RaCeR 2- Comparing different approaches to physiotherapy following surgery to repair the rotator cuff of the shoulder
| ISRCTN | ISRCTN11499185 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11499185 |
| IRAS number | 318438 |
| Secondary identifying numbers | CPMS55415, NIHR133874, IRAS 318438 |
- Submission date
- 13/03/2023
- Registration date
- 23/03/2023
- Last edited
- 03/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Tears of the tendons of the shoulder (rotator cuff) are a significant cause of shoulder pain. In 2018/2019, almost 9,000 surgical repairs were undertaken in the NHS costing up to £56.7 million in direct NHS treatment costs alone. Despite the high number of operations and surgical advancements, rehabilitation after rotator cuff repair has not advanced for over 20 years. The traditional cautious approach, where patients use a shoulder sling for about 1 month, might be contributing to sub-optimal outcomes. It is remiss that we still do not have a better understanding of the optimal approach that maximises outcomes, including early and safe return to usual activities. The study aims to investigate the effect of standard rehabilitation (4 weeks in a sling) or patient-directed rehabilitation (patients can choose to remove the sling when they feel able to).
Who can participate?
Adults over 18 years, due to have arthroscopic rotator cuff surgery.
What does the study involve?
Following surgery, participants will be randomised to standard rehabilitation (4 weeks in a sling) or patient-directed rehabilitation (patients can choose to remove the sling when they feel able to). Patients will be followed up remotely via completion of questionnaires (choosing to complete these by post or online) at 12 weeks, 6 months and 12 months post randomisation. They will also document their sling use by completing a diary for 4 weeks following surgery. At 12 months, we will invite patients to attend for an ultrasound of their rotator cuff to assess for re-tear. The study also includes the "Quintet Recruitment Intervention" (QRI) which is a well-established study that is often embedded within large trials to monitor recruitment. This involves recording discussions about the study and offering advice and training to recruiters at site.
The study will be a host trial for a SWAT (Study Within a Trial) to explore participant characteristics and their choice of paper vs online questionnaire completion.
What are the possible benefits and risks of participating?
The study will help us improve our approach to physiotherapy treatment after surgery to repair the rotator cuff of the shoulder. There are no anticipated risks of participating; taking part in this study requires time to complete the questionnaires and to attend the hospital for the ultrasound scan at twelve months.
Where is the study run from?
University Hospitals of Derby and Burton NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
September 2022 to April 2027
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
Uhdb.racer2@nhs.net
Contact information
Public, Scientific, Principal Investigator
PO34 Blatchford Building
University of Salford
Salford
M6 6PU
United Kingdom
| Uhdb.racer2@nhs.net |
Study information
| Study design | Interventional randomized controlled trial with embedded qualitative study within a trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, Telephone |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Clinical and cost-effectiveness of individualised (early) patient-directed rehabilitation versus standard rehabilitation after surgical repair of the rotator cuff of the shoulder: a multi-centre, randomised controlled trial with integrated Quintet Recruitment Intervention |
| Study acronym | RaCeR 2 |
| Study hypothesis | Individualised (early) patient-directed rehabilitation (EPDR) will be superior in terms of shoulder pain and disability compared to standard (delayed) rehabilitation after surgical repair of the rotator cuff of the shoulder. |
| Ethics approval(s) | Approved 13/04/2023, London - Stanmore Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 2071048387; stanmore.rec@hra.nhs.uk), ref: 23/LO/0195 |
| Condition | Rehabilitation after surgical repair of the rotator cuff of the shoulder |
| Intervention | Current interventions as of 22/08/2024: The study is an open-label randomised controlled trial comparing standard rehabilitation following rotator cuff repair surgery to individualised (early) patient directed rehabilitation. In standard rehabilitation, patients are required to keep their arm in a sling for 4 weeks, whereas for patient-directed rehabilitation, they may remove their sling and move their arm as they feel able, usually before 4 weeks. Patients undergoing arthroscopic repair for a full-thickness rotator cuff tear, will be approached to take part in the study before their surgery. They will be asked to complete a baseline questionnaire pre-surgery and will be randomised once arthroscopic surgery has been completed. For the first 4 weeks following surgery, they will be asked to complete a diary documenting their sling use (i.e. time out of sling). At 12 weeks, 6 months and 12 months, they will complete follow-up questionnaires to inform the study outcomes which will be inputted onto Dacima, the electronic data capture system. Participants will have a choice to complete these electronically via an email/text link, or postally via paper questionnaires. This will be coordinated centrally by Derby Clinical Trial Support Unit (DCTSU). At 12 months, participants will return for an ultrasound scan of their shoulder to assess repair integrity. We have chosen the validated, self-reported SPADI measure for shoulder pain and disability as we found this to be more responsive than the Oxford Shoulder Score (OSS) in our RaCeR pilot trial. The EQ-5D-5L is a widely used, validated measure of health-related quality of life. The study will take place across 24 sites (with scope to increase this if necessary) across the UK to recruit (and randomise) 638 patients in 24 months. Each patient will participate in the study for 12 months following randomisation. An internal pilot phase encompasses the first 6 months of recruitment and will monitor the rate of recruitment, overall and per-site, as well as the number of sites open. At the end of this pilot phase, we will assess study progress according to these criteria and act accordingly. _____ Previous interventions: The study is an open-label randomised controlled trial comparing standard rehabilitation following rotator cuff repair surgery to individualised (early) patient directed rehabilitation. In standard rehabilitation, patients are required to keep their arm in a sling for 4 weeks, whereas for patient-directed rehabilitation, they may remove their sling and move their arm as they feel able, usually before 4 weeks. Patients undergoing arthroscopic repair for a full-thickness rotator cuff tear, will be approached to take part in the study before their surgery. They will be asked to complete a baseline questionnaire pre-surgery and will be randomised once arthroscopic surgery has been completed. For the first 4 weeks following surgery, they will be asked to complete a diary documenting their sling use (i.e. time out of sling). At 12 weeks, 6 months and 12 months, they will complete follow-up questionnaires to inform the study outcomes. Participants will have a choice to complete these electronically via an email/text link, or postally via paper questionnaires. This will be coordinated centrally by Derby Clinical Trial Support Unit (DCTSU). At 12 months, participants will return for an ultrasound scan of their shoulder to assess repair integrity. We have chosen the validated, self-reported SPADI measure for shoulder pain and disability as we found this to be more responsive than the Oxford Shoulder Score (OSS) in our RaCeR pilot trial. The EQ-5D-5L is a widely used, validated measure of health-related quality of life. The study will take place across 24 sites (with scope to increase this if necessary) across the UK to recruit (and randomise) 638 patients in 24 months. Each patient will participate in the study for 12 months following randomisation. An internal pilot phase encompasses the first 6 months of recruitment and will monitor the rate of recruitment, overall and per-site, as well as the number of sites open. At the end of this pilot phase, we will assess study progress according to these criteria and act accordingly. |
| Intervention type | Other |
| Primary outcome measure | Shoulder pain and disability will be measured at 12 weeks post-randomisation using the Shoulder Pain and Disability Index (SPADI) validated questionnaire |
| Secondary outcome measures | 1. Shoulder pain and disability at 6- and 12-months post-randomisation will be measured using the total SPADI score 2. Health-related quality of life at 12-weeks, 6- and 12-months post-randomisation will be measured using the EQ-5D-5L 3. Time to return to usual activities, including work and driving, will be measured via self-report questionnaire at 12-weeks, 6- and 12-months 4. Healthcare resource use at 12-weeks, 6- and 12-months will be measured via self-report questionnaire. 5. Rotator cuff repair integrity (evidence of full-thickness re-tear; yes/ no) at 12-months will be assessed via diagnostic ultrasound scan 6. Number and nature of adverse events at 12-weeks, 6- and 12-months will be measured via self-report questionnaire and clinician report. 7. Self-report time out of sling, measured in hours, over 4 weeks post-surgery via self-report diary. |
| Overall study start date | 01/09/2022 |
| Overall study end date | 30/04/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 638; UK Sample Size: 638 |
| Participant inclusion criteria | 1. Adults awaiting arthroscopic surgical repair of a full thickness tear of their shoulder rotator cuff, of any size 2. Able to return (remote or in-person consultation) to the recruiting centre or affiliated site for rehabilitation supported by a physiotherapist trained to deliver the study interventions |
| Participant exclusion criteria | 1. No full thickness tear at surgery and/or arthroscopic repair not undertaken 2. Unable to provide informed consent 3. Patients taking part in another research study that mandates the post-operative rehabilitation pathway. |
| Recruitment start date | 01/06/2023 |
| Recruitment end date | 30/09/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Bristol Road South
Northfield
Birmingham
B31 2AP
United Kingdom
Steeton
Keighley
BD20 6TD
United Kingdom
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Acre Street
Lindley
Huddersfield
HD3 3EA
United Kingdom
Cumberland Infirmary
Infirmary Street
Carlisle
CA2 7HY
United Kingdom
Heath Road
Ipswich
IP4 5PD
United Kingdom
Mansfield Road
Sutton-in-ashfield
NG17 4JL
United Kingdom
Stoke-on-trent
ST4 6QG
United Kingdom
Ethelbert Road
Canterbury
CT1 3NG
United Kingdom
Kingston upon Thames
KT2 7QB
United Kingdom
Calow
Chesterfield
S44 5BL
United Kingdom
Lovely Lane
Warrington
WA5 1QG
United Kingdom
Gorleston
Great Yarmouth
NR31 6LA
United Kingdom
Derby Road
Nottingham
NG7 2UH
United Kingdom
Harrogate District Hospital
Lancaster Park Road
Harrogate
HG2 7SX
United Kingdom
London
E9 6SR
United Kingdom
80 Newark Street
London
E1 2ES
United Kingdom
Barrack Road
Exeter
EX2 5DW
United Kingdom
Sandford Road
Cheltenham
GL53 7AN
United Kingdom
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
London Road
Reading
RG1 5AN
United Kingdom
Cranmer Terrace
London
SW17 0RE
United Kingdom
Aberford Road
Wakefield
WF1 4DG
United Kingdom
Llanfrechfa Grange
Cwmbran
NP44 8YN
United Kingdom
Rotherham
S60 2UD
United Kingdom
Coreys Mill Lane
Stevenage
SG1 4AB
United Kingdom
2 Eday Road
Aberdeen
AB15 6RE
United Kingdom
Heol Cropin
Dafen Industrial Estate, Dafen
Llanelli
SA14 8QW
United Kingdom
Sponsor information
Hospital/treatment centre
Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
England
United Kingdom
| Phone | +44 1332 724710 |
|---|---|
| uhdb.sponsor@nhs.net | |
| Website | https://www.uhdb.nhs.uk/research |
"ROR" |
https://ror.org/04w8sxm43 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/04/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high impact, peer-reviewed journal, presentation at relevant clinical conferences and publication of materials in multimedia formats for the wider public. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 2.2 | 14/04/2023 | 31/07/2023 | No | No |
| HRA research summary | 20/09/2023 | No | No | ||
| Protocol file | version 2.4 | 09/05/2024 | 22/08/2024 | No | No |
| Protocol file | version 3.0 | 05/03/2025 | 03/04/2025 | No | No |
Additional files
Editorial Notes
03/04/2025: The following changes were made to the trial record:
1. Uploaded protocol v3.0 (not peer-reviewed) as an additional file.
2. The recruitment end date was changed from 31/05/2025 to 30/09/2025.
3. Contact details updated.
4. The study participating centres East and North Hertfordshire NHS Trust, NHS Grampian, Hywel Dda University Health Board were added.
22/08/2024: The following changes were made to the trial record:
1. The interventions were changed.
2. Uploaded protocol v2.4 (not peer-reviewed) as an additional file.
3. The study participating centres Royal Devon University Healthcare Foundation Trust
(Royal Devon and Exeter Hospital), Gloucestershire Hospitals NHS Trust, University Hospitals Coventry and Warwickshire NHS Trust, Newcastle upon Tyne Hospitals NHS Foundation Trust, Royal Berkshire NHS Foundation Trust, St George's University Hospital NHS FT , Mid Yorkshire Teaching NHS Trust, Aneurin Bevan UHB, The Rotherham NHS Foundation Trust were added.
05/01/2024: Nottingham University Hospitals, Harrogate & District NHS Foundation Trust, Homerton Healthcare NHS Foundation Trust and Barts Health NHS Trust have been added to the study participating centres.
03/10/2023: The study participating centres University Hospitals of North Midlands NHS Trust, East Kent Hospitals University NHS Foundation Trust, Kingston Hospital, Chesterfield Royal Hospital NHS Foundation Trust, Warrington and Halton Teaching Hospitals NHS Foundation Trust, James Paget University Hospital.
20/09/2023: A link to the HRA research summary was added.
31/07/2023: The following changes have been made:
1. Protocol file uploaded.
2. University Hospitals of Derby and Burton NHS Foundation Trust, Royal Orthopaedic Hospital, Airedale General Hospital, University Hospitals of Leicester NHS Trust, Calderdale and Huddersfield NHS Foundation Trust, North Cumbria Integrated Care NHS Foundation Trust, East Suffolk and North Essex NHS Foundation Trust and Sherwood Forest Hospitals NHS Foundation Trust have been added to the study participating centres and Derby Clinical Trials Support Unit (DCTSU) removed.
14/04/2023: The ethics approval date has been added.
28/03/2023: The plain English summary has been updated.
13/03/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
