Efficacy of Shoulder Mobilisation Versus Conventional Immobilisation for Nonsurgically Proximal Humerus Fracture
- Conditions
- Shoulder Fracture
- Registration Number
- NCT00326794
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
Background: Nonsurgical proximal humerus fracture is common, causing prolonged disability, for which the time to begin rehabilitation is not well determined. We assessed the feasibility and efficacy of early (within 3 days'after fracture) mobilisation of the shoulder compared with conventional 3-week immobilization followed by physiotherapy.
- Detailed Description
Methods: We randomly assigned 74 patients with impacted nonsurgically treated proximal humerus fracture to receive early passive mobilisation or conventional-treatment. The primary outcome was functional assessment of the shoulder (Constant score) at 3 months. Secondary outcomes were functional assessment at 6 weeks and at 6 months, change in pain (on a visual analogue scale) and passive range of motion.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 76
- Impacted nonsurgically treated proximal humerus fracture
- Patients over the age 20
- Pre-existing shoulder pathology
- Neurological disorders of the upper limbs
- Indication for surgery of the shoulder
- Combined polytrauma
- Difficulties with language or comprehension to understand a rehabilitation program and information
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The primary outcome was functional assessment of the shoulder (Constant score) at 3 months.
- Secondary Outcome Measures
Name Time Method Functional assessment at 6 weeks and at 6 months Change in pain (on a visual analogue scale)at 6 weeks, 3 months and at 6 months Passive range of motion at 6 weeks, 3 months and at 6 months.
Trial Locations
- Locations (1)
Hopital Cochin
🇫🇷Paris, France