Randomised evaluation of rehabilitation after acute proximal humerus (shoulder) fracture: the REACH study
ISRCTN | ISRCTN11914287 |
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DOI | https://doi.org/10.1186/ISRCTN11914287 |
IRAS number | 345581 |
Secondary identifying numbers | CPMS 63906, IRAS 345581, NIHR153139 |
- Submission date
- 09/09/2024
- Registration date
- 08/10/2024
- Last edited
- 01/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
A break (fracture) to the bone of the upper arm at the shoulder (proximal humerus) is a painful injury. It results in a sudden loss of use of the arm with recovery taking many months. Most injuries occur in people over 50 years of age after a fall, due to reduced bone strength, and are usually treated with a sling, although some fractures may need surgery.
At the moment, people are asked to see a physiotherapist a number of times to help with recovery after a proximal humerus fracture. Attending physiotherapy appointments can however be very difficult, especially for people who live alone or have poor social support networks. Driving is not possible and public transport is a struggle due to low confidence after a fall. A one-off advice session, with clear verbal and written instructions and videos of exercises patients can do at home, could be an alternative to attending a physiotherapy clinic for multiple sessions. Providing high-quality advice so people can manage their own recovery could be less of a burden for patients and their carers who might use fewer healthcare resources.
Before widely using an alternative advice approach, it is important to know that people receiving a one-off advice session would not be disadvantaged in their recovery compared with people having a series of physiotherapy appointments.
The REACH trial aims to find out the best way to support recovery and will compare the recovery of patients who receive a single advice session with a health professional and access to a workbook and videos to use at home, with the recovery of patients who are referred to see a physiotherapist
Who can participate?
People aged 16 years or above with a broken shoulder.
What does the study involve?
The two rehabilitation programmes in this study are referral for physiotherapist-supervised rehabilitation or self-directed rehabilitation. Participants allocated to self-directed rehabilitation will get detailed advice from a trained health professional in the hospital and will be provided with a workbook and access to a website with exercises that can be completed at home. Participants will be asked to complete follow-up questionnaires 2, 4 and 6 months after joining the study.
What are the possible benefits and risks of participating?
People are unlikely to be harmed by the rehabilitation programmes. The NHS already uses these types of advice and exercises for people with broken bones. Patients may feel some soreness in their shoulder after exercises but will be given advice on how to manage it. Participants may not benefit just from taking part in the study, but the results will help people who break their shoulder have a clear best pathway to recovery. Doctors and physiotherapists will use the information from this study to help treat people with broken shoulders in the future.
Where is the study run from?
The study is sponsored by the University of Exeter and run by the University of Oxford (UK)
When is the study starting and how long is it expected to run for?
October 2023 to August 2027
Who is funding the study?
National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (UK)
Who is the main contact?
Kylea Draper, reach@ndorms.ox.ac.uk
Contact information
Scientific
Medical School Building, St Luke’s Campus, Heavitree Road
Exeter
EX1 2LU
United Kingdom
0000-0001-7249-6496 | |
Phone | +44 (0)1865 223126 |
d.keene@exeter.ac.uk |
Public
University of Oxford - NDORMS
Kadoorie Centre
Level 3, John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
Phone | +44 (0)1865 223126 |
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reach@ndorms.ox.ac.uk |
Study information
Study design | Interventional randomized controlled trial |
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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 contact details to request a participant information sheet |
Scientific title | Randomised evaluation of rehabilitation after acute proximal humerus fracture (REACH): a multi-centre, non-inferiority, randomised trial to compare the clinical and cost-effectiveness of a self-directed rehabilitation programme versus physiotherapist-supervised rehabilitation (usual care) for adults with a proximal humerus fracture |
Study acronym | REACH |
Study hypothesis | The aim of the REACH trial is to compare the clinical and cost-effectiveness of a self-directed rehabilitation programme versus physiotherapist-supervised rehabilitation (usual care) for adults with non-surgically managed proximal humerus fractures. |
Ethics approval(s) |
Approved 05/09/2024, London - Chelsea Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8156; chelsea.rec@hra.nhs.uk), ref: 24/LO/0605 |
Condition | Proximal humerus fracture |
Intervention | Participants will be randomised by the local research team using a web-based service. The randomisation will be on a 1:1 basis to one of the following groups: Self-directed rehabilitation (provision of high-quality self-management advice): Participants allocated to this group will receive detailed advice by a health professional and a workbook and website with a set of exercises that can be progressed independently. Physiotherapist-supervised rehabilitation (usual care): Participants allocated to this group will receive usual fracture clinic advice and a referral to physiotherapy. Participants will be asked to complete follow-up questionnaires 2, 4 and 6 months after joining the study. |
Intervention type | Behavioural |
Primary outcome measure | Patient-reported shoulder-related pain and function measured by the Oxford Shoulder Score (OSS) at 6 months post-randomisation |
Secondary outcome measures | 1. Patient-reported shoulder-related pain and function measured by the Oxford Shoulder Score (OSS) at 2 and 4 months post-randomisation 2. Upper extremity physical function is measured using the Patient Reported Outcome Measurement Information System (PROMIS) Physical Function (Upper Extremity) at 2, 4 and 6 months post-randomisation 3. Health-related quality of life is measured using EuroQol 5 Dimensions EQ 5D-5L at 2, 4 and 6 months post-randomisation 4. Self-efficacy to exercise is measured using Self-Efficacy to Exercise Scale (SEE) at 2, 4 and 6 months post-randomisation 5. Resource use is measured by self-reported bespoke questionnaire at 2, 4 and 6 months post-randomisation 6. Rates of complications are measured using a bespoke participant questionnaire and site-completed Case Report Forms up to 6 months |
Overall study start date | 01/10/2023 |
Overall study end date | 31/08/2027 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 16 Years |
Sex | Both |
Target number of participants | Planned Sample Size: 1214; UK Sample Size: 1214 |
Participant inclusion criteria | 1. Aged 16 years or over 2. Diagnosis of a proximal humerus fracture which is to be managed non-surgically |
Participant exclusion criteria | 1. Patient has a concurrent neurological injury leading to a significant deficit in the affected arm 2. More than 21 days have elapsed since the fracture 3. Patient has other upper limb injury which may reasonably be expected to impact shoulder rehabilitation and affect responses to patient-reported outcome measures 4. Patient is unable to adhere to the trial procedures. |
Recruitment start date | 31/10/2024 |
Recruitment end date | 31/10/2026 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
80 Newark Street
London
E1 2ES
United Kingdom
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Skipton Road
Steeton
Keighley
BD20 6TD
United Kingdom
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Pensnett Road
Dudley
DY1 2HQ
United Kingdom
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
London Road
Reading
RG1 5AN
United Kingdom
Kayll Road
Sunderland
SR4 7TP
United Kingdom
East Surrey Hospital
Canada Avenue
Redhill
RH1 5RH
United Kingdom
Hardwick Lane
Bury St. Edmunds
IP33 2QZ
United Kingdom
Stirling
FK8 1DX
United Kingdom
Oxford Road
Manchester
M13 9WL
United Kingdom
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
St Marys Hospital
South Wharf Road
London
W2 1BL
United Kingdom
Bath
BA1 3NG
United Kingdom
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
Kettering
NN16 8UZ
United Kingdom
Colney
Norwich
NR4 7UY
United Kingdom
Barrack Road
Exeter
EX2 5DW
United Kingdom
Holdforth Road
Hartlepool
TS24 9AH
United Kingdom
Harlow
CM20 1QX
United Kingdom
Wrexham Technology Park
Wrexham
LL13 7TD
United Kingdom
London
SE5 9RS
United Kingdom
Wigan
WN1 2NN
United Kingdom
Sponsor information
University/education
Stocker Road
Exeter
EX4 4PY
England
United Kingdom
Phone | +44 (0)1392 726621 |
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res-sponsor@exeter.ac.uk | |
Website | http://www.exeter.ac.uk/ |
https://ror.org/03yghzc09 |
Funders
Funder type
Government
No information available
Results and Publications
Intention to publish date | 30/08/2028 |
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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 peer-reviewed journal |
IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Editorial Notes
01/04/2025: The study participating centres were updated to remove South Tees NHS Foundation Trust and add Princess Alexandra Hospital, Wrexham Maelor Hospital, King's College Hospital, and Royal Albert Edward Infirmary.
Royal Albert Edward Infirmary
09/09/2024: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).