Proximal humerus fracture Musculoskeletal Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 16 years or over 2. Diagnosis of a proximal humerus fracture which is to be managed non-surgically
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient-reported shoulder-related pain and function measured by the Oxford Shoulder Score (OSS) at 6 months post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, Scotland, United Kingdom, Wales