Condition category
Injury, Occupational Diseases, Poisoning
Date applied
03/09/2018
Date assigned
07/09/2018
Last edited
29/04/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Current plain English summary as of 29/04/2019:
Plain English summary as of 05/12/2018:
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 2021

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

Who is the main contact?
Ms Bushra Rahman
B.Rahman@warwick.ac.uk


Previous plain English summary as of 05/12/2018:
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 2021

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

Who is the main contact?
Mrs Amna Shah
Amna.Shah@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 Liverpool University Hospital
10. Royal Derby Hospital
11. Northern General Hospital
12. Yeovil District Hospital
13. Royal Victoria Infirmary
14. Harrogate District Hospital
15. Sunderland Royal Hospital

When is the study starting and how long is it expected to run for?
March 2018 to November 2021

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

Who is the main contact?
Mrs Amna Shah
Amna.Shah@warwick.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Ms Bushra Rahman

ORCID ID

Contact details

Warwick Clinical Trials Unit
Clinical Sciences Research Laboratories
University Hospitals Coventry and Warwickshire
Coventry
CV2 2DX
United Kingdom
+44 (0)2476968624
B.Rahman@warwick.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

39168

Study information

Scientific title

Acute rehabilitation following traumatic anterior shoulder dislocation

Acronym

ARTISAN

Study hypothesis

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

Gwasanaeth Moeseg Ymchwil Research Ethics Committee, 26/07/2018, ref: 18/WA/0236

Study design

Randomised; Interventional; Design type: Treatment, Education or Self-Management, Rehabilitation

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

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

Phase

Drug names

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 trial start date

01/03/2018

Overall trial end date

01/11/2021

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 478; UK Sample Size: 478

Participant 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 six 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

Recruitment start date

01/11/2018

Recruitment end date

30/09/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leicester Royal Infirmary – Infirmary Square
LE1 5WW
United Kingdom

Trial participating centre

Royal Devon and Exeter Hospital
Barrack Road
EX2 5DW
United Kingdom

Trial participating centre

Southmead Hospital
Southmead Road
BS10 5NB
United Kingdom

Trial participating centre

University Hospitals Coventry and Warwickshire (lead centre)
Clifford Bridge Road
CV2 2DX
United Kingdom

Trial participating centre

University Hospital of North Tees and Hartlepool
Hardwick
TS19 8PE
United Kingdom

Trial participating centre

Norfolk and Norwich University Hospital
Colney Lane
NR4 7UY
United Kingdom

Trial participating centre

Addenbrooke’s Hospital
Hills Road
CB2 0QQ
United Kingdom

Trial participating centre

Royal Free London Hospital
Pond Street
NW3 2QG
United Kingdom

Trial participating centre

Royal Derby Hospital
Uttoxeter Road
DE22 3NE
United Kingdom

Trial participating centre

Yeovil District Hospital
Higher Kingston
BA21 4AT
United Kingdom

Trial participating centre

Royal Victoria Infirmary
Queen Victoria Road
NE1 4LP
United Kingdom

Trial participating centre

Harrogate District Hospital
Lancaster Park Road
HG2 7SX
United Kingdom

Sponsor information

Organisation

University Hospitals Coventry and Warwickshire NHS Trust

Sponsor details

Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
+44 (0)24 765 75386
Sponsorship@warwick.ac.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 16/167/56

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement
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).

Intention to publish date

01/11/2022

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

29/04/2019: 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.