Acute rehabilitation following traumatic anterior shoulder dislocation

Plain English summary of protocol

Current plain English summary as of 24/03/2022:
Background and study aims
Shoulder dislocations occur when the upper end of the arm bone is forced out of its joint socket because of a traumatic event. It is common and results in pain, disability and decreased function. Currently in the UK, some hospitals offer a single session of advice and some offer a course of physiotherapy. The UK guidelines currently say a course of physiotherapy ‘may be helpful’, whilst other national guidelines say advice alone is needed. The aim of this study is to compare a single session of advice versus a course of physiotherapy for patients who have dislocated their shoulder.

Who can participate?
Patients aged 18 or over with a dislocated shoulder managed without an operation

What does the study involve?
Participants are randomly allocated to either a single session of advice or the same session followed by a course of physiotherapy. Both treatments are widely used, and clinical teams across the UK are familiar with both. The two treatment groups are compared for differences in shoulder function at 6 months after the injury. Improvements in function and quality of life as well as complications and resource use are also measured at 6 weeks, 3, 6, and 12 months later.

What are the possible benefits and risks of participating?
Both treatments are widely used for people with a dislocated shoulder. There is no specific advantage to participants. This study may, however, improve the treatment of patients with shoulder dislocations in the future. There are minimal risks involved with this study. Both advice alone and advice in addition to tailored physiotherapy are current practice across the NHS for the management of a dislocated shoulder. Consequently, both treatments reflect current standard practice and do not involve any substantial risks over and above standard care currently received. In order to minimise burden to patients, the completion of all follow-up questionnaires may be done at home so patients will not have to make additional trips to the hospital. Postal questionnaires will include a free post envelope to make the return of questionnaires as easy as possible.

Where is the study run from?
University Hospitals Coventry and Warwickshire (lead centre) and 49 other sites in the UK.

When is the study starting and how long is it expected to run for?
March 2018 to November 2022

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Helen Bradley/Anish Patel
artisan@warwick.ac.uk


Previous plain English summary:
Background and study aims
Shoulder dislocations occur when the upper end of the arm bone is forced out of its joint socket because of a traumatic event. It is common and results in pain, disability and decreased function. Currently in the UK, some hospitals offer a single session of advice and some offer a course of physiotherapy. The UK guidelines currently say a course of physiotherapy ‘may be helpful’, whilst other national guidelines say advice alone is needed. The aim of this study is to compare a single session of advice versus a course of physiotherapy for patients who have dislocated their shoulder.

Who can participate?
Patients aged 18 or over with a dislocated shoulder managed without an operation

What does the study involve?
Participants are randomly allocated to either a single session of advice or the same session followed by a course of physiotherapy. Both treatments are widely used, and clinical teams across the UK are familiar with both. The two treatment groups are compared for differences in shoulder function at 6 months after the injury. Improvements in function and quality of life as well as complications and resource use are also measured at 6 weeks, 3, 6 and 12 months later.

What are the possible benefits and risks of participating?
Both treatments are widely used for people with a dislocated shoulder. There is no specific advantage to participants. This study may, however, improve the treatment of patients with shoulder dislocations in the future. There are minimal risks involved with this study. Both advice alone and advice in addition to tailored physiotherapy are current practice across the NHS for the management of a dislocated shoulder. Consequently, both treatments reflect current standard practice and do not involve any substantial risks over and above standard care currently received. In order to minimise burden to patients, the completion of all follow-up questionnaires may be done at home so patients will not have to make additional trips to the hospital. Postal questionnaires will include a free post envelope to make the return of questionnaires as easy as possible.

Where is the study run from?
1. Leicester Royal Infirmary
2. Royal Devon and Exeter Hospital
3. Southmead Hospital
4. University Hospitals Coventry and Warwickshire (lead centre)
5. University Hospital of North Tees and Hartlepool
6. Norfolk and Norwich University Hospital
7. Addenbrooke’s Hospital
8. Royal Free London Hospital
9. Royal Derby Hospital
10. Yeovil District Hospital
11. Royal Victoria Infirmary
12. Harrogate District Hospital

When is the study starting and how long is it expected to run for?
March 2018 to November 2022

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Helen Bradley/Anish Patel
artisan@warwick.ac.uk

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• United Kingdom
• England
• Scotland
• Wales

Study participating centres

Results and Publications

Study outputs

Editorial Notes

18/01/2024: Publication reference added.
03/11/2022: The contact confirmed the record is up to date.
24/03/2022: The following changes have been made:
1. The city has been added to the trial participating centres “University Hospitals Coventry and Warwickshire”, “Yeovil District Hospital”, “Royal Free Hospital”, “Harrogate District Hospital”, “Southmead Hospital Bristol”, “Norfolk and Norwich University Hospital”, “Royal Devon and Exeter Hospital”, “Addenbrooke’s Hospital”, “Royal Derby Hospital”, and “Royal Victoria Infirmary”.
2. The trial participating centre “Leicester Royal Infirmary – Infirmary Square” has been changed to “Leicester Royal Infirmary” and the city has been added.
3. The trial participating centre “University Hospital of North Tees and Hartlepool” has been changed to “University Hospital of North Tees” and the city has been added.
4. The trial participating centres “Calderdale and Huddersfield Hospital”, “Peterborough City Hospital”, “Airedale General Hospital”, “Ashford and St Peter’s Hospitals”, “John Radcliffe Hospital”, “Milton Keynes University Hospital”, “Blackpool Teaching Hospitals”, “Royal Cornwall Hospital”, “Royal Berkshire Hospital”, “Sheffield Teaching Hospitals”, “York Teaching Hospital”, “Doncaster and Bassetlaw Teaching Hospitals”, “Cwm Taf Morgannwg University Health Board”, “Pilgrim Hospital”, “Lincoln County Hospital”, “Grantham and District Hospital”, “Grampian Health Board”, “Warrington and Halton Hospital”, “Ipswich Hospital”, “Musgrove Park Hospital”, “NHS Greater Glasgow and Clyde”, “Royal Blackburn Hospital”, “Sunderland Royal Hospital”, “West Suffolk Hospital”, “King’s College”, “St Georges Hospital”, “University Hospitals of Morecambe Bay”, “North Cumbria University Hospitals”, “Macclesfield District General Hospital” have been added.
5. The plain English summary has been updated.
15/03/2022: The following changes have been made:
1. The recruitment end date has been changed from 28/02/2022 to 14/03/2022.
2. The total final enrolment number has been added.
10/03/2022: The contact name has been updated and the plain English summary has been updated accordingly.
10/01/2022: The following changes were made to the trial record:
1. The contact name was updated
2. The recruitment end date was changed from 31/01/2022 to 28/02/2022.
3. The trial website was added.
05/10/2021: Publication reference added.
06/07/2021: The following changes have been made:
1. The recruitment end date has been changed from 30/07/2021 to 31/01/2022.
2. The overall trial end date has been changed from 01/11/2021 to 30/11/2022 and the plain English summary has been updated to reflect this change.
3. The intention to publish date has been changed from 01/11/2022 to 30/11/2023.
28/05/2021: Contact details updated.
18/01/2021: Publication reference added.
03/09/2020: Recruitment to this study is no longer paused. The recruitment end date was changed from 30/09/2020 to 30/07/2021.
16/04/2020: Due to current public health guidance, recruitment for this study has been paused.
17/01/2020: Contact details updated.
20/06/2019: The plain English summary and scientific contact have been updated.
28/03/2019: The condition has been changed from "Specialty: Injuries and Emergencies, Primary sub-specialty: Pre-hospital and Emergency Department Care; Health Category: Injuries and accidents; Disease/Condition: Injuries to the shoulder and upper arm" to "Shoulder dislocation" following a request from the NIHR.
05/12/2018: The following changes were made:
1. The trial participating centres were updated.
2. The plain English summary was updated.