Randomised evaluation of rehabilitation after acute proximal humerus (shoulder) fracture: the REACH study
| ISRCTN | ISRCTN11914287 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11914287 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 345581 |
| Protocol serial number | CPMS 63906, NIHR153139 |
| Sponsor | University of Exeter |
| Funder | NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC) |
- Submission date
- 09/09/2024
- Registration date
- 08/10/2024
- Last edited
- 02/12/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
University of Oxford - NDORMS, Kadoorie Centre, Level 3, John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
 ORCID ID |
0000-0001-7249-6496 |
|---|---|
| Phone | +44 (0)1865 223126 |
| david.keene@ndorms.ox.ac.uk |
Public
University of Oxford - NDORMS
Kadoorie Centre
Level 3, John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
| Phone | +44 (0)1865 223126 |
|---|---|
| reach@ndorms.ox.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | 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 objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
Patient-reported shoulder-related pain and function measured by the Oxford Shoulder Score (OSS) at 6 months post-randomisation |
| Key secondary outcome measure(s) |
1. Patient-reported shoulder-related pain and function measured by the Oxford Shoulder Score (OSS) at 2 and 4 months post-randomisation |
| Completion date | 31/08/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 1214 |
| Key inclusion criteria | 1. Aged 16 years or over 2. Diagnosis of a proximal humerus fracture which is to be managed non-surgically |
| Key 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. |
| Date of first enrolment | 12/12/2024 |
| Date of final enrolment | 12/12/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
- Scotland
- Wales
Study participating centres
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
England
80 Newark Street
London
E1 2ES
England
Hills Road
Cambridge
CB2 0QQ
England
Skipton Road
Steeton
Keighley
BD20 6TD
England
Infirmary Square
Leicester
LE1 5WW
England
Pensnett Road
Dudley
DY1 2HQ
England
Eaglestone
Milton Keynes
MK6 5LD
England
London Road
Reading
RG1 5AN
England
Kayll Road
Sunderland
SR4 7TP
England
East Surrey Hospital
Canada Avenue
Redhill
RH1 5RH
England
Hardwick Lane
Bury St. Edmunds
IP33 2QZ
England
Stirling
FK8 1DX
Scotland
Oxford Road
Manchester
M13 9WL
England
Headley Way
Headington
Oxford
OX3 9DU
England
St Marys Hospital
South Wharf Road
London
W2 1BL
England
Bath
BA1 3NG
England
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
England
Kettering
NN16 8UZ
England
Colney
Norwich
NR4 7UY
England
Barrack Road
Exeter
EX2 5DW
England
Holdforth Road
Hartlepool
TS24 9AH
England
Harlow
CM20 1QX
England
Wrexham Technology Park
Wrexham
LL13 7TD
Wales
London
SE5 9RS
England
Wigan
WN1 2NN
England
Torquay
TQ2 7AA
England
Farnworth
Bolton
BL4 0JR
England
Lewisham High Street
London
SE13 6LH
England
Lyndhurst Road
Worthing
BN11 2DH
England
Stirling
FK9 4SW
Scotland
Barrack Road
Exeter
EX2 5DW
England
Bretton Gate
Bretton
Peterborough
PE3 9GZ
England
Aldermaston Road
Basingstoke
RG24 9NA
England
Dunfermline
KY12 0SU
Scotland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/12/2025: The study participating centres were updated.
01/10/2025: The study participating centres were updated.
01/07/2025: The following changes were made:
1. A study contact was updated.
2. The date of first enrolment was changed from 31/10/2024 to 12/12/2024.
3. The date of final enrolment was changed from 31/10/2026 to 12/12/2026.
4. The study participating centres, Torbay Hospital and The Royal Bolton Hospital, were added.
5. A link was added for the participant information sheet.
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).
