Randomised evaluation of rehabilitation after acute proximal humerus (shoulder) fracture: the REACH study

ISRCTN ISRCTN11914287
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Dr David Keene
Scientific

Medical School Building, St Luke’s Campus, Heavitree Road
Exeter
EX1 2LU
United Kingdom

ORCiD logoORCID ID 0000-0001-7249-6496
Phone +44 (0)1865 223126
Email d.keene@exeter.ac.uk
Mrs Kylea Draper
Public

University of Oxford - NDORMS
Kadoorie Centre
Level 3, John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom

Phone +44 (0)1865 223126
Email reach@ndorms.ox.ac.uk

Study information

Study designInterventional randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format. Please use contact details to request a participant information sheet
Scientific titleRandomised 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 acronymREACH
Study hypothesisThe 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

ConditionProximal humerus fracture
InterventionParticipants 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 typeBehavioural
Primary outcome measurePatient-reported shoulder-related pain and function measured by the Oxford Shoulder Score (OSS) at 6 months post-randomisation
Secondary outcome measures1. 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 date01/10/2023
Overall study end date31/08/2027

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit16 Years
SexBoth
Target number of participantsPlanned Sample Size: 1214; UK Sample Size: 1214
Participant inclusion criteria1. Aged 16 years or over
2. Diagnosis of a proximal humerus fracture which is to be managed non-surgically
Participant exclusion criteria1. 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 date31/10/2024
Recruitment end date31/10/2026

Locations

Countries of recruitment

  • England
  • Scotland
  • United Kingdom
  • Wales

Study participating centres

Nottingham University Hospitals NHS Trust
Trust Headquarters
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
Barts Health NHS Trust
The Royal London Hospital
80 Newark Street
London
E1 2ES
United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge Biomedical Campus
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Airedale NHS Foundation Trust
Airedale General Hospital
Skipton Road
Steeton
Keighley
BD20 6TD
United Kingdom
University Hospitals of Leicester NHS Trust
Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom
The Dudley Group NHS Foundation Trust
Russells Hall Hospital
Pensnett Road
Dudley
DY1 2HQ
United Kingdom
Milton Keynes University Hospital NHS Foundation Trust
Standing Way
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
Royal Berkshire NHS Foundation Trust
Royal Berkshire Hospital
London Road
Reading
RG1 5AN
United Kingdom
South Tyneside and Sunderland NHS Foundation Trust
Sunderland Royal Hospital
Kayll Road
Sunderland
SR4 7TP
United Kingdom
Surrey and Sussex Healthcare NHS Trust
Trust Headquarters
East Surrey Hospital
Canada Avenue
Redhill
RH1 5RH
United Kingdom
West Suffolk NHS Foundation Trust
West Suffolk Hospital
Hardwick Lane
Bury St. Edmunds
IP33 2QZ
United Kingdom
NHS Forth Valley
33 Spittal Street
Stirling
FK8 1DX
United Kingdom
Manchester University NHS Foundation Trust
Cobbett House
Oxford Road
Manchester
M13 9WL
United Kingdom
Oxford University Hospitals NHS Foundation Trust
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Imperial College Healthcare NHS Trust
The Bays
St Marys Hospital
South Wharf Road
London
W2 1BL
United Kingdom
Royal United Hospitals Bath NHS Foundation Trust
Combe Park
Bath
BA1 3NG
United Kingdom
North Bristol NHS Trust
Southmead Hospital
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
Kettering General Hospital NHS Foundation Trust
Rothwell Road
Kettering
NN16 8UZ
United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
Colney Lane
Colney
Norwich
NR4 7UY
United Kingdom
Royal Devon University Healthcare NHS Foundation Trust
Royal Devon University NHS Ft
Barrack Road
Exeter
EX2 5DW
United Kingdom
North Tees and Hartlepool NHS Foundation Trust
University Hospital of Hartlepool
Holdforth Road
Hartlepool
TS24 9AH
United Kingdom
Princess Alexandra Hospital
Hamstel Road
Harlow
CM20 1QX
United Kingdom
Wrexham Maelor Hospital
Croesnewydd Road
Wrexham Technology Park
Wrexham
LL13 7TD
United Kingdom
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
Royal Albert Edward Infirmary
Wigan Lane
Wigan
WN1 2NN
United Kingdom

Sponsor information

University of Exeter
University/education

Stocker Road
Exeter
EX4 4PY
England
United Kingdom

Phone +44 (0)1392 726621
Email res-sponsor@exeter.ac.uk
Website http://www.exeter.ac.uk/
ROR logo "ROR" https://ror.org/03yghzc09

Funders

Funder type

Government

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC)

No information available

Results and Publications

Intention to publish date30/08/2028
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a peer-reviewed journal
IPD sharing planThe 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).