EarLy Exercise in blunt Chest wall Trauma: a feasibility trial (ELECT Trial)

Abstract

Background For patients with blunt chest wall trauma, no evidence exists regarding the optimal physiotherapy treatment aimed at 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 patients with blunt chest wall trauma, when compared to normal care. Methods A single centre, parallel, feasibility randomised controlled trial was completed at a University Teaching Hospital in Wales. 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: 1) adherence to the protocol by the physiotherapy team (more than 80% of eligible patients randomised), and 2) acceptability of the intervention by the patients (less than 30% of patients dissented to participation). Secondary: 1) ability to retrieve follow up data (response rate of more than 70% of participants) and, 2) safety of the intervention compared to routine care (no more than 10% increase in serious adverse events). Results 14 patients were recruited to the trial. Clinicians randomised 100% of eligible patients during the trial period. All feasibility criteria were fully met. The intervention was safe the number of serious adverse events was comparable between the control and intervention periods. Discussion We have demonstrated that a fully powered randomised clinical trial of the ELECT Trial is feasible. Minor methodological modifications will be made for the full trial. ISRCTN Trial registration number ISRCTN 16197429