of a South Wales Hospital in 2017 with blunt chest wall trauma. Difficulties in the management of blunt chest wall trauma patients in the ED are becoming increasingly well recognised. Historically, pain relief and chest physiotherapy have been advocated as the primary methods of managing a patient with blunt chest wall trauma, with the main aim of reducing the acute risk of the development of potentially life-threatening chest complications.
Longer-term complications have also been investigated and in a small study conducted by this research team, chronic pain was reported in 35% patients with an average pain severity score of 6 out of 10. In a similar recent prospective study of 111 patients with isolated rib fractures, a prevalence of chronic pain of 64% and disability of 67% were reported. In a 2019 study, chronic pain and disability were reported in 62% and 57% of patients at 3 months after injury respectively. If over 1800 patients are presenting to one ED in Wales per year with blunt chest wall trauma, with a prevalence of 57-67% disability at two to three months after injury, this highlights a major healthcare problem which is not currently being addressed in clinical practice. Patients are simply discharged home with no follow-up care. Clinicians are traditionally taught that the pain and disability of rib fractures resolves in six to eight weeks.
What remains unknown in blunt chest trauma literature is the best management for addressing the longer-term complications, specifically chronic pain and disability. The overall aim of this phase of work is to investigate whether early thoracic and shoulder girdle exercises improve chronic pain in blunt chest wall trauma patients, when compared to normal care (where normal care traditionally involves chest physiotherapy techniques such as breathing exercises and early mobilisation/walking and no thoracic/shoulder girdle exercises). If the trial is successful and early exercise is shown to be beneficial in reducing chronic pain in this large patient cohort, then the programme can be shared throughout Wales and the UK.
The aim of this study is to test the feasibility and methods of a future trial that compares the use of early thoracic and shoulder exercises for the management of blunt chest wall trauma patients versus normal standard care. This study will have two main aims:
1. To assess the number of patients needed for the full randomised control trial and recruitment period needed to achieve this target
2. To test the feasibility and acceptability of the proposed trial methods; including the parallel randomised controlled design, the patient recruitment and consent processes, and collection of the proposed outcome measures at certain timepoints.

Who can participate?
Any adult patient who is admitted to Morriston Hospital for 24 hours or more, with isolated blunt chest wall trauma. The patient will be approached to participate in the trial if they have the capacity to follow instructions to complete the exercise programme and complete the surveys.

What does the study involve?
Participants are randomly allocated to the intervention group or the control group. Patients chosen for the intervention group receive standard care, in addition to a programme of thoracic/shoulder girdle exercises (delivered by the physiotherapist who would routinely manage the patient as part of standard care). This programme is continued by the patient, three times per day, for seven days after assessment. The exercise programme consists of shoulder active range of movement exercises, trunk active side-flexion, rotation, forward flexion and extension range of movement exercises (all within limits of pain). The control group receive standard care only.
At the start of the study and three months later, participants complete two surveys about quality of life and pain, in order to test the usefulness of the surveys and potential difficulties in collecting the surveys after the patient has been discharged home from hospital. Participants in the intervention group record compliance with the exercise programme.
Pre-set trial feasibility criteria are assessed using a traffic light system (in which green means the target was achieved, amber means the target was not achieved but progression is possible with some minor protocol modifications, and red means progression to a full trial is not possible).
The survey responses are entered onto a paper case report form. Any survey with missing information is still included in the study and the remaining responses included in the analysis. Response rates are recorded and non-responder (participants who don't return the surveys) analysis is completed to compare the characteristics of the non-responders and the responders. Patients are identified only by their hospital numbers once completed surveys are received.

What are the possible benefits and risks of participating?
The potential benefit of the study is that the feasibility study will achieve the progression criteria and the future full trial can be developed in which the exercise programme improves blunt chest wall trauma patients’ longer-term outcomes. There are no known risks involved with participation in this study. Patients are asked to complete a number of thoracic and shoulder girdle exercises, supervised by a qualified physiotherapist responsible for the patient’s overall care.

Where is the study run from?
Morriston Hospital, Swansea with support from Swansea Trials Unit, Swansea University Medical School (UK)

When is the study starting and how long is it expected to run?
August 2018 to March 2020

Who is funding the study?
The study is funded by a Pathway to Portfolio grant from Health and Care Research Wales, on behalf of the Welsh Government

Who is the study contact?
Dr Ceri Battle
ceri.battle@wales.nhs.uk

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• United Kingdom
• Wales

Study participating centre

Sponsor information

Swansea Bay University Health Board
Hospital/treatment centre

Floor 2
ILS2 Building
Swansea University
Swansea
SA2 8PP
Wales
United Kingdom

Phone	+44 (0)1792530899
Email	anne-claire.owen@wales.nhs.uk
"ROR"	https://ror.org/04zet5t12

Funders

Funder type

Government

Results and Publications

Study outputs

Additional files

ISRCTN16197429_PROTOCOL_v1.1_10Mar2019.docx

Uploaded 30/05/2019

Editorial Notes

07/09/2020: Publication reference added.
08/10/2019: The following changes were made to the trial record:
1. The total final enrolment was added.
2. The intention to publish date was changed from 31/03/2020 to 31/03/2021.
30/05/2019: Uploaded protocol Version 1.1, 10 March 2019 (not peer reviewed).