A study comparing two types of physiotherapy after traumatic elbow injury
| ISRCTN | ISRCTN54593106 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54593106 |
| Integrated Research Application System (IRAS) | 366127 |
| Protocol serial number | 73083 |
| Sponsor | University of Oxford |
| Funder | National Institute for Health and Care Research |
- Submission date
- 19/05/2026
- Registration date
- 19/06/2026
- Last edited
- 19/06/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
Traumatic elbow injuries can lead to pain, stiffness, weakness, and difficulty returning to everyday activities. Physiotherapy rehabilitation following elbow injury varies widely, and there is limited evidence to guide the best approach to treatment. Some patients may also develop fear of movement after injury, which may affect recovery and confidence using the arm. The aim of this study is to assess whether a structured physiotherapy rehabilitation programme can be delivered successfully within the NHS and whether a larger future trial would be feasible.
Who can participate?
Adults aged 16 years and over who have sustained a traumatic bony elbow injury within the past 4 weeks may be eligible to take part. Participants will be excluded if they are unable to adhere to study procedures or if they have previously had surgery on the affected elbow.
What does the study involve?
Participants will be randomly allocated to receive either an enhanced physiotherapy rehabilitation programme or usual physiotherapy care.
Participants in the enhanced rehabilitation group will attend 4-6 physiotherapy sessions over 3 months. Treatment may include exercises and support to improve confidence moving the elbow after injury.
Participants in the usual care group will receive standard physiotherapy care routinely provided within the NHS service.
All participants will complete questionnaires and elbow movement assessments at the start of the study and again at 3 months.
What are the possible benefits and risks of participating?
Participants may benefit from physiotherapy rehabilitation and additional monitoring during recovery. The information collected may also help improve rehabilitation following elbow injury in the future.
The risks of participating are low. Some participants may experience temporary discomfort or soreness during exercises or assessments, which is common during rehabilitation after injury.
Where is the study run from?
The study is being run from the John Radcliffe Hospital and Horton General Hospital, Oxford University Hospitals NHS Foundation Trust, Oxfordshire, UK.
When is the study starting and how long is it expected to run for?
The study is expected to begin recruitment in May 2026 and run for approximately 10 months. Each participant will take part in the study for approximately 3 months.
Who is funding the study?
The study is funded by the NIHR ICA Pre-doctoral Clinical and Practitioner Academic Fellowship programme.
Who is the main contact?
Mrs Georgina Wistow, Georgie.lucas@ndorms.ox.ac.uk
Professor Karen Barker, Karen.barker@ndorms.ox.ac.uk
Contact information
Scientific, Public
Physiotherapy Research Unit, Nuffield Orthopaedic Centre
Windmill Road, Headington
Oxford
OX3 7HE
United Kingdom
 ORCID ID |
0009-0009-4080-7187 |
|---|---|
| Phone | +44 1865 737526 |
| georgie.lucas@ndorms.ox.ac.uk |
Principal investigator
Physiotherapy Research Unit, Nuffield Orthopaedic Centre
Windmill Road, Headington
Oxford
OX3 7HE
United Kingdom
| ORCID ID |
0000-0001-9363-0383 |
|---|---|
| Phone | +44 1865 738080 |
| karen.barker@ndorms.ox.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Feasibility study |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | 49565 Participant Information Sheet V3 01May2026.pdf |
| Scientific title | Physiotherapy Rehabilitation Intervention Managing Elbow - Post-Trauma |
| Study acronym | PRIME-PT |
| Study objectives | 1. To assess the willingness to be randomised - proportion of eligible patients approached who are randomised 2. To assess the recruitment rate - number of participants recruited per month per site 3. To assess the intervention adherence - proportion of participants allocated to “supervised rehabilitation” attending up to 6 physiotherapy sessions, completed patient exercise diary 4. To assess the retention - proportion of participants that complete Oxford Elbow Score at 3 months post randomisation |
| Ethics approval(s) |
Approved 07/04/2026, Yorkshire & The Humber - Leeds West Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, United Kingdom; +44 207 104 8241; leedswest.rec@hra.nhs.uk), ref: 26/YH/0060 |
| Health condition(s) or problem(s) studied | Traumatic elbow injuries |
| Intervention | Participants will be randomised in a 2:1 ratio to either an enhanced physiotherapy rehabilitation intervention or usual care using sequentially numbered, opaque, sealed envelopes prepared in advance according to a computer-generated randomisation sequence. Intervention arm: Participants allocated to the intervention group will receive 4-6 physiotherapy sessions over a 3-month period. Treatment will include range-of-movement exercises, strengthening, functional rehabilitation, education and reassurance, and graded exposure to movement to address fear of movement following injury. Exercise programmes will be individualised according to the patient’s presentation and stage of recovery. Usual care arm: Participants allocated to the usual care group will receive standard physiotherapy management routinely delivered within the NHS service, typically consisting of an initial assessment and one follow-up appointment. All participants will complete a follow-up assessment at 3 months post-randomisation, including questionnaires and elbow range-of-movement assessment. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 01/03/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Upper age limit | 110 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Key inclusion criteria | 1. Aged 16 or older 2. Had a bony elbow injury (e.g. simple dislocation, fracture dislocation, olecranon fracture, radial head fracture, distal humeral fracture) within the past 4 weeks |
| Key exclusion criteria | 1. Contraindication to participation in the study intervention 2. Previous surgery on the affected elbow 3. Unable to adhere to study procedures |
| Date of first enrolment | 01/05/2026 |
| Date of final enrolment | 01/03/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Headington
Oxford
OX3 9DU
England
Banbury
OX16 9AL
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan | Individual participant data will not be routinely shared but may be made available upon reasonable request, subject to appropriate approvals and data sharing agreements. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 3 | 01/05/2026 | 22/05/2026 | No | Yes |
Additional files
- 49565 Participant Information Sheet V3 01May2026.pdf
- Participant information sheet
Editorial Notes
22/05/2026: Trial's existence confirmed by Yorkshire & The Humber - Leeds West Research Ethics Committee.
