Efficacy of Shoulder Mobilisation Versus Conventional Immobilisation for Nonsurgically Proximal Humerus Fracture
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||Effectiveness at 3 Months of Immediate Shoulder Mobilisation Versus Conventional Immobilisation for Impacted Nonsurgically Treated Proximal Humerus Fracture: a Randomised Controlled Trial.|
- The primary outcome was functional assessment of the shoulder (Constant score) at 3 months.
- 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.
|Study Start Date:||October 2002|
|Estimated Study Completion Date:||September 2005|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00326794
|Paris, France, 75014|
|Principal Investigator:||Marie-Martine Lefevre-colau, MDPhD||APHP|