Can exercise prevent long-lasting pain and disability following a blunt injury to the chest?
| ISRCTN | ISRCTN65829737 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65829737 |
| IRAS number | 304751 |
| Secondary identifying numbers | IRAS 304751, CPMS 51071 |
- Submission date
- 01/12/2021
- Registration date
- 02/12/2021
- Last edited
- 27/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
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.
Who is funding the study?
Health and Care Research Wales (UK), on behalf of the Welsh Government
Who is the main contact?
Dr Ceri Battle, ceri.battle@wales.nhs.uk
Contact information
Scientific
Physiotherapy Dept
Morriston Hospital
Swansea
SA6 6NL
United Kingdom
 ORCID ID |
0000-0002-7503-1931 |
|---|---|
| Phone | +44 (0)1792 703124 |
| ceri.battle@wales.nhs.uk |
Study information
| Study design | Mixed methods multi-centre parallel randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet. |
| Scientific title | EarLy Exercise in blunt Chest wall Trauma: a mixed methods, multi-centre, parallel randomised controlled trial |
| Study acronym | ELECT2 |
| Study objectives | An early exercise programme, consisting of simple thoracic and shoulder girdle movements, reduces chronic pain prevalence and severity and physical disability at 3 months post-injury, in adult patients with blunt chest wall trauma presenting to hospital, when compared with normal care. |
| Ethics approval(s) | Approved 01/12/2021, London Riverside Research Ethics Committtee (Ground Floor, Temple Quay House, 2 The Square, Bristol, BS1 6PN; +44 (0)207 104 8184; riverside.rec@hra.nhs.uk), ref: 21/LO/0782 |
| Health condition(s) or problem(s) studied | Prevention of chronic pain and disability in patients with blunt chest wall trauma |
| Intervention | Patients will be randomised (patient level) to the trial using a 1:1 ratio, using Sealed Envelope (https://www.sealedenvelope.com), an independent company which is available 24 hours per day. Two stratification variables will be used for randomisation; the number of radiologically proven or clinically suspected rib fractures and the clinical frailty score, using the Clinical Frailty Scale (CFS) of the patient, specifically: Number of rib fractures: 0-2 versus 3 or more, CFS score: 1-3 versus 4-9. Intervention: Routine care plus a simple exercise programme, consisting of four thoracic and shoulder girdle movements, that the patient completes for 1 week, three times per day as tolerated. The movements involve shoulder flexion, shoulder abduction, thoracic rotation and thoracic side-flexion. Control: Routine care (including, but not exclusively, chest physiotherapy advice given as part of normal care). |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Chronic pain is measured using the Brief Pain Inventory (short form) at baseline and 3 months follow-up 2. Disability is measured using the EQ5D-5L Survey at baseline and 3 months follow-up |
| Secondary outcome measures | 1. Cost-effectiveness measured using a cost-utility (incremental cost per QALY) analysis at 3 month follow-up 2. Safety measured using rate of adverse events and serious adverse events at 3-month follow-up 3. Acceptability of programme measured using five focus groups, one per participating site, in intervention group only at end of 3-month follow-up |
| Overall study start date | 01/10/2021 |
| Completion date | 30/09/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 360 |
| Total final enrolment | 360 |
| Key inclusion criteria | 1. Presenting to hospital with a diagnosis of isolated blunt chest wall trauma (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) 2. Aged 16 years or above 3. Able to either give informed consent independently, or with support of a family member/carer or translator 4. Able to either complete the exercise programme independently, or with support of a family member/carer 5. Able to complete surveys independently, or with support of a family member/carer or translator |
| Key exclusion criteria | 1. Lacking sufficient capacity to provide informed consent or complete surveys. (Assistance from a family member/carer or translator is acceptable, if needed.) 2. Lacking sufficient capacity to complete the exercise programme either independently, or with the support of a family member/carer 3. Aged under 16 years 4. Presenting with immediately life-threatening injuries or any concurrent injury precluding participation in the intervention (patients with minor injuries not precluding participation, such as a concurrent knee ligament injury, will still be eligible) 5. Hospitalised prisoners |
| Date of first enrolment | 31/01/2022 |
| Date of final enrolment | 24/02/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
Salford
M6 8HD
United Kingdom
Wrexham
LL13 7TD
United Kingdom
Morriston
Cwmrhydyceirw
Swansea
SA6 6NL
United Kingdom
Cardiff
CF14 4XW
United Kingdom
Caerleon Road
Cwmbran
Newport
NP44 8YN
United Kingdom
Sponsor information
Hospital/treatment centre
Floor 1
ILS2 Building
Swansea University
Swansea
SA2 8PP
Wales
United Kingdom
| Phone | +44 (0)1792 530889 |
|---|---|
| anne-claire.owen@wales.nhs.uk | |
| Website | https://www.abm.wales.nhs.uk/ |
"ROR" |
https://ror.org/04zet5t12 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Health & Care Research Wales, Ymchwil Iechyd a Gofal Cymru, Health Care Research Wales, HCRW
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | The aim will be to publish the results of this study in an Emergency Medicine journal and present the results in a trauma/emergency medicine conference. The protocol will also be published. |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 07/04/2022 | 09/01/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 03/12/2024 | 27/12/2024 | Yes | No |
Editorial Notes
27/12/2024: Publication reference added.
08/03/2024: The intention to publish date was changed from 01/03/2024 to 31/12/2024.
10/03/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2023 to 24/02/2023.
2. The total final enrolment was added.
01/02/2023: Internal review.
09/01/2023: Publication reference and IPD sharing statement added. The recruitment end date was changed from 30/01/2023 to 31/03/2023.
02/12/2021: Trial's existence confirmed by London - Riverside Research Ethics Committee.
