Background The aim was to complete a feasibility study that would test the methods of the main trial, that will investigate whether early thoracic and shoulder girdle exercises reduce chronic pain in patients with blunt chest wall trauma, when compared with normal care.
Methods A single centre, parallel, feasibility randomised controlled trial was completed at a University Teaching Hospital in Wales between June and September 2019. Adult patients with blunt chest wall trauma, admitted to hospital for greater than 24 hours, with no concurrent, immediately life-threatening injuries, were included. The intervention was a simple physiotherapy programme comprising thoracic and shoulder girdle exercises. Feasibility outcome measures included: primary outcomes: (1) 80% or more of identified eligible patients were approached for potential recruitment to the trial (2) 30% or less of approached, eligible patients dissented to participate in the trial; secondary outcomes: (3) follow-up data for patient secondary outcomes can be collected for 80% or more of patients, (4) there should be no greater than 10% increase in serious adverse events in the intervention group compared with the control group.
Results A total of 19/19 (100%) patients were deemed eligible for the trial and were approached for participation, 5/19 (26%) eligible patients declined to participate in the trial, follow-up data were collected for n=10/14 (71%) patients and there were no serious adverse events reported in either group.
Conclusions We have demonstrated that a fully powered randomised clinical trial of the EarLy Exercise in blunt Chest wall Trauma Trial is feasible.
Trial registration number ISRCTN16197429
- trauma, chest
- pain management
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Handling editor Edward Carlton
Contributors All authors contributed to the conception and design of the trial. CB, HH and LN managed the running of the trial. CB, HH and CO’N completed the data analysis. CB, HH, HT, LN and CO’N wrote the initial draft and all authors contributed to its revision.
Funding This trial was supported by a Pathway to Portfolio Grant from Health and Care Research Wales.
Disclaimer The funding sources have no role in the design of this trial. The views expressed are those of the author(s) and not necessarily those of the NHS, Health and Care Research Wales, the NIHR or the Department of Health.
Competing interests None declared.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Patient consent for publication Not required.
Ethics approval Wales Research Ethics Committee 6 (19/WA/0144).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request. Data and protocol are available from the corresponding author, upon reasonable request.
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