Looking at rehabilitation methods for patients with a proximal humerus fracture
Eligibility
Local study conflicts
- Cannot be co-enrolled to any other study which is looking at upper limb outcomes
Inclusion Criteria:
- Aged 16 years or over
- Has a diagnosis of a proximal humerus fracture which is to be managed non-surgically
- Participant is within 21 days of injury
Exclusion Criteria:
- Has a concurrent neurological injury leading to a significant deficit in the affected arm
- More than 21 days have elapsed since the fracture
- Other upper limb injury which may reasonably be expected to impact shoulder rehabilitation and affect responses to patient-reported outcome measures
- Is unable to adhere to the trial procedures
If the patient is eligible:
- Inform the patient that they may be eligible for a research study
- Gain verbal agreement in principle before proceeding. Explain:
- Taking part in research is likely to improve the quality of their care
- Risks are carefully controlled - research is safe
- Explain the uncertainty that exists with respect to treatment of their condition
- If they change their mind they can withdraw their participation at any point
Step-by-Step Guide to Recruitment:
In standard working hours
- The research nurse team aims to be available Monday to Friday 08.00 - 16.00.
- Contact them via Secure Chat: Research Delivery Team
Confirming eligibility
- Patients are identified via Virtual Fracture Clinic or trauma list
- Eligibility can only be confirmed by delegated personnel (including research nurses and physiotherapists). Mr Niel Kang, consultant orthopaedic / trauma surgeon, is the PI and will know which members of staff are delegated on this study.
- For stratification purposes, it needs to be recorded if this is a 2,3 or 4 part fracture. It would help the research nurses if this was documented in the medical notes
Gaining formal consent
- If eligible, Research Nurse team will approach in upper limb clinic and give PIS
- If patient is willing to participate the research nurse team will complete consent and baseline assessments
Randomisation procedure
- Research Nurse team will complete randomisation and inform clinical teams of allocation.
Carrying out the intervention:
- If randomised to self-directed physiotherapy, research nurse or other delegated staff (physiotherapists) will provide trial specific information booklet and complete initial education programme with participant immediately following randomisation
- If randomised to supervised physiotherapy, research nurse will complete referral as per standard care
Disposition and follow-up:
- Follow-up questionnaires will be completed with the patient by the central team
- Physiotherapy and any follow-up clinic appointments to be arranged as standard care
Links for further information:
Patient video animation available at https://reach.octru.ox.ac.uk/
Tap the buttons below to show/hide a QR code link to the patient information video, or go to the site:
