Acute rehabilitation following traumatic anterior shoulder dislocation
| ISRCTN | ISRCTN63184243 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63184243 |
| Secondary identifying numbers | CPMS 39168 |
- Submission date
- 03/09/2018
- Registration date
- 07/09/2018
- Last edited
- 18/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
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
Scientific
Warwick Clinical Trials Unit
Clinical Sciences Research Laboratories
University Hospitals Coventry and Warwickshire
Coventry
CV2 2DX
United Kingdom
| Phone | +44 (0)2476968624 |
|---|---|
| artisan@warwick.ac.uk |
Study information
| Study design | Randomized; Interventional; Design type: Treatment, Education or Self-Management, Rehabilitation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Acute rehabilitation following traumatic anterior shoulder dislocation |
| Study acronym | ARTISAN |
| Study objectives | 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 trialists plan to perform a study across 30 UK hospitals to compare a single session of advice versus a course of physiotherapy for patients who have dislocated their shoulder. The primary aim is to compare the two treatment groups for differences in the Oxford Shoulder Instability Score six months after injury. This score measures function from the patients’ perspective. Improvements in functional outcome and quality of life as well as complications and resource use will be collected at 6 weeks, 3, 6 and 12 months after taking part in the study. |
| Ethics approval(s) | Gwasanaeth Moeseg Ymchwil Research Ethics Committee, 26/07/2018, ref: 18/WA/0236 |
| Health condition(s) or problem(s) studied | Shoulder dislocation |
| Intervention | Participants deemed eligible to take part in the trial, according to the protocol will be approached to be invited to the study. After time to consider, written informed consent will be obtained. Participants will be asked to complete three questionnaires at baseline; Oxford Shoulder Instability Score (OSIS), QuickDASH, and EQ5D-5L. Referral to a physiotherapist will be made at this stage. Eligibility will then be re-checked and participants will be requested to complete post injury questionnaires and receive single-session of advice from Physiotherapist. Participants will then be randomised to continue advice only following discharge from physiotherapy or receive further physiotherapy for a minimum of two sessions over a maximum of four months post randomisation. Participants will be aware of which treatment arm they have been randomised to as it’s an open label trial. Participants will be required to complete postal questionnaires at 6 weeks, 3, 6 and 12 months following randomisation to indicate their typical pre-injury and current health status. Completed questionnaires are to be posted back to the trials unit using free post envelopes provided. Some participants will also be invited to take part in a qualitative interview. |
| Intervention type | Other |
| Primary outcome measure | Oxford Shoulder Instability Score (OSIS): The OSIS is a self-completed outcome measure containing 12 questions (0-4 points each), with possible scores from 0 (best function) to 48 (worst function) (8, 11). These questions relate to activities of daily living particularly relevant to patients exhibiting shoulder instability. The OSIS has been specifically designed to assess outcome of therapy (both surgical and non-surgical) by measuring activities of daily living and pain of patients exhibiting shoulder instability. Measured at 6 months after injury. |
| Secondary outcome measures | Measured at 6 weeks, 3, 6 and 12 months after taking part in the study: 1. QuickDASH: The QuickDASH is a self-completed shortened version of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. Instead of 30 items, the QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. The questionnaire was designed to help describe the disability experienced by people with upper-limb disorders and also to monitor changes in symptoms and function over time 2. EQ-5D-5L: Is a well validated, generic health-related quality of life measure consisting of five dimensions each with 5-levels of response. Each combination of answers can be converted into a health utility score. It has good test-retest reliability, is simple for participants to use, and gives a single preference based index value for health status that can be used for broader cost-effectiveness comparative purposes 3. Complications: Complications will be reported through the following mechanisms: a) Participant reported during routine collection of follow up data; b) Local research teams will report any additional investigations or treatment of participants c) Local physiotherapists delivering the trial interventions will report any events occurring during treatment sessions d) Medical records of non-responding participants may be retrieved by local research teams at site. Complications will be defined into three categories: a) Pre-defined complications directly related to the trial interventions b) Pre-defined complications directly caused by the primary TASD event not identified by the initial assessing clinician, but subsequently identified c) Complications not related to the intervention or TASD event and will subsequently not be formally analysed or reported 4. Resource use questionnaires: The primary health-economic analysis will concentrate on direct intervention and healthcare/personal social services costs, while wider impact (societal) costs will be included within the sensitivity analyses. Participants will complete resource use questionnaires at baseline and all follow-up points, to collect resource use data associated with the interventions under examination. The trialists will use techniques common in long-term cohort studies to ensure minimum loss to follow-up, such as collection of multiple contact addresses and telephone numbers, mobile telephone numbers and email addresses. The trial team may keep in regular contact with participants using newsletters |
| Overall study start date | 01/03/2018 |
| Completion date | 30/11/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 478; UK Sample Size: 478 |
| Total final enrolment | 482 |
| Key inclusion criteria | 1. Provision of written informed consent 2. Aged 18 years or over 3. Patients have a primary traumatic acute shoulder dislocation, confirmed by radiology |
| Key exclusion criteria | 1. Bilateral shoulder dislocation 2. Having first-line surgical treatment (Indications include a displaced greater tuberosity fracture for example) 3. Cannot receive first session of physiotherapy within 6 weeks of injury 4. In the opinion of the assessing clinician there is a neurovascular complication associated with TASD 5. Unable to adhere to trial procedures or complete questionnaires; for example, a history of permanent cognitive impairment 6. Previous randomisation in the present trial |
| Date of first enrolment | 01/11/2018 |
| Date of final enrolment | 14/03/2022 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Leicester
LE1 5WW
United Kingdom
Leicester
EX2 5DW
United Kingdom
Bristol
BS10 5NB
United Kingdom
Coventry
CV2 2DX
United Kingdom
Hardwick
Stockton-on-Tees
TS19 8PE
United Kingdom
Colney
Colney
NR4 7UY
United Kingdom
Cambridge
CB2 0QQ
United Kingdom
London
NW3 2QG
United Kingdom
Derby
DE22 3NE
United Kingdom
Yeovil
BA21 4AT
United Kingdom
Newcastle Upon Tyne
NE1 4LP
United Kingdom
Harrogate
HG2 7SX
United Kingdom
Lindley
Huddersfield
HD3 3EA
United Kingdom
Bretton Gate
Peterborough
PE3 9GZ
United Kingdom
Steeton
Keighley
BD20 6TD
United Kingdom
Stanwell
Ashford
TW15 3AA
United Kingdom
Headington
Oxford
OX3 9DU
United Kingdom
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
Blackpool
FY3 8NR
United Kingdom
Truro
TR1 3LJ
United Kingdom
Reading
RG1 5AN
United Kingdom
Broomhall
Sheffield
S10 2JF
United Kingdom
Clifton
York
YO31 8HE
United Kingdom
Doncaster
DN2 5LT
United Kingdom
Navigation Park
Abercynon
CF45 4SN
United Kingdom
Boston
PE21 9QS
United Kingdom
Lincoln
LN2 5QY
United Kingdom
Grantham
NG31 8DG
United Kingdom
2 Eday Road
Aberdeen
AB15 6RE
United Kingdom
Warrington
WA5 1QG
United Kingdom
Ipswich
IP4 5PD
United Kingdom
Taunton
TA1 5DA
United Kingdom
Glasgow
G12 0XH
United Kingdom
Blackburn
BB2 3HH
United Kingdom
Sunderland
SR4 7TP
United Kingdom
Bury Saint Edmunds
IP33 2QZ
United Kingdom
London
SE5 9RS
United Kingdom
Stafford
ST16 3SR
United Kingdom
Kendal
LA9 7RG
United Kingdom
Carlisle
CA2 7HY
United Kingdom
Macclesfield
Cheshire
SK10 3BL
United Kingdom
Sponsor information
Hospital/treatment centre
Clifford Bridge Road
Coventry
CV2 2DX
England
United Kingdom
| Phone | +44 (0)24 765 75386 |
|---|---|
| Sponsorship@warwick.ac.uk | |
"ROR" |
https://ror.org/025n38288 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/11/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | It is the trialists' intention to prepare a manuscript for a high impact peer-reviewed journal, which will allow for the results to be disseminated across the orthopaedic and rehabilitation communities, the wider medical community and policy makers. The trial will be reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines (www.consort-statement.org). In addition, the findings of the study will be presented at the following international meetings: 1. European Federation of Orthopaedic and Trauma Associations 2. World Confederation for Physical Therapy This will be in addition to UK conferences which include: 1. British Elbow and Shoulder Society 2. Orthopaedic Trauma Society 3. British Orthopaedic Association 4. Chartered Society of Physiotherapy To inform patients and the public, the trialists intend to produce a lay summary, which will be made available in the trial hospitals and to trial participants via an end of trial letter. In addition, they will publicise the work through social media outlets (e.g. Facebook and Twitter) as well as websites such as Patient.co.uk. The trialists expect the results of this trial to be incorporated into the next iteration of the Cochrane review on ‘Conservative management following closed reduction of traumatic anterior dislocation of the shoulder’ and national BESS/BOA’ Patient Care Pathways: Traumatic anterior shoulder instability’. HRA guidance on information for participants at the end of a trial will be followed: https://www.hra.nhs.uk/about-us/consultations/closed-consultations/guidance-participant-information-end-study-consultation/ The publication of a trial protocol, methodology papers, trial results and trial data will be in line with the NIHR standard terms and will follow WCTU SOP 22: Publication & Dissemination. PIS will be available on this webpage: https://warwick.ac.uk/fac/med/research/ctu/trials/artisan/public Additional documents will be available on this webpage: https://warwick.ac.uk/fac/med/research/ctu/trials/artisan/public Protocol has not been published yet. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Rebecca Kearney (R.S.Kearney@warwick.ac.uk). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 19/11/2020 | 18/01/2021 | Yes | No |
| Other publications | intervention development | 17/06/2021 | 05/10/2021 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 17/01/2024 | 18/01/2024 | Yes | No |
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.
